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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Ventus Therapeutics U.S., Inc.
Study ID
NCT07260877
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • VENT-03 — DRUG
    VENT-03 is a tablet
  • Placebo — DRUG
    Placebo is a tablet

Study Details

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.

Key Dates

Start date
Dec 3, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VENT-03
    VENT-03
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Evaluate the effect of VENT-03 on the interferon gene signature in the skin [ Time Frame: Baseline to End of Double-Blind Treatment (up to Day 28) ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Investigative SiteBeverly HillsCalifornia90211-
Investigative SiteClearwaterFlorida33765-
Investigative SiteDeBaryFlorida32713-
Investigative SiteTampaFlorida33606-
Investigative SiteSaint JosephMissouri64506-
Investigative SiteFairportNew York14450-
Investigative SiteMemphisTennessee38119-
Investigative SiteAllenTexas75013-
Investigative SiteArlingtonTexas76012-
Investigative SiteColleyvilleTexas76034-

Find similar trials in Beverly Hills, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Investigative Site· Beverly Hills, CAInvestigative Site· Clearwater, FLInvestigative Site· DeBary, FLInvestigative Site· Tampa, FLInvestigative Site· Saint Joseph, MOInvestigative Site· Fairport, NY

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