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

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

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).

Study Overview

• Status: Completed
• Conditions: Eczema; Dermatitis, Atopic
• Intervention / Treatment: Drug: CC-93538; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4X7
    • Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
  • Quebec, Canada, G1V 4X7
    • Local Institution - 202
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
      • Institute for Skin Advancement
    • Calgary, Alberta, Canada, T3A 2N1
      • Local Institution - 203
    • Edmonton, Alberta, Canada, T6G 1C3
      • Local Institution - 213
    • Edmonton, Alberta, Canada, T6G 1C3
      • Rao Dermatology
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-Ho Hong Medical Inc.
    • Surrey, British Columbia, Canada, V3R 6A7
      • Local Institution - 207
    • Surrey, British Columbia, Canada, V3V 0C6
      • Local Institution - 200
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Local Institution - 205
  • Ontario
    • Markham, Ontario, Canada, L3P IX3
      • Local Institution - 208
    • Markham, Ontario, Canada, L3P IX3
      • Lynderm Research Inc
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DERMEDGE
    • Mississauga, Ontario, Canada, L4Y 4C5
      • Local Institution - 211
    • Oakville, Ontario, Canada, L6J 7W5
      • The Centre for Clinical Trials Inc.
    • Oakville, Ontario, Canada, L6J 7W5
      • Local Institution - 209
• China
  • Ichikawa, China, 272-0033
    • Kawashima Dermatology
  • Ichikawa, China, 272-0033
    • Local Institution - 503
  • Matsudo, China, 271-0092
    • Local Institution - 507
  • Matsudo, China, 271-0092
    • Miyata Dermatology Clinic
• Czechia
  • Kutná Hora, Czechia, 284 01
    • Kozni ambulance Kutna Hora
  • Kutná Hora, Czechia, 284 01
    • Local Institution - 407
  • Náchod, Czechia, 547 01
    • Dermamedica
  • Náchod, Czechia, 547 01
    • Local Institution - 403
  • Ostrava, Czechia, 702 00
    • CCBR Ostrava
  • Ostrava, Czechia, 702 00
    • Local Institution - 404
  • Pardubice, Czechia, 530 02
    • Center for Clinical and Basic Research Czech Pardubice
  • Pardubice, Czechia, 530 02
    • Local Institution - 405
  • Prague, Czechia, 130 00
    • CCBR Czech Prague s.r.o.
  • Prague, Czechia, 130 00
    • Local Institution - 400
  • Praha, Czechia, 100 00
    • Clintrial
  • Praha, Czechia, 100 00
    • Local Institution - 402
  • Praha 5, Czechia, 15006
    • FN Motol
  • Praha 5, Czechia, 15006
    • Local Institution - 401
  • Svitavy, Czechia, 568 02
    • Dermatologicka Ambulance MUDr. Petr Trestik
  • Svitavy, Czechia, 568 02
    • Local Institution - 406
• Japan
  • Fukuoka, Japan, 815-8588
    • Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
  • Fukuoka, Japan, 815-8588
    • Local Institution - 504
  • Fukuoka-Shi, Japan, 8140180
    • Local Institution - 514
  • Fukuoka-shi, Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Ichinomiya, Japan, 491-8558
    • Ichinomiya Municipal Hospital
  • Ichinomiya, Japan, 491-8558
    • Local Institution - 506
  • Itabashi-ku, Japan, 173-8606
    • Teikyo University Hospital
  • Itabashi-ku, Japan, 1738606
    • Local Institution - 511
  • Kagoshima, Japan, 890-0055
    • Local Institution - 515
  • Kagoshima, Japan, 890-0055
    • Saruwatari Dermatology Clinic
  • Kofu, Japan, 400-0027
    • Local Institution - 513
  • Kofu, Japan, 400-0027
    • Yamanashi Prefectual Central Hospital
  • Kyoto-City, Japan, 602-8566
    • Local Institution - 505
  • Kyoto-City, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Matsudo, Japan, 270-2223
    • Charme-Clinique
  • Matsudo, Japan, 270-2223
    • Local Institution - 510
  • Nagoya, Japan, 467-8602
    • Nagoya City University Hospital
  • Nagoya, Japan, 467-8602
    • Local Institution - 508
  • Obihiro, Japan, 080-0013
    • Local Institution - 512
  • Obihiro, Japan, 080-0013
    • Takagi Dermatology
  • Osaka, Japan, Osaka
    • Local Institution - 517
  • Osaka, Japan, Osaka
    • Nakatsu Hifuka Clinic
  • Sapporo, Japan, 060-0063
    • Local Institution - 501
  • Sapporo, Japan, 060-0063
    • Medical Corporation Kojinkai Housui Sogo Medical Clinic
  • Sapporo-shi, Hokkaido, Japan, 060-0063
    • Local Institution - 500
  • Sapporo-shi, Hokkaido, Japan, 060-0063
    • Sapporo Skin Clinic
  • Shinjuku, Japan, 160-0023
    • Local Institution - 502
  • Shinjuku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Yokohoma City, Kanagawa, Japan, 221-0825
    • Local Institution - 509
  • Yokohoma City, Kanagawa, Japan, 221-0825
    • Nomura Dermatology Clinic
• Poland
  • Gdansk, Poland, 80-803
    • Copernicus Podmiot Leczniczy Sp. z o.o.
  • Gdansk, Poland, 80-803
    • Local Institution - 310
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40-568
    • CARe Clinic
  • Katowice, Poland, 40-568
    • Local Institution - 309
  • Katowice, Poland, 40-611
    • Local Institution - 306
  • Lodz, Poland, 90-436
    • Centrum Medyczne Dermoklinika
  • Lodz, Poland, 90-436
    • Local Institution - 311
  • Olsztyn, Poland, 10-229
    • Miejski Szpital Zespolony w Olsztynie
  • Olsztyn, Poland, 10-229
    • Local Institution - 312
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Klinika Zdybski
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Local Institution - 300
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia Szczecinskie Centrum Medyczne
  • Szczecin, Poland, 70-332
    • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
  • Szczecin, Poland, 70-332
    • Local Institution - 308
  • Szczecin, Poland, 71-434
    • Local Institution - 302
  • Warsaw, Poland, 01-817
    • High-Med Przychodnia Specjalistyczna
  • Warsaw, Poland, 01-817
    • Local Institution - 301
  • Warsaw, Poland, 02-953
    • Klinika Ambroziak ESTEDERM
  • Warsaw, Poland, 02-953
    • Local Institution - 307
  • Warsaw, Poland, 04-141
    • Wojskowy Instytut Medyczny
  • Wroclaw, Poland, 51-685
    • Centrum Zdrowia WroMedica
  • Wroclaw, Poland, 51-685
    • Local Institution - 305
  • Wrocław, Poland, 50-367
    • Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie
  • Wrocław, Poland, 50-367
    • Local Institution - 304
  • Łódź, Poland, 90-265
    • Local Institution - 303
  • Łódź, Poland, 90-265
    • Specjalistyczne Gabinety Lekarskie DERMED
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology
    • Birmingham, Alabama, United States, 35209
      • Local Institution - 119
    • Birmingham, Alabama, United States, 35244
      • Local Institution - 114
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913-6440
      • Burke Pharmaceutical Research
    • Hot Springs, Arkansas, United States, 71913-6440
      • Local Institution - 129
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fountain Valley, California, United States, 92708
      • Local Institution - 105
  • District of Columbia
    • Washington, District of Columbia, United States, 20037-3201
      • George Washington University School of Medicine and Health Sciences
    • Washington, District of Columbia, United States, 20037-3201
      • Local Institution - 128
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Total Vein and Skin, LLC
    • Delray Beach, Florida, United States, 33484-6500
      • Local Institution - 106
    • Delray Beach, Florida, United States, 33484-6500
      • Palm Beach Dermatology Group
    • Saint Petersburg, Florida, United States, 33702
      • GCP Global Clinical Professionals
    • Saint Petersburg, Florida, United States, 33702
      • Local Institution - 135
    • Tampa, Florida, United States, 33624-2038
      • ForCare Clinical Research
    • Tampa, Florida, United States, 33624-2038
      • Local Institution - 101
    • West Palm Beach, Florida, United States, 33401-3430
      • Local Institution - 103
    • West Palm Beach, Florida, United States, 33401-3430
      • Metabolic Research Institute Inc
  • Georgia
    • Savannah, Georgia, United States, 31406-2668
      • Aeroallergy Research Labs of Savannah
    • Savannah, Georgia, United States, 31406-2668
      • Local Institution - 134
  • Illinois
    • Springfield, Illinois, United States, 62702-5115
      • Local Institution - 108
    • Springfield, Illinois, United States, 62702-5115
      • Sneeze Wheeze and Itch Associates Llc
  • Indiana
    • Clarksville, Indiana, United States, 47129-2201
      • DS Research
    • Clarksville, Indiana, United States, 47129-2201
      • Local Institution - 115
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
    • Indianapolis, Indiana, United States, 46256
      • Local Institution - 110
    • West Lafayette, Indiana, United States, 47906-1569
      • Local Institution - 107
    • West Lafayette, Indiana, United States, 47906-1569
      • Randall Dermatology
    • Westfield, Indiana, United States, 46074
      • Local Institution - 138
    • Westfield, Indiana, United States, 46074
      • Randall Dermatology - Westfield Campus
  • Kansas
    • Overland Park, Kansas, United States, 66215-2377
      • Kansas City Dermatology P.A.
    • Overland Park, Kansas, United States, 66215-2377
      • Local Institution - 116
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • DS Research
    • Louisville, Kentucky, United States, 40241
      • Local Institution - 117
  • Maryland
    • Silver Spring, Maryland, United States, 20902-5006
      • Dermassociates
    • Silver Spring, Maryland, United States, 20902-5006
      • Local Institution - 125
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Local Institution - 133
    • Clarkston, Michigan, United States, 48346
      • Skin Research Clarkston/Clarkston Dermatology
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC
    • Omaha, Nebraska, United States, 68144
      • Local Institution - 137
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • JDR Dermatology Research, LLC
    • Las Vegas, Nevada, United States, 89148
      • Local Institution - 121
  • New Jersey
    • Hackensack, New Jersey, United States, 07601-1974
      • Local Institution - 112
    • Hackensack, New Jersey, United States, 07601-1974
      • Skin Laser and Surgery Specialists of New York and New Jersey LLC
  • New York
    • Great Neck, New York, United States, 11021-5506
      • Icahn School of Medicine at Mount Sinai
    • Great Neck, New York, United States, 11021-5506
      • Local Institution - 130
    • New York, New York, United States, 10075
      • Sadick Research Group
    • New York, New York, United States, 10075
      • Local Institution - 126
  • Oklahoma
    • Norman, Oklahoma, United States, 73069-6301
      • Central Sooner Research
    • Norman, Oklahoma, United States, 73069-6301
      • Local Institution - 111
    • Tulsa, Oklahoma, United States, 74136-8303
      • Local Institution - 127
    • Tulsa, Oklahoma, United States, 74136-8303
      • Vital Prospects Clinical Research Institute PC - CRN - PPDS
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center, P.C.
    • Portland, Oregon, United States, 97223
      • Local Institution - 109
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
    • Johnston, Rhode Island, United States, 02919
      • Local Institution - 123
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research
    • Murfreesboro, Tennessee, United States, 37130
      • Local Institution - 100
  • Virginia
    • Henrico, Virginia, United States, 23233-1487
      • Clinical Research Partners LLC
    • Richmond, Virginia, United States, 23233-1436
      • Local Institution - 104
    • Richmond, Virginia, United States, 23233-1436
      • West End Dermatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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):

   1. Body Surface Area (BSA) ≥ 10%, and
   2. EASI score ≥ 16, and
   3. vIGA-AD ≥ 3, and
   4. Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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; Specified dosages on specified days; Other Names: cendakimab; RPC4064
Placebo Comparator: Placebo SC QW; Administration of placebo each week.	Other: Placebo; Specified dosages on specified days
Experimental: Dose 2: CC-93538 SC Q2W and Placebo alternating every other week 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; Specified dosages on specified days; Other Names: cendakimab; RPC4064; Other: Placebo; Specified dosages on specified days
Experimental: Dose 3: CC-93538 SC Q2W and Placebo SC weekly; 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; Specified dosages on specified days; Other Names: cendakimab; RPC4064; Other: Placebo; Specified dosages on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage Change From Baseline in EASI at 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) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better.	From initial EASI measurement to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders With an vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥ 2 Points From Baseline at 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). The rating of clear (0), almost clear (1), mild (2), moderate (3) and severe (4), will be assessed at scheduled visits. The vIGA-AD must be conducted before the EASI assessment. The vIGA-AD is a static evaluation conducted without regard to the score obtained at a previous visit. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose vIGA-AD response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR).	From initial vIGA-AD assessment to week 16
Percentage of EASI-75 Responders at 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 and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose EASI-75 response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR).	From initial EASI measurement to week 16
Percentage of EASI-90 Responders at 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) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose EASI-90 response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR).	From initial EASI measurement to week 16
Percent Change in Mean SCORAD Scores From Baseline at Week 16	The 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). The subject will assess the subjective symptoms (itch and sleepless) part of the assessment. SCORing Atopic Dermatitis Index (SCORAD) score ranges from 0 to 103, higher scores indicate more severe disease.	From initial SCORAD measurement to week 16
Percent Change From Baseline in Pruritus NRS at Week 16	Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable").	From initial NRS measurement to week 16
Percentage of Participants With a Response and Pruritus NRS Change of ≥ 4 Points From Baseline at Week 16	Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose pruritus NRS response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR).	From initial NRS assessment to week 16
Time to Achieve at Least 4 Points of Improvement in the Severity of Pruritus NRS Scale.	Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable").	From initial NRS pruritus response up to study day 127 (127 days)
Adjust Mean Percentage Change in BSA in Atopic Dermatitis From Baseline at Week 16	Body Surface Area involvement will be calculated from the sum of the number of handprints of skin afflicted with atopic dermatitis in a body region. The number of handprints of skin afflicted with atopic dermatitis in a body region can be used to determine the extent (%) to which a body region is involved with AD. When measuring, the handprint unit refers to the size of each individual subject's hand with fingers in a closed position. BSA will be calculated by the Investigator or qualified designee using the 1% handprint rule, in which the area represented by the palm with all 5 digits adducted together is approximately 1% of the subject's BSA.	From initial BSA assessment to week 16
Number of Participants With Treatment Emergent Adverse Events	Treatment emergent adverse events	From first treatment to the end of follow up, approximately 32 weeks
Number of Participants With the Presence of Serum Antibodies to CC-93538		From first treatment to the end of follow up, approximately 32 weeks
Serum Trough Concentration at Week 16	A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of CC-93538 will be summarized with descriptive statistics by treatment and visit.	At week 16
Number of Participants With Clinically Significant Laboratory Abnormalities		From first treatment to the end of follow up, approximately 32 weeks

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): November 9, 2022

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cendakimab; Atopic Dermatitis; CC-93538
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CC-93538-AD-001; 1111-1260-5462 (Registry Identifier: WHO); 2020-005212-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No