Lupus Erythematosus, CutaneousPhase 1NCT04493541
A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
A Phase 1 study testing BMS-986256 in people with Lupus Erythematosus, Cutaneous, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Erythematosus, Cutaneous
- What is being tested?
- BMS-986256
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 26 Aug 2020to 21 Apr 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy
- Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable
Who cannot join
- Active severe or unstable neuropsychiatric SLE
- Active, severe Lupus Nephritis (LN)
- Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
- Conditions
- Lupus Erythematosus, Cutaneous
- Being tested
- BMS-986256, BMS-986256 Placebo
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986256Drug
Specified Dose on Specified Days
BMS-986256 PlaceboOther
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986256 | Experimental | Not described Receives: Drug: BMS-986256 |
| Placebo | Placebo comparator | Not described Receives: Other: BMS-986256 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 24 weeks
Incidence of Adverse Events (AEs)
Measured: Up to 20 weeks
Number of laboratory test abnormalities: Hematology
Measured: Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis
Measured: Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry
Measured: Up to 20 weeks
Incidence of clinically significant changes in physical examination findings
Measured: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
Measured: Up to 20 weeks
Secondary outcomes (8)
Maximum observed plasma concentration (Cmax) of BMS-986256
Measured: Up to 20 weeks
Time to maximum concentration (Tmax) of BMS-986256
Measured: Up to 20 weeks
Trough observed plasma concentration (Ctrough) of BMS-986256
Measured: Up to 20 weeks
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256
Measured: Up to 20 weeks
Maximum observed plasma concentration (Cmax) of metabolite BMT-271199
Measured: Up to 20 weeks
Time to maximum concentration (Tmax) of metabolite BMT-271199
Measured: Up to 20 weeks
Trough observed plasma concentration (Ctrough) of metabolite BMT-271199
Measured: Up to 20 weeks
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start26 Aug 2020
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, CutaneousStudies 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
- 13 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
- NCT04493541
- Sponsor's protocol ID
- IM026-027
- Other IDs
- 2019-004044-29, 2019
- Status last verified
- May 2023
- First submitted
- 28 Jul 2020
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04493541
- Acronym / sponsor ID
- IM026-027
- Conditions
- Lupus Erythematosus, Cutaneous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 30 Jul 2020 (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 and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-986256 | Experimental | Drug: BMS-986256 |
| Placebo | Placebo comparator | Other: BMS-986256 Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy
- Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable
Key exclusion criteria (4 listed)
- Active severe or unstable neuropsychiatric SLE
- Active, severe Lupus Nephritis (LN)
- Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains
- 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-986256Specified Dose on Specified Days | Drug | BMS-986256 |
| BMS-986256 PlaceboSpecified Dose on Specified Days | Other | Placebo |
Primary outcome
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 24 weeks
Incidence of Adverse Events (AEs)
Time frame: Up to 20 weeks
Number of laboratory test abnormalities: Hematology
Time frame: Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis
Time frame: Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry
Time frame: Up to 20 weeks
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
Time frame: Up to 20 weeks
8 secondary outcomes
Maximum observed plasma concentration (Cmax) of BMS-986256
Time frame: Up to 20 weeks
Time to maximum concentration (Tmax) of BMS-986256
Time frame: Up to 20 weeks
Trough observed plasma concentration (Ctrough) of BMS-986256
Time frame: Up to 20 weeks
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256
Time frame: Up to 20 weeks
Maximum observed plasma concentration (Cmax) of metabolite BMT-271199
Time frame: Up to 20 weeks
Time to maximum concentration (Tmax) of metabolite BMT-271199
Time frame: Up to 20 weeks
Trough observed plasma concentration (Ctrough) of metabolite BMT-271199
Time frame: Up to 20 weeks
Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199
Time frame: Up to 20 weeks
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 9 May 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986256 in people with Lupus Erythematosus, Cutaneous, run by Bristol-Myers Squibb at 1 site in Germany.
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 2 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 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?
Incidence of Serious Adverse Events (SAEs) (time frame: Up to 24 weeks). The study lists 11 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 9 May 2023.