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

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

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.

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

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

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

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

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

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.

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

Number of Participants With PCSA: Hematology

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).

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

Number of Participants With PCSA: Electrolyte Parameters

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.

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

Number of Participants With PCSA: Metabolic Parameters

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).

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

Number of Participants With PCSA: Renal Function Parameters

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

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

Number of Participants With PCSA: Liver Function Parameters

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

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

Number of Participants With PCSA: Urinalysis

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

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

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

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).

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