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NCT04992546 · ClinicalTrials.gov registry record · Phase 2
Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis
A Phase 2 study, sponsored by Principia Biopharma, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT04992546 is a Phase 2 study that has completed, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 39 participants.
The verdict
NCT04992546, a Phase 2 study, has completed, sponsored by Principia Biopharma, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
This was a Ph2a study that consists of a double-blind, intra-patient placebo-controlled treatment period and an open-label uncontrolled treatment period with objective to evaluate the safety, tolerability, PK and preliminary efficacy of PRN473 in up to 40 patients with mild to moderate AD. On Day 1 (Baseline) of the Blinded Period, 2 target lesions with a difference no greater than 1 point in Total Sign Score (TSS) were randomly assigned to treatment in an intra-patient 1:1 manner, one lesion to PRN473 and the other to matching placebo. Participation took approximately 13 weeks, including up to a 5-week screening period, a 6-week treatment period, end of study assessments 1 day after last dose, and a safety follow-up phone call 2 weeks after last dose.
Interventions
- DRUG Placebo
- DRUG PRN473 (SAR444727)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-08-13 |
| Est. Completion | 2022-12-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04992546
The ClinicalTrials.gov registry entry for NCT04992546 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Principia Biopharma, a Sanofi Company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04992546 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04992546 about?
NCT04992546 is a clinical study titled "Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis". This was a Ph2a study that consists of a double-blind, intra-patient placebo-controlled treatment period and an open-label uncontrolled treatment period with objective to evaluate the safety, tolerability, PK and preliminary efficacy of PRN473 in up to 40 patients with mild to moderate AD. On Day 1...
What is the current status of trial NCT04992546?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2021-08-13. Estimated completion is 2022-12-28.
What interventions are being tested in trial NCT04992546?
The interventions under investigation include: Placebo (DRUG), PRN473 (SAR444727) (DRUG).
Who is sponsoring clinical trial NCT04992546?
This trial is sponsored by Principia Biopharma, a Sanofi Company, which has 8 total clinical trials registered on ClinicalTrials.gov.
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