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NCT04781816 · ClinicalTrials.gov registry record · Phase 2
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT04781816: Completed Phase 2 study, sponsored by Sanofi.
NCT04781816 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04781816, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study 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
Primary Outcome
The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher
Interventions
- DRUG Placebo
- DRUG SAR443122
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2023-06-26 |
| Phase | Phase 2 |
What the finished NCT04781816 record still lists
NCT04781816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04781816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04781816 about?
NCT04781816 is a clinical study titled "Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus". 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...
What is the current status of trial NCT04781816?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2021-04-01. Estimated completion is 2023-06-26.
What interventions are being tested in trial NCT04781816?
The interventions under investigation include: Placebo (DRUG), SAR443122 (DRUG).
Who is sponsoring clinical trial NCT04781816?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04781816's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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