Drugs / Amlitelimab
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06686628 | Nov 2024 → Nov 2025 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT05796479 | Apr 2022 → May 2023 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04449939 | Jul → Nov 2020 | immune system disorder | Kymab Limited | Completed | No outcome recorded |
| Phase 1 | NCT03161288 | May 2017 → Mar 2018 | immune system disorder | Kymab Limited | Completed | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT06557772 | Aug 2024 → Aug 2026 overdue | celiac disease | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06444451 | Jun 2024 → Sep 2025 | alopecia areata | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06195072 | Apr 2024 → Nov 2026 expected | interstitial lung disease, scleroderma | Scleroderma Research Foundation, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06118099 | Nov 2023 → Feb 2025 | hidradenitis | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06015308 | Oct 2023 → Oct 2025 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT06033833 | Sep 2023 → Sep 2026 | asthma | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05769777 | Apr 2023 → Jun 2031 expected | atopic eczema | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05421598 | Jun 2022 → Oct 2024 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT05131477 | Dec 2021 → Apr 2023 | atopic eczema | Kymab Limited | Completed | Met primary |
| Phase 2 | NCT03754309 | Dec 2018 → May 2020 | atopic eczema | Kymab Limited | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05492578 | Aug 2022 → Jan 2029 expected | atopic eczema | Sanofi | Enrolling by invitation | No outcome recorded |
| Phase 35 trials · 3 met primary | ||||||
| Phase 3 | NCT06407934 | May 2024 → Jun 2026 overdue | atopic eczema | Sanofi | Active not recruiting | Met primary |
| Phase 3 | NCT06241118 | Feb 2024 → Sep 2027 expected | atopic eczema | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT06224348 | Jan 2024 → Aug 2025 | atopic eczema | Sanofi | Completed | Met primary |
| Phase 3 | NCT06181435 | Dec 2023 → Nov 2025 | atopic eczema | Sanofi | Completed | Mixed |
| Phase 3 | NCT06130566 | Nov 2023 → Jul 2025 | atopic eczema | Sanofi | Completed | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-03-28 | Sanofi | Results Press Release: AAD: new results from Sanofi's amlitelimab phase 3 studies in atopic dermatitis presented in late-breaking research session sanofi.com ↗
Positive results from three phase 3 studies of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L), in moderate-to-severe atopic dermatitis (AD) as a monotherapy and in combination with topical therapies, showed improvements in skin clearance and disease severity with amlitelimab treatment compared to placebo in patients aged 12 years and older. |
| 2026-01-23 | Sanofi | Results Press Release: Sanofi's amlitelimab confirms its potential in atopic dermatitis sanofi.com ↗
In the SHORE phase 3 study, amlitelimab in combination with topical therapies met all primary and key secondary endpoints at Week 24 with efficacy progressively increasing throughout the treatment period with some patients improving as early as Week 2 |
| 2025-09-04 | Sanofi | Results Press Release: Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis sanofi.com ↗
Amlitelimab, dosed every four weeks or every 12 weeks, demonstrated statistically significant and clinically meaningful efficacy in skin clearance and disease severity compared to placebo at Week 24, with efficacy progressively increasing throughout the treatment period |
| 2025-04-15 | Sanofi | Results Press Release: Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD sanofi.com ↗
Preliminary results from the TIDE-Asthma phase 2 study (clinical study identifier: NCT05421598) show that the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium dose. |
| 2025-02-28 | Sanofi | Results Media Update: AAD: new data advance Sanofi’s scientific leadership across innovative treatments for inflammatory skin diseases sanofi.com ↗
New amlitelimab phase 2 data show impact on symptoms for patients with moderate-to-severe AD |
| 2024-03-11 | Sanofi | Results Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis sanofi.com ↗
Positive results from Part 2 of the investigational amlitelimab Phase 2b study STREAM-AD showed sustained improvement of signs and symptoms for 28 weeks in adults with moderate to severe AD who previously responded to amlitelimab and continued treatment. |
| 2023-10-13 | Sanofi | Results Press Release: Late-breaking amlitelimab Phase 2b data presented at EADV show potential best-in-class profile in atopic dermatitis sanofi.com ↗
Patients treated with amlitelimab experienced up to 61.5% improvement in average Eczema Area and Severity Index (EASI) score from baseline at week 16, the primary endpoint, with continued improvement seen through 24 weeks |
| 2023-06-27 | Sanofi | Results Press Release: Positive topline Phase 2b data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody sanofi.com ↗
In this dose-ranging study, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index (EASI) score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied. |
| 2021-09-30 | Sanofi | Results Press Release: New, late-breaking data at EADV highlights emerging clinical profile of amlitelimab (formerly KY1005) in adults with inadequately controlled moderate-to-severe atopic dermatitis sanofi.com ↗
Positive results from a Phase 2a study evaluating the safety and efficacy of amlitelimab, a human monoclonal antibody targeting key immune system regulator OX40-Ligand, were presented as a late-breaker today at the European Academy of Dermatology and Venerology (EADV) 2021 Virtual Congress. |
All press releases naming this drug 11 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | amlitelimab | “The safety, tolerability, immunogenicity, and pharmacokinetic (PK) profile of an anti-OX40L monoclonal antibody (KY1005, currently amlitelimab) were evaluated.” PMID 35092305 ↗ Mar 2022 |
| Known as | KY-1005-2D10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594569 ↗ |
| Known as | KY1005 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03754309 ↗ |
| Known as | SAR-445229 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594569 ↗ |
| Action | Inhibit | “Tumor necrosis factor ligand superfamily member 4 inhibitor” CHEMBL4594569 ↗ |
| Modality | Monoclonal antibody | “The safety, tolerability, immunogenicity, and pharmacokinetic (PK) profile of an anti-OX40L monoclonal antibody (KY1005, currently amlitelimab) were evaluated.” PMID 35092305 ↗ Mar 2022 |
| Route | Subcutaneous | “Single lower dose KY1005 by s.c. injection” NCT04449939 ↗ |
| Target | TNFSF4 | “Tumor necrosis factor ligand superfamily member 4 inhibitor” CHEMBL4594569 ↗ |