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Amlitelimab

Generic Name
Amlitelimab

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

First Posted Date
2024-11-13
Last Posted Date
2024-12-27
Lead Sponsor
Sanofi
Target Recruit Count
20
Registration Number
NCT06686628
Locations
🇩🇪

Investigational Site Number : 2760001, Berlin, Germany

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

Phase 2
Recruiting
Conditions
Coeliac Disease
Celiac Disease
Interventions
Drug: Placebo
Dietary Supplement: Gluten-free product (GFP)
Dietary Supplement: SIGE
First Posted Date
2024-08-16
Last Posted Date
2025-05-21
Lead Sponsor
Sanofi
Target Recruit Count
204
Registration Number
NCT06557772
Locations
🇦🇷

Investigational Site Number : 0320012, Buenos Aires, Argentina

🇹🇷

Investigational Site Number : 7920003, Gaziantep, Turkey

🇺🇸

FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052, Arcadia, California, United States

and more 98 locations

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata

Phase 2
Active, not recruiting
Conditions
Alopecia Areata
Interventions
Drug: Placebo
First Posted Date
2024-06-05
Last Posted Date
2025-02-03
Lead Sponsor
Sanofi
Target Recruit Count
166
Registration Number
NCT06444451
Locations
🇯🇵

Investigational Site Number : 3920003, Ebina-shi, Kanagawa, Japan

🇯🇵

Investigational Site Number : 3920001, Yokohama, Japan

🇯🇵

Investigational Site Number : 3920002, Kamiamakusa, Kumamoto, Japan

and more 70 locations

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

Phase 3
Recruiting
Conditions
Dermatitis Atopic
Interventions
Drug: Placebo
First Posted Date
2024-05-09
Last Posted Date
2025-05-15
Lead Sponsor
Sanofi
Target Recruit Count
961
Registration Number
NCT06407934
Locations
🇨🇳

Investigational Site Number : 1560041, Shenyang, China

🇨🇳

Investigational Site Number : 1560026, Shenyang, China

🇨🇳

Investigational Site Number : 1560064, Shenzhen, China

and more 307 locations

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

Phase 3
Recruiting
Conditions
Dermatitis Atopic
Interventions
Drug: Placebo
Drug: Topical corticosteroids
First Posted Date
2024-02-05
Last Posted Date
2025-04-17
Lead Sponsor
Sanofi
Target Recruit Count
249
Registration Number
NCT06241118
Locations
🇨🇳

Investigational Site Number : 1560035, Ningbo, China

🇨🇳

Investigational Site Number : 1560001, Shanghai, China

🇨🇳

Investigational Site Number : 1560041, Shenyang, China

and more 135 locations

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

Phase 3
Active, not recruiting
Conditions
Dermatitis Atopic
Interventions
Drug: Placebo
Drug: Topical corticosteroids
Drug: Topical calcineurin inhibitors
First Posted Date
2024-01-25
Last Posted Date
2025-05-02
Lead Sponsor
Sanofi
Target Recruit Count
643
Registration Number
NCT06224348
Locations
🇨🇳

Investigational Site Number : 1560047, Tianjin, China

🇨🇳

Investigational Site Number : 1560049, Wuhan, China

🇨🇳

Investigational Site Number : 1560003, Wuxi, China

and more 162 locations

Platform Clinical Study for Conquering Scleroderma

Phase 2
Recruiting
Conditions
Interstitial Lung Disease Due to Systemic Disease
Scleroderma
Interventions
First Posted Date
2024-01-08
Last Posted Date
2025-03-11
Lead Sponsor
Scleroderma Research Foundation, Inc.
Target Recruit Count
400
Registration Number
NCT06195072
Locations
🇺🇸

University of Alabama - Division of Pulmonary and Critical Care Medicine, Birmingham, Alabama, United States

🇺🇸

Keck School of Medicine at USC Medical Center, Los Angeles, California, United States

🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

and more 29 locations

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)

Phase 3
Recruiting
Conditions
Dermatitis Atopic
Interventions
Drug: Placebo
First Posted Date
2023-12-26
Last Posted Date
2025-05-06
Lead Sponsor
Sanofi
Target Recruit Count
547
Registration Number
NCT06181435
Locations
🇨🇳

Investigational Site Number : 1560029, Hangzhou, China

🇨🇳

Investigational Site Number : 1560007, Jinan, China

🇮🇹

Investigational Site Number : 3800022, Vicenza, Italy

and more 138 locations

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

Phase 3
Active, not recruiting
Conditions
Dermatitis Atopic
Interventions
Drug: Placebo
First Posted Date
2023-11-14
Last Posted Date
2025-05-07
Lead Sponsor
Sanofi
Target Recruit Count
601
Registration Number
NCT06130566
Locations
🇬🇷

Investigational Site Number : 3000002, Thessaloniki, Greece

🇬🇷

Investigational Site Number : 3000003, Thessaloniki, Greece

🇮🇳

Investigational Site Number : 3560001, Ahmedabad, India

and more 145 locations

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

Phase 2
Active, not recruiting
Conditions
Hidradenitis
Interventions
Drug: Placebo
First Posted Date
2023-11-07
Last Posted Date
2025-02-26
Lead Sponsor
Sanofi
Target Recruit Count
90
Registration Number
NCT06118099
Locations
🇺🇸

Medical Dermatology Specialists Site Number : 8400002, Phoenix, Arizona, United States

🇺🇸

Center for Dermatology Clinical Research Site Number : 8400010, Fremont, California, United States

🇺🇸

Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011, Margate, Florida, United States

and more 39 locations
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