Amlitelimab

Generic Name: Amlitelimab

Clinical Trials

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

Phase 2

Active, not recruiting

Conditions: Asthma

Interventions: Drug: Amlitelimab
Drug: Placebo

First Posted Date: 2023-09-13

Last Posted Date: 2025-05-15

Lead Sponsor: Sanofi

Target Recruit Count: 335

Registration Number: NCT06033833

Locations: 🇵🇱
Investigational Site Number : 6160003, Elblag, Poland
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Investigational Site Number : 6160002, Gdansk, Poland
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Bensch Research Associates- Site Number : 8400004, Stockton, California, United States

and more 65 locations

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

Phase 2

Recruiting

Conditions: Dermatitis Atopic

Interventions: Drug: Amlitelimab
Drug: Placebo
Biological: Tdap vaccine
Biological: PPS vaccine

First Posted Date: 2023-08-29

Last Posted Date: 2025-03-25

Lead Sponsor: Sanofi

Target Recruit Count: 215

Registration Number: NCT06015308

Locations: 🇺🇸
Clinical Research Center of Alabama - Homewood- Site Number : 8401101, Birmingham, Alabama, United States
🇺🇸
Center for Dermatology and Plastic Surgery- Site Number : 8401119, Scottsdale, Arizona, United States
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Orange County Clinical Trials- Site Number : 8401271, Anaheim, California, United States

and more 54 locations

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

Phase 2

Recruiting

Conditions: Dermatitis Atopic

Interventions: Drug: Amlitelimab

First Posted Date: 2023-03-15

Last Posted Date: 2025-04-17

Lead Sponsor: Sanofi

Target Recruit Count: 901

Registration Number: NCT05769777

Locations: 🇦🇷
Investigational Site Number : 0320003, Buenos Aires, Argentina
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Investigational Site Number : 0320002, Buenos Aires, Argentina
🇦🇷
Investigational Site Number : 0320004, Buenos Aires, Argentina

and more 169 locations

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials

Phase 2

Recruiting

Conditions: Dermatitis Atopic

Interventions: Drug: Amlitelimab
Drug: Topical corticosteroids
Drug: Topical calcineurin inhibitors
Drug: Oral corticosteroids

First Posted Date: 2022-08-08

Last Posted Date: 2025-04-24

Lead Sponsor: Sanofi

Target Recruit Count: 1551

Registration Number: NCT05492578

Locations: 🇨🇿
Investigational Site Number : 2032104, Ostrava, Czechia
🇨🇿
Investigational Site Number : 2032102, Prague, Czechia
🇨🇿
Investigational Site Number : 2032101, Prague, Czechia

and more 120 locations

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

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: Placebo
Drug: Amlitelimab

First Posted Date: 2022-06-16

Last Posted Date: 2025-04-22

Lead Sponsor: Sanofi

Target Recruit Count: 446

Registration Number: NCT05421598

Locations: 🇨🇦
Investigational Site Number : 1240003, Quebec, Canada
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Investigational Site Number : 1240007, Trois-Rivieres, Quebec, Canada
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Treasure Valley Medical Research Site Number : 8400031, Boise, Idaho, United States

and more 110 locations

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

Phase 2

Completed

Conditions: Atopic Dermatitis
Eczema

Interventions: Drug: Placebo
Drug: KY1005

First Posted Date: 2021-11-23

Last Posted Date: 2024-04-30

Lead Sponsor: Kymab Limited

Target Recruit Count: 390

Registration Number: NCT05131477

Locations: 🇺🇸
Investigative Site Number: 1007, Miami, Florida, United States
🇵🇱
Investigative site #2420, Łódź, Poland
🇺🇸
Investigative Site Number: 1014, Beverly, Massachusetts, United States

and more 98 locations

A Study of Subcutaneous KY1005 in Healthy Volunteers

Phase 1

Completed

Conditions: Immune System Diseases

Interventions: Drug: KY1005

First Posted Date: 2020-06-29

Last Posted Date: 2021-09-30

Lead Sponsor: Kymab Limited

Target Recruit Count: 24

Registration Number: NCT04449939

Locations: 🇬🇧
Hammersmith Medicines Research, London, United Kingdom

A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis

Phase 2

Completed

Conditions: Dermatitis, Atopic

Interventions: Drug: Placebo
Drug: KY1005

First Posted Date: 2018-11-27

Last Posted Date: 2023-01-27

Lead Sponsor: Kymab Limited

Target Recruit Count: 89

Registration Number: NCT03754309

Locations: 🇩🇪
Kymab investigational site 106, Kiel, Germany
🇩🇪
Kymab investigational site 113, Leipzig, Germany
🇵🇱
Kymab investigational site 207, Gdansk, Poland

and more 16 locations

A Study of KY1005 in Healthy Volunteers

Phase 1

Completed

Conditions: Immune System Diseases

Interventions: Drug: KY1005
Drug: Placebo

First Posted Date: 2017-05-19

Last Posted Date: 2019-08-29

Lead Sponsor: Kymab Limited

Target Recruit Count: 64

Registration Number: NCT03161288

Locations: 🇳🇱
Centre for Human Drug Research, Leiden, Netherlands

Drug Development Updates

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