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A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis

Sponsor
Celgene (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04800315
Collaborator
(none)
214
Enrollment
157
Locations
4
Arms
17.7
Anticipated Duration (Months)
1.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
214 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Cendakimab (CC-93538) in Adult Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date :
May 14, 2021
Anticipated Primary Completion Date :
Jul 14, 2022
Anticipated Study Completion Date :
Nov 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose 1: CC-93538 SC QW

Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.

Drug: CC-93538
Subcutaneous once weekly
Other Names:
  • RPC4064

    		•
    Experimental: Dose 2: CC-93538 and Placebo SC Q2W

    Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind.

    Drug: CC-93538
    Subcutaneous once weekly
    Other Names:
  • RPC4064

    • Other: Placebo
    Subcutaneous Every other week
    Experimental: Dose 3: CC-93538 and Placebo SC Q2W

    Starting at the baseline visit, active IP and matching placebo will be administered. On the alternate weeks, placebo will be administered weekly to maintain the blind.

    Drug: CC-93538
    Subcutaneous once weekly
    Other Names:
  • RPC4064

    • Other: Placebo
    Subcutaneous Every other week
    Placebo Comparator: Placebo SC QW

    Administration of placebo each week.

    Other: Placebo
    Subcutaneous Every other week

    Outcome Measures

    Primary Outcome Measures

    1. Percent change in EASI from Baseline at Week 16 [Up to week 16]

      The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD)

    Secondary Outcome Measures

    1. Proportion of participants with an vIGAAD score from Baseline at Week 16 [Up to week 16]

      The Validated Investigator Global Assessment (vIGA)-AD is a validated 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded).

    2. Proportion of participants with at least a 75% improvement from Baseline in Eczema Area and Severity Index (EASI-75) at Week 16 [Up to week 16]

      The EASI is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD.

    3. Percent change from Baseline in Pruritus Numerical Rating Scale (NRS) at Week 16 [Up to week 16]

      Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.

    4. Proportion of participants with Pruritus NRS change of ≥ 4 points from Baseline at Week 16 [Up to week 16]

      Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.

    5. Time to achieve at least 4 points of improvement in the severity of pruritus NRS scale in the first 16 weeks of treatment [Up to week 16]

      Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.

    6. Proportion of participants with at least a 90% improvement from Baseline in Eczema Area and Severity Index (EASI-90) at Week 16 [Up to week 16]

      The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD)

    7. Mean change in SCORAD Scores from Baseline at Week 16 [Up to week 16]

      The Scoring Atopic Dermatitis Index (SCORAD) is a validated scoring index for atopic dermatitis, which combines extent (0 to 100), severity (0 to 18), and subjective symptoms (0 to 20) based on pruritus and sleep loss, each scored (0 to 10).

    8. Percent change in BSA involved with AD from baseline at Week 16 [Up to week 16]

      Percentage body surface area of the skin that displays signs or symptoms consistent with atopic dermatitis

    9. Incidence of Adverse Events (AEs) [Up to week 32]

      An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

    10. Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538 [Up to week 32]

      Evaluated by the presence of anti-drug antibodies to CC-93538

    11. Pharmacokinetics-Cthrough [Up to week 32]

      Serum trough concentration of CC-93538

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Participants must satisfy the following criteria to be enrolled in the study:

    1. Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF).

    2. Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that has been present for ≥ 1 year prior to the baseline visit (Day 1).

    3. Participant has moderate to severe, active, and symptomatic AD defined by meeting all of the following criteria on the day of the baseline visit (Day 1):

    4. Body Surface Area (BSA) ≥ 10%, and

    5. EASI score ≥ 16, and

    6. vIGA-AD ≥ 3, and

    7. Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.

    8. Participant must have a documented history of inadequate response to treatment with topical medications for at least 4 weeks, unless topical treatments are otherwise medically inadvisable or has required systemic therapy for control of disease.

    9. Participant must be willing to apply a stable dose of topical emollient (eg, over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days prior to the Baseline visit and continue application throughout the study.

    10. Participant must commit to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.

    11. Participants currently receiving concomitant medications for any reason other than AD, such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable regimen, which is defined as not starting a new drug, changing, or stopping dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the treatment duration of the study.

    12. Female participants of childbearing potential must agree to practice a highly effective method of contraception.

    Exclusion Criteria:

    1. The presence of any of the following will exclude a participant from enrollment: Evidence of an active and/or concurrent inflammatory skin condition (eg, seborrheic dermatitis, psoriasis, acute allergic contact dermatitis, etc.) that would interfere with the Investigator or participant-driven evaluations of AD.

    2. Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline).

    3. Use of topical treatments that could affect the assessment of AD (eg, corticosteroids, calcineurin inhibitors, tars, antibiotic creams, topical antihistamines) within 7 days of the Day 1 visit.

    4. Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit.

    5. Evidence of immunosuppression, participant is receiving, or has received systemic immunosuppressive or immunomodulating drugs (eg, azathioprine, cyclosporine, systemic corticosteroids, interferon gamma (IFN-γ), Janus kinase inhibitors, methotrexate, mycophenolate-mofetil, etc.) within 4 weeks prior to the Baseline visit.

    6. Treatment with immunomodulatory biologics

    7. Concurrent treatment with another IP

    8. Received a live attenuated vaccine within 1 month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the study.

    9. Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.

    10. Ongoing infection

    11. A history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent. A known hypersensitivity to any ingredient in the investigational product (IP) is also exclusionary.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of Alabama Birmingham Alabama United States 35209
    2 Local Institution - 119 Birmingham Alabama United States 35209
    3 Cahaba Dermatology Birmingham Alabama United States 35244
    4 Local Institution - 114 Birmingham Alabama United States 35244
    5 Burke Pharmaceutical Research Hot Springs Arkansas United States 71913-6440
    6 Local Institution - 129 Hot Springs Arkansas United States 71913-6440
    7 First OC Dermatology Fountain Valley California United States 92708
    8 Local Institution - 105 Fountain Valley California United States 92708
    9 George Washington University School of Medicine and Health Sciences Washington District of Columbia United States 20037-3201
    10 Local Institution - 128 Washington District of Columbia United States 20037-3201
    11 Total Vein and Skin, LLC Boynton Beach Florida United States 33437
    12 Local Institution - 106 Delray Beach Florida United States 33484-6500
    13 Palm Beach Dermatology Group Delray Beach Florida United States 33484-6500
    14 GCP Global Clinical Professionals Saint Petersburg Florida United States 33702
    15 Local Institution - 135 Saint Petersburg Florida United States 33702
    16 ForCare Clinical Research Tampa Florida United States 33624-2038
    17 Local Institution - 101 Tampa Florida United States 33624-2038
    18 Local Institution - 103 West Palm Beach Florida United States 33401-3430
    19 Metabolic Research Institute Inc West Palm Beach Florida United States 33401-3430
    20 Aeroallergy Research Labs of Savannah Savannah Georgia United States 31406-2668
    21 Local Institution - 134 Savannah Georgia United States 31406-2668
    22 Local Institution - 108 Springfield Illinois United States 62702-5115
    23 Sneeze Wheeze and Itch Associates LLC Springfield Illinois United States 62702-5115
    24 DS Research Clarksville Indiana United States 47129-2201
    25 Local Institution - 115 Clarksville Indiana United States 47129-2201
    26 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46256
    27 Local Institution - 110 Indianapolis Indiana United States 46256
    28 Local Institution - 107 West Lafayette Indiana United States 47906-1569
    29 Randall Dermatology West Lafayette Indiana United States 47906-1569
    30 Local Institution - 138 Westfield Indiana United States 46074
    31 Randall Dermatology - Westfield Campus Westfield Indiana United States 46074
    32 Kansas City Dermatology P.A. Overland Park Kansas United States 66215-2377
    33 Local Institution - 116 Overland Park Kansas United States 66215-2377
    34 DS Research Louisville Kentucky United States 40241
    35 Local Institution - 117 Louisville Kentucky United States 40241
    36 DermAssociates Silver Spring Maryland United States 20902-5006
    37 Local Institution - 125 Silver Spring Maryland United States 20902-5006
    38 Local Institution - 133 Clarkston Michigan United States 48346
    39 Skin Research Clarkston/Clarkston Dermatology Clarkston Michigan United States 48346
    40 Local Institution - 137 Omaha Nebraska United States 68144
    41 Skin Specialists PC Omaha Nebraska United States 68144
    42 JDR Dermatology Research, LLC Las Vegas Nevada United States 89148
    43 Local Institution - 121 Las Vegas Nevada United States 89148
    44 Local Institution - 112 Hackensack New Jersey United States 07601-1974
    45 Skin Laser and Surgery Specialists of New York and New Jersey LLC Hackensack New Jersey United States 07601-1974
    46 Icahn School of Medicine at Mount Sinai Great Neck New York United States 11021-5506
    47 Local Institution - 130 Great Neck New York United States 11021-5506
    48 Local Institution - 126 New York New York United States 10075
    49 Sadick Research Group New York New York United States 10075
    50 Central Sooner Research Norman Oklahoma United States 73069-6301
    51 Local Institution - 111 Norman Oklahoma United States 73069-6301
    52 Local Institution - 127 Tulsa Oklahoma United States 74136-8303
    53 Vital Prospects Clinical Research Institute PC - CRN - PPDS Tulsa Oklahoma United States 74136-8303
    54 Local Institution - 109 Portland Oregon United States 97223
    55 Oregon Medical Research Center, P.C. Portland Oregon United States 97223
    56 Clinical Partners, LLC Johnston Rhode Island United States 02919
    57 Local Institution - 123 Johnston Rhode Island United States 02919
    58 International Clinical Research Murfreesboro Tennessee United States 37130
    59 Local Institution - 100 Murfreesboro Tennessee United States 37130
    60 Clinical Research Partners LLC Henrico Virginia United States 23233-1487
    61 Local Institution - 104 Richmond Virginia United States 23233-1436
    62 West End Dermatology Associates Richmond Virginia United States 23233-1436
    63 Institute for Skin Advancement Calgary Alberta Canada T3A 2N1
    64 Local Institution - 203 Calgary Alberta Canada T3A 2N1
    65 Local Institution - 213 Edmonton Alberta Canada T6G 1C3
    66 Rao Dermatology Edmonton Alberta Canada T6G 1C3
    67 Dr. Chih-ho Hong Medical Inc. Surrey British Columbia Canada V3R 6A7
    68 Local Institution - 207 Surrey British Columbia Canada V3R 6A7
    69 Enverus Medical Research Surrey British Columbia Canada V3V 0C6
    70 Local Institution - 200 Surrey British Columbia Canada V3V 0C6
    71 Local Institution - 205 Winnipeg Manitoba Canada R3M 3Z4
    72 Wiseman Dermatology Research Inc. Winnipeg Manitoba Canada R3M 3Z4
    73 Local Institution - 208 Markham Ontario Canada L3P IX3
    74 Lynderm Research Inc Markham Ontario Canada L3P IX3
    75 DermEdge Mississauga Ontario Canada L4Y 4C5
    76 Local Institution - 211 Mississauga Ontario Canada L4Y 4C5
    77 Local Institution - 209 Oakville Ontario Canada L6J 7W5
    78 The Centre for Clinical Trials Inc. Oakville Ontario Canada L6J 7W5
    79 Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ Quebec Canada G1V 4X7
    80 Local Institution - 202 Quebec Canada G1V 4X7
    81 Kawashima Dermatology Ichikawa China 272-0033
    82 Local Institution - 503 Ichikawa China 272-0033
    83 Local Institution - 507 Matsudo China 271-0092
    84 Miyata Dermatology Clinic Matsudo China 271-0092
    85 Kozni ambulance Kutna Hora Kutná Hora Czechia 284 01
    86 Local Institution - 407 Kutná Hora Czechia 284 01
    87 Dermamedica Náchod Czechia 547 01
    88 Local Institution - 403 Náchod Czechia 547 01
    89 CCBR Ostrava Ostrava Czechia 702 00
    90 Local Institution - 404 Ostrava Czechia 702 00
    91 Center for Clinical and Basic Research Czech Pardubice Pardubice Czechia 530 02
    92 Local Institution - 405 Pardubice Czechia 530 02
    93 CCBR Czech Prague s.r.o. Prague Czechia 130 00
    94 Local Institution - 400 Prague Czechia 130 00
    95 FN Motol Praha 5 Czechia 15006
    96 Local Institution - 401 Praha 5 Czechia 15006
    97 Clintrial Praha Czechia 100 00
    98 Local Institution - 402 Praha Czechia 100 00
    99 Dermatologicka Ambulance MUDr. Petr Trestik Svitavy Czechia 568 02
    100 Local Institution - 406 Svitavy Czechia 568 02
    101 Fukuoka University Hospital Fukuoka-shi, Fukuoka Japan 814-0180
    102 Local Institution - 514 Fukuoka-shi, Fukuoka Japan 814-0180
    103 Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers Fukuoka Japan 815-8588
    104 Local Institution - 504 Fukuoka Japan 815-8588
    105 Ichinomiya Municipal Hospital Ichinomiya Japan 491-8558
    106 Local Institution - 506 Ichinomiya Japan 491-8558
    107 Local Institution - 511 Itabashi-ku Japan 173-8606
    108 Teikyo University Hospital Itabashi-ku Japan 173-8606
    109 Local Institution - 515 Kagoshima Japan 890-0055
    110 Saruwatari Dermatology Clinic Kagoshima Japan 890-0055
    111 Local Institution - 513 Kofu Japan 400-0027
    112 Yamanashi Prefectual Central Hospital Kofu Japan 400-0027
    113 Local Institution - 505 Kyoto-City Japan 602-8566
    114 University Hospital Kyoto Prefectural University of Medicine Kyoto-City Japan 602-8566
    115 Charme-Clinique Matsudo Japan 270-2223
    116 Local Institution - 510 Matsudo Japan 270-2223
    117 Local Institution - 508 Nagoya Japan 467-8602
    118 Nagoya City University Hospital Nagoya Japan 467-8602
    119 Local Institution - 512 Obihiro Japan 080-0013
    120 Takagi Dermatology Obihiro Japan 080-0013
    121 Local Institution - 517 Osaka Japan Osaka
    122 Nakatsu Hifuka Clinic Osaka Japan Osaka
    123 Local Institution - 500 Sapporo-shi, Hokkaido Japan 060-0063
    124 Sapporo Skin Clinic Sapporo-shi, Hokkaido Japan 060-0063
    125 Local Institution - 501 Sapporo Japan 060-0063
    126 Medical Corporation Kojinkai Housui Sogo Medical Clinic Sapporo Japan 060-0063
    127 Local Institution - 502 Shinjuku Japan 160-0023
    128 Tokyo Medical University Hospital Shinjuku Japan 160-0023
    129 Local Institution - 509 Yokohoma City, Kanagawa Japan 221-0825
    130 Nomura Dermatology Clinic Yokohoma City, Kanagawa Japan 221-0825
    131 Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland 80-803
    132 Local Institution - 310 Gdansk Poland 80-803
    133 Care Clinic Katowice Poland 40-568
    134 Local Institution - 309 Katowice Poland 40-568
    135 Centrum Medyczne Angelius Provita Katowice Poland 40-611
    136 Local Institution - 306 Katowice Poland 40-611
    137 Centrum Medyczne Dermoklinika Lodz Poland 90-436
    138 Local Institution - 311 Lodz Poland 90-436
    139 Local Institution - 312 Olsztyn Poland 10-229
    140 Miejski Szpital Zespolony w Olsztynie Olsztyn Poland 10-229
    141 Klinika Zdybski Ostrowiec Świętokrzyski Poland 27-400
    142 Local Institution - 300 Ostrowiec Świętokrzyski Poland 27-400
    143 Laser Clinic Dermatologia Laserowa Medycyna Estetyczna Szczecin Poland 70-332
    144 Local Institution - 308 Szczecin Poland 70-332
    145 Local Institution - 302 Szczecin Poland 71-434
    146 Twoja Przychodnia Szczecinskie Centrum Medyczne Szczecin Poland 71-434
    147 High-Med Przychodnia Specjalistyczna Warsaw Poland 01-817
    148 Local Institution - 301 Warsaw Poland 01-817
    149 Klinika Ambroziak Estederm Warsaw Poland 02-953
    150 Local Institution - 307 Warsaw Poland 02-953
    151 Wojskowy Instytut Medyczny Warsaw Poland 04-141
    152 Centrum Zdrowia WroMedica Wroclaw Poland 51-685
    153 Local Institution - 305 Wroclaw Poland 51-685
    154 Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie Wrocław Poland 50-367
    155 Local Institution - 304 Wrocław Poland 50-367
    156 Local Institution - 303 Łódź Poland 90-265
    157 Specjalistyczne Gabinety Lekarskie DERMED Łódź Poland 90-265

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT04800315
    Other Study ID Numbers:
    • CC-93538-AD-001
    • 1111-1260-5462
    • 2020-005212-22
    First Posted:
    Mar 16, 2021
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Celgene
    Atopic Dermatitis
    Cendakimab
    CC-93538
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Jul 19, 2022