Clinical Trials List
Protocol NumberACT17754
Completed
2025-02-01 - 2025-08-05
Phase II
Recruiting4
ICD-10L22
Diaper dermatitis
ICD-9691.0
Diaper or napkin rash
A multinational, multicenter, double-blind, placebo-controlled Phase 2 study to evaluate efficacy and safety of SAR444656 in adult participants with moderate to severe atopic dermatitis
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Sponsor
Sanofi-Aventis Recherche & Développement
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Yu-Huei Huang Division of Dermatology
- Chun-Bing Chen Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- Chun-Wei Lu Division of Dermatology
- Chin-Yi Yang Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蕭百芬 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- DINGDAR LEE Division of Dermatology
- 張綜顯 Division of Dermatology
- 吳貞宜 Division of Dermatology
- Yun-Ting Chang Division of Dermatology
- 何翊芯 Division of Dermatology
- 馬聖翔 Division of Dermatology
- Cheng-Yuan Li Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Woan-Ruoh Lee
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
moderate to severe atopic dermatitis
Objectives
To assess the efficacy of SAR444656 on AD lesions
compared with placebo in adult participants with
moderate to severe AD.
Test Drug
tablet
Active Ingredient
SAR444656
Dosage Form
110
Dosage
25mg
Endpoints
Percent change from baseline in EASI at Week 16.
Inclution Criteria
Age
I 01. Participant must be 18 years of age inclusive, or older at the time of signing the informed
consent.
Type of participant and disease characteristics
I 02. Participants with AD as defined by the American Academy of Dermatology Consensus
Criteria (16) for at least 1 year before the baseline visit.
I 03. EASI ≥12 at screening and at baseline visit.
I 04. vIGA (17) score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
at screening and baseline visit.
I 05. AD involvement ≥10% of BSA at screening and baseline visit.
I 06. Baseline PP-NRS ≥4
I 07. Participant must have documented history within 6 months prior to baseline visit, of either
inadequate response or inadvisability to topical medications.
I 08. Participants must have applied daily topical emollient (moisturizer) for at least the
7 consecutive days immediately before the baseline visit. Participants should continue
using daily emollient (moisturizer) during the study.
I 09. Participant must be willing and able to complete the electronic diary for the duration of the
study as required by the study protocol.
I 10. All Contraceptive use by men and women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
A) Male participants
Male participants are eligible to participate if they agree to the following during the study
intervention period and for at least 13 weeks after the last administration of study
intervention:
• Refrain from donating or cryopreserving sperm
PLUS, either:
- Be abstinent from heterosexual or homosexual intercourse as their preferred and usual
lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR
- Must agree to use contraception/barrier as detailed below:
- A male condom and an additional highly effective contraceptive method
as described in Appendix 4 Contraceptive and barrier guidance (Section 10.4)
when having sexual intercourse with a WOCBP who is not currently pregnant.
- A male condom when engaging in any activity that allows for passage of ejaculate
to another person.
B) Female participants
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and
one of the following conditions applies:- Is a WONCBP as defined in Appendix 4 Contraceptive and barrier guidance
(Section 10.4)
OR
- Is a WOCBP and agrees to use a contraceptive method that is highly effective (with
a failure rate of < 1% per year), preferably with low user dependency, as described in
Appendix 4 Contraceptive and barrier guidance (Section 10.4) during the study
intervention period (to be effective before starting the intervention) and for at least
4 weeks after the last administration of study intervention and agrees not to donate or
cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
• A WOCBP must have a negative highly sensitive pregnancy test (serum as required by
local regulations) within 4 weeks before the first administration of study intervention, see
Section 8.3.5 Pregnancy testing of the protocol. If a urine test cannot be confirmed as
negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the
participant must be excluded from participation if the serum pregnancy result is positive.
I 01. Participant must be 18 years of age inclusive, or older at the time of signing the informed
consent.
Type of participant and disease characteristics
I 02. Participants with AD as defined by the American Academy of Dermatology Consensus
Criteria (16) for at least 1 year before the baseline visit.
I 03. EASI ≥12 at screening and at baseline visit.
I 04. vIGA (17) score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
at screening and baseline visit.
I 05. AD involvement ≥10% of BSA at screening and baseline visit.
I 06. Baseline PP-NRS ≥4
I 07. Participant must have documented history within 6 months prior to baseline visit, of either
inadequate response or inadvisability to topical medications.
I 08. Participants must have applied daily topical emollient (moisturizer) for at least the
7 consecutive days immediately before the baseline visit. Participants should continue
using daily emollient (moisturizer) during the study.
I 09. Participant must be willing and able to complete the electronic diary for the duration of the
study as required by the study protocol.
I 10. All Contraceptive use by men and women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
A) Male participants
Male participants are eligible to participate if they agree to the following during the study
intervention period and for at least 13 weeks after the last administration of study
intervention:
• Refrain from donating or cryopreserving sperm
PLUS, either:
- Be abstinent from heterosexual or homosexual intercourse as their preferred and usual
lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR
- Must agree to use contraception/barrier as detailed below:
- A male condom and an additional highly effective contraceptive method
as described in Appendix 4 Contraceptive and barrier guidance (Section 10.4)
when having sexual intercourse with a WOCBP who is not currently pregnant.
- A male condom when engaging in any activity that allows for passage of ejaculate
to another person.
B) Female participants
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and
one of the following conditions applies:- Is a WONCBP as defined in Appendix 4 Contraceptive and barrier guidance
(Section 10.4)
OR
- Is a WOCBP and agrees to use a contraceptive method that is highly effective (with
a failure rate of < 1% per year), preferably with low user dependency, as described in
Appendix 4 Contraceptive and barrier guidance (Section 10.4) during the study
intervention period (to be effective before starting the intervention) and for at least
4 weeks after the last administration of study intervention and agrees not to donate or
cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
• A WOCBP must have a negative highly sensitive pregnancy test (serum as required by
local regulations) within 4 weeks before the first administration of study intervention, see
Section 8.3.5 Pregnancy testing of the protocol. If a urine test cannot be confirmed as
negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the
participant must be excluded from participation if the serum pregnancy result is positive.
Exclusion Criteria
E 01. Presence of other skin conditions that may interfere with study assessments such as
psoriasis, tinea corporis, lupus erythematosus.
E 02. Any other clinically significant disease, condition, or medical history that, in the opinion
of the Investigator, would interfere with participant safety, trial evaluations, and/or trial
procedures. Examples include, but are not limited to participants with short life
expectancy, participants with uncontrolled diabetes (hemoglobin A1c ≥9%), participants
with cardiovascular conditions, severe renal conditions (eg, participants on dialysis),
immunosuppression conditions, neurological conditions (eg, demyelinating diseases),
hepato-biliary conditions such as hepatitis virus infections, drug- or alcohol-related liver
disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis,
Wilson’s disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary
sclerosing cholangitis, moderate or severe hepatic impairment (Child Pugh B or C) or any
other liver disease considered clinically significant by the Investigator, active major
autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc),
other severe endocrinological, gastrointestinal, metabolic, pulmonary, or lymphatic
diseases.
E 03. Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals,
antifungals, anthelminthics) within 4 weeks prior to baseline (1 week in the event of
superficial infections).
E 04. Known history of, or suspected, significant current immunosuppression, including history
of invasive opportunistic or helminth infections despite infection resolution or otherwise
recurrent infections of abnormal frequency or prolonged duration.
E 05. History of solid organ or stem cell transplant.
E 06. Participant with history of splenectomy.
E 07. Participant with history of any malignancy or lymphoproliferative disease, except if the
participant has been free from disease for ≥5 years. Successfully treated non-metastatic
cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ
of the cervix are allowed.
E 08. History (within last 2 years prior to baseline) of prescription drug or substance abuse,
including alcohol, considered significant by the Investigator.
E 09. Family history of sudden death or long QT syndrome.
E 10. History of congenital or drug-induced long QT syndrome.
E 11. Congestive heart failure (NYHA Class 2-4), greater than Class 1 angina pectoris,
acute coronary syndrome within prior 6 months, known structural heart disease.
E 12. History of any major cardiovascular events (eg, myocardial infarction, unstable angina
pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior
to screening.
E 13. History of ventricular fibrillation, ventricular tachycardia, Torsades de Pointes,
atrial fibrillation, syncope not explained by non-cardiac etiology.
E 14. Uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mm Hg
or consistent diastolic blood pressure ≥90 mm Hg despite antihypertensive medication.
E 15. Bradycardia with heart rate <50 beats per minute during screening.
E 16. Supine 12-lead triplicate ECG demonstrating a mean QTcF interval >440 msec
or QRS interval >110 msec in ECG obtained during screening.
E 17. Serum potassium, magnesium, or calcium below lower limit of normal during screening.
psoriasis, tinea corporis, lupus erythematosus.
E 02. Any other clinically significant disease, condition, or medical history that, in the opinion
of the Investigator, would interfere with participant safety, trial evaluations, and/or trial
procedures. Examples include, but are not limited to participants with short life
expectancy, participants with uncontrolled diabetes (hemoglobin A1c ≥9%), participants
with cardiovascular conditions, severe renal conditions (eg, participants on dialysis),
immunosuppression conditions, neurological conditions (eg, demyelinating diseases),
hepato-biliary conditions such as hepatitis virus infections, drug- or alcohol-related liver
disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis,
Wilson’s disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary
sclerosing cholangitis, moderate or severe hepatic impairment (Child Pugh B or C) or any
other liver disease considered clinically significant by the Investigator, active major
autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc),
other severe endocrinological, gastrointestinal, metabolic, pulmonary, or lymphatic
diseases.
E 03. Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals,
antifungals, anthelminthics) within 4 weeks prior to baseline (1 week in the event of
superficial infections).
E 04. Known history of, or suspected, significant current immunosuppression, including history
of invasive opportunistic or helminth infections despite infection resolution or otherwise
recurrent infections of abnormal frequency or prolonged duration.
E 05. History of solid organ or stem cell transplant.
E 06. Participant with history of splenectomy.
E 07. Participant with history of any malignancy or lymphoproliferative disease, except if the
participant has been free from disease for ≥5 years. Successfully treated non-metastatic
cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ
of the cervix are allowed.
E 08. History (within last 2 years prior to baseline) of prescription drug or substance abuse,
including alcohol, considered significant by the Investigator.
E 09. Family history of sudden death or long QT syndrome.
E 10. History of congenital or drug-induced long QT syndrome.
E 11. Congestive heart failure (NYHA Class 2-4), greater than Class 1 angina pectoris,
acute coronary syndrome within prior 6 months, known structural heart disease.
E 12. History of any major cardiovascular events (eg, myocardial infarction, unstable angina
pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior
to screening.
E 13. History of ventricular fibrillation, ventricular tachycardia, Torsades de Pointes,
atrial fibrillation, syncope not explained by non-cardiac etiology.
E 14. Uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mm Hg
or consistent diastolic blood pressure ≥90 mm Hg despite antihypertensive medication.
E 15. Bradycardia with heart rate <50 beats per minute during screening.
E 16. Supine 12-lead triplicate ECG demonstrating a mean QTcF interval >440 msec
or QRS interval >110 msec in ECG obtained during screening.
E 17. Serum potassium, magnesium, or calcium below lower limit of normal during screening.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
200 participants
