← Back to Search

Other

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met in order to become a participant of this research experiment?

"This experimental therapy is recruiting 40 individuals between 18 and 70 years of age that are diagnosed with dermatitis. The proper selection criteria must be met, including: having two target lesions no further than 1 point apart on the trunk or upper extremities (excluding palms), being in generally good health as judged by a medical professional, an affected body surface area of at least 1% but not more than 14%, a validated Investigator Global Assessment-atopic dermatitis score of moderate or mild at screening, if female, proof of negative pregnancy test and agreement to practice abstinence/effective contraceptive use for 4 weeks prior to visit, and stable disease with no significant"

Answered by AI

How many healthcare facilities are administering this research?

"24 medical centres are recruiting patients for this trial, including Investigational Site Number :8400013 in Tampa, California Allergy & Asthma Medical Group-Site Number:8400008 in Los Angeles, and Florida International Research Center-Site Number:8400017 in Miami. Moreover, many other locations have joined the study as well."

Answered by AI

Is this investigation extending recruitment to those aged 80 or over?

"This clinical trial has set the lower and upper bounds of eligible participants at 18 years old and 70, respectively."

Answered by AI

What risks and hazards are associated with the administration of PRN473 (SAR444727)?

"Due to the lack of existing clinical data validating PRN473 (SAR444727) efficacy, its safety was judged a 2 on the scale. However, there is evidence that it can be used without causing harm."

Answered by AI

Are there still opportunities available for individuals to join this research program?

"Currently, this medical trial is recruiting participants. It was initially advertised on August 13th 2021 with the last update being made on October 26th 2022 according to clinicaltrials.gov information."

Answered by AI

What is the enrollment capacity for this research project?

"To commence the trial, 40 eligible participants are necessary. Principia Biopharma, a Sanofi Company is responsible for coordinating and supervising the operation of this study from sites like 8400013 in Tampa, Florida and California Allergy & Asthma Medical Group-Site Number:8400008 in Los Angeles."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis
2021. "Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04992546.
~11 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top