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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: Branebrutinib; Other: Placebo; Drug: BMS-986166

Study type: Interventional

Funder types: Industry

Identifiers

NCT05014438

U1111-1259-1220 (Registry Identifier)

IM018-005

2020-004767-77 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Treatment BMS-986166 Dose 1

Experimental group

Treatment:

Drug: BMS-986166

Treatment BMS-986166 Dose 2

Experimental group

Treatment:

Drug: BMS-986166

Treatment BMS-986166 Dose 3

Experimental group

Treatment:

Drug: BMS-986166

Treatment Branebrutinib

Experimental group

Treatment:

Drug: Branebrutinib