A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis

NCT05014438 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IM018-0052020-004767-77U1111-1259-1220
• Study Type: interventional
• Target: 17
• Locations: 6 countries
• Sites: 41

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166 and of branebrutinib, each versus placebo, for the treatment of participants with moderate to severe atopic dermatitis.

Conditions

Dermatitis, Atopic

Keywords

Atopic Dermatitis; BMS-986166; BMS-986195; Branebrutinib

Outcome Measures

Primary Outcomes (1)

• Mean Percentage Change From Baseline in EASI Score at Week 16

  The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent 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 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.

  From baseline and 16 weeks

Secondary Outcomes (12)

• Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16

  From baseline and 16 weeks

• Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16

  From baseline and 16 weeks

• Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16

  From baseline and 16 weeks

• Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16

  From baseline and 16 weeks

• Mean Change From Baseline in Percentage of Affected BSA at Week 16

  From baseline and 16 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Treatment BMS-986166 Dose 1

EXPERIMENTAL

Drug: BMS-986166

Treatment BMS-986166 Dose 2

EXPERIMENTAL

Drug: BMS-986166

Treatment BMS-986166 Dose 3

EXPERIMENTAL

Drug: BMS-986166

Treatment Branebrutinib

EXPERIMENTAL

Drug: Branebrutinib

Interventions

BMS-986166 DRUG

Specified dose on specified days

Treatment BMS-986166 Dose 1; Treatment BMS-986166 Dose 2; Treatment BMS-986166 Dose 3

Branebrutinib DRUG

Specified dose on specified days

Also known as: BMS-986195

Treatment Branebrutinib

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

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

You may qualify if:

• Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of Hanifin's and Rajka's (E-HR) criteria at Screening
• Disease duration of at least 24 months since diagnosis by any criteria
• Documented history of inadequate control of AD by a stable regimen (≥ 4 weeks) of topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of randomization, or inappropriateness of therapy due to side effects or safety risks leading to prior discontinuation
• Application of fixed doses of an additive-free, basic bland emollient twice-daily for ≥ 7 days before baseline visit and for the duration of the study

You may not qualify if:

• Any major illness/condition or evidence of an unstable clinical condition or local active infection/infectious illness that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study or interfere with the interpretation of study results
• Clinically relevant cardiovascular conditions or pulmonary conditions
• High likelihood - based on participant history, and investigator judgement - of requiring rescue therapy in \< 4 weeks prior to randomization
• Evidence of acute flare between the Screening and Baseline/ Randomization
• Skin lesion(s) and/or pruritus due to conditions other than AD that would interfere with the study specified assessments

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (42)

Local Institution - 0091

Fremont, California, 94538, United States

Location

Local Institution - 0112

Brandon, Florida, 33511, United States

Location

Local Institution - 0061

Coral Gables, Florida, 33134, United States

Location

Local Institution - 0110

Margate, Florida, 33063, United States

Location

Local Institution - 0006

Miami Lakes, Florida, 33014, United States

Location

Local Institution

Tampa, Florida, 33613, United States

Location

Local Institution - 0008

Skokie, Illinois, 60077, United States

Location

Local Institution - 0081

Indianapolis, Indiana, 46250, United States

Location

Local Institution - 0083

Louisville, Kentucky, 40217, United States

Location

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, 20850, United States

Location

Local Institution - 0051

Saint Joseph, Missouri, 64506, United States

Location

Local Institution

New York, New York, 10029, United States

Location

Local Institution - 0078

Philadelphia, Pennsylvania, 19103, United States

Location

Local Institution - 0094

Pittsburgh, Pennsylvania, 15213, United States

Location

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

Local Institution

San Antonio, Texas, 78213, United States

Location

Local Institution - 0003

Morgantown, West Virginia, 26505, United States

Location

Premier Dermatology

Kogarah, New South Wales, 2217, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Westmead Hospital-Dermatology

Westmead, New South Wales, 2145, Australia

Location

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

Local Institution

Linz, 4020, Austria

Location

Local Institution

Markham, Ontario, L3P 1X2, Canada

Location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4C 9M7, Canada

Location

SIMa Recherche

Verdun, Quebec, H4G 3E7, Canada

Location

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117, Germany

Location

Local Institution

Berlin, 12459, Germany

Location

Local Institution - 0034

Bochum, 44793, Germany

Location

Universitätsklinikum Bonn-Studienzentrum Dermatologie

Bonn, 53127, Germany

Location

SRH Wald-Klinikum Gera-Zentrum für klinische Studien

Gera, 07548, Germany

Location

Local Institution

Hanover, 30625, Germany

Location

Universitatsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Local Institution

Munich, 80337, Germany

Location

KliFOs - Klinische Forschung Osnabrück

Osnabrück, 49074, Germany

Location

Private Practice - Dr. Ralph von Kiedrowski

Selters, 56242, Germany

Location

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

NZOZ Centrum Medyczne KERmed

Bydgoszcz, 85-231, Poland

Location

ETYKA Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

Local Institution - 0130

Córdoba, Andalusia, 14004, Spain

Location

Hospital General Universitario de Alicante-Dermatology

Alicante, 03010, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología

Las, 35010, Spain

Location

Hospital Universitario La Paz-UCICEC/DERMA

Madrid, 28046, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

BMS-986166; branebrutinib

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: July 29, 2021
• First Posted: August 20, 2021
• Study Start: August 17, 2021
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: October 18, 2023
• Results First Posted: October 18, 2023

Record last verified: 2023-09

Locations

US (17); AU (4); DE (10); PL (3); ES (4); CA (3)