Dermatitis, AtopicPhase 1NCT06248814
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis
A Phase 1 study testing BMS-986326 in people with Dermatitis, Atopic, run by Bristol-Myers Squibb at 13 sites in 5 countries.
Trial summary
The purpose of this study is to assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- BMS-986326
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 6 Mar 2024to 6 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have diagnosis of atopic dermatitis (AD) at least 12 months prior to screening
- Documented history of inadequate response to treatment with topical medication for at least 4 weeks, unless topical treatments are otherwise medically inadvisable, or has required systemic therapy for control of disease
- All the following must be present to confirm moderate-to-severe AD
- Eczema Area and Severity Index score ≥ 12 (at Screening and Day 1)
- Body Surface Area ≥ 10% (at Screening and Day 1)
- Validated Investigator Global Assessment for Atopic Dermatitis ≥ 3 (at Screening and Day 1)
- Peak Pruritus Numerical Rating Scale ≥ 4 (at Screening)
Who cannot join
- Evidence of an active and/or concurrent inflammatory skin condition that would interfere with the Investigator or subject-driven evaluations of AD
- Any major surgery within the last 30 days before the first dose of study intervention, or any surgery planned during the course of the study
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
France3 sites
Local Institution - 0006
Clermont-Ferrand, 63003
Local Institution - 0010
Nice, 06200
Local Institution - 0008
Pierre-Bénite, 69495
Germany3 sites
Local Institution - 0011
Berlin, State of Berlin, 10117
Local Institution - 0005
Chemnitz, Saxony, 09117
Local Institution - 0012
Lübeck, Schleswig-Holstein, 23562
Poland3 sites
Local Institution - 0016
Katowice, Silesian Voivodeship, 40-081
Local Institution - 0015
Krakow, Lesser Poland Voivodeship, 30-149
Local Institution - 0001
Rzeszów, Podkarpackie Voivodeship, 35-055
Czechia2 sites
Local Institution - 0009
Pardubice, 530 02
Local Institution - 0004
Prague, PR, 100 00
Spain2 sites
Local Institution - 0002
Córdoba, X, 14004
Local Institution - 0013
Las Palmas de Gran Canaria, GC, 35010
About this study
Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled, Single Dose, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 at Two Dose Levels in Adult Participants With Atopic Dermatitis
The purpose of this study is to assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD).
- Conditions
- Dermatitis, Atopic
- Being tested
- BMS-986326, Placebo
- Keywords
- Skin Disease, Dermatitis, Eczema
- Medical subject headings
- Dermatitis, Atopic, Skin Diseases, Dermatitis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986326Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Placebo, followed by BMS-986326 Dose A or Dose B | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo |
| BMS-986326 Dose A, followed by Placebo | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo |
| BMS-986326 Dose B, followed by Placebo | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to approximately 224 days
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately 224 days
Number of participants with clinical laboratory abnormalities
Measured: Up to approximately 224 days
Number of participants with vital sign abnormalities
Measured: Up to approximately 224 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to approximately 224 days
Number of participants with physical examination abnormalities
Measured: Up to approximately 224 days
Secondary outcomes (7)
Maximum observed concentration (Cmax)
Measured: Up to approximately 224 days
Time of maximum observed concentration (Tmax)
Measured: Up to approximately 224 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Up to approximately 224 days
Change from baseline in regulatory T cell (Treg) count
Measured: Up to approximately 224 days
Change from baseline in Treg-to- conventional T cell (Tconv) ratio
Measured: Up to approximately 224 days
Incidence of anti-drug antibody (ADA)
Measured: Up to approximately 224 days
Mean percentage change from baseline at selected visits through 112 days in EASI score
Measured: Up to approximately 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start6 Mar 2024
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 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
- NCT06248814
- Sponsor's protocol ID
- IM034-1014
- Other IDs
- 2022-502997-18
- Status last verified
- Nov 2025
- First submitted
- 31 Jan 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-blind, Placebo-controlled, Single Dose, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 at Two Dose Levels in Adult Participants With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06248814
- Acronym / sponsor ID
- IM034-1014
- Conditions
- Dermatitis, Atopic
- Keywords
- Skin Disease, Dermatitis, Eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
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 assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo, followed by BMS-986326 Dose A or Dose B | Experimental | Drug: BMS-986326, Other: Placebo |
| BMS-986326 Dose A, followed by Placebo | Experimental | Drug: BMS-986326, Other: Placebo |
| BMS-986326 Dose B, followed by Placebo | Experimental | Drug: BMS-986326, Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have diagnosis of atopic dermatitis (AD) at least 12 months prior to screening
- Documented history of inadequate response to treatment with topical medication for at least 4 weeks, unless topical treatments are otherwise medically inadvisable, or has required systemic therapy for control of disease
- All the following must be present to confirm moderate-to-severe AD
Key exclusion criteria (4 listed)
- Evidence of an active and/or concurrent inflammatory skin condition that would interfere with the Investigator or subject-driven evaluations of AD
- Any major surgery within the last 30 days before the first dose of study intervention, or any surgery planned during the course of the study
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- Other protocol-defined inclusion/exclusion criteria apply
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-986326Specified dose on specified days | Drug | BMS-986326 Dose A, followed by Placebo, BMS-986326 Dose B, followed by Placebo, Placebo, followed by BMS-986326 Dose A or Dose B |
| PlaceboSpecified dose on specified days | Other | BMS-986326 Dose A, followed by Placebo, BMS-986326 Dose B, followed by Placebo, Placebo, followed by BMS-986326 Dose A or Dose B |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to approximately 224 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 224 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to approximately 224 days
Number of participants with vital sign abnormalities
Time frame: Up to approximately 224 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to approximately 224 days
Number of participants with physical examination abnormalities
Time frame: Up to approximately 224 days
7 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Up to approximately 224 days
Time of maximum observed concentration (Tmax)
Time frame: Up to approximately 224 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to approximately 224 days
Change from baseline in regulatory T cell (Treg) count
Time frame: Up to approximately 224 days
Change from baseline in Treg-to- conventional T cell (Tconv) ratio
Time frame: Up to approximately 224 days
Incidence of anti-drug antibody (ADA)
Time frame: Up to approximately 224 days
Mean percentage change from baseline at selected visits through 112 days in EASI score
Time frame: Up to approximately 112 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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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
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986326 in people with Dermatitis, Atopic, run by Bristol-Myers Squibb at 13 sites in 5 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 7 inclusion and 4 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Germany, Poland, Czechia, Spain. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events (AEs) (time frame: Up to approximately 224 days). The study lists 6 primary outcomes in all. 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 8 Dec 2025.