At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo Controlled, Proof of Concept Study Assessing the Efficacy and Safety of the RIPK1-inhibitor SAR443122 in Patients With Moderate to Severe Subacute or Discoid/Chronic Cutaneous Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating SAR443122 and Placebo for Cutaneous Lupus Erythematosus. Completed, enrolled 78 participants across 50 sites in 15 countries.
Detailed Summary
Primary Objective: * Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: * Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity) * Assess the effect of SAR443122 on CLE induced itch and overall pain * Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo * Assess the effect of SAR443122 on the CLASI components score * Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) * Assess oral cavities for patients with oral lesions * Assess the disease specific quality of life (QoL) * Assess the safety and tolerability of SAR443122 in patients with CLE * Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE
Study Details
Timeline
Interventions
Pharmaceutical form: Capsule Route of administration: Oral
Pharmaceutical form: Capsule Route of administration: Oral