At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Amlitelimab (drug), Placebo (drug), Topical corticosteroids (drug), Topical tacrolimus or pimecrolimus (drug)
- How long the study runs
- Study runs about 55 months (dates as stated)
- About the drug or intervention
- Amlitelimab — drug: Pharmaceutical form: Injection solution Route of administration: Subcutaneous · Placebo — drug: Pharmaceutical form: Injection solution Route of administration: Subcutaneous · Topical corticosteroids — drug: Pharmaceutical form: Various Topical formulation Route of administration: Topical · Topical tacrolimus or pimecrolimus — drug: Pharmaceutical form: Various Topical formulation Route of administration: Topical
- Patient visit burden
- "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)." (as stated by sponsor)
In plain English
This Sanofi study is testing amlitelimab, given as an injection under the skin, in people aged 12 and over with moderate-to-severe atopic dermatitis (eczema). Participants must already have tried a biologic eczema medicine or an oral JAK inhibitor (a type of medicine called a Janus kinase inhibitor) without good enough results. Everyone will also use topical corticosteroids (steroid creams or ointments) alongside the study medicine.
Who can take part
- Aged 12 or over when signing the consent form
- Diagnosed with atopic dermatitis (eczema) for at least 1 year
- Did not respond well enough in the past to a biologic eczema medicine or an oral JAK inhibitor
- Have moderate-to-severe eczema, measured at the start of the study (a doctor's severity score of 3 or 4, an eczema severity score of 16 or more, eczema covering at least 10% of the body surface, and an itch score of 4 or more out of 10 on average each week)
- Able and willing to attend study visits and follow the study procedures
- Weigh at least 25 kg
Who may not be able to
- Have another skin condition that would make eczema assessments difficult
- Have a history of, or suspected, significant weakening of the immune system
- Have cancer now or in the past (except non-melanoma skin cancer fully removed more than 5 years ago)
- Have had a solid organ or stem cell transplant
- Have an active or long-term infection, including a worm infection needing treatment, in the 4 weeks before the start
- Test positive for HIV, hepatitis B or hepatitis C at screening
- Have active tuberculosis (TB), latent TB, incomplete TB treatment, suspected TB outside the lungs, or a high risk of catching TB
- Have received certain other treatments within a set time before the study starts
- Have significant abnormal laboratory results, in the researcher's opinion, at screening
- Are allergic or hypersensitive to the study medicine or any of its ingredients
What taking part involves
- • Amlitelimab given as an injection under the skin
- • Continuing to use topical corticosteroids (steroid creams or ointments) as background treatment
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and exactly what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- All
- Number of participants
- 464
- Started
- 2024-02-29
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for dermatitis atopic
- • Phase3 - 464 participants
- • 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
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with dermatitis atopic
Where?
- • Bristol - Investigational Site Number : 8260013
- • Plymouth - Investigational Site Number : 8260012
- • London - Investigational Site Number : 8262603
- • London - Investigational Site Number : 8260015
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years and over
- Who can join: All genders
What the study is looking for
- ✓Participants must be 12 years of age (when signing agreement to take part 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
Who cannot take part
- ✗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...
- ✗History of solid organ or stem cell transplant
See the full criteria
Where Is This Study? (8 UK sites)
Investigational Site Number : 8260013
Bristol BS2 8HW, United Kingdom
Investigational Site Number : 8260012
Plymouth PL6 8DH, United Kingdom
Investigational Site Number : 8262603
London E11 1NR, United Kingdom
Investigational Site Number : 8260015
London SW10 9NH, United Kingdom
Investigational Site Number : 8260003
Portsmouth PO3 6DW, United Kingdom
Investigational Site Number : 8260009
Leeds Ls7 4sa, United Kingdom
Investigational Site Number : 8260010
Nottingham NG17 4JL, United Kingdom
Investigational Site Number : 8260008
Liverpool L7 8XP, United Kingdom