Clinical Trials List
Protocol NumberACT17754
Completed
2025-02-01 - 2025-08-05
Recruiting4
ICD-10L22
Diaper dermatitis
ICD-9691.0
Diaper or napkin rash
A multinational, multicenter, double-blind, placebo-controlled phase 2 trial evaluating the efficacy and safety of SAR444656 in adult subjects with moderate to severe atopic dermatitis.
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Sponsor
Thermo fisher Co., Ltd. Taiwan Branch
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/25
Investigators and Locations
Co-Principal Investigator
- 蕭百芬 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Hsien Shih Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 何翊芯 Division of Dermatology
- 吳貞宜 Division of Dermatology
- DINGDAR LEE Division of Dermatology
- Cheng-Yuan Li Division of Dermatology
- 馬聖翔 Division of Dermatology
- Yun-Ting Chang Division of Dermatology
- 張綜顯 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wen-Hung Chung
Co-Principal Investigator
- Chung-Yao Hsu Division of Dermatology
- Chun-Bing Chen Division of Dermatology
- Yu-Huei Huang Division of Dermatology
- Chin-Yi Yang Division of Dermatology
- Chun-Wei Lu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
The study aimed to evaluate the efficacy of SAR444656 compared to placebo in treating AD lesions in adult subjects with moderate to severe AD. • Percentage change in EASI from baseline to week 16.
Objectives
This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group, phase 2, 4-group trial evaluating the efficacy and safety of SAR444656 in adult subjects with moderate to severe AD (who have poor response to local therapy or for whom local therapy is not recommended and who are suitable for systemic therapy).
Test Drug
SAR444656
Active Ingredient
SAR444656
Dosage Form
TABLETS
Dosage
25mg
Endpoints
The study aimed to evaluate the efficacy of SAR444656 compared to placebo in adult subjects with moderate to severe Alzheimer's disease (AD) lesions.
Percentage change in EASI from baseline to week 16
Percentage change in EASI from baseline to week 16
Inclution Criteria
Age
I 01. Participants must be at least 18 years old when signing the participant consent form.
Participant Type and Disease Characteristics
I 02. Participants must have had Alzheimer's disease (AD) for at least one year prior to the baseline return visit.
I 03. At screening and at the baseline return visit, the Eczema Area and Skin Severity Index (EASI) must be ≥ 12.
I 04. At screening and at the baseline return visit, the Validated Investigator Global Assessment (vIGA) score must be ≥ 3 (IGA scores range from 0 to 4, where 3 is moderate and 4 is severe).
I 05. At screening and at the baseline return visit, AD must have affected ≥ 10% of the body surface area (BSA).
I 06. Peak pruritus numeric rating scale (PP-NRS) score ≥ 4 at baseline.
Note: The baseline weekly average of the daily PP-NRS will be calculated based on the 7 consecutive days immediately preceding the baseline return visit. At least 4 daily scores are required over the 7 days. If this requirement is not met, randomization should be postponed, but the screening period should not be extended beyond 30 days.
I 07. Participants must have a medical history of inadequate response to or unrecommended use of topical medications within the 6 months prior to the baseline return visit.
Note: • Acceptable documentation includes contemporaneous medical records documenting topical prescriptions and treatment outcomes, or principal investigator documentation based on communications with the patient's treating physician.
• Inadequate response to topical medication is defined as the failure to achieve or maintain remission or a low disease activity state (IGA ≤ 2) despite daily treatment with moderate to high potency topical corticosteroids (TCS) for at least 28 days or the maximum duration recommended in the product prescribing information (e.g., 14 days for ultra-potency TCS), whichever is shorter.
• Inadequate response to topical medication is also considered if a participant has failed systemic therapy (e.g., cyclosporine, methotrexate, azathioprine, or mycophenolate mofetil) for AD within the 6 months prior to screening.
• Not recommended is defined as a significant side effect or safety risk, i.e., a side effect or safety risk that, as assessed by the trial administrator or treating physician, outweighs the potential treatment benefit (e.g., allergic reaction, significant skin atrophy, systemic effects, or an urgent reaction).
I 08. Participants must use a topical moisturizer daily for at least 7 consecutive days immediately preceding their baseline return visit. Participants should continue using their daily moisturizer during the trial.
I 09. Participants must be willing and able to complete an electronic log during the trial as required by the trial protocol.
Weight
Not applicable.
Sex, Contraception/Barrier Methods, and Pregnancy Testing Requirements/Breastfeeding
I 10. All contraceptive methods used by men and women should comply with local regulations applicable to contraceptive methods used by clinical trial participants.
A) Male Participants
Male participants are eligible to participate if they agree to adhere to the following during the trial intervention and for at least 13 weeks after the last trial intervention:
• No sperm donation or cryopreservation
And additionally, one of the following:
- Agree to maintain abstinence and that avoiding heterosexual or homosexual sexual activity is their preferred and habitual lifestyle (long-term abstinence).
Or
- Must agree to use contraception/barrier methods, detailed below:
- When having sexual intercourse with a currently non-pregnant, fertile woman (WOCBP), use a male condom in conjunction with a highly effective method of contraception.
- When engaging in any activity that could result in ejaculation into another person, use a male condom.
B) Female Participants
• Female participants are eligible to participate if they are not pregnant or breastfeeding and meet one of the following criteria:
- Are a non-fertile woman (WONCBP)
Or
- Are a WOCBP and agree to use a highly effective method of contraception (annual failure rate < 1%) during the trial intervention (which should remain effective before the start of the trial intervention) and for at least 4 weeks after the last trial intervention, preferably a method with low user dependence, and agree not to donate or cryopreserve eggs (ovules, oocytes) for reproductive purposes during this period.
• A high-sensitivity pregnancy test (serum pregnancy test as required by local regulations) must be negative for WOCBPs within 4 weeks prior to the first trial intervention. If a urine test cannot confirm a negative result (e.g., an inconclusive result), a serological pregnancy test must be performed. In such cases, if the serological pregnancy test result is positive, the participant must be excluded from the trial.
Informed Consent
I 11. The participant must be capable of signing a participant consent form, including compliance with the informed consent form (ICF) and the requirements and limitations set forth in this trial protocol.
I 01. Participants must be at least 18 years old when signing the participant consent form.
Participant Type and Disease Characteristics
I 02. Participants must have had Alzheimer's disease (AD) for at least one year prior to the baseline return visit.
I 03. At screening and at the baseline return visit, the Eczema Area and Skin Severity Index (EASI) must be ≥ 12.
I 04. At screening and at the baseline return visit, the Validated Investigator Global Assessment (vIGA) score must be ≥ 3 (IGA scores range from 0 to 4, where 3 is moderate and 4 is severe).
I 05. At screening and at the baseline return visit, AD must have affected ≥ 10% of the body surface area (BSA).
I 06. Peak pruritus numeric rating scale (PP-NRS) score ≥ 4 at baseline.
Note: The baseline weekly average of the daily PP-NRS will be calculated based on the 7 consecutive days immediately preceding the baseline return visit. At least 4 daily scores are required over the 7 days. If this requirement is not met, randomization should be postponed, but the screening period should not be extended beyond 30 days.
I 07. Participants must have a medical history of inadequate response to or unrecommended use of topical medications within the 6 months prior to the baseline return visit.
Note: • Acceptable documentation includes contemporaneous medical records documenting topical prescriptions and treatment outcomes, or principal investigator documentation based on communications with the patient's treating physician.
• Inadequate response to topical medication is defined as the failure to achieve or maintain remission or a low disease activity state (IGA ≤ 2) despite daily treatment with moderate to high potency topical corticosteroids (TCS) for at least 28 days or the maximum duration recommended in the product prescribing information (e.g., 14 days for ultra-potency TCS), whichever is shorter.
• Inadequate response to topical medication is also considered if a participant has failed systemic therapy (e.g., cyclosporine, methotrexate, azathioprine, or mycophenolate mofetil) for AD within the 6 months prior to screening.
• Not recommended is defined as a significant side effect or safety risk, i.e., a side effect or safety risk that, as assessed by the trial administrator or treating physician, outweighs the potential treatment benefit (e.g., allergic reaction, significant skin atrophy, systemic effects, or an urgent reaction).
I 08. Participants must use a topical moisturizer daily for at least 7 consecutive days immediately preceding their baseline return visit. Participants should continue using their daily moisturizer during the trial.
I 09. Participants must be willing and able to complete an electronic log during the trial as required by the trial protocol.
Weight
Not applicable.
Sex, Contraception/Barrier Methods, and Pregnancy Testing Requirements/Breastfeeding
I 10. All contraceptive methods used by men and women should comply with local regulations applicable to contraceptive methods used by clinical trial participants.
A) Male Participants
Male participants are eligible to participate if they agree to adhere to the following during the trial intervention and for at least 13 weeks after the last trial intervention:
• No sperm donation or cryopreservation
And additionally, one of the following:
- Agree to maintain abstinence and that avoiding heterosexual or homosexual sexual activity is their preferred and habitual lifestyle (long-term abstinence).
Or
- Must agree to use contraception/barrier methods, detailed below:
- When having sexual intercourse with a currently non-pregnant, fertile woman (WOCBP), use a male condom in conjunction with a highly effective method of contraception.
- When engaging in any activity that could result in ejaculation into another person, use a male condom.
B) Female Participants
• Female participants are eligible to participate if they are not pregnant or breastfeeding and meet one of the following criteria:
- Are a non-fertile woman (WONCBP)
Or
- Are a WOCBP and agree to use a highly effective method of contraception (annual failure rate < 1%) during the trial intervention (which should remain effective before the start of the trial intervention) and for at least 4 weeks after the last trial intervention, preferably a method with low user dependence, and agree not to donate or cryopreserve eggs (ovules, oocytes) for reproductive purposes during this period.
• A high-sensitivity pregnancy test (serum pregnancy test as required by local regulations) must be negative for WOCBPs within 4 weeks prior to the first trial intervention. If a urine test cannot confirm a negative result (e.g., an inconclusive result), a serological pregnancy test must be performed. In such cases, if the serological pregnancy test result is positive, the participant must be excluded from the trial.
Informed Consent
I 11. The participant must be capable of signing a participant consent form, including compliance with the informed consent form (ICF) and the requirements and limitations set forth in this trial protocol.
Exclusion Criteria
E 01. The presence of other skin conditions that may interfere with the assessment of the test, such as psoriasis, tinea corporis, or lupus erythematosus.
E 02. Any other clinically significant disease, condition, or history that the trial administrator believes would affect participant safety, trial evaluation, and/or trial procedures, including but not limited to: a shorter life expectancy, poorly controlled diabetes (heme A1c ≥ 9%), cardiovascular disease, severe kidney disease (e.g., participants on dialysis), immunosuppressive disease, neurological disease (e.g., demyelinating disease), hepatobiliary disease (e.g., hepatitis virus infection, drug- or alcohol-related liver disease, non-alcoholic fatty liver disease, autoimmune hepatitis, hemostasis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, moderate or severe hepatic impairment (Child Pugh B or C) or any other liver disease deemed clinically significant by the trial administrator, active major autoimmune disease (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other serious endocrine, gastrointestinal, metabolic, pulmonary, or lymphatic diseases.
E 03. 4 days prior to the baseline period Any active or chronic infection requiring systemic treatment (e.g., antibiotics, antiviral agents, antifungals, anthelmintics) within one week (or one week if a superficial infection occurs).
E04. Known history of or suspected current significant immunosuppression, including a history of invasive opportunistic or helmintic infections despite infection remission, or other recurrent infections with unusual frequency or prolonged duration.
E05. History of solid organ or stem cell transplantation.
E06. Participants who have undergone splenectomy.
E07. Participants with a history of any malignancy or lymphoproliferative disorder, unless the participant has been disease-free for ≥ 5 years.
Inclusion is permitted for successfully cured non-metastatic squamous cell carcinoma of the skin, basal cell carcinoma, or localized cervical carcinoma in situ.
E08. History of prescription drug or substance abuse (including alcohol) within the most recent 2 years prior to the baseline period, deemed serious by the trial administrator.
E09. Family history of sudden death or long QT syndrome.
E10. E11. History of congenital or drug-induced long QT syndrome.
E12. Congestive heart failure [New York Heart Association (NYHA) 2-4], angina pectoris grade 1 or higher, acute coronary syndrome within the past 6 months, known structural heart disease.
E13. History of any major cardiovascular event (e.g., myocardial infarction, unstable angina, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
E14. History of ventricular fibrillation, ventricular tachycardia, polymorphic ventricular tachycardia, atrial fibrillation, or syncope that cannot be explained by non-cardiac causes.
E15. Poorly controlled hypertension, defined as a persistent systolic blood pressure ≥ 150 mm Hg or a persistent diastolic blood pressure ≥ 90 mm Hg despite antihypertensive medication.
E16. Bradycardia during screening, with a heart rate < 50 bpm. E16. During screening, three 12-lead ECGs performed while supine showed a mean QTcF interval > 440 ms or a QRS interval > 110 ms.
E17. During screening, serum potassium, magnesium, or calcium levels were below the lower limit of normal.
Previous/Concurrent Therapies
E18. The participant underwent major surgery within 4 weeks prior to screening, or plans to undergo any non-urgent major surgery during the trial.
E19. Received an active (attenuated) vaccine within 12 weeks prior to Day 1, or plans to receive an active vaccine during the trial.
E20. Received an inactive vaccine (e.g., inactive seasonal influenza, COVID-19 vaccine) within 14 days prior to Day 1 of the trial.
E21. Received any contraindicated therapy (unless otherwise stated) within the specified timeframe prior to the baseline return visit.
Previous/Concurrent Clinical Trial Experience
E22. Previous use of IRAK4 Inhibitors or degrading agents.
Diagnostic Assessment
E 23. History of human immunodeficiency virus (HIV) infection, or a positive HIV serological test at screening.
E 24. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening.
E 25. Positive hepatitis C virus (HCV) antibody test at screening.
E 26. Any of the following abnormal laboratory test results at the baseline return visit:
• Heme < 9 g/dL
• Absolute neutrophil count < 1.5 x 10⁹/L
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN)
• Total bilirubin > 1.5 • ULN > 1.5 (If total bilirubin has been separated and direct bilirubin < 35%, unconjugated bilirubin > 1.5 times ULN is allowed)
• Platelet count < 100 x 10⁹/L (< 100,000/μl)
E 27. Evidence of active or latent tuberculosis (TB) with a history (e.g., chest X-ray), examination, and TB testing record: positive QuantiFERON® TB Gold IGRA test or two inconclusive results at screening (regardless of previous treatment status).
Other Exclusion Criteria
E 28. Individuals placed in an institution due to regulations or legal orders; prisoners or participants lawfully detained.
E 29. Participants are deemed unfit to participate for any reason, including medical or clinical conditions, or participants may not follow the trial procedures, in the judgment of the trial administrator.
E 30. Participants must be employees of the clinical trial center or other individuals directly involved in the execution of the trial, or immediate family members of such individuals (in accordance with Section 1.61 of Regulation E6 of the International Council for Harmonisation-Good Clinical Practice (ICH-GCP)).
E 31. Sensitivity to any trial intervention or its components or the drug, or other allergies deemed by the trial administrator to constitute a contraindication to participation in the trial.
E 32. Any specific national regulations that would disqualify a participant from participating in this trial.
E 02. Any other clinically significant disease, condition, or history that the trial administrator believes would affect participant safety, trial evaluation, and/or trial procedures, including but not limited to: a shorter life expectancy, poorly controlled diabetes (heme A1c ≥ 9%), cardiovascular disease, severe kidney disease (e.g., participants on dialysis), immunosuppressive disease, neurological disease (e.g., demyelinating disease), hepatobiliary disease (e.g., hepatitis virus infection, drug- or alcohol-related liver disease, non-alcoholic fatty liver disease, autoimmune hepatitis, hemostasis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, moderate or severe hepatic impairment (Child Pugh B or C) or any other liver disease deemed clinically significant by the trial administrator, active major autoimmune disease (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other serious endocrine, gastrointestinal, metabolic, pulmonary, or lymphatic diseases.
E 03. 4 days prior to the baseline period Any active or chronic infection requiring systemic treatment (e.g., antibiotics, antiviral agents, antifungals, anthelmintics) within one week (or one week if a superficial infection occurs).
E04. Known history of or suspected current significant immunosuppression, including a history of invasive opportunistic or helmintic infections despite infection remission, or other recurrent infections with unusual frequency or prolonged duration.
E05. History of solid organ or stem cell transplantation.
E06. Participants who have undergone splenectomy.
E07. Participants with a history of any malignancy or lymphoproliferative disorder, unless the participant has been disease-free for ≥ 5 years.
Inclusion is permitted for successfully cured non-metastatic squamous cell carcinoma of the skin, basal cell carcinoma, or localized cervical carcinoma in situ.
E08. History of prescription drug or substance abuse (including alcohol) within the most recent 2 years prior to the baseline period, deemed serious by the trial administrator.
E09. Family history of sudden death or long QT syndrome.
E10. E11. History of congenital or drug-induced long QT syndrome.
E12. Congestive heart failure [New York Heart Association (NYHA) 2-4], angina pectoris grade 1 or higher, acute coronary syndrome within the past 6 months, known structural heart disease.
E13. History of any major cardiovascular event (e.g., myocardial infarction, unstable angina, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
E14. History of ventricular fibrillation, ventricular tachycardia, polymorphic ventricular tachycardia, atrial fibrillation, or syncope that cannot be explained by non-cardiac causes.
E15. Poorly controlled hypertension, defined as a persistent systolic blood pressure ≥ 150 mm Hg or a persistent diastolic blood pressure ≥ 90 mm Hg despite antihypertensive medication.
E16. Bradycardia during screening, with a heart rate < 50 bpm. E16. During screening, three 12-lead ECGs performed while supine showed a mean QTcF interval > 440 ms or a QRS interval > 110 ms.
E17. During screening, serum potassium, magnesium, or calcium levels were below the lower limit of normal.
Previous/Concurrent Therapies
E18. The participant underwent major surgery within 4 weeks prior to screening, or plans to undergo any non-urgent major surgery during the trial.
E19. Received an active (attenuated) vaccine within 12 weeks prior to Day 1, or plans to receive an active vaccine during the trial.
E20. Received an inactive vaccine (e.g., inactive seasonal influenza, COVID-19 vaccine) within 14 days prior to Day 1 of the trial.
E21. Received any contraindicated therapy (unless otherwise stated) within the specified timeframe prior to the baseline return visit.
Previous/Concurrent Clinical Trial Experience
E22. Previous use of IRAK4 Inhibitors or degrading agents.
Diagnostic Assessment
E 23. History of human immunodeficiency virus (HIV) infection, or a positive HIV serological test at screening.
E 24. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening.
E 25. Positive hepatitis C virus (HCV) antibody test at screening.
E 26. Any of the following abnormal laboratory test results at the baseline return visit:
• Heme < 9 g/dL
• Absolute neutrophil count < 1.5 x 10⁹/L
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN)
• Total bilirubin > 1.5 • ULN > 1.5 (If total bilirubin has been separated and direct bilirubin < 35%, unconjugated bilirubin > 1.5 times ULN is allowed)
• Platelet count < 100 x 10⁹/L (< 100,000/μl)
E 27. Evidence of active or latent tuberculosis (TB) with a history (e.g., chest X-ray), examination, and TB testing record: positive QuantiFERON® TB Gold IGRA test or two inconclusive results at screening (regardless of previous treatment status).
Other Exclusion Criteria
E 28. Individuals placed in an institution due to regulations or legal orders; prisoners or participants lawfully detained.
E 29. Participants are deemed unfit to participate for any reason, including medical or clinical conditions, or participants may not follow the trial procedures, in the judgment of the trial administrator.
E 30. Participants must be employees of the clinical trial center or other individuals directly involved in the execution of the trial, or immediate family members of such individuals (in accordance with Section 1.61 of Regulation E6 of the International Council for Harmonisation-Good Clinical Practice (ICH-GCP)).
E 31. Sensitivity to any trial intervention or its components or the drug, or other allergies deemed by the trial administrator to constitute a contraindication to participation in the trial.
E 32. Any specific national regulations that would disqualify a participant from participating in this trial.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
200 participants
