🏛️ Verified NIH Record • Updated 2026-08-14

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) (NCT04895696)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Beeline Medicines Corporation

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (5 items).

Location: Local Institution - 0100 — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Active severe lupus nephritis (LN) as assessed by the investigator
  • Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
  • Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
  • Antiphospholipid Syndrome Other protocol-defined inclusion/exclusion criteria apply

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (147 Sites)

  • Local Institution - 0100 — Birmingham, Alabama
  • Local Institution - 0123 — Huntington Beach, California
  • Local Institution - 0170 — La Jolla, California
  • Local Institution - 0159 — La Palma, California
  • Local Institution - 0172 — San Diego, California
  • Local Institution - 0164 — Woodland Hills, California
  • Local Institution - 0121 — Clearwater, Florida
  • Local Institution - 0167 — Kissimmee, Florida
  • Local Institution - 0122 — Orlando, Florida
  • Local Institution - 0173 — Ormond Beach, Florida
  • Local Institution - 0154 — Plantation, Florida
  • Local Institution - 0137 — South Miami, Florida
  • Local Institution - 0155 — Tamarac, Florida
  • Local Institution - 0160 — Atlanta, Georgia
  • Local Institution - 0205 — Suwanee, Georgia
  • Local Institution - 0146 — Orland Park, Illinois
  • Local Institution - 0187 — Hopkinsville, Kentucky
  • Local Institution - 0171 — Baton Rouge, Louisiana
  • Local Institution - 0134 — Wheaton, Maryland
  • Local Institution - 0070 — Eagan, Minnesota
  • Local Institution - 0124 — St Louis, Missouri
  • Local Institution - 0165 — St Louis, Missouri
  • Local Institution - 0091 — Las Vegas, Nevada
  • Local Institution - 0219 — West Long Branch, New Jersey
  • Local Institution - 0140 — Manhasset, New York

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗