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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520098-12-00

Acronym

VENT-03-201

Enrollment

Registered

2025-08-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Lupus Erythematosus

Brief summary

Change from baseline in CLASI-A score on Day 28

Detailed description

Treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG), physical examination, and safety laboratory assessments Change from baseline in MXA immunostaining in lesional skin biopsy Plasma concentrations and PK parameters of VENT-03

Interventions

DRUGVENT-03

DRUGPlacebo tablets are composed of excipients found in VENT-03 tablets. Placebo tablets are identical to VENT-03 tablets.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in CLASI-A score on Day 28	—

Secondary

Measure	Time frame
Treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG), physical examination, and safety laboratory assessments Change from baseline in MXA immunostaining in lesional skin biopsy Plasma concentrations and PK parameters of VENT-03	—

Countries

Bulgaria, Czechia, France, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026