A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.

• Sponsor: Celgene (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02185040
• Collaborator: (none)
• Enrollment: 42
• Locations: 35
• Arms: 5
• Actual Duration (Months): 48.3
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether CC-220 is effective for the treatment of skin, joint and serological manifestations of systemic lupus erythematosus.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: CC-220; Drug: CC-220; Drug: CC-220; Drug: CC-220; Drug: Placebo	Phase 2

Detailed Description

The study consists of 2 parts. Part 1 is a randomized, double-blind, placebo controlled, ascending dose study to evaluate the safety and tolerability of CC-220 in SLE subjects.

Subject participation in Part 1 consists of 3 phases:

• Pre-treatment Screening Phase: up to 28 days prior to the first dose of the investigational product (IP)

• Treatment Phase: up to 84 days

• Observation Phase: 84 day post-treatment A total of approximately 40 subjects will be randomized into 4 dose groups with a 4:1 ratio of CC-220 (0.3 mg every other day [QOD], 0.3 mg everyday [QD], 0.6 mg and 0.3 mg on alternating days, and 0.6 mg QD) or matching placebo. In each dosing arm, 8 subjects will receive active drug and 2 subjects will receive placebo. The Treatment Phase will be up to 84 days in duration for all dose groups. Subjects who discontinue IP early and all subjects who complete the 84 day treatment phase will enter into the Observational Follow-up Phase for an 84 day period. A subject will be permitted to reduce their dose one time during Part 1 of the study.

Part 2 is the Active Treatment Extension Phase (ATEP) which is an extension to evaluate the long-term efficacy and safety/tolerability of CC-220 in SLE subjects who completed Part 1 of the study. Subjects who complete the Treatment Phase of Part 1 of the study will be eligible to receive CC-220 in the ATEP for up to 2 years. All subjects who participate in the ATEP will receive either 0.3 mg QD or 0.6 mg and 0.3 mg QD on alternating days. Subjects who terminate the Treatment Phase of Part 1 early will not be eligible for entry into the ATEP.

Subject participation consists of two phases:

• Active Treatment Extension Phase: Up to 2 years

• Observational Follow-up Phase: One month

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus Erythematosus
• Actual Study Start Date: Sep 16, 2014
• Actual Primary Completion Date: Sep 25, 2018
• Actual Study Completion Date: Sep 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CC-220 0.3mg Every Other Day (QOD) Part 1: CC-220 0.3mg capsules by mouth every other day (QOD)	Drug: CC-220; 0.3 mg oral capsules once every other day with or without food
Experimental: CC-220 0.3mg Every Day (QD) Part 1: CC-220 0.3mg capsules by mouth every day (QD) ATEP: CC-220 0.3 mg capsules by mouth every day (QD)	Drug: CC-220; Subjects will receive 0.3 mg oral capsules every day with or without food
Experimental: CC-220 0.6mg/0.3mg alternating dose QD Part 1: CC-220 0.6 mg and 0.3mg capsules PO on alternating days ATEP:CC-220 0.6 mg and 0.3 mg capsules PO on alternating days	Drug: CC-220; CC-220 oral capsules 0.6 mg and 0.3 mg on alternating days with or without food
Experimental: CC-220 0.6mg QD Part 1: CC-220 0.6mg capsules by mouth QD	Drug: CC-220; CC-220 oral capsule 0.6 mg QD with or without food
Placebo Comparator: Placebo QD Part 1: Identically matching placebo capsules PO QD	Drug: Placebo; Matching oral placebo daily

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase [From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts.]

   A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.

2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase [From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.]

   A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.

Secondary Outcome Measures

1. Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide [Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.]

   The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.

2. Maximum Observed Concentration (Cmax) Of Iberdomide [Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.]

   Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.

3. Time to Reach Maximum Concentration (Tmax) of Iberdomide [Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.]

   Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.

4. Terminal Phase Half-Life (T1/2) Of Iberdomide [Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.]

   Terminal phase half-life in plasma, calculated as [(In 2)/λz]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.

5. Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

   The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.

6. Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

   The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.

7. Change From Baseline in Swollen Joint Count During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

   Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.

8. Change From Baseline in Tender Joint Count During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

   Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.

9. Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

   The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.

10. Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

    The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none 1 = mild disease 2 = moderate disease 3 = severe disease

11. Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

    The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).

12. Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

    The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.

13. Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

    The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an "X" representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement.

14. Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

    The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.

15. Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point [Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.]

    SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Part 1

• The subject has an established diagnosis of systemic lupus erythematosus (SLE) as defined by the 1997 Update of the 1982 ACR Revised Criteria for Classification of SLE at screening. The diagnosis is fulfilled provided that at least 4 criteria are met.

• Disease history of SLE ≥ 6 months at baseline

• Females of childbearing potential (FCBP) must:

• Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.

• Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.

• Male subjects must:

• Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy.

• If the subject is using oral corticosteroids, the daily dose must be less than or equal to 10 mg of prednisone or equivalent during the study; the dose must be stable over the 4 weeks preceding screening and throughout the study.

• All subjects taking hydroxychloroquine, chloroquine and/or quinacrine during the study must have documentation of a normal ophthalmologic examination performed within 1 year of the Baseline Visit.

• For subjects not taking corticosteroids, or antimalarials, the last dose (in case of previous use) must be at least 4 weeks prior to screening.

ATEP

• Male or female 18 years of age or older

• Understand and voluntarily sign an ICD prior to the initiation of any study related assessments/procedures

• Able to adhere to the study visit schedule and other protocol requirements. Pregnancy

• Females of childbearing potential (FCBP) must:

• Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.

• Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.

• Male subjects must:

• Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)

• Male subjects must agree not to donate semen or sperm during therapy and for at least 90 days following the discontinuation of IP.

• All subjects must:

• Understand that the IP could have potential teratogenic risk

• Agree to abstain from donating blood while taking IP and for 28 days following discontinuation of the IP

• Agree not to share IP with another person

• Other than the subject, FCBP and males able to father a child should not handle the IP or touch the capsules unless gloves are worn

• Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan. Concomitant Medications

• If the subject is using oral corticosteroids, the daily dose must be less than or equal to 10 mg of prednisone or equivalent during the study; the dose must be stable over the 4 weeks preceding randomization and throughout the study.

• All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of a normal ophthalmologic examination performed within 1 year of the Baseline Visit.

• For subjects not taking corticosteroids the last dose (in case of previous use) must be at least 4 weeks prior to screening.

Exclusion Criteria

• The subject has been treated with intra-articular, intramuscular or IV pulse corticosteroids within 4 weeks of screening.

• The subject has received high dose oral prednisone (> 100 mg/day) within 4 weeks of screening.

• The subject has received cyclophosphamide, azathioprine or mycophenolate mofetil within 12 weeks of screening.

• The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 pharmacokinetic half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to screening; OR participation in two or more investigational drug trials within 12 months of screening.

• Unstable lupus nephritis defined as: proteinuria > 1.0 g/24 hour /1.73 m2 OR eGFR of less than 60 mL/1.73 m2 CNS disease, including active severe CNS lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), cerebritis or CNS vasculitis) requiring therapeutic intervention within 6 months of screening.

• The subject has New York Heart Association (NYHA) Class III or IV congestive heart failure.

• Presence of hepatitis B surface antigen (HBsAG). Subjects may have a positive anti-hepatitis B core antibody (anti-HBc) if the anti-hepatitis B surface antibody (anti-HBs) is positive as well.

• Antibodies to hepatitis C at Screening.

• The subject has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease or acquired immune deficiency syndrome (AIDs).

• Has a history of an organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.

• Malignancy or history of malignancy, except for:

• treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;

• treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of Screening

• Systemic bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 2 weeks prior to Screening and no new or recurrent infections prior to the Baseline visit.

• History of venous thrombosis or any thromboembolic events within 2 years of screening.

• Clinical evidence of significant unstable or uncontrolled acute or chronic disease not due to SLE (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, psychiatric or infectious disease) which in the opinion of the investigator could put the subject at undue risk or confound study results.

• Presence of active uveitis or any other clinically significant ophthalmological finding.

• History or current diagnosis of peripheral or radicular neuropathy. Any clinically significant abnormalities on ECG, which, in the opinion of the investigator would interfere with safe participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Arizona Arthritis and Rheumatology Research, PLLC	Paradise Valley	Arizona	United States	85253
3	University of Arizona Clinical and Translational Science Research Center	Tucson	Arizona	United States	85724
4	UCSD Center for Innovative Therapy	La Jolla	California	United States	92037
5	Dermatology Research Associates	Los Angeles	California	United States	90045
6	East Bay Rheumatology Medical Group Inc.	San Leandro	California	United States	94578
7	Clinical Science Institute	Santa Monica	California	United States	90404
8	Los Angeles Biomedical Research Institute at Harbor - UCLA	Torrance	California	United States	90502
9	Inland Rheumatology Clinical Trials	Upland	California	United States	91786
10	Vipul Joshi, MD, PA, dba Bay Area Arthritis and Osteoporosis	Brandon	Florida	United States	33511
11	Emory University School of Medicine	Atlanta	Georgia	United States	30303
12	Advanced Medical Research	Atlanta	Georgia	United States	30342
13	Arthritis Research and Treatment Center	Stockbridge	Georgia	United States	30281
14	Northwestern Medical Group; Department of Dermatology	Chicago	Illinois	United States	60611
15	Northshore University Health System	Skokie	Illinois	United States	60077
16	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62794
17	Tulane University Health Sciences Center	New Orleans	Louisiana	United States	70112
18	Northwell Health / Division of Rheumatology	Lake Success	New York	United States	11042
19	Feinstein Institute For Medical Research	Manhasset	New York	United States	11030
20	NYU Langone Medical Center	New York	New York	United States	10016
21	Columbia Presbyterian Medical Center	New York	New York	United States	10032-370
22	Univ of Rochester Medical Center	Rochester	New York	United States	14642
23	DJL Clinical Research	Charlotte	North Carolina	United States	28210
24	MetroHealth Medical Systems	Cleveland	Ohio	United States	44109
25	Ohio State University Medical Center	Columbus	Ohio	United States	43230
26	University of Toledo Medical Center	Toledo	Ohio	United States	43614
27	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
28	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
29	University of Pennsylvania Health Systems	Philadelphia	Pennsylvania	United States	19104
30	UMPC Lupus Center of Excellence	Pittsburgh	Pennsylvania	United States	15261
31	Low Country Rheumatology PA	Charleston	South Carolina	United States	29406
32	Austin Regional Clinic	Austin	Texas	United States	78731
33	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
34	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502
35	Seattle Arthritis Clinic	Seattle	Washington	United States	98133

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Shimon Korish, M.D., Celgene

Study Documents (Full-Text)

• Study Protocol - Jun 18, 2018
• Statistical Analysis Plan: CC-220-SLE-001-SAP-Part1_Redacted25July2016 - Jul 25, 2016
• Statistical Analysis Plan: CC-220-SLE-001-ATEP.31Oct2018_Redacted - Oct 31, 2018

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT02185040
• Other Study ID Numbers: CC-220-SLE-001
• First Posted: Jul 9, 2014
• Last Update Posted: Mar 19, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Celgene: Lupus, Systemic Lupus, SLE
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

Participant Flow

Recruitment Details	The multi-center study was conducted in the United States. Forty-two participants were enrolled at 11 study sites.
Pre-assignment Detail	In part 1 of the study, participants were randomly assigned to 1 of 4 dose cohorts; within each cohort participants were randomized in a 4:1 ratio to receive iberdomide or placebo. Participants who completed the Part 1 treatment phase were eligible to receive iberdomide for up to 2 years in the active treatment extension phase (ATEP).

Arm/Group Title	Part 1: Placebo	Part 1: Iberdomide 0.3 mg QOD	Part 1: Iberdomide 0.3 mg QD	Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days	Part 1: Iberdomide 0.6 mg QD	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.	Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.	Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Period Title: Part 1 Treatment Phase
STARTED	8	8	8	9	9	0	0
COMPLETED	7	6	7	7	6	0	0
NOT COMPLETED	1	2	1	2	3	0	0
Period Title: Part 1 Treatment Phase
STARTED	0	0	0	0	0	9	8
COMPLETED	0	0	0	0	0	6	1
NOT COMPLETED	0	0	0	0	0	3	7

Baseline Characteristics

Arm/Group Title	Part 1: Placebo	Part 1: Iberdomide 0.3 mg QOD	Part 1: Iberdomide 0.3 mg QD	Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days	Part 1: Iberdomide 0.6 mg QD	Total
Arm/Group Description	Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.	Participants received 0.3 mg iberdomide capsules QD up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules QD during ATEP up to 2 years.	Participants received iberdomide 0.6 mg capsules on alternating (ALT) days with 0.3 mg iberdomide capsules on alternating days up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days during the ATEP up to 2 years.	Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.	Total of all reporting groups
Overall Participants	8	8	8	9	9	42
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	44.8 (6.58)	46.0 (8.62)	48.0 (10.85)	49.8 (13.07)	47.2 (13.56)	47.2 (10.60)
Sex: Female, Male (Count of Participants)
Female	7 87.5%	8 100%	7 87.5%	8 88.9%	9 100%	39 92.9%
Male	1 12.5%	0 0%	1 12.5%	1 11.1%	0 0%	3 7.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 37.5%	1 12.5%	1 12.5%	1 11.1%	1 11.1%	7 16.7%
Not Hispanic or Latino	5 62.5%	7 87.5%	7 87.5%	8 88.9%	8 88.9%	35 83.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 12.5%	0 0%	0 0%	0 0%	0 0%	1 2.4%
Black or African American	2 25%	2 25%	4 50%	1 11.1%	4 44.4%	13 31%
White	5 62.5%	6 75%	4 50%	7 77.8%	5 55.6%	27 64.3%
Other	0 0%	0 0%	0 0%	1 11.1%	0 0%	1 2.4%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	33.029 (5.8922)	30.119 (5.7386)	36.426 (9.9918)	27.012 (4.9291)	28.553 (8.3143)	30.873 (7.6362)
Cutaneous Lupus Area and Severity Index Activity Score (CLASI) Activity Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.3 (5.90)	17.6 (12.89)	6.3 (9.07)	8.4 (8.63)	12.4 (16.48)	9.8 (11.76)
Hybrid SELENA Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	6.8 (1.83)	8.4 (4.07)	5.5 (2.07)	6.7 (3.16)	5.7 (1.87)	6.6 (2.79)
Physician's Global Assessment (PGA) (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	0.95 (0.518)	1.50 (0.648)	1.50 (0.614)	1.22 (0.353)	1.40 (0.598)	1.31 (0.565)
Baseline Swollen Joint Count (Swollen Joints) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Swollen Joints]	4.0 (2.12)	5.2 (2.28)	7.0 (5.22)	6.3 (2.49)	4.0 (1.15)	5.5 (3.11)
Baseline Tender Joint Count (Joints) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Joints]	10.0 (7.21)	7.3 (4.97)	14.3 (9.66)	16.9 (9.09)	13.3 (11.29)	12.7 (8.90)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase
Description	A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time Frame	From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts.

Outcome Measure Data

Analysis Population Description

The safety population included all participants who were randomized and received at least 1 dose of IP. For all participants, this was the treatment group to which they were randomized.

Arm/Group Title	Part 1: Placebo	Part 1: Iberdomide 0.3 mg QOD	Part 1: Iberdomide 0.3 mg QD	Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days	Part 1: Iberdomide 0.6 mg QD
Arm/Group Description	Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.	Participants received 0.3 mg iberdomide capsules once a day for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.	Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Measure Participants	8	8	8	9	9
Any TEAE	5 62.5%	7 87.5%	7 87.5%	8 88.9%	8 88.9%
Any IP-related TEAE	1 12.5%	2 25%	2 25%	4 44.4%	6 66.7%
Any Severe TEAE	1 12.5%	0 0%	0 0%	1 11.1%	2 22.2%
Any Serious TEAE	2 25%	0 0%	0 0%	1 11.1%	1 11.1%
Any Serious IP-related TEAE	0 0%	0 0%	0 0%	0 0%	1 11.1%
Any TEAE Leading to IP Interruption	0 0%	0 0%	1 12.5%	1 11.1%	5 55.6%
Any TEAE Leading to IP Withdrawal	1 12.5%	0 0%	0 0%	2 22.2%	3 33.3%
Any TEAE Leading to Death	0 0%	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase
Description	A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time Frame	From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Any TEAE	9 112.5%	7 87.5%
Any IP-related TEAE	2 25%	5 62.5%
Any Severe TEAE	0 0%	5 62.5%
Any Serious TEAE	0 0%	4 50%
Any Serious IP-related TEAE	0 0%	0 0%
Any TEAE Leading to IP Interruption	2 25%	5 62.5%
Any TEAE Leading to IP Withdrawal	1 12.5%	4 50%
Any TEAE Leading to Death	0 0%	0 0%

3. Secondary Outcome

Title	Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide
Description	The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame	Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.

Outcome Measure Data

Analysis Population Description

The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.

Arm/Group Title	Part 1: Iberdomide 0.3 mg QOD	Part 1: Iberdomide 0.3 mg QD	Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days	Part 1: Iberdomide 0.6 mg QD
Arm/Group Description	Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.	Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.	Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Measure Participants	3	3	5	4
Day 1	10.82 (17.9)	11.29 (42.6)	34.15 (45.5)	38.73 (76.5)
Day 29	13.34 (14.1)	15.55 (1.8)	24.85 (110.5)	52.65 (82.4)

4. Secondary Outcome

Title	Maximum Observed Concentration (Cmax) Of Iberdomide
Description	Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame	Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.

Outcome Measure Data

Analysis Population Description

The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.

Arm/Group Title	Part 1: Iberdomide 0.3 mg QOD	Part 1: Iberdomide 0.3 mg QD	Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days	Part 1: Iberdomide 0.6 mg QD
Arm/Group Description	Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.	Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.	Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Measure Participants	3	3	5	4
Day 1	0.90 (41.3)	0.64 (42.4)	2.92 (50.6)	2.35 (63.1)
Day 29	1.02 (4.3)	1.09 (1.8)	2.37 (42.7)	3.51 (51.7)

5. Secondary Outcome

Title	Time to Reach Maximum Concentration (Tmax) of Iberdomide
Description	Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame	Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.

Outcome Measure Data

Analysis Population Description

The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.

Arm/Group Title	Part 1: Iberdomide 0.3 mg QOD	Part 1: Iberdomide 0.3 mg QD	Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days	Part 1: Iberdomide 0.6 mg QD
Arm/Group Description	Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.	Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.	Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Measure Participants	3	3	5	4
Day 1	4.00	6.00	1.92	4.01
Day 29	4.00	2.00	3.00	2.02

6. Secondary Outcome

Title	Terminal Phase Half-Life (T1/2) Of Iberdomide
Description	Terminal phase half-life in plasma, calculated as [(In 2)/λz]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame	Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.

Outcome Measure Data

Analysis Population Description

The Pharmacokinetic population included all participants in the safety population with at least one non-missing plasma concentration datum available.

Arm/Group Title	Part 1: Iberdomide 0.3 mg QOD	Part 1: Iberdomide 0.3 mg QD	Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days	Part 1: Iberdomide 0.6 mg QD
Arm/Group Description	Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.	Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.	Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.	Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.
Measure Participants	1	3	5	4
Day 1	7.50 (NA)	10.25 (NA)	7.96 (22.8)	9.55 (0.2)
Day 29	8.46 (NA)	11.85 (4.1)	9.39 (11.1)	11.32 (4.8)

7. Secondary Outcome

Title	Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point
Description	The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP. The number analyzed at each time point includes participants with a baseline value >= 4 and non-missing post-baseline value.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	0.0 0%	12.5 156.3%
Week 4	0.0 0%	14.3 178.8%
Week 12	66.7 833.8%	0.0 0%
Week 24	83.3 1041.3%	20.0 250%
Week 36	66.7 833.8%	0.0 0%
Week 48	50.0 625%	20.0 250%
Week 60	33.3 416.3%	20.0 250%
Week 72	80.0 1000%	0.0 0%
Week 84	80.0 1000%	0.0 0%
Week 96	40.0 500%	0.0 0%
Week 100 Follow-Up	40.0 500%	0.0 0%

8. Secondary Outcome

Title	Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point
Description	The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	0.2 (1.56)	-1.0 (2.39)
Week 4	0.2 (1.56)	-1.7 (2.93)
Week 12	-1.8 (2.92)	-0.9 (1.07)
Week 24	-2.8 (2.60)	-1.2 (2.59)
Week 36	-3.1 (1.95)	0.3 (2.06)
Week 48	-2.9 (1.95)	-1.0 (2.65)
Week 60	-2.6 (1.90)	-1.8 (4.02)
Week 72	-3.0 (1.67)	-1.3 (1.15)
Week 84	-3.0 (1.67)	-1.0 (1.41)
Week 96	-2.0 (1.79)	0.0 (NA)
Week 100 Follow-Up	-1.7 (2.43)	0.3 (1.71)

9. Secondary Outcome

Title	Change From Baseline in Swollen Joint Count During the ATEP by Time Point
Description	Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-1.2 (3.11)	-0.4 (0.74)
Week 4	-1.8 (2.99)	-0.6 (2.64)
Week 12	-2.6 (4.81)	-0.3 (0.95)
Week 24	-2.1 (5.84)	1.2 (1.30)
Week 36	-3.9 (4.67)	-0.2 (2.17)
Week 48	-3.6 (5.35)	0.6 (1.34)
Week 60	-2.6 (5.74)	0.4 (1.52)
Week 72	-4.0 (5.10)	0.7 (1.15)
Week 84	-4.2 (5.49)	0.0 (0.00)
Week 96	-3.7 (5.75)	0.0 (NA)
Week 100 Follow-Up	-3.6 (5.26)	-0.4 (0.55)

10. Secondary Outcome

Title	Change From Baseline in Tender Joint Count During the ATEP by Time Point
Description	Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-0.9 (2.37)	-2.5 (4.63)
Week 4	-0.9 (3.76)	-2.0 (3.27)
Week 12	0.5 (6.02)	-3.7 (7.67)
Week 24	-3.9 (4.19)	-3.6 (10.97)
Week 36	-5.1 (5.30)	-3.8 (9.65)
Week 48	-5.9 (6.99)	-3.0 (8.97)
Week 60	-5.6 (9.78)	-4.4 (10.99)
Week 72	-6.2 (6.59)	-6.7 (12.42)
Week 84	-7.3 (10.78)	0.0 (0.00)
Week 96	-7.0 (7.92)	0.0 (NA)
Week 100 Follow-Up	-4.1 (3.63)	-1.4 (3.44)

11. Secondary Outcome

Title	Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point
Description	The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-21.40 (40.529)	-13.35 (28.556)
Week 4	-32.13 (45.400)	-18.32 (58.924)
Week 12	-18.42 (68.423)	-36.46 (33.648)
Week 24	13.54 (147.030)	-44.69 (24.366)
Week 36	-0.56 (116.911)	-43.98 (31.724)
Week 48	-46.97 (44.154)	-46.00 (22.343)
Week 60	-65.64 (40.889)	-47.51 (28.871)
Week 72	-55.13 (41.583)	-40.35 (9.924)
Week 84	-65.71 (24.535)	-32.46 (1.241)
Week 96	-75.38 (23.492)	-26.32 (NA)
Follow-Up Week 100	-53.04 (39.635)	-18.82 (37.296)

12. Secondary Outcome

Title	Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point
Description	The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none 1 = mild disease 2 = moderate disease 3 = severe disease
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-0.08 (0.139)	-0.10 (0.245)
Week 4	-0.26 (0.510)	-0.17 (0.407)
Week 12	-0.15 (0.407)	-0.31 (0.389)
Week 24	-0.28 (0.686)	-0.20 (0.394)
Week 36	-0.30 (0.141)	-0.36 (0.590)
Week 48	-0.53 (0.556)	-0.26 (0.594)
Week 60	-0.37 (0.550)	-0.24 (0.498)
Week 72	-0.48 (0.471)	-0.23 (0.666)
Week 84	-0.57 (0.468)	-0.30 (0.707)
Week 96	-0.52 (0.595)	-0.20 (NA)
Follow-Up Week 100	-0.21 (0.769)	0.10 (0.354)

13. Secondary Outcome

Title	Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point
Description	The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-0.5 (5.76)	3.3 (5.38)
Week 4	2.0 (7.04)	0.7 (9.03)
Week 12	-2.2 (6.98)	2.0 (6.03)
Week 24	-6.3 (6.55)	3.0 (5.60)
Global Score Week 36	-7.3 (5.74)	1.6 (9.13)
Week 48	-6.1 (7.84)	1.4 (5.68)
Week 60	-6.3 (6.37)	0.4 (4.83)
Week 72	-7.5 (4.46)	4.3 (8.50)
Week 84	-7.8 (8.04)	-1.0 (1.41)
Week 96	-0.52 (0.595)	-0.20 (NA)
Follow-Up Week 100	-6.3 (7.20)	-3.9 (4.62)

14. Secondary Outcome

Title	Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt
Description	The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-1.0 (2.65)	0.8 (1.49)
Week 4	-0.8 (2.74)	0.9 (2.01)
Week 12	-1.1 (2.67)	1.3 (2.21)
Week 24	-1.0 (2.88)	0.6 (1.34)
Week 36	-0.7 (3.30)	0.7 (1.57)
Week 48	-1.4 (2.99)	0.9 (2.01)
Week 60	-1.1 (3.18)	1.1 (2.41)
Week 72	0.2 (1.57)	0.0 (0.00)
Week 84	0.2 (0.98)	0.0 (0.00)
Week 96	-0.2 (0.98)	0.0 (NA)
Follow-Up Week 100	-0.6 (0.98)	0.2 (1.10)

15. Secondary Outcome

Title	Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point
Description	The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an "X" representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-10.0 (20.30)	-4.0 (13.48)
Week 4	-4.1 (16.96)	-3.7 (12.23)
Week 12	-15.9 (30.77)	-8.0 (20.60)
Week 24	-13.6 (17.27)	-4.0 (8.80)
Week 36	-21.1 (20.96)	-17.2 (17.48)
Week 48	-29.9 (20.58)	-12.8 (14.48)
Week 60	-23.0 (20.65)	-12.6 (10.74)
Week 72	-22.8 (26.96)	-25.7 (19.55)
Week 84	-10.3 (24.61)	-14.0 (19.80)
Week 96	-9.8 (34.52)	-20.0 (NA)

16. Secondary Outcome

Title	Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point
Description	The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-0.1 (0.33)	0.0 (0.00)
Week 4	0.0 (0.00)	-1.0 (2.24)
Week 12	-0.6 (1.77)	-0.9 (2.73)
Week 24	0.1 (0.83)	-2.2 (4.38)
Week 36	0.1 (0.38)	-2.2 (4.38)
Week 48	0.3 (0.76)	-2.4 (4.83)
Week 60	0.4 (0.79)	-2.6 (5.81)
Week 72	0.3 (0.82)	-0.7 (1.15)
Week 84	0.7 (1.63)	-1.0 (1.41)
Week 96	0.0 (0.00)	0.0 (NA)
Follow-Up Week 100	-0.3 (1.25)	0.0 (0.00)

17. Secondary Outcome

Title	Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point
Description	SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.
Time Frame	Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Outcome Measure Data

Analysis Population Description

The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.

Arm/Group Title	ATEP: Iberdomide 0.3 mg QD	ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days
Arm/Group Description	Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.	Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.
Measure Participants	9	8
Week 1	-0.1 (0.33)	0.0 (0.00)
Week 4	-0.1 (0.33)	-0.1 (0.38)
Week 12	-0.1 (0.35)	-0.1 (0.38)
Week 24	-0.1 (0.35)	-0.2 (0.45)
Week 36	0.0 (0.00)	-0.2 (0.45)
Week 48	0.0 (0.00)	-0.2 (0.45)
Week 60	0.0 (0.00)	-0.2 (0.45)
Week 72	0.0 (0.00)	0.0 (0.00)
Week 84	0.0 (0.00)	0.0 (0.00)
Week 96	0.0 (0.00)	0.0 (NA)
Follow-Up Week 100	0.6 (1.13)	0.0 (0.00)

Adverse Events

Time Frame	TEAEs were monitored from the date of the first dose of IP until 28 days after the last dose of IP or study IP discontinuation in Part 1; median treatment duration was 12.0 weeks for the placebo, 0.3 mg Iberdomide QOD and 0.3 mg QD cohorts and 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts
Adverse Event Reporting Description	For the ATEP, TEAEs were monitored from the date of the first dose of IP until 28 days after the last dose or study IP discontinuation; median duration of treatment was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.
Arm/Group Title	Part 1: Placebo		Part 1: Iberdomide 0.3 mg QOD		Part 1: Iberdomide 0.3 mg QD		Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD		Part 1: Iberdomide 0.6 mg QD		ATEP: Iberdomide 0.3 mg QD		ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
Arm/Group Description	Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.		Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.		Participants received 0.3 mg iberdomide capsules once a day for up to 84 days during the Part 1 treatment phase.		Participants received iberdomide 0.6 mg and 0.3 mg on alternating days for up to 84 days during the Part 1 treatment phase.		Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.		Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.		Participants originally randomized to iberdomide 0.6 mg capsules QD or 0.6 mg Iberdomide capsules alternating days with 0.3 mg iberdomide capsules or placebo capsules QD chorts (in these respective groups), during the Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days when entered into the active treatment extension phase up to 2 years.
All Cause Mortality
	Part 1: Placebo		Part 1: Iberdomide 0.3 mg QOD		Part 1: Iberdomide 0.3 mg QD		Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD		Part 1: Iberdomide 0.6 mg QD		ATEP: Iberdomide 0.3 mg QD		ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Serious Adverse Events
	Part 1: Placebo		Part 1: Iberdomide 0.3 mg QOD		Part 1: Iberdomide 0.3 mg QD		Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD		Part 1: Iberdomide 0.6 mg QD		ATEP: Iberdomide 0.3 mg QD		ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/8 (25%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		1/9 (11.1%)		0/9 (0%)		4/8 (50%)
Eye disorders
Vitreous detachment	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Infections and infestations
Pneumonia	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Nervous system disorders
Seizure	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Psychiatric disorders
Schizoaffective disorder	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Vascular disorders
Deep vein thrombosis	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Part 1: Placebo		Part 1: Iberdomide 0.3 mg QOD		Part 1: Iberdomide 0.3 mg QD		Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD		Part 1: Iberdomide 0.6 mg QD		ATEP: Iberdomide 0.3 mg QD		ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/8 (62.5%)		7/8 (87.5%)		7/8 (87.5%)		8/9 (88.9%)		8/9 (88.9%)		9/9 (100%)		7/8 (87.5%)
Blood and lymphatic system disorders
Eosinophilia	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Neutropenia	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		2/9 (22.2%)		1/9 (11.1%)		1/8 (12.5%)
Cardiac disorders
Palpitations	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Ear and labyrinth disorders
Vertigo	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Eye disorders
Dry eye	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Episcleritis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Eye pain	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Keratitis	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Lacrimation increased	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Ocular discomfort	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Retinopathy hypertensive	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Scleritis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Gastrointestinal disorders
Abdominal pain	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Abdominal pain upper	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Cheilitis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Constipation	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Dental caries	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Dental necrosis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Diarrhoea	1/8 (12.5%)		1/8 (12.5%)		1/8 (12.5%)		2/9 (22.2%)		2/9 (22.2%)		1/9 (11.1%)		3/8 (37.5%)
Duodenal polyp	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Dyspepsia	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Flatulence	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Food poisoning	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Gastritis	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Gastrooesophageal reflux disease	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Gingival bleeding	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Hiatus hernia	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Lip blister	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Nausea	1/8 (12.5%)		1/8 (12.5%)		3/8 (37.5%)		3/9 (33.3%)		0/9 (0%)		2/9 (22.2%)		0/8 (0%)
Pancreatitis	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Toothache	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Vomiting	1/8 (12.5%)		0/8 (0%)		1/8 (12.5%)		1/9 (11.1%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
General disorders
Gait disturbance	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		2/9 (22.2%)		0/8 (0%)
Influenza like illness	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Oedema peripheral	1/8 (12.5%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Swelling	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Infections and infestations
Acute sinusitis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Bacteriuria	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Bronchitis	0/8 (0%)		0/8 (0%)		2/8 (25%)		0/9 (0%)		0/9 (0%)		3/9 (33.3%)		3/8 (37.5%)
Conjunctivitis	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Ear infection	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Folliculitis	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Gastroenteritis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		1/8 (12.5%)
Herpes virus infection	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Hordeolum	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Influenza	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		1/8 (12.5%)
Laryngitis	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Lyme disease	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Nasopharyngitis	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		2/9 (22.2%)		0/8 (0%)
Onychomycosis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Oral candidiasis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Pharyngitis	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Pneumonia	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		1/9 (11.1%)		1/8 (12.5%)
Sinusitis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		2/9 (22.2%)		1/8 (12.5%)
Staphylococcal infection	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Tooth abscess	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Upper respiratory tract infection	1/8 (12.5%)		1/8 (12.5%)		1/8 (12.5%)		1/9 (11.1%)		1/9 (11.1%)		4/9 (44.4%)		3/8 (37.5%)
Urinary tract infection	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		2/9 (22.2%)		2/8 (25%)
Viral upper respiratory tract infection	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Injury, poisoning and procedural complications
Contusion	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		2/9 (22.2%)		0/8 (0%)
Laceration	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Investigations
Hepatic enzyme increased	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Neutrophil count decreased	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		1/8 (12.5%)
Weight increased	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Metabolism and nutrition disorders
Hypovitaminosis	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Vitamin D deficiency	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		2/9 (22.2%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		1/8 (12.5%)
Back pain	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Bursitis	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Fibromyalgia	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Muscle spasms	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Muscle twitching	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Muscular weakness	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Musculoskeletal pain	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		2/8 (25%)
Neck pain	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Osteoarthritis	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		2/9 (22.2%)		0/8 (0%)
Pain in extremity	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		2/9 (22.2%)		0/8 (0%)
Synovial cyst	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Systemic lupus erythematosus	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Nervous system disorders
Dizziness	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		2/8 (25%)
Headache	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Lethargy	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Nerve root compression	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Small fibre neuropathy	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Psychiatric disorders
Anxiety	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Generalised anxiety disorder	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Insomnia	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Irritability	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Middle insomnia	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Renal and urinary disorders
Pollakiuria	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Stress urinary incontinence	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Urinary incontinence	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Reproductive system and breast disorders
Cervical polyp	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Dysmenorrhoea	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Galactorrhoea	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Menorrhagia	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Menstruation irregular	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Nipple disorder	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Cough	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		1/9 (11.1%)		0/9 (0%)		2/8 (25%)
Dyspnoea	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Pleuritic pain	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Pulmonary embolism	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Sinus congestion	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		1/8 (12.5%)
Skin and subcutaneous tissue disorders
Alopecia	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Angioedema	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Blister	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Dermatitis	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		2/9 (22.2%)		0/9 (0%)		0/8 (0%)
Ecchymosis	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Hidradenitis	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		1/8 (12.5%)
Nail discolouration	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Pain of skin	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Prurigo	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Pruritus	0/8 (0%)		0/8 (0%)		0/8 (0%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Rash follicular	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Rash macular	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		1/9 (11.1%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Rash maculo-papular	0/8 (0%)		1/8 (12.5%)		0/8 (0%)		1/9 (11.1%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Rash papular	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Skin lesion	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		1/9 (11.1%)		0/8 (0%)
Urticaria	0/8 (0%)		0/8 (0%)		1/8 (12.5%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		0/8 (0%)
Vascular disorders
Deep vein thrombosis	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.