Clinical Trials List
2023-04-01 - 2028-12-31
Phase II
Recruiting7
ICD-10L22
Diaper dermatitis
ICD-9691.0
Diaper or napkin rash
An Open-Label multinational, multicenter study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in participants aged 12 years and older with moderate to severe atopic dermatitis
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Trial Applicant
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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
- 陳柏樺 Division of Dermatology
- 卓雍哲 Division of Dermatology
- WEI-HSIN WU Division of Dermatology
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 魏秀娟 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Bing Chen Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- 紀景琪 Division of Dermatology
- Chin-Yi Yang Division of Dermatology
- Yu-Huei Huang Division of Dermatology
- Chun-Wei Lu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張廖年峰 Division of Dermatology
- Chang-Ching Wei Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Donald Liu
- 游凱晶 Division of Dermatology
- Chia-Lun Chou
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Emergent Adverse Events (TEAEs)
• Percentage of participants who experienced Treatment-
Emergent Serious Adverse Events (TESAEs)
Inclution Criteria
I 05. vIGA-AD of 3 or 4 at baseline visit/V2 (on the 0 to 4 vIGA-AD scale, vIGA-AD 3 and 4
for moderate and severe respectively).
I 06. AD involvement of 10% or more of BSA at baseline visit/V2.
I 07. Weekly average of daily PP-NRS of ≥4 at baseline visit/V2. This calculation shall include
all reported values in the 7 days immediately preceding the baseline visit. A minimum of
4 scores is required to allow calculation of the average. For participants who have not
entered at least 4 daily PP-NRS during the 7 days immediately preceding the planned
enrollment date, enrollment should be postponed until this requirement is met, but without
exceeding the 28-day maximum duration for screening.
I 08. Must demonstrate understanding and appropriate use of the e-diary and participant
questionnaires, including collection of PP-NRS prior to baseline visit/V2.
I 09. Able and willing to comply with requested study visits and procedures.
Exclusion Criteria
(eg, psoriasis, tinea corporis, lupus erythematosus) as per investigator’s judgment.
E 02. Known history of or suspected significant current immunosuppression, including history of
invasive opportunistic or helminthic infections despite infection resolution or otherwise
recurrent infections of abnormal frequency or prolonged duration.
E 03. Any malignancies or history of malignancies prior to baseline (except for non-melanoma
skin cancer that has been excised and completely cured for more than 5 years prior to
baseline).
E 04. History of solid organ (including corneal transplant) or stem cell transplant.
E 05. Any pre-planned major elective surgery known about at baseline that in the opinion of the
investigator would necessitate that IMP be permanently discontinued or require more than
three doses to be missed.
E 06. Severe concomitant illness that would in the Investigator’s opinion inhibit the participant’s
participation in the study, including for example, but not limited to, hypertension, renal
disease, neurological conditions, heart failure and pulmonary disease.
Note: For adolescent participants (12 to 17 years of age), screening for underlying medical
comorbidity (see Section 5.2) is recommended to be done by a pediatrician in case of
participants with a <3rd percentile of the body weight either relative to age
(ie, weight-to-age percentile) or relative to the height (ie, weight-to-height percentile), as
per the country national-specific percentile chart.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
901 participants
