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Unknown

Afimetoran for Lupus

Phase 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody
Be older than 18 years old
Must not have
Antiphospholipid Syndrome
Timeline
Screening 14 days
Treatment Varies
Follow Up 3 days
Awards & highlights

Study Summary

This trial will test a new Lupus medication to see if it is effective, safe, and well tolerated.

Who is the study for?
This trial is for people with active Systemic Lupus Erythematosus (SLE) who meet specific criteria, including a positive test for certain lupus-related antibodies and a minimum disease activity score. It's not open to those with severe lupus nephritis, Antiphospholipid Syndrome, unstable neuropsychiatric symptoms, or if their main diagnosis isn't SLE.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Afimetoran versus a placebo in individuals with active SLE. Participants will be randomly assigned to receive either Afimetoran or a placebo to compare outcomes and gather long-term data on Afimetoran's performance.See study design
What are the potential side effects?
While the specific side effects of Afimetoran are not listed here, common side effects in trials like this may include nausea, headache, fatigue, possible allergic reactions or flare-ups of SLE symptoms. Safety and tolerability are key focuses of this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I tested positive for lupus-related antibodies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with Antiphospholipid Syndrome.

Timeline

Screening ~ 14 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 14 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Secondary outcome measures
Change from baseline in PGA score of disease activity at Week 24 and Week 48
Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)
Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Afimetoran: Dose 3Experimental Treatment1 Intervention
Group II: Afimetoran: Dose 2Experimental Treatment1 Intervention
Group III: Afimetoran: Dose 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,631 Previous Clinical Trials
4,126,400 Total Patients Enrolled
5 Trials studying Lupus
1,111 Patients Enrolled for Lupus

Media Library

Afimetoran (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04895696 — Phase 2
Lupus Research Study Groups: Placebo, Afimetoran: Dose 1, Afimetoran: Dose 2, Afimetoran: Dose 3
Lupus Clinical Trial 2023: Afimetoran Highlights & Side Effects. Trial Name: NCT04895696 — Phase 2
Afimetoran (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895696 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this medical investigation?

"This medical research requires 344 individuals suffering from Libman-Sacks disease to take part, who should be within the 18 and 70 year old age range."

Answered by AI

Does this experiment have vacancies for participants?

"Patient recruitment is still ongoing for this trial, as evidenced by updates to the clinicaltrials.gov listing on November 14th 2022. It was first posted publicly in October 2021."

Answered by AI

Are there many centers conducting this exploration in North America?

"This clinical trial is now accepting patients at 50 distinct sites, including Middleburg Heights, Memphis and San Diego. To ensure minimal disruption to your life, please select a clinic that is closest in proximity to you."

Answered by AI

What have been the findings in regards to potential risks of BMS-986256 (Oral) for patients?

"The safety of BMS-986256 (Oral) has been assigned a score of 2 based on the available evidence. This is because, although there have been some studies confirming its safety, no research exists yet that demonstrates its efficacy."

Answered by AI

Does this investigation offer novel approaches to patient care?

"Since 2020, BMS-986256 (Oral) has been a focus of research. The first investigation into its efficacy was sponsored by Bristol-Myers Squibb and included 24 participants - following this initial assessment the drug received Phase 1 approval. Currently, 2 trials are running in 99 cities across 18 nations around the world."

Answered by AI

Are geriatric participants eligible for inclusion in this experiment?

"In order to be a viable candidate for this trial, applicants must fall between the ages of 18 and 70. If underaged or geriatric patients are interested in participating, there are other clinical trials with slightly altered eligibility requirements; 18 studies available to those below 18 years old and 106 studies open for seniors over 65."

Answered by AI

How many participants are currently being observed in this clinical trial?

"The trial necessitates 344 qualified participants, who must visit either Local Institution in Middleburg Heights, Ohio or Shelby Research LLC in Memphis, Tennessee to partake."

Answered by AI

Are there any precedential studies that demonstrate the effectiveness of BMS-986256 in an oral form?

"Presently, there are two active medical trials researching the effects of BMS-986256 (Oral). While most of these experiments are being carried out in Osorno and LOS Lagos, a total of 233 clinical centres across the world have been enlisted for this research."

Answered by AI
~81 spots leftby May 2025