Dermatitis, AtopicPhase 2NCT05014438
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
A Phase 2 study testing BMS-986166 and Branebrutinib in people with Dermatitis, Atopic, run by Bristol-Myers Squibb at 42 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- BMS-986166 and Branebrutinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 42 sitesin 7 countries
- Study dates
- 17 Aug 2021to 22 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
42 sites in 7 countries.
42 sites in 7 countries
United States17 sites
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
Local Institution - 0112
Brandon, Florida, 33511
Local Institution - 0061
Coral Gables, Florida, 33134
Local Institution - 0091
Fremont, California, 94538
Local Institution - 0081
Indianapolis, Indiana, 46250
Local Institution - 0083
Louisville, Kentucky, 40217
Local Institution - 0110
Margate, Florida, 33063
Local Institution - 0006
Miami Lakes, Florida, 33014
Local Institution - 0003
Morgantown, West Virginia, 26505
Local Institution
New York, New York, 10029
Local Institution - 0078
Philadelphia, Pennsylvania, 19103
Local Institution - 0094
Pittsburgh, Pennsylvania, 15213
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, 20850
Local Institution - 0051
Saint Joseph, Missouri, 64506
Local Institution
San Antonio, Texas, 78213
Local Institution - 0008
Skokie, Illinois, 60077
Local Institution
Tampa, Florida, 33613
Germany10 sites
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117
Local Institution
Berlin, 12459
Local Institution - 0034
Bochum, 44793
Universitätsklinikum Bonn-Studienzentrum Dermatologie
Bonn, 53127
SRH Wald-Klinikum Gera-Zentrum für klinische Studien
Gera, 07548
Local Institution
Hanover, 30625
Universitatsklinikum Schleswig-Holstein
Kiel, 24105
Local Institution
Munich, 80337
KliFOs - Klinische Forschung Osnabrück
Osnabrück, 49074
Private Practice - Dr. Ralph von Kiedrowski
Selters, 56242
Australia4 sites
Sinclair Dermatology
East Melbourne, Victoria, 3002
Premier Dermatology
Kogarah, New South Wales, 2217
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Westmead Hospital-Dermatology
Westmead, New South Wales, 2145
Spain4 sites
Hospital General Universitario de Alicante-Dermatology
Alicante, 03010
Local Institution - 0130
Córdoba, Andalusia, 14004
Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
Las, 35010
Hospital Universitario La Paz-UCICEC/DERMA
Madrid, 28046
Canada3 sites
Local Institution
Markham, Ontario, L3P 1X2
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4C 9M7
SIMa Recherche
Verdun, Quebec, H4G 3E7
Poland3 sites
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85-231
ETYKA Osrodek Badan Klinicznych
Olsztyn, 10-117
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, 02-962
About this study
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
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
- Being tested
- BMS-986166, Branebrutinib, Placebo
- Keywords
- Atopic Dermatitis, BMS-986166, BMS-986195, Branebrutinib
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986166Drug
Specified dose on specified days
BranebrutinibDrug
Also called BMS-986195
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Treatment BMS-986166 Dose 1 | Experimental | Not described Receives: Drug: BMS-986166 |
| Treatment BMS-986166 Dose 2 | Experimental | Not described Receives: Drug: BMS-986166 |
| Treatment BMS-986166 Dose 3 | Experimental | Not described Receives: Drug: BMS-986166 |
| Treatment Branebrutinib | Experimental | Not described Receives: Drug: Branebrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From baseline and 16 weeks
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.
Measured: From baseline and 16 weeks
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.
Measured: From baseline and 16 weeks
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.
Measured: From baseline and 16 weeks
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.
Measured: From baseline and 16 weeks
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.
Measured: From initial treatment to 30 days post discontinuation, approximately 29 weeks
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
Measured: From initial treatment to 30 days post discontinuation, approximately 29 weeks
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.
Measured: Week 24 after initial treatment
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.
Measured: Week 24 after initial treatment
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).
Measured: Week 24 after initial treatment
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.
Measured: Week 24 after initial treatment
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
Measured: Week 24 after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start17 Aug 2021
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014438
- Sponsor's protocol ID
- IM018-005
- Other IDs
- 2020-004767-77, U1111-1259-1220
- Status last verified
- Sep 2023
- First submitted
- 29 Jul 2021
- Last updated
- 18 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05014438
- Acronym / sponsor ID
- IM018-005
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic Dermatitis, BMS-986166, BMS-986195, Branebrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Posted 18 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986166Specified dose on specified days | Drug | Treatment BMS-986166 Dose 1, Treatment BMS-986166 Dose 2, Treatment BMS-986166 Dose 3 |
| BranebrutinibAlso: BMS-986195Specified dose on specified days | Drug | Treatment Branebrutinib |
| PlaceboSpecified dose on specified days | Other | Placebo |
Primary outcome
Mean Percentage Change From Baseline in EASI Score at Week 16
Time frame: From baseline and 16 weeks
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.
12 secondary outcomes
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
Time frame: From baseline and 16 weeks
Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16
Time frame: From baseline and 16 weeks
Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16
Time frame: From baseline and 16 weeks
Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16
Time frame: From baseline and 16 weeks
Mean Change From Baseline in Percentage of Affected BSA at Week 16
Time frame: From baseline and 16 weeks
Number of Participants With Mild Moderate or Severe AEs
Time frame: From initial treatment to 30 days post discontinuation, approximately 29 weeks
Number of Participants With Mild Moderate or Severe SAEs
Time frame: From initial treatment to 30 days post discontinuation, approximately 29 weeks
Number of Participants With Clinically Relevant ECG Abnormalities
Time frame: Week 24 after initial treatment
Number of Participants With Clinically Relevant OCT Abnormalities
Time frame: Week 24 after initial treatment
Number of Participants With Clinically Relevant PFT Abnormalities
Time frame: Week 24 after initial treatment
Number of Participants With Clinically Meaningful Changes in Vital Signs
Time frame: Week 24 after initial treatment
Number of Participants With Clinically Relevant Changes in LFTs
Time frame: Week 24 after initial treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
42 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986166 and Branebrutinib in people with Dermatitis, Atopic, run by Bristol-Myers Squibb at 42 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Germany, Australia, Spain, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percentage Change From Baseline in EASI Score at Week 16 (time frame: From baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.