Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis
Brief description of study
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.
Detailed description of study
Study duration per patient is approximately 56 days including a 42-days treatment period.
Clinical Study Identifier: NCT04992546
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Atopic Dermatitis
Age: Between 18 Years - 70 Years
Gender: Male or Female
- 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.
- 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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