LupusPhase 1NCT06013995
A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus
A Phase 1 study testing BMS-986326 in people with Lupus, run by Bristol-Myers Squibb at 20 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus
- What is being tested?
- BMS-986326
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 20 sitesin 8 countries
- Study dates
- 21 Sep 2023to 14 Apr 2026
- 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
- Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).
- Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring).
- Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score).
Who cannot join
- SLE that is considered by the Investigator to be severe.
- Drug-induced CLE and drug-induced SLE.
- Women who are pregnant or breastfeeding.
- Current use of >10 mg prednisone (or equivalent) per day.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
20 sites in 8 countries.
20 sites in 8 countries
United States7 sites
Local Institution - 0055
Clearwater, Florida, 33765
Local Institution - 0005
Duncansville, Pennsylvania, 16635
Local Institution - 0062
Las Vegas, Nevada, 89102
Skin Sciences
Louisville, Kentucky, 40217
Local Institution - 0048
San Diego, California, 92108
Arthritis Northwest, PLLC
Spokane, Washington, 99204
Local Institution - 0029
Tampa, Florida, 33606
Germany3 sites
Local Institution - 0044
Berlin, 10117
Local Institution - 0071
Dessau, 06847
Local Institution - 0047
Dresden, 01307
Argentina2 sites
Local Institution - 0075
CABA, Buenos Aires F.D., 1430
Local Institution - 0070
Pilar, Buenos Aires, 1629
Poland2 sites
Local Institution - 0074
Poznan, 61-848
Local Institution - 0069
Warsaw, 02-953
Romania2 sites
Local Institution - 0065
Bucharest, Bucharest, 11658
Local Institution - 0064
Cluj-Napoca, Cluj, 400006
Spain2 sites
Local Institution - 0046
A Coruña, A Coruña [La Coruña], 15006
Local Institution - 0045
Córdoba, Córdoba, 14004
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 in Adult Participants With Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus
The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.
- Conditions
- Lupus
- Being tested
- BMS-986326, Placebo for BMS-986326
- Keywords
- Pharmacokinetics, BMS-986326, Cutaneous Lupus, discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), Systemic lupus erythematosus (SLE)
- Medical subject headings
- Lupus Erythematosus, Discoid, Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
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
Placebo for BMS-986326Other
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: BMS-986326 Dose 1 IV | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo for BMS-986326 |
| Cohort B: BMS-986326 Dose 2 IV | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo for BMS-986326 |
| Cohort C1: BMS-986326 Dose 3 IV | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo for BMS-986326 |
| Cohort C2: BMS-986326 Dose 3 SC | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo for BMS-986326 |
| Cohort D2: BMS-986326 Dose 4 SC | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo for BMS-986326 |
| Cohort E2: BMS-986326 Dose 3 SC | Experimental | Not described Receives: Drug: BMS-986326; Other: Placebo for BMS-986326 |
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 228 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 228 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 228 days
Number of participants with vital sign abnormalities
Measured: Up to 228 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 228 days
Number of participants with physical examination abnormalities
Measured: Up to 228 days
Secondary outcomes (7)
Maximum observed serum concentration (Cmax)
Measured: Predose and post-dose up to Day 167
Time of Cmax (Tmax)
Measured: Predose and post-dose up to Day 167
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Measured: Predose and post-dose up to Day 167
Serum PK parameters such as AUC(TAU)
Measured: Predose and post-dose up to Day 167
Change from baseline in regulatory T cells (Treg) count to Day 144
Measured: Baseline up to Day 144
Change from baseline in Treg-to-conventional t cells (Tconv) ratio
Measured: Baseline up to Day 144
Number of participants with anti-drug antibodies
Measured: Baseline up to Day 167
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start21 Sep 2023
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 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
- NCT06013995
- Sponsor's protocol ID
- IM034-1000
- Other IDs
- 2022-503009-39
- Status last verified
- May 2026
- First submitted
- 23 Aug 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.html
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 in Adult Participants With Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06013995
- Acronym / sponsor ID
- IM034-1000
- Conditions
- Lupus
- Keywords
- Pharmacokinetics, BMS-986326, Cutaneous Lupus, discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), Systemic lupus erythematosus (SLE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 28 Aug 2023 (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 evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A: BMS-986326 Dose 1 IV | Experimental | Drug: BMS-986326, Other: Placebo for BMS-986326 |
| Cohort B: BMS-986326 Dose 2 IV | Experimental | Drug: BMS-986326, Other: Placebo for BMS-986326 |
| Cohort C1: BMS-986326 Dose 3 IV | Experimental | Drug: BMS-986326, Other: Placebo for BMS-986326 |
| Cohort C2: BMS-986326 Dose 3 SC | Experimental | Drug: BMS-986326, Other: Placebo for BMS-986326 |
| Cohort D2: BMS-986326 Dose 4 SC | Experimental | Drug: BMS-986326, Other: Placebo for BMS-986326 |
| Cohort E2: BMS-986326 Dose 3 SC | Experimental | Drug: BMS-986326, Other: Placebo for BMS-986326 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).
- Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring).
- Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score).
Key exclusion criteria (5 listed)
- SLE that is considered by the Investigator to be severe.
- Drug-induced CLE and drug-induced SLE.
- Women who are pregnant or breastfeeding.
- Current use of >10 mg prednisone (or equivalent) per day.
- Note: 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 | Cohort A: BMS-986326 Dose 1 IV, Cohort B: BMS-986326 Dose 2 IV, Cohort C1: BMS-986326 Dose 3 IV, Cohort C2: BMS-986326 Dose 3 SC, Cohort D2: BMS-986326 Dose 4 SC, Cohort E2: BMS-986326 Dose 3 SC |
| Placebo for BMS-986326Specified dose on specified days | Other | Cohort A: BMS-986326 Dose 1 IV, Cohort B: BMS-986326 Dose 2 IV, Cohort C1: BMS-986326 Dose 3 IV, Cohort C2: BMS-986326 Dose 3 SC, Cohort D2: BMS-986326 Dose 4 SC, Cohort E2: BMS-986326 Dose 3 SC |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 228 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 228 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 228 days
Number of participants with vital sign abnormalities
Time frame: Up to 228 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 228 days
Number of participants with physical examination abnormalities
Time frame: Up to 228 days
7 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: Predose and post-dose up to Day 167
Time of Cmax (Tmax)
Time frame: Predose and post-dose up to Day 167
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Predose and post-dose up to Day 167
Serum PK parameters such as AUC(TAU)
Time frame: Predose and post-dose up to Day 167
Change from baseline in regulatory T cells (Treg) count to Day 144
Time frame: Baseline up to Day 144
Change from baseline in Treg-to-conventional t cells (Tconv) ratio
Time frame: Baseline up to Day 144
Number of participants with anti-drug antibodies
Time frame: Baseline up to Day 167
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 26 May 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.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
20 sites in 8 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 Lupus, run by Bristol-Myers Squibb at 20 sites in 8 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 3 inclusion and 5 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Germany, Argentina, Poland, Romania and 3 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. 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 228 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 26 May 2026.