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ClinicalTrials.gov public records Last synced Oct 18, 2026, 2:41 PM EDT

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Showing 1–17 of 17 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Amlitelimab Clear all
Completed Phase 2 Interventional Results available

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

NCT05421598
View directory record Official record
Conditions
Asthma
Interventions
Amlitelimab, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 75 Years
Enrollment
437 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
21
States / cities
La Jolla, California • Los Angeles, California • San Jose, California + 18 more
Source: ClinicalTrials.gov public record
Updated Mar 30, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Completed Phase 3 Interventional

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)

NCT06181435
View directory record Official record
Conditions
Dermatitis Atopic
Interventions
Amlitelimab, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
12 Years and older
Enrollment
589 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
43
States / cities
Scottsdale, Arizona • Tucson, Arizona • Lomita, California + 38 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Completed Phase 2 Interventional

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

NCT06015308
View directory record Official record
Conditions
Dermatitis Atopic
Interventions
Amlitelimab, Placebo, Tdap vaccine, PPS vaccine
Drug · Biological
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
224 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
47
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Anaheim, California + 40 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Active, not recruiting Phase 3 Interventional

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

NCT06241118
View directory record Official record
Conditions
Dermatitis Atopic
Interventions
Amlitelimab, Placebo, Topical corticosteroids, Topical tacrolimus or pimecrolimus
Drug
Lead sponsor
Sanofi
Industry
Eligibility
12 Years and older
Enrollment
464 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
43
States / cities
Birmingham, Alabama • Scottsdale, Arizona • North Little Rock, Arkansas + 36 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Active, not recruiting Phase 3 Interventional

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

NCT06407934
View directory record Official record
Conditions
Dermatitis Atopic
Interventions
Amlitelimab, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
12 Years and older
Enrollment
1,541 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
82
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Tucson, Arizona + 67 more
Source: ClinicalTrials.gov public record
Updated Jul 10, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Completed Phase 3 Interventional

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

NCT06224348
View directory record Official record
Conditions
Dermatitis Atopic
Interventions
Amlitelimab, Placebo, Topical corticosteroids, Topical calcineurin inhibitors
Drug
Lead sponsor
Sanofi
Industry
Eligibility
12 Years and older
Enrollment
643 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
40
States / cities
Birmingham, Alabama • Fort Smith, Arkansas • Encino, California + 32 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Active, not recruiting Phase 2 Interventional

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

NCT05769777
View directory record Official record
Conditions
Dermatitis Atopic
Interventions
Amlitelimab
Drug
Lead sponsor
Sanofi
Industry
Eligibility
12 Years and older
Enrollment
999 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2031
U.S. locations
22
States / cities
Birmingham, Alabama • Litchfield Park, Arizona • Bryant, Arkansas + 17 more
Source: ClinicalTrials.gov public record
Updated Apr 23, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Completed Phase 2 Interventional Results available

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

NCT05131477
View directory record Official record
Conditions
Eczema, Atopic Dermatitis
Interventions
Amlitelimab, Placebo
Drug
Lead sponsor
Kymab Limited
Industry
Eligibility
18 Years to 75 Years
Enrollment
390 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
20
States / cities
Fremont, California • Sacramento, California • Boca Raton, Florida + 16 more
Source: ClinicalTrials.gov public record
Updated Jul 3, 2025 · Synced Oct 18, 2026, 2:41 PM EDT
Active, not recruiting Phase 2 Interventional

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

NCT06557772
View directory record Official record
Conditions
Coeliac Disease, Celiac Disease
Interventions
Amlitelimab, Placebo, SIGE, Gluten-free product (GFP)
Drug · Dietary Supplement
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 75 Years
Enrollment
229 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
35
States / cities
Scottsdale, Arizona • Arcadia, California • Lancaster, California + 32 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Terminated Phase 2 Interventional

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

NCT06033833
View directory record Official record
Conditions
Asthma
Interventions
Amlitelimab, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 75 Years
Enrollment
335 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
8
States / cities
Stockton, California • Boynton Beach, Florida • Miami Lakes, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants

NCT07146750
View directory record Official record
Conditions
Healthy Volunteers
Interventions
SAR445229
Combination Product
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
212 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 20, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Terminated Phase 2 Interventional

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

NCT06444451
View directory record Official record
Conditions
Alopecia Areata
Interventions
Amlitelimab, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
166 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
17
States / cities
Birmingham, Alabama • Fountain Valley, California • Fremont, California + 14 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Recruiting Phase 2 Interventional

Platform Clinical Study for Conquering Scleroderma

NCT06195072
View directory record Official record
Conditions
Interstitial Lung Disease Due to Systemic Disease, Scleroderma
Interventions
Amlitelimab, BI 1015550 (Nerandomilast), Placebo
Drug
Lead sponsor
Scleroderma Research Foundation, Inc.
Other
Eligibility
18 Years and older
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
34
States / cities
Birmingham, Alabama • Los Angeles, California • Palo Alto, California + 23 more
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT05796479
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Amlitelimab DP1, Amlitelimab DP2
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
Hialeah, Florida
Source: ClinicalTrials.gov public record
Updated Sep 19, 2025 · Synced Oct 18, 2026, 2:41 PM EDT
Terminated Phase 2 Interventional

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

NCT06118099
View directory record Official record
Conditions
Hidradenitis
Interventions
Amlitelimab, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 70 Years
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
12
States / cities
Phoenix, Arizona • Fremont, California • Margate, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 4, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Completed Phase 3 Interventional

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

NCT06130566
View directory record Official record
Conditions
Dermatitis Atopic
Interventions
Amlitelimab, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
12 Years and older
Enrollment
601 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
42
States / cities
Scottsdale, Arizona • Fountain Valley, California • Fremont, California + 36 more
Source: ClinicalTrials.gov public record
Updated Jul 22, 2026 · Synced Oct 18, 2026, 2:41 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional

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

NCT05492578
View directory record Official record
Conditions
Dermatitis Atopic
Interventions
Amlitelimab, Topical corticosteroids, Topical calcineurin inhibitors, Oral corticosteroids
Drug
Lead sponsor
Sanofi
Industry
Eligibility
12 Years and older
Enrollment
1,856 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2029
U.S. locations
101
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Tucson, Arizona + 77 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 18, 2026, 2:41 PM EDT