A Phase 2 interventional study of PRN473 (SAR444727) and Placebo in Atopic Dermatitis, sponsored by Principia Biopharma, a Sanofi Company. Completed at 12 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Principia Biopharma, a Sanofi Company · Phase 2, Interventional, and Treatment
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 duration per patient was approximately 56 days including a 42-days treatment period.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 39 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Principia Biopharma, a Sanofi Company is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: PRN473 (SAR444727)
Multiple topical doses of placebo for 14 days, and PRN473 (SAR444727) for 28 days
Drug: PRN473 (SAR444727) · Drug: Placebo
White to off-white gel suspension
White to off-white gel suspension
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
Maximum Plasma Concentration (Cmax) of SAR444727
Plasma samples were collected at indicated timepoints for assessment of SAR444727 concentrations.
Time frame: Day 1, 4 hours post-dose; Day 15, 1 hour post-dose and Day 43, 12 hours post-dose
The study was conducted at 12 centers in 2 countries. A total of 74 participants were screened from 13 Aug 2021 to 27 Oct 2022, of which 35 were screen failures due to not meeting eligibility criteria.
| Milestone | SAR444727 5% BID+Placebo (Double Blinded Period), Then SAR444727 5% BID (Open Label Period) |
|---|---|
| Started | 39 |
| Completed | 37 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Doses missed due to covid-19 pandemic circumstances at the site | 1 |
| Milestone | SAR444727 5% BID+Placebo (Double Blinded Period), Then SAR444727 5% BID (Open Label Period) |
|---|---|
| Started | 38 |
| Completed | 34 |
| Not completed | 4 |
| Withdrew: Adverse event | 3 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Participants | SAR444727 5% BID+Placebo: Double Blinded Period | SAR444727 5% BID: Open Label Period |
|---|---|---|
| TEAEs | 7 | 12 |
| TESAEs | 0 | 0 |
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
| Participants | SAR444727 5% BID+Placebo (Double Blinded Period), Then SAR444727 5% BID (Open Label Period) |
|---|---|
| Supine systolic blood pressure | 0 |
| Supine diastolic blood pressure | 0 |
| Supine HR | 0 |
| Body temperature | 0 |
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.
| Participants | SAR444727 5% BID+Placebo (Double Blinded Period), Then SAR444727 5% BID (Open Label Period) |
|---|---|
| HR < 50 bpm | 0 |
| HR > 90 bpm | 1 |
| HR > 90 bpm and increase from baseline >= 20 bpm | 0 |
| HR > 100 bpm | 0 |
| PR interval > 200 msec | 1 |
| PR interval > 200 msec and increase from baseline >= 25% | 0 |
| PR interval > 220 msec | 0 |
| QRS interval > 110 msec | 2 |
| QRS interval > 110 msec and increase from baseline >= 25% | 0 |
| QRS interval > 120 msec | 0 |
| QT interval > 500 msec | 0 |
| QTc interval > 450 msec | 1 |
| QTc interval > 480 msec | 0 |
| QTc interval increase from baseline (30-60) msec | 2 |
| QTc interval increase from baseline > 60 msec | 0 |
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).
| Participants | SAR444727 5% BID+Placebo: Double Blinded Period | SAR444727 5% BID: Open Label Period |
|---|---|---|
| Hb <= 115 g/L (M); <= 95 g/L (F) | 0 | 1 |
| Hb >=185 g/L (M) or >=165 g/L (F) | 0 | 0 |
| Hb decrease from baseline >=20 g/L | 0 | 0 |
| Hematocrit <=0.37 v/v (M) or <=0.32 v/v (F) | 0 | 1 |
| Hematocrit >=0.55 v/v (M) or >=0.5 v/v (F) | 0 | 0 |
| RBC >=6 Tera/L | 0 | 0 |
| Platelets <100 Giga/L | 0 | 0 |
| Platelets >=700 Giga/L | 0 | 0 |
| Neutrophils <1.5 Giga/L (NB) or <1.0 Giga/L (B) | 0 | 0 |
| Lymphocytes: > 4.0 Giga/L | 1 | 2 |
| Monocytes: >0.7 Giga/L | 2 | 7 |
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.
| Participants | SAR444727 5% BID+Placebo: Double Blinded Period | SAR444727 5% BID: Open Label Period |
|---|---|---|
| Sodium <=129 mmol/L | 0 | 0 |
| Sodium >=160 mmol/L | 0 | 0 |
| Potassium <3 mmol/L | 0 | 0 |
| Potassium >=5.5 mmol/L | 1 | 1 |
| Chloride <80 mmol/L | 0 | 0 |
| Chloride >115 mmol/L | 0 | 0 |
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).
| Participants | SAR444727 5% BID+Placebo: Double Blinded Period | SAR444727 5% BID: Open Label Period |
|---|---|---|
| Glucose <=3.9 mmol/L and <LLN | 0 | 0 |
| Glucose >=11.1 mmol/L (unfas) or >=7 mmol/L (fas) | 2 | 4 |
| Albumin <=25 g/L | 0 | 0 |
| CK > 3 ULN | 1 | 0 |
| CK > 10 ULN | 1 | 0 |
| C-Reactive protein: > 2 ULN or 10 mg/L (if ULN not provided) | 1 | 5 |
Criteria for PCSA: Creatinine: \>=150 micromoles per liter (mcmol/L), \>=30% change from baseline, \>=100% change from baseline.
| Participants | SAR444727 5% BID+Placebo: Double Blinded Period | SAR444727 5% BID: Open Label Period |
|---|---|---|
| Creatinine >=150 mcmol/L | 0 | 0 |
| Creatinine >=30% change from baseline | 1 | 3 |
| Creatinine >=100% change from baseline | 0 | 0 |
Liver function parameters assessments included alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin, and gamma glutamyl transferase (GGT).
| Participants | SAR444727 5% BID+Placebo: Double Blinded Period | SAR444727 5% BID: Open Label Period |
|---|---|---|
| ALT | 0 | 0 |
| AST | 0 | 0 |
| Alkaline phosphatase | 0 | 0 |
| Lactate dehydrogenase | 0 | 0 |
| Total bilirubin | 0 | 0 |
| Direct bilirubin | 0 | 0 |
| GGT | 0 | 0 |
Urinalysis parameters assessments included potential of Hydrogen (pH), urobilinogen, and specific gravity.
| Participants | SAR444727 5% BID+Placebo: Double Blinded Period | SAR444727 5% BID: Open Label Period |
|---|---|---|
| pH | 0 | 0 |
| Urobilinogen | 0 | 0 |
| Specific gravity | 0 | 0 |
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).
| percentage of participants | Placebo: Double Blinded Period | SAR444727 5% BID: Double Blinded Period |
|---|---|---|
| Burning | 23.7 | 17.9 |
| Pruritus | 31.6 | 25.6 |
| Erythema | 47.4 | 48.7 |
Plasma samples were collected at indicated timepoints for assessment of SAR444727 concentrations.
| nanogram/milliliter | SAR444727 5% BID+Placebo (Double-blinded Period), Then SAR444727 5% BID (Open Label Period) |
|---|---|
| Day 1, 4 hours post-dose | 0 ± 0.096 |
| Day 15, 1 hour post-dose | 0 ± 0.152 |
| Day 43, 12 hours post-dose | 0 ± 0.035 |
Collected over TEAE data was collected from the first IMP administration (Day 1) up to Day 58. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SAR444727 5% BID+Placebo: Double Blinded Period | 0/39 (0%) | 0/39 (0%) | 7/39 (17.9%) |
| SAR444727 5% BID: Open Label Period | 0/38 (0%) | 0/38 (0%) | 12/38 (31.6%) |
| Event | SAR444727 5% BID+Placebo: Double Blinded Period | SAR444727 5% BID: Open Label Period |
|---|---|---|
| HeadacheNervous system disorders | 1/39 | 3/38 |
| BronchitisInfections and infestations | 0/39 | 1/38 |
| Gastroenteritis viralInfections and infestations | 0/39 | 1/38 |
| MastitisInfections and infestations | 0/39 | 1/38 |
| Pharyngitis streptococcalInfections and infestations | 0/39 | 1/38 |
| Upper respiratory tract infectionInfections and infestations | 0/39 | 1/38 |
| Food allergyImmune system disorders | 0/39 | 1/38 |
| DermatitisSkin and subcutaneous tissue disorders | 0/39 | 1/38 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 0/39 | 1/38 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 0/39 | 1/38 |
The randomized population included all participants from the screened population who had been allocated to a randomized treatment by interactive response technology (IRT) regardless of whether the treatment was received.
| Age, Continuous(years) | SAR444727 5% BID+Placebo (Double-blinded Period), Then SAR444727 5% BID (Open Label Period) |
|---|---|
| Mean | 39.8 ± 14.2 |
| Sex: Female, Male(Participants) | SAR444727 5% BID+Placebo (Double-blinded Period), Then SAR444727 5% BID (Open Label Period) |
|---|---|
| Female | 24 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | SAR444727 5% BID+Placebo (Double-blinded Period), Then SAR444727 5% BID (Open Label Period) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 12 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Principia Biopharma, a Sanofi Company