Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: amlitelimab: -Participants with body weight more than equal to 40kg- 125 mg permL amlitelimab solution in a PFS to deliver 250 mg of amlitelimab in a 2 mL injection, Treatment duration,
Sponsors
Sanofi Healthcare India Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1- Participants must be at least 12 years of age inclusive, at the time of the informed consent is signed. 2- Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria (2014) (47) for 1 year or longer at baseline. 3- Participant must have documented history within 6 months prior to screening visit, of either inadequate response or inadvisability of topical treatments. 4- EASI less than equal to 16 at baseline visit. 5- IGA of 3 or 4 at baseline visit (on the 0 to 4 IGA scale, IGA 3 and 4 for moderate and severe respectively). 6- AD involvement of 10% or more of BSA at baseline visit. 7- Weekly average of daily PP-NRS of � 4 at baseline visit. This calculation shall include all reported values in the 7 days immediately preceding the baseline visit. 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. 8- I 08. Must have applied topical bland emollient (moisturizer) at least once daily for a minimum of 5 out of 7 consecutive days before baseline visit. Note: preferably additive free, basic bland emollient approved by the Investigator. Participant may use prescription emollients or emollients containing additives (eg, urea) if such emollients were initiated before the screening visit. 9- Must demonstrate understanding and appropriate use of the e-diary and participant questionnaires, including collection of PP-NRS prior to baseline visit. 10- Able and willing to comply with requested study visits and procedures. 11- Body weight must be more than equal to 25 kg. 12- All participants-Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 13- Capable of giving a signed informed assent and or consent as described in Appendix 1 (Section 10.1) of the protocol which includes the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. The signed ICF must always be present at the time of inclusion
Exclusion criteria
Exclusion criteria: 1- Skin co-morbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, lupus erythematosus) as per Investigators judgment. 2- 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. 3- Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline). 4- History of solid organ or stem cell transplant. 5- Any pre-planned major elective surgery known about at baseline visit that in the Investigatorââ?¬•s opinion would necessitate that IMP be permanently discontinued or require an interval greater than 12 weeks between doses. 6- Severe concomitant illness that would, in the Investigators opinion, inhibit the participants participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease. 7- Any medical or psychiatric condition which, in the Investigators opinion may present an unreasonable risk to the study participants as a result of his her participation in this clinical study, may make participants participation unreliable, or may interfere with study assessments. 8- Presence of either of the following at Screening or Baseline Visits- 8a-active suicidal ideation or suicidal ideation in the past 6 months as indicated by a positive response (Yes) to Question 1, 2, or 3, of the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Questions. 8b-presence of active suicidal ideation with an intent andor plan or any lifetime history of suicidal ideation with an intent andor plan as indicated by a positive response (Yes) to Question 4 or 5 of C-SSRS Suicidal Ideation Questions. 8c- presence of active suicidal behavior or any lifetime history of suicidal behavior including suicide attempt (including actual attempt, interrupted attempt, or aborted attempt), preparatory acts for suicide attempt, or non-suicidal self-injurious behavior as indicated by a positive response (Yes) to any Suicide Behavior Questions of C-SSRS. 8d- assessment by the Investigator through participant interview and review of medical history of high risk of suicidal behavior. 9-Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections) and any infection which as per Investigators opinion precludes the participants participation in the study (including confirmed coronavirus disease 2019 [COVID 19] infection). 10- In the Investigators opinion, medical conditions related to prior AD medications that have not healedfully recovered for more than 2 weeks before Screening Visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis 11- Treatment with a live (attenuated) vaccine within 12 weeks prior to baseline, failure to complete non-live immunization required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline. 12- Prior use of any oral JAK inhibitor or topical ruxolitinib that exceeded 6 months. 13- Hav
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of amlitelimab monotherapy administered by subcutaneous (SC) injection in comparison to placebo in participants aged 12 years and older with moderate-to-severe atopic dermatitis (AD)Timepoint: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of amlitelimab monotherapy administered by SC injection in comparison to placebo in participants aged 12 years & older with moderate-to-severe AD.Timepoint: Week 24 | — |
Countries
Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Israel, Poland, Republic of Korea, Taiwan, United States of America
Contacts
Public ContactMs. Dhara Patel
Sanofi Healthcare India Private Limited
Outcome results
None listed