PRN473 (SAR444727) for Atopic Dermatitis

Phase-Based Progress Estimates
Investigational Site Number :1240008, Burlington, CanadaAtopic DermatitisPRN473 (SAR444727) - Drug
18 - 70
All Sexes
What conditions do you have?

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Day 1 to Day 43

Day 43
Plasma PRN473 concentrations
Until Day 56
Adverse events (AEs) and serious AEs
Assessment of local cutaneous tolerability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

PRN473 (SAR444727)
1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

39 Total Participants · 2 Treatment Groups

Primary Treatment: PRN473 (SAR444727) · Has Placebo Group · Phase 2

PRN473 (SAR444727)
Experimental Group · 1 Intervention: PRN473 (SAR444727) · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
PRN473 (SAR444727)
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 43

Who is running the clinical trial?

Principia Biopharma, a Sanofi CompanyLead Sponsor
7 Previous Clinical Trials
572 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least two target lesions 100 cm2 or greater with a difference no greater than 1 point in lesion TSS and at least 5 cm apart located on the trunk (excluding genitals) or upper extremities (excluding palms).
You have been diagnosed with mild to moderate Alzheimer's disease.\n
You have at least 1.0% BSA and no more than 14.0% BSA.
You have moderate to severe atopic dermatitis of the scalp, trunk, or both.
You are female and have child-bearing potential
You have no active or stable disease that would interfere with the evaluation.
You have a history of Alzheimer's disease for at least 6 months as determined by the Investigator through patient interview.

Frequently Asked Questions

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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 information." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.