๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-20

Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus (NCT05966480)

A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Dose Levels of ESK-001 in Adult Patients With Systemic Lupus Erythematosus

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Alumis Inc

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.

Who can join: Review the eligibility criteria below.

Location: Investigator Site #1046 โ€” Anniston, Alabama

Age range: 18 Years to 70 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (169 Sites)

Showing the first 25 of 169 sites.

  • Investigator Site #1046 โ€” Anniston, Alabama
  • Investigator Site #1104 โ€” La Jolla, California
  • Investigator Site #1050 โ€” Los Alamitos, California
  • Investigator Site #1168 โ€” Mission Hills, California
  • Investigator Site #1174 โ€” Napa, California
  • Investigator Site #1061 โ€” Upland, California
  • Investigator Site #1048 โ€” Aventura, Florida
  • Investigator Site #1063 โ€” Avon Park, Florida
  • Investigator Site #1176 โ€” Bradenton, Florida
  • Investigator Site #1045 โ€” Clearwater, Florida
  • Investigator Site #1055 โ€” Coral Gables, Florida
  • Investigator Site #1097 โ€” Coral Springs, Florida
  • Investigator Site #1091 โ€” Daytona Beach, Florida
  • Investigator Site #1051 โ€” DeBary, Florida
  • Investigator Site #1087 โ€” Hollywood, Florida
  • Investigator Site #1135 โ€” Kissimmee, Florida
  • Investigator Site #1060 โ€” Miami, Florida
  • Investigator Site #1093 โ€” Miami, Florida
  • Investigator Site #1057 โ€” Miami, Florida
  • Investigator Site #1067 โ€” Miami Lakes, Florida
  • Investigator Site #1090 โ€” Plantation, Florida
  • Investigator Site #1089 โ€” Tampa, Florida
  • Investigator Site #1170 โ€” Atlanta, Georgia
  • Investigator Site #1052 โ€” College Park, Georgia
  • Investigator Site #1204 โ€” Chesterfield, Missouri

๐Ÿ’ฐ 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 ยง 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.

Explore by condition: All SLE clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—