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

Dermatitis, Atopic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05014438
• Other study ID #: IM018-005
• Secondary ID: 2020-004767-77U1
• Status: Completed
• Phase: Phase 2
• Start date: August 17, 2021
• Est. completion date: August 22, 2022

Study information

• Verified date: September 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• BMS-986166
Specified dose on specified days
• Branebrutinib
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Premier Dermatology	Kogarah	New South Wales
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	Westmead Hospital-Dermatology	Westmead	New South Wales
Austria	Local Institution	Linz
Canada	Local Institution	Markham	Ontario
Canada	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario
Canada	SIMa Recherche	Verdun	Quebec
Germany	Charité Universitaetsmedizin Berlin - Campus Mitte	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution - 0034	Bochum
Germany	Universitätsklinikum Bonn-Studienzentrum Dermatologie	Bonn
Germany	SRH Wald-Klinikum Gera-Zentrum für klinische Studien	Gera
Germany	Local Institution	Hannover
Germany	Universitatsklinikum Schleswig-Holstein	Kiel
Germany	Local Institution	Munich
Germany	KliFOs - Klinische Forschung Osnabrück	Osnabrück
Germany	Private Practice - Dr. Ralph von Kiedrowski	Selters
Poland	NZOZ Centrum Medyczne KERmed	Bydgoszcz
Poland	ETYKA Osrodek Badan Klinicznych	Olsztyn
Poland	Royalderm Agnieszka Nawrocka	Warszawa	Mazowieckie
Spain	Hospital General Universitario de Alicante-Dermatology	Alicante
Spain	Local Institution - 0130	Cordoba	Andalucía
Spain	Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología	Las
Spain	Hospital Universitario La Paz-UCICEC/DERMA	Madrid
United States	The University of Texas Health Science Center at Houston	Bellaire	Texas
United States	Local Institution - 0112	Brandon	Florida
United States	Local Institution - 0061	Coral Gables	Florida
United States	Local Institution - 0091	Fremont	California
United States	Local Institution - 0081	Indianapolis	Indiana
United States	Local Institution - 0083	Louisville	Kentucky
United States	Local Institution - 0110	Margate	Florida
United States	Local Institution - 0006	Miami Lakes	Florida
United States	Local Institution - 0003	Morgantown	West Virginia
United States	Local Institution	New York	New York
United States	Local Institution - 0078	Philadelphia	Pennsylvania
United States	Local Institution - 0094	Pittsburgh	Pennsylvania
United States	Dermatology and Skin Cancer Specialists, LLC	Rockville	Maryland
United States	Local Institution - 0051	Saint Joseph	Missouri
United States	Local Institution	San Antonio	Texas
United States	Local Institution - 0008	Skokie	Illinois
United States	Local Institution	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	The vIGA-AD is a static 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, and oozing/crusting (lichenification excluded).; The rating of cleared (0), almost cleared (1), mild (2), moderate (3), and severe (4) will be assessed.	From baseline and 16 weeks
Secondary	Percentage of Participants Exhibiting a = 50% (EASI-50) Reduction 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	Percentage of Participants Exhibiting a = 4-point Improvement From Baseline in Pruritus NRS at Week 16	Participants will complete a daily diary recording the intensity of their pruritus they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable").; The lower the score the better.	From baseline and 16 weeks
Secondary	Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16	Participants will complete a daily diary recording the intensity of their pruritus and the average quality of sleep they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The quality of sleep will be assessed using a validated 11-point NRS ranging from 0 ("the best possible sleep") to 10 ("the worst possible sleep).; The lower the score the better.	From baseline and 16 weeks
Secondary	Mean Change From Baseline in Percentage of Affected BSA at Week 16	A widely used method of measuring Body Surface Area (BSA) involvement by AD, is the rule of nines in which for each section of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], genitals [1%]) and will be reported as a percentage of all major body sections combined.	From baseline and 16 weeks
Secondary	Number of Participants With Mild Moderate or Severe AEs	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.; Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.; Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities.; Severe: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.	From initial treatment to 30 days post discontinuation, approximately 29 weeks
Secondary	Number of Participants With Mild Moderate or Severe SAEs	A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability; Is a congenital anomaly/birth defect.; Is an important medical event	From initial treatment to 30 days post discontinuation, approximately 29 weeks
Secondary	Number of Participants With Clinically Relevant ECG Abnormalities	12 Lead Electrocardiogram (ECG). The participant will remain supine for 5 to 10 minutes prior to the ECG and must have lab work done after the tracing so that the ECG results remain as accurate as possible.	Week 24 after initial treatment
Secondary	Number of Participants With Clinically Relevant OCT Abnormalities	Optical coherence tomography (OCT) is a non-invasive imaging test. It uses light waves to take cross-section pictures of your retina. Diagnosis is made by an ophthalmologist.	Week 24 after initial treatment
Secondary	Number of Participants With Clinically Relevant PFT Abnormalities	Pulmonary function tests (PFT) include: forced expiratory volume (FEV1), percent predicted FEV1, forced vital capacity (FVC), percent predicted FVC, and Diffusion capacity of carbon monoxide (DLCO).	Week 24 after initial treatment
Secondary	Number of Participants With Clinically Meaningful Changes in Vital Signs	The following vital signs will be assessed: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and body temperature.	Week 24 after initial treatment
Secondary	Number of Participants With Clinically Relevant Changes in LFTs	Liver Function Tests (LFTs) will include the following measurements: ALT OR AST > 3 X ULN; ALT OR AST > 5 X ULN; ALT OR AST > 8 X ULN; TOTAL BILIRUBIN > 2 X ULN; ALT OR AST > 3 X ULN AND (TOTAL BILIRUBIN > 2 X ULN OR INR >1.5); AST = aspartate aminotransferase ALT = alanine aminotransferase ULN = Upper limit number INR = International Normalized Ratio	Week 24 after initial treatment

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