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Completed

NCT Number: NCT04992546

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number :1240008, Hamilton, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRN473 (SAR444727)

Drug

White to off-white gel suspension

Placebo

Drug

White to off-white gel suspension

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    Time frame: From the first IMP administration (Day 1) up to Day 58

    An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that occurred from the time of the first IMP in the safety analysis period.

  2. Number of Participants With Potentially Clinically Significant Abnormalities (PCSA): Vital Signs

    Time frame: From the first IMP administration (Day 1) up to Day 45

    Vital signs assessments included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate (HR), and body temperature. Criteria for PCSA: Supine SBP: ≤ 95 mmHg and decrease from baseline ≥ 20 mmHg, ≥ 160 mmHg and increase from baseline ≥ 20 mmHg; Supine DBP : ≤ 45 mmHg and decrease from baseline ≥ 10 mmHg, ≥ 110 mmHg and increase from baseline ≥ 10 mmHg; Orthostatic SBP: ≤ -20 mmHg; Orthostatic DBP: ≤ -10 mmHg; Supine PR: ≤ 50 beats/min and decrease from baseline ≥ 20 beats/min, ≥ 120 beats/min and increase from baseline ≥ 20 beats/min; Weight :≥ 5% decrease from baseline, ≥ 5% increase from baseline

  3. Number of Participants With PCSA in 12-Lead Electrocardiogram (ECG)

    Time frame: From the first IMP administration (Day 1) up to Day 45

    Criteria for PCSA: HR: less than (<) 50 beats per minute (bpm), > 90 bpm, > 90 bpm and increase from baseline > = 20 bpm, > 100 bpm; PR interval: > 200 milliseconds (msec), > 200 msec and increase from baseline >= 25 %, > 220 msec; QRS interval: greater than (>) 110 msec, > 110 msec and increase from baseline greater than or equal to (>=) 25%, > 120 msec; QT interval: > 500 msec; QTc interval > 450 msec; > 480 msec, increase from baseline (30-60) msec, increase from baseline > 60 msec.

  4. Number of Participants With PCSA: Hematology

    Time frame: From the first IMP administration (Day 1) up to Day 45

    Criteria for PCSA: Hemoglobin (Hb) <=115 grams per liter (g/L) (Male[M]) or <=95 g/L (Female[F]), >= 185 g/L (M) or >=165 g/L (F), decrease from baseline >= 20 g/L; Hematocrit: <=0.37 volume/volume (v/v) (M) or <=0.32 v/v (F), >=0.55 v/v (M) or >=0.5 v/v (F); Red blood cells (RBC): >=6 Tera/L; Platelets: < 100 Giga/L, >=700 Giga/L; Neutrophils: <1.5 Giga/L (Non-Black [NB]) or <1.0 Giga/L (Black [B]); Lymphocytes: > 4.0 Giga/L; Monocytes: >0.7 Giga/L; Basophils: >0.1 Giga/L; Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L).

  5. Number of Participants With PCSA: Electrolyte Parameters

    Time frame: From the first IMP administration (Day 1) up to Day 45

    Criteria for PCSA: Sodium: <=129 millimoles (mmol)/L, >=160 mmol/L; Potassium: <3 mmol/L, >=5.5 mmol/L and Chloride: <80 mmol/L, >115 mmol/L.

  6. Number of Participants With PCSA: Metabolic Parameters

    Time frame: From the first IMP administration (Day 1) up to Day 45

    Criteria for PCSA: Glucose: <=3.9 mmol/L and < lower limit of normal range (LLN); >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas]); Albumin: <=25 g/L; Creatine kinase (CK): > 3 ULN, > 10 ULN; C-Reactive protein: > 2 ULN or 10 mg(milligram)/L (if ULN not provided).

  7. Number of Participants With PCSA: Renal Function Parameters

    Time frame: From the first IMP administration (Day 1) up to Day 45

    Criteria for PCSA: Creatinine: >=150 micromoles per liter (mcmol/L), >=30% change from baseline, >=100% change from baseline.

  8. Number of Participants With PCSA: Liver Function Parameters

    Time frame: From the first IMP administration (Day 1) up to Day 45

    Liver function parameters assessments included alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin, and gamma glutamyl transferase (GGT).

  9. Number of Participants With PCSA: Urinalysis

    Time frame: From the first IMP administration (Day 1) up to Day 45

    Urinalysis parameters assessments included potential of Hydrogen (pH), urobilinogen, and specific gravity.

  10. Percentage of Participants With Application-Site Event During Double-Blind Period

    Time frame: From the first IMP administration (Day 1) up to Week 2

    Grading of application-site local tolerability symptoms (burning, pruritus, and erythema) were recorded using the grading scale following each dosing during the double-blind period. Grading of application site tolerability symptoms graded from 0 (none) to 3 (severe).

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of SAR444727

    Time frame: Day 1, 4 hours post-dose; Day 15, 1 hour post-dose and Day 43, 12 hours post-dose

    Plasma samples were collected at indicated timepoints for assessment of SAR444727 concentrations.

Sponsors and collaborators

Lead sponsor

Principia Biopharma, a Sanofi Company

Industry

Registry information

Official study title

A Randomized, Intra-patient, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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