amlitelimab SC (KY1005 SC) / Sanofi - LARVOL DELTA

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) (clinicaltrials.gov) - P3 | N=589 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

HYDRO: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo (clinicaltrials.gov) - P2 | N=224 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Impact of amlitelimab on lichenification in atopic dermatitis: post-hoc results from the STREAM-AD phase 2b study of moderate-to-severe Atopic dermatitis (CDA 2025) - P2 | "In Part 1, adult participants with moderate-to-severe AD were randomized 1:1:1:1:1 to subcutaneous amlitelimab (250 mg with 500-mg loading dose [250 mg+LD], n=77; 250 mg, n=78; 125 mg, n=77; 62.5 mg, n=79) or placebo every 4 weeks (n=79). At Week 24, amlitelimab improved EASI lichenification scores across all body regions. Amlitelimab may be an effective future treatment for moderate-to-severe AD characterized by lichenification."

P2b data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • TNFSF4

68-week safety results of amlitelimab in participants with moderate-to-severe atopic dermatitis from STREAM-AD Phase 2b dose-ranging and withdrawal study (CDA 2025) - P2 | "Part 1 involved 24-week treatment period of 388 participants with subcutaneous amlitelimab (250 mg with 500 mg loading dose [250mg +LD], n=77; 250mg, n=78; 125mg, n=77; 62.5mg, n=78) or placebo (n=78) every 4 weeks. In the STREAM-AD Phase 2b trial, amlitelimab was well tolerated and demonstrated an acceptable safety profile in the Part 2 (responder) population up to 68 weeks."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TNFSF4

Amlitelimab Reduces Th2-, Th1-, and Th17/22-Related Gene Expression and Protein Levels in Adults With Moderate-to-Severe Atopic Dermatitis: Results From an Exploratory Analysis of the Phase 2b STREAM-AD Study (EAACI 2025) - P2 | "In Part 1, adults with moderate-to-severe AD were randomized to receive subcutaneous amlitelimab (250mg + 500-mg loading dose, 250mg, 125mg, or 62.5mg) or placebo every 4W. It also reduced protein levels associated with Th17/22-related inflammation including the proinflammatory cytokine IL-32 (p<0.001). Conclusion Amlitelimab significantly normalized/reduced genes and proteins associated with AD inflammation in adults with moderate-to-severe AD, further supporting OX40L blockade as a relevant target for treating AD-related inflammation."

Clinical • IO biomarker • P2b data • Atopic Dermatitis • Dermatitis • Immunology • CXCL10 • CXCL9 • IL32 • TNFSF4

RIVER-ASTHMA: Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study (clinicaltrials.gov) - P2 | N=335 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

COAST 1: 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 (clinicaltrials.gov) - P3 | N=601 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | N=420 ➔ 601

Enrollment change • Enrollment closed • Monotherapy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

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) (clinicaltrials.gov) - P3 | N=547 | Recruiting | Sponsor: Sanofi | N=420 ➔ 547

Enrollment change • Monotherapy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ESTUARY: 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 (clinicaltrials.gov) - P3 | N=961 | Recruiting | Sponsor: Sanofi | Trial completion date: Jan 2027 ➔ Apr 2027

Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SHORE: 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 (clinicaltrials.gov) - P3 | N=643 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

TIDE-asthma: Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma (clinicaltrials.gov) - P2 | N=446 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Amlitelimab: clinically meaningful efficacy in asthma (GlobeNewswire) - P2 | N=446 | TIDE (NCT05421598) | Sponsor: Sanofi | "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 and low doses. However, the study demonstrates amlitelimab's compelling efficacy in heterogeneous inflammatory asthma, potentially representing a breakthrough for this underserved patient population if observed in later studies. Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose at week 60. The study also demonstrated nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control....Full and final results will be presented at a forthcoming medical meeting."

P2 data • Asthma • Immunology

HYDRO: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo (clinicaltrials.gov) - P2 | N=215 | Recruiting | Sponsor: Sanofi | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Apr 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Interim results of RIVER-AD: 28-week open-label safety and efficacy of amlitelimab in patients with atopic dermatitis not initially achieving clinical response at Week 24 of the STREAM-AD phase 2b trial (AAD 2025) - P2/3 | "This interim analysis evaluated safety, change in EASI, EASI-75, EASI-90, and IGA 0/1 response following 28-weeks of subcutaneous amlitelimab 250mg every-4-weeks (Q4W) in RIVER-AD in participants not achieving clinical response at Week 24 of STREAM-AD with amlitelimab or placebo. Interim RIVER-AD results demonstrated clinical improvements after 28 weeks of subcutaneous 250mg Q4W amlitelimab treatment in participants with moderate-to-severe AD not achieving clinical response at Week 24 of STREAM-AD, with a safety profile similar to that observed in STREAM-AD."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Amlitelimab Reduces Th2-, Th1-, and Th17/22-Related Cytokines and Chemokines in Adults With Moderate-to-Severe Atopic Dermatitis): Results From an Exploratory Analysis of the Phase 2b STREAM-AD Study (AAD 2025) - P2 | "In Part 1, adults with moderate-to-severe AD were randomized to receive subcutaneous amlitelimab (250mg with 500-mg loading dose, 250mg, 125mg, 62.5mg) or placebo every 4 weeks. Amlitelimab significantly reduced proteins associated with AD inflammation in adults with moderate-to-severe AD, further supporting that OX40L blockade is a relevant target for treating AD-related inflammation."

Clinical • IO biomarker • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • CCL2 • CCL20 • CCL22 • CXCL10 • CXCL9 • IL13 • IL17A • IL17C • IL6 • TNFSF4

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=166 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Alopecia • Dermatology • Immunology

Sanofi Healthcare Gets CDSCO Panel Nod To Study Amlitelimab For Atopic Dermatitis (Medical Dialogues) - "Drug major Sanofi Healthcare India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of amlitelimab in adult participants with moderate to severe atopic dermatitis. This came after Sanofi Healthcare India presented phase II/III clinical study protocol no. LTS17367 amendment number 05 version 1 Dated 16 Aug 2024. This is 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."

New P2/3 trial • Atopic Dermatitis • Immunology

Amlitelimab SC: Data from P3 COAST-1 trial (NCT06130566) for atopic dermatitis in 2026 (Sanofi) - Q4 & FY 2024 Results: Data from P3 COAST-2 trial (NCT06181435) for atopic dermatitis in 2026

P3 data • Atopic Dermatitis • Dermatology • Immunology

Amlitelimab SC: Data readout from P2 trial (NCT06118099) for hidradenitis suppurativa in H1 2025 (Sanofi) - Q4 & FY 2024 Results

P2 data • Hidradenitis Suppurativa • Immunology

Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology

Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. (PubMed, J Allergy Clin Immunol) - P2 | "Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through Week 52. Sustained responses were observed in the majority of patients after amlitelimab withdrawal for 28 weeks."

Clinical • IO biomarker • Journal • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Sanofi | Trial completion date: Feb 2026 ➔ Feb 2028

Monotherapy • Trial completion date • Alopecia • Dermatology • Immunology

Amlitelimab SC: Data readout from P2 TIDE-asthma trial (NCT05421598) for asthma in H1 2025 (Sanofi) - Q3 2024 Results

P2 data • Asthma • Immunology

Impact of amlitelimab (an anti-OX40 Ligand antibody) on atopic dermatitis of the head and neck: post hoc results from the STREAM-AD phase 2b study of moderate-to-severe atopic dermatitis (EADV 2024) - P2 | "In Part 1, adult participants with moderate-to-severe AD were randomised 1:1:1:1:1 to subcutaneous amlitelimab every 4 weeks (250 mg with 500 mg loading dose (250 mg +LD), n=77; 250 mg, n=78; 125 mg, n=77; 62.5 mg, n=79) or placebo every 4 weeks (n=79) . Amlitelimab improved EASI head and neck subscores vs placebo at Week 24, and was effective across all signs (erythema, oedema/papulation, excoriation, and lichenification) of head and neck AD. Amlitelimab may be an effective future treatment option for patients with moderate-to-severe AD with hard-to-treat lesions on the head and neck."

P2b data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TNFSF4

Amlitelimab (an anti-OX40 Ligand antibody) normalises the atopic dermatitis gene signature in the skin of patients with moderate-to-severe atopic dermatitis (EADV 2024) - P2 | "In Part 1, adults with moderate-to-severe AD were randomised 1:1:1:1:1 to receive subcutaneous amlitelimab (250 mg with 500 mg loading dose (LD; n=77), 250 mg (n=78), 125 mg (n=77), or 62.5 mg (n=79)) , or placebo (n=79) every 4 weeks over 24 weeks. Following 16 weeks of treatment with amlitelimab, a normalisation in the AD gene signature was observed in lesional skin compared to baseline, supporting the clinical improvements seen in AD lesions ."

Clinical • Gene Signature • IO biomarker • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • TNFSF4