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PRN473 (SAR444727) for Atopic Dermatitis

Phase 2
Waitlist Available
Research Sponsored by Principia Biopharma, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 4 hours post-dose; day 15, 1 hour post-dose and day 43, 12 hours post-dose
Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of an investigational drug called PRN473 in people with Alzheimer's disease.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 4 hours post-dose; day 15, 1 hour post-dose and day 43, 12 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 4 hours post-dose; day 15, 1 hour post-dose and day 43, 12 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With PCSA in 12-Lead Electrocardiogram (ECG)
Number of Participants With PCSA: Electrolyte Parameters
Number of Participants With PCSA: Hematology
+7 more
Secondary outcome measures
Maximum Plasma Concentration (Cmax) of SAR444727

Side effects data

From 2022 Phase 2 trial • 39 Patients • NCT04992546
8%
Headache
3%
Mastitis
3%
Limb injury
3%
Dermatitis atopic
3%
Bronchitis
3%
Upper respiratory tract infection
3%
Dermatitis
3%
Pharyngitis streptococcal
3%
Food allergy
3%
Vessel puncture site pain
3%
Dermatitis contact
3%
Gastroenteritis viral
3%
Activated partial thromboplastin time prolonged
100%
80%
60%
40%
20%
0%
Study treatment Arm
SAR444727 5% BID+Placebo: Double Blinded Period
SAR444727 5% BID: Open Label Period

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR444727 5% BID per lesionExperimental Treatment1 Intervention
During the double-blinded period, 2 target lesions per participant (with difference no greater than 1 point in total sign scores [TSS]) were randomized in 1:1 ratio to receive either SAR44727 Gel 5 percent (%) or matching placebo (i.e., each participant was treated with both SAR444727 5% BID and placebo in parallel). During open-label period, participants applied SAR444727 Gel, 5% twice daily (BID) to the all atopic dermatitis (AD)-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.
Group II: Placebo then SAR444727 5% BID per lesionPlacebo Group2 Interventions
Multiple topical doses of placebo for 14 days, and PRN473 (SAR444727) for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRN473 (SAR444727)
2021
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Principia Biopharma, a Sanofi CompanyLead Sponsor
7 Previous Clinical Trials
544 Total Patients Enrolled
~10 spots leftby May 2025
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