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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05014438




Registration number
NCT05014438
Ethics application status
Date submitted
29/07/2021
Date registered
20/08/2021
Date last updated
18/10/2023

Titles & IDs
Public title
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Scientific title
A Phase 2, Randomized, Double-blinded, Placebo-controlled, 5 Parallel-group Study of BMS-986166 or Branebrutinib for the Treatment of Patients With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
2020-004767-77
Secondary ID [2] 0 0
IM018-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis, Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986166
Treatment: Drugs - Branebrutinib
Other interventions - Placebo

Placebo Comparator: Placebo -

Experimental: Treatment BMS-986166 Dose 1 -

Experimental: Treatment BMS-986166 Dose 2 -

Experimental: Treatment BMS-986166 Dose 3 -

Experimental: Treatment Branebrutinib -


Treatment: Drugs: BMS-986166
Specified dose on specified days

Treatment: Drugs: Branebrutinib
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Percentage Change From Baseline in EASI Score at Week 16
Timepoint [1] 0 0
From baseline and 16 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From baseline and 16 weeks
Secondary outcome [2] 0 0
Percentage of Participants Exhibiting a = 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16
Timepoint [2] 0 0
From baseline and 16 weeks
Secondary outcome [3] 0 0
Percentage of Participants Exhibiting a = 4-point Improvement From Baseline in Pruritus NRS at Week 16
Timepoint [3] 0 0
From baseline and 16 weeks
Secondary outcome [4] 0 0
Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16
Timepoint [4] 0 0
From baseline and 16 weeks
Secondary outcome [5] 0 0
Mean Change From Baseline in Percentage of Affected BSA at Week 16
Timepoint [5] 0 0
From baseline and 16 weeks
Secondary outcome [6] 0 0
Number of Participants With Mild Moderate or Severe AEs
Timepoint [6] 0 0
From initial treatment to 30 days post discontinuation, approximately 29 weeks
Secondary outcome [7] 0 0
Number of Participants With Mild Moderate or Severe SAEs
Timepoint [7] 0 0
From initial treatment to 30 days post discontinuation, approximately 29 weeks
Secondary outcome [8] 0 0
Number of Participants With Clinically Relevant ECG Abnormalities
Timepoint [8] 0 0
Week 24 after initial treatment
Secondary outcome [9] 0 0
Number of Participants With Clinically Relevant OCT Abnormalities
Timepoint [9] 0 0
Week 24 after initial treatment
Secondary outcome [10] 0 0
Number of Participants With Clinically Relevant PFT Abnormalities
Timepoint [10] 0 0
Week 24 after initial treatment
Secondary outcome [11] 0 0
Number of Participants With Clinically Meaningful Changes in Vital Signs
Timepoint [11] 0 0
Week 24 after initial treatment
Secondary outcome [12] 0 0
Number of Participants With Clinically Relevant Changes in LFTs
Timepoint [12] 0 0
Week 24 after initial treatment

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2022
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Premier Dermatology - Kogarah
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital-Dermatology - Westmead
Recruitment hospital [4] 0 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
West Virginia
Country [12] 0 0
Austria
State/province [12] 0 0
Linz
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Bochum
Country [17] 0 0
Germany
State/province [17] 0 0
Bonn
Country [18] 0 0
Germany
State/province [18] 0 0
Gera
Country [19] 0 0
Germany
State/province [19] 0 0
Hannover
Country [20] 0 0
Germany
State/province [20] 0 0
Kiel
Country [21] 0 0
Germany
State/province [21] 0 0
Munich
Country [22] 0 0
Germany
State/province [22] 0 0
Osnabrück
Country [23] 0 0
Germany
State/province [23] 0 0
Selters
Country [24] 0 0
Poland
State/province [24] 0 0
Mazowieckie
Country [25] 0 0
Poland
State/province [25] 0 0
Bydgoszcz
Country [26] 0 0
Poland
State/province [26] 0 0
Olsztyn
Country [27] 0 0
Spain
State/province [27] 0 0
Andalucía
Country [28] 0 0
Spain
State/province [28] 0 0
Alicante
Country [29] 0 0
Spain
State/province [29] 0 0
Las
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05014438
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries