Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PRN473 (SAR444727)
PRN473 · 1 trial · 1 indication
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.
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
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.
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).
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.
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).
Criteria for PCSA: Creatinine: \>=150 micromoles per liter (mcmol/L), \>=30% change from baseline, \>=100% change from baseline.
Liver function parameters assessments included alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin, and gamma glutamyl transferase (GGT).
Urinalysis parameters assessments included potential of Hydrogen (pH), urobilinogen, and specific gravity.
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).
| Arm | Type | Description |
|---|---|---|
| SAR444727 5% BID per lesion | EXPERIMENTAL | During the double-blinded period, 2 target lesions per participant (with difference no greater than 1 point in total sign scores \[TSS\]) were randomized in 1:1 ratio to receive either SAR44727 Gel 5 percent (%) or matching placebo (i.e., each participant was treated with both SAR444727 5% BID and placebo in parallel). During open-label period, participants applied SAR444727 Gel, 5% twice daily (BID) to the all atopic dermatitis (AD)-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42. |
| Placebo then SAR444727 5% BID per lesion | PLACEBO_COMPARATOR | Multiple topical doses of placebo for 14 days, and PRN473 (SAR444727) for 28 days |
| Name | Type | Description |
|---|---|---|
| PRN473 (SAR444727) | DRUG | White to off-white gel suspension |
| Placebo | DRUG | White to off-white gel suspension |
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 scre...
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PRN473 is an investigational small molecule being developed for the treatment of atopic dermatitis, a chronic inflammatory skin condition. It is intended for topical administration in patients with mild to moderate disease. The drug is currently in Phase 2 clinical development and has not been approved for any indication.
PRN473 targets Bruton's tyrosine kinase (BTK), a protein involved in immune cell signaling. By inhibiting BTK, the drug is designed to modulate inflammatory pathways associated with atopic dermatitis. This targeted approach is being evaluated for topical treatment of the condition.
PRN473 is being developed by Sanofi, a global pharmaceutical company. Sanofi trades on the Nasdaq under the ticker symbol SNY. The company is responsible for the clinical development of PRN473, including the completed Phase 2a trial in atopic dermatitis.
PRN473 is in Phase 2 clinical development. A Phase 2a trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any regulatory agency for atopic dermatitis or any other indication.
PRN473 has been evaluated in one completed clinical trial: NCT04992546, a Phase 2a study of the safety, tolerability, and pharmacokinetics of topically administered PRN473 in patients with mild to moderate atopic dermatitis. The trial enrolled 39 patients across the United States and Canada.
Yes, PRN473 is also known as SAR444727. Both names refer to the same investigational small molecule developed by Sanofi for atopic dermatitis. The dual naming reflects Sanofi's internal compound designation system.