amlitelimab SC (KY1005 SC) / Sanofi - LARVOL DELTA

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

P2 data • Hidradenitis Suppurativa • 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

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

68-week safety results of amlitelimab (an anti-OX40 Ligand antibody) in patients with moderate-to-severe atopic dermatitis from STREAM-AD Phase 2b dose-ranging and withdrawal study (EADV 2024) - P2 | "Part 1 involved a 24-week treatment period (last dose at Week 20) with 388 participants treated with subcutaneous amlitelimab or placebo every 4 weeks (Q4W; 250mg with 500mg loading dose (250mg +LD), n=77; 250mg, n=78; 125mg, n=77; 62.5mg, n=78; placebo, n=78) . 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

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=1310 | Recruiting | Sponsor: Sanofi | Phase classification: P2 ➔ P2/3

Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Celiac Disease • Immunology

A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease (clinicaltrials.gov) - P2 | N=204 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Celiac Disease • 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 | N=1310 | Recruiting | Sponsor: Sanofi | N=450 ➔ 1310 | Trial completion date: Apr 2028 ➔ Dec 2028 | Trial primary completion date: Oct 2027 ➔ Dec 2028

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

Sanofi Q2: strong performance with 10% sales growth; 2024 guidance upgraded (GlobeNewswire) - "The phase 2 study assessing efficacy and safety of subcutaneous injections of amlitelimab in patients aged 18 years and older with severe alopecia areata enrolled the first patients (clinical study identifier: NCT06444451); The CONQUEST phase 2 study assessing efficacy and safety of subcutaneous injections of amlitelimab in patients aged 18 years and older with systemic sclerosis enrolled the first patients (clinical study identifier: NCT06195072)."

Enrollment open • Atopic Dermatitis • Dermatology • Immunology • Scleroderma • Systemic Sclerosis

Sanofi Q2: strong performance with 10% sales growth; 2024 guidance upgraded (Sanofi Press Release) - "The phase 2 study assessing efficacy and safety of subcutaneous injections of amlitelimab in patients aged 18 years and older with severe alopecia areata enrolled the first patients..."

Enrollment open • Alopecia • Immunology

Amlitelimab SC: Data readout from P2 TIDE-asthma trial (NCT05421598) for asthma in H2 2024 (Sanofi) - Q2 2024 Results: Data readout from P2 trial (NCT06118099) for hidradenitis suppurativa in H1 2025

P2 data • Asthma • Hidradenitis Suppurativa • Immunology

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 | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Alopecia • Dermatology • Immunology

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 | Not yet recruiting | Sponsor: Sanofi

Monotherapy • New P2 trial • Alopecia • Dermatology • Immunology

CONQUEST: Platform Clinical Study for Conquering Scleroderma (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Scleroderma Research Foundation, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Amlitelimab (an OX40 ligand antibody) significantly reduces serum IgE and LDH, and epidermal hyperplasia in adults with moderate-to-severe atopic dermatitis (EAACI 2024) - P2 | "In Part 1, adults with moderate-to-severe AD were randomized 1:1:1:1:1 to receive subcutaneous amlitelimab Q4W (250 mg with 500 mg loading dose [LD; n=77], 250 mg [n=78], 125 mg [n=77], 62.5 mg [n=79]), or placebo (n=79) every 4 weeks over 24 weeks. At Week 16, amlitelimab significantly reduced epidermal thickness (p<0.01) and cytokeratin 16 staining in the epidermis (p<0.001), while epidermal thickness and cytokeratin 16 staining were not significantly reduced in the placebo arm (p=0.71 and p=0.71, respectively). Conclusion Amlitelimab significantly reduced serum total IgE and LDH levels as well as epidermal hyperplasia in adults with moderate-to-severe AD, further supporting that OX40L blockade is a relevant target for the treatment of AD-related inflammation."

Clinical • IO biomarker • Atopic Dermatitis • Dermatitis • Immunology • KRT16 • TNFSF4

Efficacy and safety of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis (AD): a phase 2b trial (STREAM-AD) (EAACI 2024) - P2 | "In Part 1, adult participants were randomized 1:1:1:1:1 to subcutaneous amlitelimab Q4W (250mg with 500mg loading dose [+ LD], n=77; 250mg, n=78; 125mg, n=77; 62.5mg, n=79) or placebo Q4W (n=79). Conclusion Clinically meaningful efficacy with amlitelimab was demonstrated over 52 wks, with an acceptable safety profile. Clinical responses were maintained in most patients 28 wks after treatment discontinuation."

Clinical • IO biomarker • P2b data • Atopic Dermatitis • Dermatitis • Immunology • TNFSF4