A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor (AQUA)

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Dermatitis Atopic

Treatments: Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical tacrolimus or pimecrolimus; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06241118

U1111-1295-3059 (Registry Identifier)

EFC17599 (Other Identifier)

2023-508099-12 (Registry Identifier)

Details and patient eligibility

About

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.

The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.

Study details include:

At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).

The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.

The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening and a 36-week randomized double-blind period.

The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 [RIVER-AD] study).

Enrollment: 249 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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249 participants in 3 patient groups, including a placebo group

Amlitelimab dose 1

Experimental group

Description:

Subcutaneous injection as per protocol

Treatment:

Drug: Topical tacrolimus or pimecrolimus

Drug: Topical corticosteroids

Drug: Amlitelimab

Amlitelimab dose 2

Experimental group

Description:

Subcutaneous injection as per protocol

Treatment:

Drug: Topical tacrolimus or pimecrolimus

Drug: Topical corticosteroids

Drug: Amlitelimab

Placebo

Placebo Comparator group

Description:

Subcutaneous injection as per protocol

Treatment:

Drug: Placebo

Drug: Topical tacrolimus or pimecrolimus

Drug: Topical corticosteroids