Phase 2a Study of the Safety, Tolerability, and Pharmacok... | NCT04992546

NCT04992546

ID	Type	Description	Link
U1111-1260-4204	Registry Identifier	ICTRP
PRN473-0005	Other Identifier	Principia Biopharma

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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	Drug: PRN473 (SAR444727) Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
PRN473 (SAR444727)	Drug	White to off-white gel suspension	Placebo then SAR444727 5% BID per lesion SAR444727 5% BID per lesion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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	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.	From the first IMP administration (Day 1) up to Day 45

Secondary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax) of SAR444727	Plasma samples were collected at indicated timepoints for assessment of SAR444727 concentrations.	Day 1, 4 hours post-dose; Day 15, 1 hour post-dose and Day 43, 12 hours post-dose

Eligibility Module

Eligibility Criteria

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.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Collaborative Neuroscience Research-Site Number:8400004		Long Beach	California	90806	United States

References Module

Label	URL
ACT17131 Plain Language Results Summary	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SAR444727 5% BID+Placebo (Double Blinded Period), Then SAR444727 5% BID (Open Label Period)	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 in parallel (i.e., each participant was treated with both SAR444727 5% BID and placebo). 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 1, 2022	Dec 10, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

FG00039 subjects78 units

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.

Arm/Group Information

ID	Title	Description
BG000	SAR444727 5% BID+Placebo (Double-blinded Period), Then SAR444727 5% BID (Open Label Period)	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 in parallel (i.e., each participant was treated with both SAR444727 5% BID and placebo). 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.

Units	Counts
Participants	BG00039

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00039.8± 14.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00024
Male	BG00015

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The Safety population included all randomized participants who received any amount of IMP. TEAE and TESAE were assessed per patient according to study design.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo: Double Blinded Period	During the double-blinded period, 2 target lesions per participant (with difference no greater than 1 point in TSS) were randomized in 1:1 ratio to receive either SAR44727 Gel 5% or matching placebo (i.e., each participant was treated with both SAR444727 5% BID and placebo in parallel). This group represents the AE which occurred while participants were treated with both SAR444727 5% BID and placebo at the same time.
OG001	SAR444727 5% BID: Open Label Period	During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.

Units	Counts
Participants	OG00039 OG00138

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG0007 OG00112

TESAEs

Title	Measurements
	OG000

Primary

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

The Safety population included all randomized participants who received any amount of IMP. Only data from the participants analyzed were reported. PCSAs were assessed per patient according to study design.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo (Double Blinded Period), Then SAR444727 5% BID (Open Label Period)	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 in parallel (i.e., each participant was treated with both SAR444727 5% BID and placebo). 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.

Primary

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo (Double Blinded Period), Then SAR444727 5% BID (Open Label Period)	During the double-blinded period, 2 target lesions per participant (with difference no greater than 1 point in TSS) were randomized in 1:1 ratio to receive either SAR44727 Gel 5% or matching placebo in parallel (i.e., each participant was treated with both SAR444727 5% BID and placebo). During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.

Units

Primary

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).

The Safety population included all randomized participants who received any amount of IMP. Only those participants with data available were analyzed. PCSAs were assessed per patient according to study design.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo: Double Blinded Period	During the double-blinded period, 2 target lesions per participant (with difference no greater than 1 point in TSS) were randomized in 1:1 ratio to receive either SAR44727 Gel 5% or matching placebo (i.e., each participant was treated with both SAR444727 5% BID and placebo in parallel). This group represents the PCSA which occurred while participants were treated with both SAR444727 5% BID and placebo at the same time.
OG001	SAR444727 5% BID: Open Label Period

Primary

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo: Double Blinded Period	During the double-blinded period, 2 target lesions per participant (with difference no greater than 1 point in TSS) were randomized in 1:1 ratio to receive either SAR44727 Gel 5% or matching placebo (i.e., each participant was treated with both SAR444727 5% BID and placebo in parallel). This group represents the PCSA which occurred while participants were treated with both SAR444727 5% BID and placebo at the same time.
OG001	SAR444727 5% BID: Open Label Period	During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.

Primary

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).

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo: Double Blinded Period	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). This group represents the PCSA which occurred while participants were treated with both SAR444727 5% BID and placebo at the same time.
OG001	SAR444727 5% BID: Open Label Period	During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.

Primary

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.

The safety population included all randomized participants who received any amount of IMP. Only those participants with data available were analyzed. PCSAs were assessed per patient according to study design.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo: Double Blinded Period	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). This group represents the PCSA which occurred while participants were treated with both SAR444727 5% BID and placebo at the same time.
OG001	SAR444727 5% BID: Open Label Period	During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.

Primary

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).

The Safety population included all randomized participants who received any amount of IMP. PCSAs were assessed per patient according to study design.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo: Double Blinded Period	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). This group represents the PCSA which occurred while participants were treated with both SAR444727 5% BID and placebo at the same time.
OG001	SAR444727 5% BID: Open Label Period	During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.

Primary

Number of Participants With PCSA: Urinalysis

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

The Safety population included all randomized participants who received any amount of IMP. PCSAs were assessed per patient according to study design.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo: Double Blinded Period	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). This group represents the PCSA which occurred while participants were treated with both SAR444727 5% BID and placebo at the same time.
OG001	SAR444727 5% BID: Open Label Period	During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.

Units	Counts

Primary

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).

The Safety population included all randomized participants who received any amount of IMP.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	Placebo: Double Blinded Period	During the double blinded period, 2 target lesions per participant (with difference no greater than 1 point in TSS) were randomized in 1:1 ratio to receive either SAR44727 Gel 5% or matching placebo.
OG001	SAR444727 5% BID: Double Blinded Period	During double blinded period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.

Units	Counts
Participants

Secondary

Maximum Plasma Concentration (Cmax) of SAR444727

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

The Pharmacokinetic (PK) population included all participants who received any amount of IMP and had at least 1 PK sample. Only those participants with data available were analyzed.

Posted

Mean

Standard Deviation

nanogram/milliliter

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

ID	Title	Description
OG000	SAR444727 5% BID+Placebo (Double-blinded Period), Then SAR444727 5% BID (Open Label Period)	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 in parallel (i.e., each participant was treated with both SAR444727 5% BID and placebo). 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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SAR444727 5% BID+Placebo: Double Blinded Period	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). This group represents the AE which occurred while participants were treated with both SAR444727 5% BID and placebo at the same time.	0	39	0	39	7	39
EG001	SAR444727 5% BID: Open Label Period	During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.	0	38	0	38	12	38

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Mastitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Food allergy	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0013 events3 affected38 at risk
Burning sensation	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Migraine	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected39 at risk EG0010 events0 affected38 at risk
Vessel puncture site pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Application site urticaria	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected38 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk

First MCP Posted Date

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
C000722660	PRN473

During open-label period, participants applied SAR444727 Gel, 5% BID to the all AD-affected areas, except the scalp, palms, soles and genitals through Days 15 to 42.