A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2a Trial of VENT-03 in Adults with Active Cutaneous Lupus Erythematosus
Phase 2
24
about 9 months
18–80
10 sites in CA, FL, MO +3
What this study is about
Researchers are testing whether VENT-03 can treat adults with active cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). The trial also aims to evaluate the safety and how the body processes VENT-03. Participants will take either VENT-03 or a placebo daily for several weeks, followed by a period where all participants switch to VENT-03.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo
- 2.Take VENT-03
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Secondary: Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy, Cmax: Maximum Observed Plasma Concentration for VENT-03, Number of participants with Moderate or Severe Treatment Emergent Adverse Events (TEAEs), Number of participants with at least one Treatment Emergent Adverse Event (TEAE) and/or Serious Adverse Event (SAE), Percentage of Participants with ≥ 1 Treatment Emergent Adverse Event (AE) leading to Treatment Discontinuation
Immune