Active Lungs & Breathing NIHR-supported project Digestion, Kidneys & Other Organs

A Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group 48-week extension study to evaluate the treatment response and safety of two amlitelimab dose regimens administered as monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis

Funder NIHR (part of DHSC)
Recipient organisation NIHR Guy's and St Thomas' Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Feb 2025 — Jan 2027

In plain English

AI plain-English summary

A new drug, amlitelimab, is being tested in a 48-week extension study to see if it can keep controlling the symptoms of moderate-to-severe atopic dermatitis when the frequency of injections is reduced or stopped. This matters because existing treatments for this chronic, itchy skin condition often fail or cause side effects. The study follows patients who completed an earlier 24-week trial, testing whether those who responded well can maintain benefits on a less frequent dose, and whether those who did not respond can still improve with a shorter interval between injections. Neither patients nor doctors know who receives the drug versus a placebo, ensuring unbiased results. If successful, amlitelimab could offer a new, long-term treatment option for adolescents and adults with atopic dermatitis. A drug that works with fewer injections would directly improve quality of life by reducing the burden of frequent dosing. It would also fill a gap in the current treatment landscape, where many patients cycle through therapies without lasting relief. The study’s design—testing dose reduction and discontinuation—could also inform future strategies for managing other chronic inflammatory diseases.

View original technical description
Atopic dermatitis (AD) is a chronic inflammatory skin disease that causes itch and leaves red blotches on the skin. This disease can affect health, social functioning, well-being and quality of life. Available AD medicines are not always effective or suitable and may cause side effects. There is a need for new treatments. This extension study evaluates the safety and treatment response of amlitelimab for AD, in participants who already completed a 24-week amlitelimab study (parent study) and if benefits can be maintained if the treatment frequency is continued, reduced, or stopped. For participants who did not have significant treatment response at the end of the parent study, this study will evaluate if benefit can be obtained by continuing or decreasing the interval between 2 doses. The study is a double-blind, placebo-controlled study with 2 periods: a treatment period (48 weeks), and a safety follow up period (16 weeks). Two different dosing intervals of amlitelimab will be compared to a placebo (dummy treatment). “Double-blind” means that neither the participant taking part, nor the study doctors know who is given the medicine or the placebo. This is done to make sure that the study results are not influenced in any way. Amlitelimab works by blocking immune cells involved in the inflammation process. Amlitelimab or placebo is injected under the skin. The treatment is randomly chosen for each participant meaning determined by chance using a computer program. This works like flipping a coin. The placebo looks like the medicine being tested, but it does not have any real medicine in it. If necessary topical treatments may be given to control intolerable AD symptoms.People 12 years and older with moderate to severe AD and have completed a 24-week parent study can take part in the study. Medical history of patients will be analaysed. If any of exclusion criteria are met, they cannot participate.

Researchers

Carsten Flohr (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in participants aged 18 years and older with moderate-to-severe atopic dermatitis.
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in participants aged 18 years and older with moderate-to-severe atopic dermatitis. (COAST 2)
A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis who participated in KY1005-CT05 (DRI17366)
An Open-Label multinational, multicenter study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adolescent patients aged 12 years and older (?12 and < 18) with moderate to severe atopic dermatitis.
A randomized, double-blind, placebo-controlled, parallelgroup, dose ranging study to assess the efficacy, safety, and tolerability of subcutaneous amlitelimab in adult participants with moderate-to-severe asthma

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