Table of Contents

• Clinical trials overview
• Atopic dermatitis studies
• Other conditions studied
• Who can join these trials
• Main outcomes measured
• Trial phases and study status

Clinical trials overview

Amlitelimab is being studied in interventional clinical trials, which means researchers give a study treatment and then measure the results.^[1] The source data shows trials in atopic dermatitis, asthma, hidradenitis suppurativa, celiac disease, alopecia areata, and interstitial lung disease secondary to systemic sclerosis.^[1]

Most of the studies compare Amlitelimab with placebo, which is a look-alike treatment with no active study drug.^[1] Some studies also compare different dose regimens or look at long-term treatment after earlier trials.^[1]

Atopic dermatitis studies

The largest group of trials is in atopic dermatitis, a long-term skin disease that causes itchy and inflamed skin.^[1] Several Phase 3 trials studied people aged 12 years and older with moderate-to-severe disease, either on background topical corticosteroids or as monotherapy, which means treatment without another main study drug.^[1]

In these studies, the main goal was to show whether Amlitelimab could improve skin disease better than placebo.^[1] One Phase 3 study focused on participants who had not responded well enough to prior biologic therapy or an oral JAK inhibitor, which is a type of treatment taken by mouth that affects immune signaling.^[1]

There are also longer-term studies in atopic dermatitis. One Phase 2 long-term study looked at safety in participants aged 12 years and older, and a Phase 4 study looked at long-term safety and efficacy in people from previous atopic dermatitis trials.^[1] Another Phase 3 study examined whether people who already responded to treatment could keep that response when treatment continued or was withdrawn.^[1]

Other conditions studied

A Phase 2 proof-of-concept study tested Amlitelimab in adults with hidradenitis suppurativa, a painful skin condition with swollen lumps and tunnels under the skin.^[1] The study measured clinical response at Week 16 using HiSCR50, a response measure that looks for at least a 50% improvement.^[1]

In asthma, one Phase 2 dose-ranging study looked at adults with moderate-to-severe, uncontrolled asthma and measured the annualized rate of severe exacerbation events over 48 weeks.^[1] Another Phase 2 long-term asthma study followed adults who had already completed a previous Amlitelimab asthma study and looked mainly at safety and tolerability, meaning how well the treatment was handled over time.^[1]

A Phase 2a/b study in adults with non-responsive celiac disease looked at whether Amlitelimab could improve changes in the intestinal lining, both in people following a gluten-free diet and in people with background gluten exposure.^[1] A Phase 2 study in adults with severe alopecia areata, a condition that causes hair loss, measured change in SALT score at Week 36 to see whether lost hair could regrow.^[1]

Another Phase 2 trial studied people with interstitial lung disease secondary to systemic sclerosis, also called SSc-ILD.^[1] That study measured change in forced vital capacity, which is the amount of air a person can force out of the lungs after a deep breath.^[1]

Who can join these trials

Eligibility depends on the specific trial.^[1] Some studies include adults only, while several atopic dermatitis studies include participants aged 12 years and older.^[1]

The trials also focus on people with specific disease features, such as moderate-to-severe atopic dermatitis, uncontrolled asthma, severe alopecia areata with at least 50% scalp hair loss, or non-responsive celiac disease.^[1] Some studies also require previous treatment history, such as an inadequate response to earlier biologic therapy or an oral JAK inhibitor in atopic dermatitis.^[1]

Main outcomes measured

The main outcome, or primary endpoint, is the key result researchers use to judge the study.^[1] In the atopic dermatitis trials, the main endpoints included the vIGA-AD score, the EASI score, and whether participants reached clear or almost clear skin with a meaningful drop from baseline, which means from the starting point before treatment.^[1]

In hidradenitis suppurativa, the main endpoint was HiSCR50 at Week 16.^[1] In asthma, the main endpoint was the annualized rate of severe exacerbation events over 48 weeks, and in the long-term asthma study it was the percentage of participants with treatment-emergent adverse events.^[1]

In celiac disease, researchers measured change in villus height to crypt depth ratio, which is a way to assess the shape and health of the intestinal lining.^[1] In alopecia areata, the main endpoint was change in SALT score at Week 36.^[1] In SSc-ILD, the main endpoint was change in forced vital capacity at Week 52.^[1]

Trial phases and study status

The source data includes Phase 2, Phase 3, and Phase 4 studies.^[1] Phase 2 studies are usually earlier studies, Phase 3 studies are larger confirmatory studies, and Phase 4 studies look at longer-term follow-up after earlier research.^[1]

Some trials are marked Completed, while others are Authorised.^[1] In the source data, completed trials include several atopic dermatitis studies, the asthma dose-ranging study, the hidradenitis suppurativa study, and the alopecia areata study.^[1] Authorised studies include additional atopic dermatitis, asthma, celiac disease, and interstitial lung disease trials.^[1]