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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

Study acronym: AERIS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jul 2026 → Dec 2026
See other at-risk trials from Ventus Therapeutics U.S., Inc.

Record History

  1. Primary completion pushed from Jul 2026 to Dec 2026 Completion pushed from Sep 2026 to Mar 2027 · Study sites: 32 to 34 · Eligibility criteria expanded, about 19 words · 1 more Show 4 more changesShow less
    • Completion pushed from Sep 2026 to Mar 2027
    • Study sites: 32 to 34
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 8 entries
  2. Trial sites expanded: 27 → 32 locationsv5
  3. Re-verified, no change to tracked fieldsv4
  4. Study sites: 10 to 27v3
  5. Primary endpoint revised Start date changed from estimate of Dec 2025 to Dec 3, 2025 · Eligibility criteria shortened, about 6 words · Secondary endpoints: 7 to 8v2 Show 3 more changesShow less
    • Start date changed from estimate of Dec 2025 to Dec 3, 2025
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07260877
Lead Sponsor Ventus Therapeutics U.S., Inc.
Conditions Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus), CLE
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov