SPIRIT P3: A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02584855
• Collaborator: (none)
• Enrollment: 394
• Locations: 106
• Arms: 4
• Actual Duration (Months): 37.5
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: Ixekizumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 394 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter Study With a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period From Week 36 to Week 104 to Evaluate the Long-Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
• Actual Study Start Date: Sep 14, 2015
• Actual Primary Completion Date: Oct 30, 2018
• Actual Study Completion Date: Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ixekizumab Open Label Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).	Drug: Ixekizumab; Administered SC; Other Names: LY2439821
Experimental: Ixekizumab Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Drug: Ixekizumab; Administered SC; Other Names: LY2439821
Placebo Comparator: Placebo Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)	Drug: Ixekizumab; Administered SC; Other Names: LY2439821 ; Drug: Placebo; Administered SC
Experimental: IXE80Q2W Non-randomized Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period. Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821

Outcome Measures

Primary Outcome Measures

1. Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA]) [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity & severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose & date of last attended visit in Period 3.

Secondary Outcome Measures

1. Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   Relapsed participants are defined as participants no longer meeting Coates criteria for MDA. MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or body surface area (BSA) ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.

2. Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC) [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   TJC is the number of tender and painful joints determined for each participant by examination of 68 joints.TJC possible values range from 0 to 68. A lower TJC indicated less number of joints with tenderness. A higher TJC indicated more joint tenderness. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Loss of Response = Not Meeting less than or equal to 1 TJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.

3. Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC) [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   SJC is the number of swollen joints determined for each participant by examination of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joints with swelling. A higher SJC indicated more joints with swelling. Swelling was defined as palpable fluctuating synovitis of the joint. Loss of Response = Not Meeting less than or equal to 1 SJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.

4. Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI) [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Loss of Response = Not Meeting less than or equal to 1 PASI total score. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.

5. Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   BSA is an investigator evaluated measure, where the percentage of involvement of psoriasis on each participant's BSA is assessed. BSA was measured on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. Loss of Response = Not meeting less than or equal to 3% BSA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.

6. Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   The pain VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two endpoints whereby the respondent places a mark on the line to indicate his or her response The scale ranges from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 15 Pain VAS. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.

7. Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   Participants scored their overall assessment of their psoriatic arthritis (PsA) activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 20 PatGA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.

8. Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI) [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. Loss of Response = Not Meeting less than or equal to 0.5 HAQ-DI. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.

9. Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points [Double Blind Randomization through Week 104 (or Early Termination or Relapse)]

   Tender entheseal points was based on the assessment of the 18 entheseal points. Loss of Response = Not Meeting less than or equal to 1 Tender Entheseal Point. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.

10. Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits) [Open Label Baseline through Double-Blind Randomization (Week 36 to 64)]

    Time to meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits. Time to first response (in weeks) = [(date of first response - date of first injection of study treatment in the Open-Label Treatment Period)+1]/7. Open-Label Treatment Period ended at the time when a participant was randomized so the end time was not the same for all participants. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.

11. Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA [Relapse in MDA After Double Blind Randomization through Week 104 (or Early Termination)]

    MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Time to first response (in weeks) = (date of first response - date of first injection of study treatment in the Relapse Period + 1)/7.

12. Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) [Baseline, 40 Weeks from Double Blind Randomization (Week 36 to 64)]

    The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment group, baseline measure, geographic region, cDMARD use, treatment week, baseline measure-by-treatment week interaction term, and treatment week-by-treatment interaction term as fixed factors. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

• Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints

• Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)

• Men must agree to use a reliable method of birth control or remain abstinent during the study

• Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

• Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)

Exclusion Criteria:

• Current or prior use of biologic agents for treatment of Ps or PsA

• Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDS)

• Current use of more than one cDMARDs

• Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA

• Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy

• Serious disorder or illness other than psoriatic arthritis

• Serious infection within the last 3 months

• Breastfeeding or nursing (lactating) women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Arthritis & Rheumatology Research	Glendale	Arizona	United States	85306
2	Arizona Arthritis & Rheumatology Research, PLLC	Mesa	Arizona	United States	85202
3	Arizona Arthritis Research, PLC	Phoenix	Arizona	United States	85032
4	University of California, Davis - Health Systems	Sacramento	California	United States	95817
5	East Bay Rheumatology Medical Group	San Leandro	California	United States	94578
6	Arthritis & Osteoporosis Treatment Center, PA	Orange Park	Florida	United States	32073
7	Florida Medical Clinic PA	Zephyrhills	Florida	United States	33542
8	Physicians Clinic of Iowa	Cedar Rapids	Iowa	United States	54203
9	Heartland Research Associates	Wichita	Kansas	United States	67207
10	Klein and Associates MD, PA	Cumberland	Maryland	United States	21502
11	Klein and Associates MD, PA	Hagerstown	Maryland	United States	21740
12	University of Massachusetts Medical Center	Worcester	Massachusetts	United States	01605
13	Glacier View Research Institute	Kalispell	Montana	United States	59901
14	Arthritis, Rheumatic & Back Disease Associates	Voorhees	New Jersey	United States	08043
15	Weill Cornell Physicians at Brooklyn Heights	Brooklyn	New York	United States	11201
16	Robert A. Harrell, III, MD	Durham	North Carolina	United States	27704
17	Pennsylvania Regional Center for Arthritis & Osteoarthritis	Wyomissing	Pennsylvania	United States	19610
18	Pioneer Research Solutions	Cypress	Texas	United States	77429
19	Arthritis Care & Diagnostic Center P.A.	Dallas	Texas	United States	75231
20	Kadlec Clinic Rheumatology	Kennewick	Washington	United States	99336
21	Seattle Rheumatology Associates, P.L.L.C.	Seattle	Washington	United States	98122
22	Arthritis Northwest Rheumatology	Spokane	Washington	United States	99204
23	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Plovdiv		Bulgaria	4000
24	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Plovdiv		Bulgaria	4002
25	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ruse		Bulgaria	7002
26	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sofia		Bulgaria	1784
27	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brno		Czechia	60200
28	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brno		Czechia	638 00
29	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ceska Lipa		Czechia	470 01
30	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ostrava		Czechia	722 00
31	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pardubice		Czechia	53002
32	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Praha 2		Czechia	128 50
33	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Praha 4 Nusle		Czechia	140 00
34	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Praha 5		Czechia	15800
35	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Praha		Czechia	13000
36	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Uherske Hradiste		Czechia	686 01
37	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Zlin		Czechia	760 01
38	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tallinn		Estonia	10117
39	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tallinn		Estonia	10128
40	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tallinn		Estonia	10138
41	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tallinn		Estonia	13419
42	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tartu		Estonia	50107
43	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chihuahua		Mexico	03100
44	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cuautitlan Izcalli		Mexico	54769
45	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Durango		Mexico	34000
46	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Guadalajara		Mexico	45040
47	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Monterrey		Mexico	64610
48	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Morelia		Mexico	58260
49	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Luis Potosi		Mexico	78213
50	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bialystok		Poland	15879
51	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Krakow		Poland	30-510
52	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Krakow		Poland	31-023
53	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Krakow		Poland	31-501
54	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lublin		Poland	20-582
55	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nowa Sol		Poland	67100
56	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nowy Duninow		Poland	09505
57	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Poznan		Poland	61-113
58	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sochaczew		Poland	96500
59	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Torun		Poland	87-100
60	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warsaw		Poland	00-465
61	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warszawa		Poland	00660
62	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warszawa		Poland	01-868
63	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warszawa		Poland	02-118
64	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wroclaw		Poland	51-124
65	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chelyabinsk		Russian Federation	454076
66	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ekaterinburg		Russian Federation	620043
67	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kazan		Russian Federation	420012
68	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Moscow		Russian Federation	119333
69	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Novosibirsk		Russian Federation	630061
70	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	St. Petersburg		Russian Federation	190068
71	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	St. Petersburg		Russian Federation	191186
72	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	St. Petersburg		Russian Federation	194291
73	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bratislava		Slovakia	83103
74	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bratislava		Slovakia	84231
75	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kosice		Slovakia	040 15
76	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Povazska Bystrica		Slovakia	01701
77	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Senica		Slovakia	90501
78	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Stara Lubovna		Slovakia	06401
79	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Svidnik		Slovakia	08901
80	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Trnava		Slovakia	91701
81	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Zvolen		Slovakia	96001
82	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cape Town		South Africa	7405
83	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kempton Park		South Africa	1619
84	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Port Elizabeth		South Africa	6057
85	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pretoria		South Africa	0002
86	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pretoria		South Africa	0084
87	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Stellenbosch		South Africa	7600
88	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	La Coruna		Spain	15006
89	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Malaga		Spain	29009
90	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sabadell		Spain	08208
91	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Santander		Spain	39008
92	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sevilla		Spain	41010
93	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kharkiv		Ukraine	61039
94	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kharkiv		Ukraine	61176
95	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kyiv		Ukraine	03151
96	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lviv		Ukraine	79011
97	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Odesa		Ukraine	65026
98	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Vinnytsia		Ukraine	21029
99	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Vinnytsia		Ukraine	21030
100	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Vinnytsya		Ukraine	21018
101	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Zaporizhzhia		Ukraine	69600
102	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Goodmayes		United Kingdom	IG7 4DY
103	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Harlow		United Kingdom	CM20 1QX
104	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London		United Kingdom	E11 1NR
105	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Truro		United Kingdom	TR1 3LJ
106	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Statistical Analysis Plan: Statistical Analysis Plan V3 - Oct 25, 2018
• Statistical Analysis Plan: Statistical Analysis Plan Blinding and Unblinding Plan V3 - Oct 27, 2017
• Study Protocol - Mar 21, 2017

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02584855
• Other Study ID Numbers: 14518; I1F-MC-RHBF; 2015-002433-22
• First Posted: Oct 23, 2015
• Last Update Posted: Nov 15, 2019
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Eli Lilly and Company: Spondyloarthritis; Spondylarthropathy
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic; Ixekizumab

Study Results

Participant Flow

Recruitment Details	This study had four periods: Period 1: Screening period lasting from 4 to 30 days before Week 0, Period 2: Initial open-label treatment period from Week 0 up to Week 36, Period 3: randomized double-blind withdrawal period from Week 36 to week 104 (or, early termination or relapse) and Period 4: post treatment follow-up.
Pre-assignment Detail	Participants were randomized during week 36 to week 64. The criteria for randomization in period 3 was having received ixekizumab (IXE) 80 mg Q2W for at least 6 months and meeting Coates criteria for minimal disease activity (MDA) for 3 consecutive months over 4 consecutive visits.The criteria was met anytime from 36 to 64 weeks.

Arm/Group Title	Ixekizumab Open Label	IXE80Q2W Non-randomized	Ixekizumab	Placebo	IXE80Q2W Post-Treatment Follow-up Period	Placebo Post-Treatment Follow-up Period
Arm/Group Description	Open-Label Treatment Period (OLTP): Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (Week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).	Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period. Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)	Participants did not receive any study treatment during post treatment follow-up period. Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.	Participants did not receive any study treatment during post treatment follow-up period. Placebo Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
Period Title: Open-Label Treatment Period
STARTED	394	0	0	0	0	0
Received at Least One Dose of Study Drug	394	0	0	0	0	0
Met Randomization Criteria	158	0	0	0	0	0
Non-randomized	133	0	0	0	0	0
COMPLETED	291	0	0	0	0	0
NOT COMPLETED	103	0	0	0	0	0
Period Title: Open-Label Treatment Period
STARTED	0	133	79	79	0	0
Relapsed	0	0	67	30	0	0
COMPLETED	0	118	77	78	0	0
NOT COMPLETED	0	15	2	1	0	0
Period Title: Open-Label Treatment Period
STARTED	0	0	0	0	355	12
COMPLETED	0	0	0	0	347	12
NOT COMPLETED	0	0	0	0	8	0

Baseline Characteristics

Arm/Group Title	Ixekizumab Open Label
Arm/Group Description	Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
Overall Participants	394
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.4 (11.40)
Sex: Female, Male (Count of Participants)
Female	212 53.8%
Male	182 46.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 4.1%
Not Hispanic or Latino	330 83.8%
Unknown or Not Reported	48 12.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	6 1.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 0.3%
White	385 97.7%
More than one race	2 0.5%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	32 8.1%
Czechia	90 22.8%
Ukraine	43 10.9%
Poland	60 15.2%
Mexico	16 4.1%
South Africa	26 6.6%
United Kingdom	23 5.8%
Slovakia	16 4.1%
Bulgaria	20 5.1%
Estonia	47 11.9%
Russia	10 2.5%
Spain	11 2.8%

Outcome Measures

1. Primary Outcome

Title	Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])
Description	Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity & severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose & date of last attended visit in Period 3.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in randomized withdrawal Intent-to-Treat population. Censored participants were Ixekizumab = 49 and Placebo =12.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	79	79
Median (95% Confidence Interval) [Weeks]	NA	22.29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Placebo
	Comments	Log Rank Test adjusting for geographic region and conventional disease-modifying antirheumatic drug (cDMARD) use at the time of double blind randomization.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Log Rank
	Comments

2. Secondary Outcome

Title	Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA
Description	Relapsed participants are defined as participants no longer meeting Coates criteria for MDA. MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or body surface area (BSA) ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in randomized withdrawal Intent-to-Treat population.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	79	79
Number (95% Confidence Interval) [percentage of participants]	40.5 10.3%	86.1 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Placebo
	Comments	Logistic regression adjusting for treatment, geographic region, and cDMARD use at the time of double-blind randomization .
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-45.6
	Confidence Interval	(2-Sided) 95%; -58.8 to -32.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)
Description	TJC is the number of tender and painful joints determined for each participant by examination of 68 joints.TJC possible values range from 0 to 68. A lower TJC indicated less number of joints with tenderness. A higher TJC indicated more joint tenderness. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Loss of Response = Not Meeting less than or equal to 1 TJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had tender joint counts <= 1 at time of randomization. Censored participants: Ixekizumab= 29 and Placebo= 16.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	56	57
Median (95% Confidence Interval) [weeks]	64.29	22.29

4. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)
Description	SJC is the number of swollen joints determined for each participant by examination of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joints with swelling. A higher SJC indicated more joints with swelling. Swelling was defined as palpable fluctuating synovitis of the joint. Loss of Response = Not Meeting less than or equal to 1 SJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population who had swollen joint counts <= 1 at time of randomization. Censored participants: Ixekizumab= 61 and Placebo = 40.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	72	73
Median (95% Confidence Interval) [weeks]	NA	28.71

5. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)
Description	The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Loss of Response = Not Meeting less than or equal to 1 PASI total score. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in the randomized withdrawal intent-to-treat population Who had PASI <= 1 at time of randomization. Censored participants: Ixekizumab = 64 and Placebo = 43.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	73	77
Median (95% Confidence Interval) [weeks]	NA	36.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Placebo
	Comments	Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Log Rank
	Comments

6. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA
Description	BSA is an investigator evaluated measure, where the percentage of involvement of psoriasis on each participant's BSA is assessed. BSA was measured on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. Loss of Response = Not meeting less than or equal to 3% BSA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in the randomized Withdrawal Intent-to-Treat Population who had BSA <= 3% at time of randomization. Censored participants: Ixekizumab=70 and Placebo= 59.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	73	78
Median (95% Confidence Interval) [weeks]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Placebo
	Comments	Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Log Rank
	Comments

7. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score
Description	The pain VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two endpoints whereby the respondent places a mark on the line to indicate his or her response The scale ranges from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 15 Pain VAS. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had Pain VAS <= 15 at time of randomization. Censored participants: Ixekizumab=42 and Placebo= 7.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	72	68
Median (95% Confidence Interval) [weeks]	NA	16.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Placebo
	Comments	Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Log Rank
	Comments

8. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score
Description	Participants scored their overall assessment of their psoriatic arthritis (PsA) activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 20 PatGA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population Who had PatGA VAS <= 20 at time of randomization. Censored participants: Ixekizumab= 57 and Placebo=18.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	77	74
Median (95% Confidence Interval) [weeks]	NA	20.57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab
	Comments	Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Log Rank
	Comments

9. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. Loss of Response = Not Meeting less than or equal to 0.5 HAQ-DI. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population Who had HAQ-DI <= 0.5 at Time of randomization. Censored participants: Ixekizumab= 55 and Placebo=53.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	69	68
Median (95% Confidence Interval) [weeks]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Placebo
	Comments	Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Log Rank
	Comments

10. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points
Description	Tender entheseal points was based on the assessment of the 18 entheseal points. Loss of Response = Not Meeting less than or equal to 1 Tender Entheseal Point. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame	Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had tender Entheseal Point <= 1 at time of randomization. Censored participants: Ixekizumab= 58 and Placebo= 58.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse).
Measure Participants	73	72
Median (95% Confidence Interval) [weeks]	NA	NA

11. Secondary Outcome

Title	Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits)
Description	Time to meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits. Time to first response (in weeks) = [(date of first response - date of first injection of study treatment in the Open-Label Treatment Period)+1]/7. Open-Label Treatment Period ended at the time when a participant was randomized so the end time was not the same for all participants. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
Time Frame	Open Label Baseline through Double-Blind Randomization (Week 36 to 64)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in initial open-label treatment period. Censored participants were 239.

Arm/Group Title	Ixekizumab Open Label
Arm/Group Description	Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
Measure Participants	394
Median (95% Confidence Interval) [weeks]	64.43

12. Secondary Outcome

Title	Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA
Description	MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Time to first response (in weeks) = (date of first response - date of first injection of study treatment in the Relapse Period + 1)/7.
Time Frame	Relapse in MDA After Double Blind Randomization through Week 104 (or Early Termination)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and relapsed in MDA After Double Blind Randomization Until Re-Gain MDA. Censored participants were: Ixekizumab= 3 and Placebo= 3.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	30	67
Median (95% Confidence Interval) [weeks]	4.71	4.14

13. Secondary Outcome

Title	Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment group, baseline measure, geographic region, cDMARD use, treatment week, baseline measure-by-treatment week interaction term, and treatment week-by-treatment interaction term as fixed factors. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
Time Frame	Baseline, 40 Weeks from Double Blind Randomization (Week 36 to 64)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug had a baseline and post baseline measure in the Double-Blind Withdrawal Period.

Arm/Group Title	Ixekizumab	Placebo
Arm/Group Description	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).	Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Measure Participants	51	22
Least Squares Mean (Standard Error) [score on a scale]	-0.79 (0.06)	-0.67 (0.06)

Adverse Events

Time Frame	Up To 3 Years
Adverse Event Reporting Description	All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Arm/Group Title	Ixekizumab Open Label		Ixekizumab		Placebo		IXE80Q2W Non-randomized Population to Withdrawal Period		IXE80Q2W Relapse Period		IXE80Q2W Post-Treatment Follow-up Period		Placebo Post-Treatment Follow-up Period
Arm/Group Description	Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).		Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).		Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse).		Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period. Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.		IXE80Q2W Relapse Period Double Blind Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse). Double Blind Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse).		Participants did not receive any study treatment during post treatment follow-up period. Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.		Participants did not receive any study treatment during post treatment follow-up period. Placebo Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
All Cause Mortality
	Ixekizumab Open Label		Ixekizumab		Placebo		IXE80Q2W Non-randomized Population to Withdrawal Period		IXE80Q2W Relapse Period		IXE80Q2W Post-Treatment Follow-up Period		Placebo Post-Treatment Follow-up Period
	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	2/394 (0.5%)		0/79 (0%)		0/79 (0%)		0/133 (0%)		0/97 (0%)		0/355 (0%)		0/12 (0%)
Serious Adverse Events
	Ixekizumab Open Label		Ixekizumab		Placebo		IXE80Q2W Non-randomized Population to Withdrawal Period		IXE80Q2W Relapse Period		IXE80Q2W Post-Treatment Follow-up Period		Placebo Post-Treatment Follow-up Period
	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	20/394 (5.1%)		1/79 (1.3%)		2/79 (2.5%)		6/133 (4.5%)		1/97 (1%)		4/355 (1.1%)		0/12 (0%)
Cardiac disorders
Acute myocardial infarction	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Angina unstable	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Coronary artery disease	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Gastrointestinal disorders
Crohn's disease	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Gastritis	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Gastrointestinal necrosis	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Intestinal obstruction	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Large intestine polyp	0/394 (0%)	0	0/79 (0%)	0	1/79 (1.3%)	1	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
General disorders
Drowning	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Non-cardiac chest pain	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	1/355 (0.3%)	1	0/12 (0%)	0
Cholelithiasis	2/394 (0.5%)	2	0/79 (0%)	0	0/79 (0%)	0	1/133 (0.8%)	1	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Hepatic steatosis	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	1/355 (0.3%)	1	0/12 (0%)	0
Infections and infestations
Bronchitis	2/394 (0.5%)	2	0/79 (0%)	0	0/79 (0%)	0	1/133 (0.8%)	1	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Erysipelas	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	1/355 (0.3%)	1	0/12 (0%)	0
Pneumonia	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Sinusitis	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Urinary tract infection	0/394 (0%)	0	0/79 (0%)	0	1/79 (1.3%)	1	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Injury, poisoning and procedural complications
Fall	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	1/133 (0.8%)	1	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Foreign body in eye	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Humerus fracture	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	1/133 (0.8%)	1	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Meniscus injury	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	1/133 (0.8%)	1	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Radius fracture	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	1/133 (0.8%)	1	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Road traffic accident	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	1/133 (0.8%)	1	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Thermal burn	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Upper limb fracture	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	1/97 (1%)	1	0/355 (0%)	0	0/12 (0%)	0
Investigations
Troponin increased	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	1/355 (0.3%)	1	0/12 (0%)	0
Musculoskeletal and connective tissue disorders
Foot deformity	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Osteoarthritis	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma	1/212 (0.5%)	1	0/32 (0%)	0	0/39 (0%)	0	0/78 (0%)	0	0/53 (0%)	0	0/195 (0%)	0	0/6 (0%)	0
Nervous system disorders
Embolic stroke	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Transient ischaemic attack	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Vascular headache	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Reproductive system and breast disorders
Endometriosis	0/212 (0%)	0	1/32 (3.1%)	1	0/39 (0%)	0	0/78 (0%)	0	0/53 (0%)	0	0/195 (0%)	0	0/6 (0%)	0
Ovarian cyst	0/212 (0%)	0	0/32 (0%)	0	0/39 (0%)	0	1/78 (1.3%)	1	0/53 (0%)	0	0/195 (0%)	0	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/394 (0%)	0	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	1/355 (0.3%)	1	0/12 (0%)	0
Respiratory failure	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Skin and subcutaneous tissue disorders
Angioedema	1/394 (0.3%)	1	0/79 (0%)	0	0/79 (0%)	0	0/133 (0%)	0	0/97 (0%)	0	0/355 (0%)	0	0/12 (0%)	0
Other (Not Including Serious) Adverse Events
	Ixekizumab Open Label		Ixekizumab		Placebo		IXE80Q2W Non-randomized Population to Withdrawal Period		IXE80Q2W Relapse Period		IXE80Q2W Post-Treatment Follow-up Period		Placebo Post-Treatment Follow-up Period
	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	143/394 (36.3%)		25/79 (31.6%)		14/79 (17.7%)		37/133 (27.8%)		30/97 (30.9%)		19/355 (5.4%)		0/12 (0%)
General disorders
Injection site reaction	59/394 (15%)	270	1/79 (1.3%)	8	0/79 (0%)	0	2/133 (1.5%)	20	7/97 (7.2%)	27	0/355 (0%)	0	0/12 (0%)	0
Infections and infestations
Bronchitis	18/394 (4.6%)	23	4/79 (5.1%)	4	1/79 (1.3%)	1	5/133 (3.8%)	5	4/97 (4.1%)	5	0/355 (0%)	0	0/12 (0%)	0
Nasopharyngitis	34/394 (8.6%)	37	11/79 (13.9%)	13	4/79 (5.1%)	4	19/133 (14.3%)	22	13/97 (13.4%)	17	2/355 (0.6%)	2	0/12 (0%)	0
Oral herpes	9/394 (2.3%)	10	4/79 (5.1%)	9	1/79 (1.3%)	3	2/133 (1.5%)	3	2/97 (2.1%)	2	2/355 (0.6%)	2	0/12 (0%)	0
Upper respiratory tract infection	49/394 (12.4%)	66	9/79 (11.4%)	14	4/79 (5.1%)	5	12/133 (9%)	18	9/97 (9.3%)	10	8/355 (2.3%)	8	0/12 (0%)	0
Investigations
Alanine aminotransferase increased	11/394 (2.8%)	14	4/79 (5.1%)	4	1/79 (1.3%)	2	2/133 (1.5%)	2	1/97 (1%)	2	3/355 (0.8%)	3	0/12 (0%)	0
Aspartate aminotransferase increased	6/394 (1.5%)	8	4/79 (5.1%)	4	1/79 (1.3%)	2	1/133 (0.8%)	1	1/97 (1%)	3	2/355 (0.6%)	2	0/12 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma	0/212 (0%)	0	2/32 (6.3%)	2	0/39 (0%)	0	0/78 (0%)	0	0/53 (0%)	0	0/195 (0%)	0	0/6 (0%)	0
Skin and subcutaneous tissue disorders
Psoriasis	2/394 (0.5%)	2	0/79 (0%)	0	4/79 (5.1%)	4	2/133 (1.5%)	3	1/97 (1%)	1	4/355 (1.1%)	4	0/12 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.