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

Study on Investigational Medication for Mild to Moderate Atopic Dermatitis

Not Recruiting
18 years - 70 years
All
Phase 2
39 participants needed

Study Overview

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

Participation took 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.

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atopic Dermatitis
  • Age: 18 years - 70 years
  • Gender: All

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 was evaluated for the entire body except scalp, palms, soles and genitals.
  • HadAD involvement (excluding scalp, palms, soles and genitals) of at least 1.0% BSA and no more than 14.0% BSA.
  • Had 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 had failed 2 or more prior systemic treatments for AD.
  • Patients who had 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 had 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 used of a BTK inhibitor.
  • Women who were pregnant, wishing to become pregnant during the study, or were breastfeeding.
  • Patients were 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 had undergone major surgery within 4 weeks prior to Day 1 or patients who had a major surgery planned during the study.
  • Regular use of drugs of abuse or regular alcohol consumption within 6 months prior to the study.

Updated on 01 Mar 2024. Study ID: NCT04992546

This study investigates the safety and effects of an investigational medication in patients with mild to moderate atopic dermatitis (AD). Atopic dermatitis is a skin condition that causes itchy and inflamed skin. The study aims to understand how the investigational medication works compared to a placebo, which is a substance that looks like the medicine but does not have any active ingredients.

Participants will be involved in a double-blind, intra-patient placebo-controlled treatment period, meaning neither the participants nor the researchers know who is receiving the investigational medication or the placebo. Two target skin lesions will be treated, one with the investigational medication and the other with a placebo, to compare their effects. After this period, there will be an open-label phase where all participants receive the investigational medication.

  • Who can participate: Adults aged 18 to 70 years with mild to moderate atopic dermatitis can participate. Participants must have a history of AD for at least 6 months and stable disease for 4 weeks prior to the study. Key exclusions include prior failure of two or more systemic treatments for AD and recent vaccinations.
  • Study details: Participants will apply the investigational medication to one of their skin lesions while the other lesion receives a placebo. The placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants must follow the study procedures and attend all scheduled visits.
  • Study timelines: The study will last 56 days.