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A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
NCT04895696 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Afimetoran
Study Locations (20)
Florida
- Local Institution - 0121 — Clearwater
- Local Institution - 0167 — Kissimmee
- Local Institution - 0122 — Orlando
- Local Institution - 0173 — Ormond Beach
- Local Institution - 0154 — Plantation
- Local Institution - 0137 — South Miami
- Local Institution - 0155 — Tamarac
California
- Local Institution - 0123 — Huntington Beach
- Local Institution - 0170 — La Jolla
- Local Institution - 0159 — La Palma
- Local Institution - 0172 — San Diego
- Local Institution - 0164 — Woodland Hills
Georgia
- Local Institution - 0160 — Atlanta
- Local Institution - 0205 — Suwanee
Alabama
- Local Institution - 0100 — Birmingham
Illinois
- Local Institution - 0146 — Orland Park
Kentucky
- Local Institution - 0187 — Hopkinsville
Louisiana
- Local Institution - 0171 — Baton Rouge
Maryland
- Local Institution - 0134 — Wheaton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2021-10-11 |
| Est. Completion | 2029-04-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04895696
The ClinicalTrials.gov registry entry for NCT04895696 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04895696 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04895696 about?
NCT04895696 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)". The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to plac...
What is the current status of trial NCT04895696?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 268 participants. The study started on 2021-10-11. Estimated completion is 2029-04-22.
What conditions does trial NCT04895696 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04895696?
The interventions under investigation include: Placebo (OTHER), Afimetoran (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04895696?
This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04895696 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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