In short
Amlitelimab is being studied in several clinical trials to see how well it works and how safe it is. These trials include people with atopic dermatitis, asthma, hidradenitis suppurativa, celiac disease, alopecia areata, and interstitial lung disease linked to systemic sclerosis. Most studies compare Amlitelimab with placebo and measure symptom improvement and safety.
Key points
- Amlitelimab is being tested in several clinical trials, mostly for atopic dermatitis, but also for asthma, hidradenitis suppurativa, celiac disease, alopecia areata, and interstitial lung disease linked to systemic sclerosis. The studies include adults and, in some atopic dermatitis trials, people aged 12 years and older. Trial phases range from Phase 2 to Phase 4, showing both early testing and longer-term follow-up. Many studies compare Amlitelimab with placebo to see if it improves symptoms better than no active treatment. The main results include skin scores, asthma flare-ups, hair regrowth, lung function, intestinal healing, and safety measures.
Clinical trials overview
Amlitelimab is being studied in interventional clinical trials, which means researchers give a study treatment and then measure the results. The source data shows trials in atopic dermatitis, asthma, hidradenitis suppurativa, celiac disease, alopecia areata, and interstitial lung disease secondary to systemic sclerosis.
Most of the studies compare Amlitelimab with placebo, which is a look-alike treatment with no active study drug. Some studies also compare different dose regimens or look at long-term treatment after earlier trials.
Atopic dermatitis studies
The largest group of trials is in atopic dermatitis, a long-term skin disease that causes itchy and inflamed skin. 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.
In these studies, the main goal was to show whether Amlitelimab could improve skin disease better than placebo. 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.
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. Another Phase 3 study examined whether people who already responded to treatment could keep that response when treatment continued or was withdrawn.
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. The study measured clinical response at Week 16 using HiSCR50, a response measure that looks for at least a 50% improvement.
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. 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.
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. 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.
Another Phase 2 trial studied people with interstitial lung disease secondary to systemic sclerosis, also called SSc-ILD. 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.
Who can join these trials
Eligibility depends on the specific trial. Some studies include adults only, while several atopic dermatitis studies include participants aged 12 years and older.
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. Some studies also require previous treatment history, such as an inadequate response to earlier biologic therapy or an oral JAK inhibitor in atopic dermatitis.
Main outcomes measured
The main outcome, or primary endpoint, is the key result researchers use to judge the study. 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.
In hidradenitis suppurativa, the main endpoint was HiSCR50 at Week 16. 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.
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. In alopecia areata, the main endpoint was change in SALT score at Week 36. In SSc-ILD, the main endpoint was change in forced vital capacity at Week 52.
Trial phases and study status
The source data includes Phase 2, Phase 3, and Phase 4 studies. 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.
Some trials are marked Completed, while others are Authorised. 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. Authorised studies include additional atopic dermatitis, asthma, celiac disease, and interstitial lung disease trials.