Recruiting NCT06241118

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

Phase III Interventional Dermatitis Atopic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Amlitelimab, Placebo, Topical corticosteroids, Topical tacrolimus or pimecrolimus.
Who it may be relevant to: Registry conditions: Dermatitis Atopic. Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Canada +18
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

Overview

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).

Interventions

Drug Amlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Drug Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Drug Topical corticosteroids
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Drug Topical tacrolimus or pimecrolimus
Pharmaceutical form: Various Topical formulation Route of administration: Topical

Primary outcome measures

EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36 [Time frame: Week 36]
EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36 [Time frame: Week 36]
US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36 [Time frame: Week 36]

Secondary outcome measures (12)

Proportion of participants reaching EASI-75 at Week 36 (for US and US reference countries only) [Time frame: Week 36]
Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting and a reduction from baseline of ≥2 points) [Time frame: Baseline to Week 36]
Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4 [Time frame: Baseline to Week 36]
Proportion of participants reaching EASI-75 [Time frame: Baseline to Week 24]
Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points [Time frame: Baseline to Week 24]
Proportion of participants reaching EASI-90 [Time frame: Baseline to Week 36]
Proportion of participants reaching EASI-100 [Time frame: Baseline to Week 36]
Proportion of participants with PP-NRS ≤1 [Time frame: Baseline to Week 36]
Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old [Time frame: Baseline to Week 36]
Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4 [Time frame: Baseline to Week 36]
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years [Time frame: Baseline to Week 36]
Proportion of participants with a reduction in CDLQI ≥6 from baseline in participants with age ≥12 to <16 years old and with CDLQI baseline ≥6 [Time frame: Baseline to Week 36]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 43 centers

University of Alabama at Birmingham- Site Number : 8401267 — Birmingham
Center for Dermatology and Plastic Surgery- Site Number : 8401119 — Scottsdale
Arkansas Dermatology - North Little Rock- Site Number : 8401244 — North Little Rock
Encino Research Center- Site Number : 8401042 — Encino
Center for Dermatology Clinical Research- Site Number : 8401018 — Fremont
Long Beach Clinical Trials- Site Number : 8401188 — Long Beach
Dermatology Research Associates - Los Angeles- Site Number : 8401092 — Los Angeles
LA Universal Research Center- Site Number : 8401064 — Los Angeles
… and 35 more centers

China · 15 centers

Investigational Site Number : 1560031 — Changchun
Investigational Site Number : 1560057 — Chongqing
Investigational Site Number : 1560021 — Guangzhou
Investigational Site Number : 1560036 — Guangzhou
Investigational Site Number : 1560044 — Hangzhou
Investigational Site Number : 1560002 — Hangzhou
Investigational Site Number : 1560009 — Hangzhou
Investigational Site Number : 1560034 — Nanyang
… and 7 more centers

Canada · 8 centers

Investigational Site Number : 1240019 — Calgary
Investigational Site Number : 1240016 — Edmonton
Investigational Site Number : 1240058 — Burlington
Investigational Site Number : 1240020 — Hamilton
Investigational Site Number : 1240053 — London
Investigational Site Number : 1240035 — Toronto
Investigational Site Number : 1240054 — Toronto
Investigational Site Number : 1240028 — Regina

United Kingdom · 8 centers