Amlitelimab (SAR445229, KY1005) is a fully human monoclonal antibody in clinical development for moderate-to-severe atopic dermatitis. It targets OX40-ligand and has shown phase 3 efficacy signals in SHORE and COAST studies. Global regulatory submissions were planned, but the product was still unapproved at the time of source publication.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Atopic dermatitis updates in 2026 included long-term upadacitinib safety, phase 3 amlitelimab and rademikibart data, and 5-year interim dupilumab results in children. A market report also listed multiple emerging therapies in late-stage development.
Phase 3 trial results show amlitelimab met primary endpoints in two monotherapy studies for moderate-to-severe atopic dermatitis, with combination therapy demonstrating the strongest efficacy. The investigational OX40L-targeting antibody showed comparable efficacy between every-4-week and every-12-week dosing intervals. Safety data revealed two cases of Kaposi sarcoma in patients with known risk factors among 4,630 exposed patients.
Over 25 companies are developing 30+ therapies for celiac disease, with recent positive trial results and FDA Fast Track designation. A new blood test using T-cell receptor sequencing may enable noninvasive diagnosis and monitoring.
The alopecia areata treatment market is projected to grow significantly through 2036, driven by rising prevalence and the anticipated launch of emerging therapies including JAK inhibitors and novel drug classes targeting immune pathways.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06686628 |
An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates |
COMPLETED | PHASE1 |
| NCT06557772 |
A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06444451 |
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06407934 |
A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis |
ACTIVE_NOT_RECRUITING | PHASE3 |
| 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 |
RECRUITING | PHASE3 |
| NCT06224348 |
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids |
COMPLETED | PHASE3 |
| NCT06195072 |
Platform Clinical Study for Conquering Scleroderma |
RECRUITING | PHASE2 |
| NCT06181435 |
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2) |
COMPLETED | PHASE3 |
| NCT06130566 |
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis |
COMPLETED | PHASE3 |
| NCT06118099 |
Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa |
TERMINATED | PHASE2 |
