Atopic DermatitisPhase 2NCT04992546
Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis
A Phase 2 study testing PRN473 (SAR444727) in people with Atopic Dermatitis, run by Principia Biopharma, a Sanofi Company at 12 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- PRN473 (SAR444727)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 13 Aug 2021to 28 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
J&S Studies-Site Number:8400015
Bryan, Texas, 77802
Remington Davis Inc-Site Number:8400012
Columbus, Ohio, 43215
Center for Clinical Studies, LTD. LLP-Site Number:8400014
Houston, Texas, 77004
Collaborative Neuroscience Research-Site Number:8400004
Long Beach, California, 90806
California Allergy & Asthma Medical Group-Site Number:8400008
Los Angeles, California, 90025
Florida International Research Center-Site Number:8400017
Miami, Florida, 33173
Progressive Clinical Research-Site Number:8400002
San Antonio, Texas, 78213
Lenus Research & Medical Group-Site Number:8400006
Sweetwater, Florida, 33172
Clinical Research Trials of Florida, Inc-Site Number:8400013
Tampa, Florida, 33607
Canada3 sites
Investigational Site Number :1240008
Hamilton, Ontario, L8L 3C3
Investigational Site Number :1240007
London, Ontario, N6H 5L5
Investigational Site Number :1240002
Québec, G1G 3Y8
About this study
Official 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
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.
Read the detailed description
Study duration per patient was approximately 56 days including a 42-days treatment period.
- Conditions
- Atopic Dermatitis
- Being tested
- PRN473 (SAR444727), Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRN473 (SAR444727)Drug
White to off-white gel suspension
PlaceboDrug
White to off-white gel suspension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PRN473 (SAR444727) |
| Placebo then SAR444727 5% BID per lesion | Placebo comparator | Multiple topical doses of placebo for 14 days, and PRN473 (SAR444727) for 28 days Receives: Drug: PRN473 (SAR444727); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: From the first IMP administration (Day 1) up to Week 2
Secondary outcomes (1)
Maximum Plasma Concentration (Cmax) of SAR444727
Plasma samples were collected at indicated timepoints for assessment of SAR444727 concentrations.
Measured: Day 1, 4 hours post-dose; Day 15, 1 hour post-dose and Day 43, 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start13 Aug 2021
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Principia Biopharma, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992546
- Sponsor's protocol ID
- ACT17131
- Other IDs
- U1111-1260-4204, PRN473-0005
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2021
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04992546
- Acronym / sponsor ID
- ACT17131
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Principia Biopharma, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study duration per patient was approximately 56 days including a 42-days treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR444727 5% BID per lesion | Experimental | Drug: PRN473 (SAR444727)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 | Drug: PRN473 (SAR444727), Drug: PlaceboMultiple topical doses of placebo for 14 days, and PRN473 (SAR444727) for 28 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRN473 (SAR444727)White to off-white gel suspension | Drug | Placebo then SAR444727 5% BID per lesion, SAR444727 5% BID per lesion |
| PlaceboWhite to off-white gel suspension | Drug | Placebo then SAR444727 5% BID per lesion |
Primary outcome
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.
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
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.
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).
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.
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).
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.
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).
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.
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).
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ACT17131 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRN473 (SAR444727) in people with Atopic Dermatitis, run by Principia Biopharma, a Sanofi Company at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.