Amlitelimab

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

AsthmaAtopic DermatitisAlopecia AreataHidradenitis SuppurativaSclerodermaCeliac DiseaseDermatitis, Atopic

1050 competitors in Asthma

#DrugCompanyPhaseTrials

1

Amlitelimab

Sanofi

Phase 3

22

Veramyst

GSK

Preclinical

463

Singulair

AstraZeneca

Preclinical

174

Cinqair

Teva

Preclinical

135

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

306

Atrovent

Boehringer Ingelheim

Preclinical

57

Arcoxia

Novartis

Preclinical

—8

Formoterol Fumarate

AstraZeneca

Preclinical

89

Symbicort

AstraZeneca

Preclinical

610

Atrovent

Boehringer Ingelheim

Preclinical

2Show 20 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Atopic Dermatitis6 trials

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

Recruiting·Sanofi·Phase 2·NCT05769777·901 enrolled

A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

Completed·Sanofi·Phase 2·NCT06015308·224 enrolled

Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

Completed·KKymab Limited·Phase 2·NCT05131477·390 enrolled

Show 3 more trials

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·Sanofi·Phase 3·NCT06224348·643 enrolled

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·Sanofi·Phase 3·NCT06130566·601 enrolled

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·Sanofi·Phase 3·NCT06181435·589 enrolled

Dermatitis, Atopic3 trials

A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Active, not recruiting·Sanofi·Phase 3·NCT06407934·1,541 enrolled

A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.

Enrolling by invitation·Sanofi·Preclinical·NCT05492578·1,663 enrolled

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

Recruiting·Sanofi·Phase 3·NCT06241118·636 enrolled

Asthma2 trials

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

Completed·Sanofi·Phase 2·NCT05421598·446 enrolled

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

Active, not recruiting·Sanofi·Phase 2·NCT06033833·335 enrolled

Drug1 trial

A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants

Completed·Sanofi·Phase 1·NCT05796479·32 enrolled

Scleroderma1 trial

Platform Clinical Study for Conquering Scleroderma

Recruiting·SScleroderma Research Foundation, Inc.·Phase 2·NCT06195072·400 enrolled

4 more indications

Alopecia Areata1 trial

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·Sanofi·Phase 2·NCT06444451·166 enrolled

Hidradenitis Suppurativa1 trial

Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Terminated·Sanofi·Phase 2·NCT06118099·90 enrolled

Celiac Disease1 trial

A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease

Active, not recruiting·Sanofi·Phase 2·NCT06557772·229 enrolled

AML1 trial

An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates

Active, not recruiting·Sanofi·Phase 1·NCT06686628·23 enrolled

Details

Drug Info

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