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

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    40
  • sponsor
    Principia Biopharma, a Sanofi Company
Updated on 7 October 2022

Summary

This is 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) will be randomly assigned to treatment in an intra-patient 1:1 manner, one lesion to PRN473 and the other to matching placebo.

Participation will take 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.

Description

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

Details
Condition Atopic Dermatitis
Treatment Placebo, PRN473 (SAR444727)
Clinical Study IdentifierNCT04992546
SponsorPrincipia Biopharma, a Sanofi Company
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female adults 18 to 70 years of age (inclusive) at the time of informed consent
Diagnosed with mild to moderate AD
History of AD for at least 6 months as determined by the Investigator through patient interview
Stable disease for the 4 weeks prior to the screening visit with no significant flares in AD as determined by the Investigator
Validated Investigator Global Assessment-atopic dermatitis (vIGA-AD) score of Moderate or Mild at Screening. The vIGA-AD is evaluated for the entire body except scalp, palms, soles and genitals
Has AD involvement (excluding scalp, palms, soles and genitals) of at least 1.0% BSA and no more than 14.0% BSA
Has 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)
If female, patients with child-bearing potential must have a negative pregnancy test, and agree to practice true abstinence or agree to use highly effective contraception
If male, agree to use a male condom and highly effective contraception with female partners of child-bearing potential
In good health as judged by the Investigator

Exclusion Criteria

Patients who have failed 2 or more prior systemic treatments for AD
Patients who have received a live or attenuated vaccine in the last 12 weeks or intend to receive a live or attenuated vaccine during the study
Patients who cannot discontinue prohibited medications and treatments prior to the Baseline visit and during the study
Has unstable AD, based on the judgement of the Investigator, or any consistent requirement for high potency topical steroids to manage AD signs or symptoms
Patients who have significant active systemic or localized bacterial, viral, fungal, and helminth infection in the last 30 days
Patients unwilling to refrain from prolonged sun exposure or use of a tanning bed or other artificial light emitting devices for 4 weeks prior to Baseline and during the study
Patients with other skin conditions that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator
Patients with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome
Previous use of a BTK inhibitor
Women who are pregnant, wishing to become pregnant during the study, or are breastfeeding
Patients currently undergoing allergy (eg, food allergy testing or skin prick testing), patch testing, or food challenges, or plan to do so during the study
Patients who have undergone major surgery within 4 weeks prior to Day 1 or patients who have a major surgery planned during the study
Regular use of drugs of abuse or regular alcohol consumption within 6 months prior to the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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