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

NCT04800315 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CC-93538-AD-0011111-1260-54622020-005212-22
• Study Type: interventional
• Target: 221
• Locations: 6 countries
• Sites: 157

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).

Conditions

Dermatitis, Atopic; Eczema

Keywords

Atopic Dermatitis; Cendakimab; CC-93538

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

  From initial vIGA-AD assessment to week 16

• Percentage of EASI-75 Responders at Week 16

  From initial EASI measurement to week 16

• Percentage of EASI-90 Responders at Week 16

  From initial EASI measurement to week 16

• Percent Change in Mean SCORAD Scores From Baseline at Week 16

  From initial SCORAD measurement to week 16

• Percent Change From Baseline in Pruritus NRS at Week 16

  From initial NRS measurement to week 16

Study Arms (4)

Dose 1: CC-93538 SC QW

EXPERIMENTAL

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

Drug: CC-93538

Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2W

EXPERIMENTAL

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; Other: Placebo

Dose 3: CC-93538 SC Q2W and Placebo SC weekly

EXPERIMENTAL

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; Other: Placebo

Placebo SC QW

PLACEBO COMPARATOR

Administration of placebo each week.

Other: Placebo

Interventions

CC-93538 DRUG

Specified dosages on specified days

Also known as: RPC4064, cendakimab

Dose 1: CC-93538 SC QW; Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2W; Dose 3: CC-93538 SC Q2W and Placebo SC weekly

Placebo OTHER

Specified dosages on specified days

Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2W; Dose 3: CC-93538 SC Q2W and Placebo SC weekly; Placebo SC QW

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must satisfy the following criteria to be enrolled in the study:
• 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).
• 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).
• 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):
• Body Surface Area (BSA) ≥ 10%, and
• EASI score ≥ 16, and
• vIGA-AD ≥ 3, and
• Pruritus Numeric Rating Scale (NRS) severity score ≥ 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.
• 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.
• 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.
• 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.
• Female participants of childbearing potential must agree to practice a highly effective method of contraception.

You may not qualify if:

• 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.
• Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline).
• 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.
• Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit.
• 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.
• Treatment with immunomodulatory biologics
• Concurrent treatment with another IP
• 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.
• Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.
• Ongoing infection

Sponsors & Collaborators

• Celgene: lead

Study Sites (157)

Clinical Research Center of Alabama

Birmingham, Alabama, 35209, United States

Location

Local Institution - 119

Birmingham, Alabama, 35209, United States

Location

Cahaba Dermatology

Birmingham, Alabama, 35244, United States

Location

Local Institution - 114

Birmingham, Alabama, 35244, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913-6440, United States

Location

Local Institution - 129

Hot Springs, Arkansas, 71913-6440, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Local Institution - 105

Fountain Valley, California, 92708, United States

Location

George Washington University School of Medicine and Health Sciences

Washington D.C., District of Columbia, 20037-3201, United States

Location

Local Institution - 128

Washington D.C., District of Columbia, 20037-3201, United States

Location

Total Vein and Skin, LLC

Boynton Beach, Florida, 33437, United States

Location

Local Institution - 106

Delray Beach, Florida, 33484-6500, United States

Location

Palm Beach Dermatology Group

Delray Beach, Florida, 33484-6500, United States

Location

GCP Global Clinical Professionals

St. Petersburg, Florida, 33702, United States

Location

Local Institution - 135

St. Petersburg, Florida, 33702, United States

Location

ForCare Clinical Research

Tampa, Florida, 33624-2038, United States

Location

Local Institution - 101

Tampa, Florida, 33624-2038, United States

Location

Local Institution - 103

West Palm Beach, Florida, 33401-3430, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401-3430, United States

Location

Aeroallergy Research Labs of Savannah

Savannah, Georgia, 31406-2668, United States

Location

Local Institution - 134

Savannah, Georgia, 31406-2668, United States

Location

Local Institution - 108

Springfield, Illinois, 62702-5115, United States

Location

Sneeze Wheeze and Itch Associates LLC

Springfield, Illinois, 62702-5115, United States

Location

DS Research

Clarksville, Indiana, 47129-2201, United States

Location

Local Institution - 115

Clarksville, Indiana, 47129-2201, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Local Institution - 110

Indianapolis, Indiana, 46256, United States

Location

Local Institution - 107

West Lafayette, Indiana, 47906-1569, United States

Location

Randall Dermatology

West Lafayette, Indiana, 47906-1569, United States

Location

Local Institution - 138

Westfield, Indiana, 46074, United States

Location

Randall Dermatology - Westfield Campus

Westfield, Indiana, 46074, United States

Location

Kansas City Dermatology P.A.

Overland Park, Kansas, 66215-2377, United States

Location

Local Institution - 116

Overland Park, Kansas, 66215-2377, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Local Institution - 117

Louisville, Kentucky, 40241, United States

Location

DermAssociates

Silver Spring, Maryland, 20902-5006, United States

Location

Local Institution - 125

Silver Spring, Maryland, 20902-5006, United States

Location

Local Institution - 133

Clarkston, Michigan, 48346, United States

Location

Skin Research Clarkston/Clarkston Dermatology

Clarkston, Michigan, 48346, United States

Location

Local Institution - 137

Omaha, Nebraska, 68144, United States

Location

Skin Specialists PC

Omaha, Nebraska, 68144, United States

Location

JDR Dermatology Research, LLC

Las Vegas, Nevada, 89148, United States

Location

Local Institution - 121

Las Vegas, Nevada, 89148, United States

Location

Local Institution - 112

Hackensack, New Jersey, 07601-1974, United States

Location

Skin Laser and Surgery Specialists of New York and New Jersey LLC

Hackensack, New Jersey, 07601-1974, United States

Location

Icahn School of Medicine at Mount Sinai

Great Neck, New York, 11021-5506, United States

Location

Local Institution - 130

Great Neck, New York, 11021-5506, United States

Location

Local Institution - 126

New York, New York, 10075, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Central Sooner Research

Norman, Oklahoma, 73069-6301, United States

Location

Local Institution - 111

Norman, Oklahoma, 73069-6301, United States

Location

Local Institution - 127

Tulsa, Oklahoma, 74136-8303, United States

Location

Vital Prospects Clinical Research Institute PC - CRN - PPDS

Tulsa, Oklahoma, 74136-8303, United States

Location

Local Institution - 109

Portland, Oregon, 97223, United States

Location

Oregon Medical Research Center, P.C.

Portland, Oregon, 97223, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Local Institution - 123

Johnston, Rhode Island, 02919, United States

Location

International Clinical Research

Murfreesboro, Tennessee, 37130, United States

Location

Local Institution - 100

Murfreesboro, Tennessee, 37130, United States

Location

Clinical Research Partners LLC

Henrico, Virginia, 23233-1487, United States

Location

Local Institution - 104

Richmond, Virginia, 23233-1436, United States

Location

West End Dermatology Associates

Richmond, Virginia, 23233-1436, United States

Location

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1, Canada

Location

Local Institution - 203

Calgary, Alberta, T3A 2N1, Canada

Location

Local Institution - 213

Edmonton, Alberta, T6G 1C3, Canada

Location

Rao Dermatology

Edmonton, Alberta, T6G 1C3, Canada

Location

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Local Institution - 207

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Local Institution - 200

Surrey, British Columbia, V3V 0C6, Canada

Location

Local Institution - 205

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Local Institution - 208

Markham, Ontario, L3P IX3, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P IX3, Canada

Location

DermEdge

Mississauga, Ontario, L4Y 4C5, Canada

Location

Local Institution - 211

Mississauga, Ontario, L4Y 4C5, Canada

Location

Local Institution - 209

Oakville, Ontario, L6J 7W5, Canada

Location

The Centre for Clinical Trials Inc.

Oakville, Ontario, L6J 7W5, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

Québec, G1V 4X7, Canada

Location

Local Institution - 202

Québec, G1V 4X7, Canada

Location

Kawashima Dermatology

Ichikawa, 272-0033, China

Location

Local Institution - 503

Ichikawa, 272-0033, China

Location

Local Institution - 507

Matsudo, 271-0092, China

Location

Miyata Dermatology Clinic

Matsudo, 271-0092, China

Location

Kozni ambulance Kutna Hora

Kutná Hora, 284 01, Czechia

Location

Local Institution - 407

Kutná Hora, 284 01, Czechia

Location

Dermamedica

Náchod, 547 01, Czechia

Location

Local Institution - 403

Náchod, 547 01, Czechia

Location

CCBR Ostrava

Ostrava, 702 00, Czechia

Location

Local Institution - 404

Ostrava, 702 00, Czechia

Location

Center for Clinical and Basic Research Czech Pardubice

Pardubice, 530 02, Czechia

Location

Local Institution - 405

Pardubice, 530 02, Czechia

Location

Clintrial

Prague, 100 00, Czechia

Location

Local Institution - 402

Prague, 100 00, Czechia

Location

CCBR Czech Prague s.r.o.

Prague, 130 00, Czechia

Location

Local Institution - 400

Prague, 130 00, Czechia

Location

FN Motol

Prague, 15006, Czechia

Location

Local Institution - 401

Prague, 15006, Czechia

Location

Dermatologicka Ambulance MUDr. Petr Trestik

Svitavy, 568 02, Czechia

Location

Local Institution - 406

Svitavy, 568 02, Czechia

Location

Local Institution - 514

Fukuoka, 8140180, Japan

Location

Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers

Fukuoka, 815-8588, Japan

Location

Local Institution - 504

Fukuoka, 815-8588, Japan

Location

Fukuoka University Hospital

Fukuoka-shi, Fukuoka, 814-0180, Japan

Location

Ichinomiya Municipal Hospital

Ichinomiya, 491-8558, Japan

Location

Local Institution - 506

Ichinomiya, 491-8558, Japan

Location

Teikyo University Hospital

Itabashi-ku, 173-8606, Japan

Location

Local Institution - 511

Itabashi-ku, 1738606, Japan

Location

Local Institution - 515

Kagoshima, 890-0055, Japan

Location

Saruwatari Dermatology Clinic

Kagoshima, 890-0055, Japan

Location

Local Institution - 513

Kofu, 400-0027, Japan

Location

Yamanashi Prefectual Central Hospital

Kofu, 400-0027, Japan

Location

Local Institution - 505

Kyoto, 602-8566, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Charme-Clinique

Matsudo, 270-2223, Japan

Location

Local Institution - 510

Matsudo, 270-2223, Japan

Location

Local Institution - 508

Nagoya, 467-8602, Japan

Location

Nagoya City University Hospital

Nagoya, 467-8602, Japan

Location

Local Institution - 512

Obihiro, 080-0013, Japan

Location

Takagi Dermatology

Obihiro, 080-0013, Japan

Location

Local Institution - 517

Osaka, Osaka, Japan

Location

Nakatsu Hifuka Clinic

Osaka, Osaka, Japan

Location

Local Institution - 501

Sapporo, 060-0063, Japan

Location

Medical Corporation Kojinkai Housui Sogo Medical Clinic

Sapporo, 060-0063, Japan

Location

Local Institution - 500

Sapporo-shi, Hokkaido, 060-0063, Japan

Location

Sapporo Skin Clinic

Sapporo-shi, Hokkaido, 060-0063, Japan

Location

Local Institution - 502

Shinjuku, 160-0023, Japan

Location

Tokyo Medical University Hospital

Shinjuku, 160-0023, Japan

Location

Local Institution - 509

Yokohoma City, Kanagawa, 221-0825, Japan

Location

Nomura Dermatology Clinic

Yokohoma City, Kanagawa, 221-0825, Japan

Location

Copernicus Podmiot Leczniczy Sp. z o.o.

Gdansk, 80-803, Poland

Location

Local Institution - 310

Gdansk, 80-803, Poland

Location

Care Clinic

Katowice, 40-568, Poland

Location

Local Institution - 309

Katowice, 40-568, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Local Institution - 306

Katowice, 40-611, Poland

Location

Local Institution - 303

Lodz, 90-265, Poland

Location

Specjalistyczne Gabinety Lekarskie DERMED

Lodz, 90-265, Poland

Location

Centrum Medyczne Dermoklinika

Lodz, 90-436, Poland

Location

Local Institution - 311

Lodz, 90-436, Poland

Location

Local Institution - 312

Olsztyn, 10-229, Poland

Location

Miejski Szpital Zespolony w Olsztynie

Olsztyn, 10-229, Poland

Location

Klinika Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Local Institution - 300

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

Szczecin, 70-332, Poland

Location

Local Institution - 308

Szczecin, 70-332, Poland

Location

Local Institution - 302

Szczecin, 71-434, Poland

Location

Twoja Przychodnia Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

High-Med Przychodnia Specjalistyczna

Warsaw, 01-817, Poland

Location

Local Institution - 301

Warsaw, 01-817, Poland

Location

Klinika Ambroziak Estederm

Warsaw, 02-953, Poland

Location

Local Institution - 307

Warsaw, 02-953, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 04-141, Poland

Location

Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie

Wroclaw, 50-367, Poland

Location

Local Institution - 304

Wroclaw, 50-367, Poland

Location

Centrum Zdrowia WroMedica

Wroclaw, 51-685, Poland

Location

Local Institution - 305

Wroclaw, 51-685, Poland

Location

Related Publications (1)

• Blauvelt A, Guttman-Yassky E, Lynde C, Khattri S, Schlessinger J, Imafuku S, Tada Y, Morita A, Wiseman M, Kwiek B, Machkova M, Zhang P, Linaberry M, Li J, Zhang S, Franchin G, Charles ED, De Oliveira CHMC, Silverberg JI. Cendakimab in Patients With Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Aug 1;160(8):856-864. doi: 10.1001/jamadermatol.2024.2131.

  PMID: 39018038 DERIVED

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

cendakimab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: May 14, 2021
• Primary Completion: July 20, 2022
• Study Completion: November 9, 2022
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

PL (27); CN (4); JP (30); US (62); CA (18); CZ (16)