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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: Completed Phase 2 study, sponsored by Principia Biopharma, a Sanofi Company.
NCT04992546 is a Phase 2 study that has completed, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically importan
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 |
What the finished NCT04992546 record still lists
NCT04992546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04992546 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04992546's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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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