amlitelimab SC (KY1005 SC) / Sanofi - LARVOL DELTA

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 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Two additional phase 3 studies, AQUA (clinical study identifier: NCT06241118) and ESTUARY (clinical study identifier: NCT06407934) are anticipated to report results in H2 2026. (GlobeNewswire) - "Global regulatory submissions are planned for H2 2026, unchanged."

Filing • P3 data • Atopic Dermatitis

Press Release: Sanofi’s amlitelimab confirms its potential in atopic dermatitis (GlobeNewswire) - "In the SHORE study, amlitelimab, dosed either Q4W or Q12W in conjunction with medium-potency background topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI), met all primary and key secondary endpoints compared to placebo plus TCS with or without TCI at Week 24, across both US and EU estimands."

P3 data • Atopic Dermatitis

Preliminary analysis from ATLANTIS phase 2 open-label study (GlobeNewswire) - "In addition, a preliminary analysis of the ongoing, open-label ATLANTIS phase 2 study (clinical study identifier: NCT05769777) indicated that amlitelimab dosed Q4W progressively improved skin clearance and disease severity beyond Week 24 to Week 52 in 591 patients aged 12 years and older with moderate-to-severe AD. In this preliminary analysis, amlitelimab was well-tolerated through Week 52."

P2 data • Atopic Dermatitis

COAST 2 study (GlobeNewswire) - "In the COAST 2 study, amlitelimab monotherapy dosed either Q4W or Q12W met the primary endpoint of the proportion of patients achieving vIGA-AD 0/1 and a reduction from baseline score of ≥2 points compared to placebo at Week 24, as assessed for the US and US reference countries. The key secondary endpoint of the proportion of patients who achieved vIGA-AD 0/1 with barely perceptible erythema (BPE), as assessed for the US and US reference countries, did not achieve statistical significance. For the EU and EU reference countries, amlitelimab dosed either Q4W or Q12W did not achieve statistical significance for the co-primary endpoints of proportion of patients achieving vIGA-AD 0/1 and EASI-75 compared to placebo."

P3 data • Atopic Dermatitis

Amlitelimab: Regulatory submission for atopic dermatitis in H2 2026 (44th Annual J.P. Morgan Healthcare Conference, Sanofi)

Filing • Atopic Dermatitis • Immunology

Amlitelimab: Regulatory submission for atopic dermatitis in H2 2026 (44th Annual J.P. Morgan Healthcare Conference, Sanofi)

Filing • Atopic Dermatitis • Immunology

RIVER-AD: Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (clinicaltrials.gov) - P2/3 | N=1663 | Enrolling by invitation | Sponsor: Sanofi | Recruiting ➔ Enrolling by invitation

Enrollment status • 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=1541 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

O13 Impact of amlitelimab (an anti-OX40 ligand antibody) on atopic dermatitis by body region: post hoc results from the STREAM-AD phase IIb study of moderate-to-severe atopic dermatitis. (PubMed, Br J Dermatol) - 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, n = 77; 250 mg, n = 78; 125 mg, n = 77; 62.5 mg, n = 79) or placebo (n = 79) every 4 weeks. The primary endpoint, percentage change in EASI score at week 16, was met. In this post hoc analysis, EASI subscores using least-squares mean percentage change from baseline were assessed at week 24. Data on or after treatment discontinuation or use of rescue or prohibited medications were considered missing and were imputed by worst observation carried forward."

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

A Post Hoc Analysis of Atopic Dermatitis of the Head and Neck and Other Body Regions from the Amlitelimab STREAM-AD Phase 2b Study. (PubMed, Dermatol Ther (Heidelb)) - P2 | "Improvements in AD signs and severity were observed with amlitelimab across all body regions. Notably, clinical responses were sustained following treatment withdrawal, supporting the potential for extended dosing intervals and durable off-treatment efficacy. Amlitelimab may be a treatment option for hard-to-treat head and neck AD that disproportionately impairs quality of life."

Journal • P2b data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=212 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed

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 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Amlitelimab Reduces Th2-, Th1-, and Th17/22-Related Gene Expression and Protein Levels in Adults with Moderate-to-Severe Atopic Dermatitis: Results from STREAM-AD Phase 2b Analysis (ISDS 2025) - P2 | "In Part 1, adults with moderate-to-severe AD were randomized to receive subcutaneous amlitelimab (250mg + 500mg loading dose, 250mg, 125mg, or 62.5mg) or placebo every 4W. Additionally, it reduced protein levels associated with Th17/22-related inflammation including the proinflammatory cytokine IL-32 (p<0.001). Amlitelimab effectively normalized/reduced AD-associated gene and protein expression, reinforcing OX40L blockade as a relevant therapeutic strategy for AD-related inflammation."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • CXCL10 • CXCL9 • IL32 • TNFSF4

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 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=90 | Terminated | Sponsor: Sanofi | Trial completion date: Jan 2027 ➔ Oct 2025 | Active, not recruiting ➔ Terminated; Sponsor decision; the decision is not related to any safety concern

Trial completion date • Trial termination • Dermatology • Hidradenitis Suppurativa • Immunology

Amlitelimab SC: “All primary and key secondary endpoints met in AD phase 3 study”; Atopic dermatitis (Sanofi) - Q3 2025 Results

P3 data • Atopic Dermatitis • Immunology

Amlitelimab SC: “Encouraging efficacy, specifically in difficult-to-treat subgroup in phase 2 study”; Asthma (Sanofi) - Q3 2025 Results

P2 data • Asthma • 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=1500 | Recruiting | Sponsor: Sanofi | Trial primary completion date: Oct 2026 ➔ Jun 2026

Trial primary completion date • 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=1500 | Recruiting | Sponsor: Sanofi | N=961 ➔ 1500 | Trial primary completion date: Jun 2026 ➔ Oct 2026

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

Population Pharmacokinetic and Pharmacodynamic Modeling for the Prediction of the Extended Amlitelimab Phase 3 Dosing Regimen in Atopic Dermatitis. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "The PopPK model was developed using phase 1 (healthy volunteers) and phase 2 (participants with AD) trial data, including individual exposure variables from the STREAM-AD phase 2b trial following subcutaneous amlitelimab doses ranging from 62.5 to 250 mg given every 4 weeks (Q4W). Simulations identified that a twofold dose reduction would allow participants < 40 kg to achieve amlitelimab exposures within the range observed in participants ≥ 40 kg on 250 mg Q4W or Q12W. These results support evaluation of a Q12W dosing regimen for adults and adolescents in phase 3 trials."

Journal • P3 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=212 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open

Durable maintenance of EASI-90 with amlitelimab in adults with moderate-to-severe atopic dermatitis: 52-week results from the STREAM-AD phase 2b trial (EADV 2025) - P2 | "Adults with moderate-to-severe AD (N=390) were randomised 1:1:1:1:1 to receive subcutaneous amlitelimab every 4 weeks (Q4W; 250 mg + 500-mg loading dose [LD], n=77; 250 mg, n=78; 125 mg, n=77; or 62.5 mg, n=79) or placebo Q4W (n=79) in Part 1. The results demonstrate that a high proportion of clinical responders achieved EASI-90 response at Week 24. The majority maintained EASI-90 response with continued amlitelimab treatment at Week 52. Notably, EASI-90 was also maintained at Week 52 after 28 weeks of withdrawal from amlitelimab by the majority of Week 24 EASI-90 responders."

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

ATLANTIS: Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=901 | Recruiting | Sponsor: Sanofi | Trial completion date: Oct 2028 ➔ Jun 2031 | Trial primary completion date: Oct 2028 ➔ Jun 2031

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

Late Breaking Abstract - Amlitelimab phase 2 clinical trial results in patients with moderate-to-severe asthma (ERS 2025) - P2 | "Adults (N=437; 18-75yrs) with moderate-to-severe asthma were randomized 2:2:1:2 to subcutaneous amlitelimab 250mg +500mg loading dose (LD), 125mg +250mg LD, 62.5mg +125mg LD, or placebo (PBO) given every 4wks (Q4W) for 24wks, then Q12W to Wk60. Amlitelimab was well tolerated, reduced AAER and improved FEV1 and asthma control in patients with moderate-to-severe asthma, notably in subgroups with elevated EOS or NEUT. Efficacy enrichment by NEUT suggests amlitelimab may modulate inflammation beyond Type 2."

Clinical • IO biomarker • Late-breaking abstract • P2 data • Asthma • Immunology • Inflammation • Respiratory Diseases