NCT04992546

Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis

A Randomized, Intra-patient, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Principia Biopharma, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study duration per patient was approximately 56 days including a 42-days treatment period.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	PRN473 (SAR444727)	White to off-white gel suspension
DRUG	Placebo	White to off-white gel suspension

Timeline

• Start date: 2021-08-13
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2021-08-05
• Last updated: 2025-09-10
• Results posted: 2024-03-01

Locations

12 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study