A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus (NCT07260877)
π©Ί Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to answer are: * Does VENT-03 affect the activity and severity of CLE? * What side effects do participants have when taking VENT-03? Researchers will compare VENT-03 to a placebo (a look-alike substance that contains no drug) to see if VENT-03 works to treat patients with CLE. Participants will: * Take VENT-03 or a placebo for 4 weeks, then all participants will switch to VENT-03 for another 8 weeks; * Visit the clinic once a month for checkups and tests.
Who can join: Review the eligibility criteria below.
Location: Investigative Site β Beverly Hills, California
Age range: 18 Years to 80 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (32 Sites)
Showing the first 25 of 32 sites.
- Investigative Site β Beverly Hills, California
- Investigative Site β Clearwater, Florida
- Investigative Site β DeBary, Florida
- Investigative Site β Tampa, Florida
- Investigative Site β Indianapolis, Indiana
- Investigative Site β Flint, Michigan
- Investigative Site β Troy, Michigan
- Investigative Site β Saint Joseph, Missouri
- Investigative Site β Fairport, New York
- Investigative Site β Memphis, Tennessee
- Investigative Site β Allen, Texas
- Investigative Site β Arlington, Texas
- Investigative Site β Colleyville, Texas
- Investigative Site β Haskovo,
- Investigative Site β Plovdiv,
- Investigative Site β Sofia,
- Investigative Site β Paris,
- Investigative Site β Toulouse,
- Investigative Site β Tbilisi,
- Investigative Site β Szeged,
- Investigative Site β Bialystok,
- Investigative Site β OΕwiΔcim,
- Investigative Site β Poznan,
- Investigative Site β RzeszΓ³w,
- Investigative Site β ΕlΔ skie,
π Contact the Study Coordinator
Phone: (913) 410-2156
Email: AERIS@iconplc.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° 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 Β§ 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.
More studies in Cutaneous Lupus Erythematosus (CLE)
- A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus β Philadelphia, Pennsylvania
- Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus β Philadelphia, Pennsylvania
Explore by condition: All Cutaneous Lupus Erythematosus (CLE) clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.