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Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate 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
Summary
This trial tests PRN473, a new medication for treating skin lesions in people with mild to moderate eczema. It aims to help those whose current treatments aren't fully effective by reducing inflammation and improving skin healing.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 4 hours post-dose; day 15, 1 hour post-dose and day 43, 12 hours post-dose
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With PCSA in 12-Lead Electrocardiogram (ECG)
Number of Participants With PCSA: Electrolyte Parameters
Number of Participants With PCSA: Hematology
+7 moreSecondary study objectives
Maximum Plasma Concentration (Cmax) of SAR444727
Side effects data
From 2022 Phase 2 trial • 39 Patients • NCT049925468%
Headache
3%
Limb injury
3%
Dermatitis
3%
Gastroenteritis viral
3%
Bronchitis
3%
Dermatitis atopic
3%
Vessel puncture site pain
3%
Dermatitis contact
3%
Mastitis
3%
Pharyngitis streptococcal
3%
Food allergy
3%
Upper respiratory tract infection
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
9 Previous Clinical Trials
596 Total Patients Enrolled