A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic... | NCT06224348 | Trialant

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic... | NCT06224348 | Trialant

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Participants must be 12 years of age (when signing informed consent form)

Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)

Documented history (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)

v-IGA-AD of 3 or 4 at baseline visit

EASI score of 16 or higher at baseline

AD involvement of 10% or more of BSA at baseline

Weekly average of daily PP-NRS of ≥ 4 at baseline visit.

Able and willing to comply with requested study visits and procedures

Body weight ≥25 kg

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Skin co-morbidity that would adversely affect the ability to undertake AD assessments

Known history of or suspected significant current immunosuppression

Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)

History of solid organ or stem cell transplant

Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline

Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit

Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB

Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit

In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening

History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial