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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 78 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04781816
The ClinicalTrials.gov registry entry for NCT04781816 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04781816 reports 0 study locations.
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.
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