How many Amlitelimab clinical trials are there?

17 Amlitelimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 3 are actively recruiting participants. 8 are marked completed.

Are Amlitelimab clinical trials recruiting in 2026?

Yes — 3 Amlitelimab trials are actively recruiting in 2026, with 67 U.S. sites across 32 states. See the recruiting trials and the per-state site list further down this page.

What conditions is Amlitelimab being studied for?

Amlitelimab is being studied for Dermatitis Atopic, Asthma, Celiac Disease, Coeliac Disease, Eczema and 6 more. The trials are grouped by indication on this page.

What phase is Amlitelimab in?

Amlitelimab clinical trials span 5 Phase 3, 9 Phase 2, 2 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.

Who sponsors Amlitelimab clinical trials?

The lead sponsor across the most Amlitelimab trials is Sanofi, with 2 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Amlitelimab Clinical Trials (2026): 17 Studies for Dermatitis Atopic & Asthma

Creator: Hipa.ai Research
Published: 2026-05-12T16:51:18.781Z

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: June 12, 2026.

17 Amlitelimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 8 indications (including Dermatitis Atopic & Asthma) and 8,998 total planned enrollment. 5 Phase 3 Amlitelimab trials and 9 Phase 2 are listed. 3 Amlitelimab clinical trials are actively recruiting at 67 U.S. sites across 32 states. Most recent activity: NCT05769777 (Jun 2031).

Where to Participate: All Amlitelimab Trial Sites in the U.S. (67 sites across 32 states)

Every actively recruiting Amlitelimabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

State	Facility	City	Trial	Map
AL	University of Alabama - Division of Pulmonary and Critical Care Medicine	Birmingham35294	NCT06195072	Map
AL	University of Alabama at Birmingham- Site Number : 8401267	Birmingham35233	NCT06241118	Map
AZ	Center for Dermatology and Plastic Surgery- Site Number : 8401119	Scottsdale85260	NCT06241118	Map
AR	Arkansas Dermatology - North Little Rock- Site Number : 8401244	North Little Rock72117	NCT06241118	Map
CA	Encino Research Center- Site Number : 8401042	Encino91436	NCT06241118	Map
CA	Center for Dermatology Clinical Research- Site Number : 8401018	Fremont94538	NCT06241118	Map
CA	Long Beach Clinical Trials- Site Number : 8401188	Long Beach90806	NCT06241118	Map
CA	Cedars-Sinai Medical Center	Los Angeles90048	NCT06195072	Map
CA	Dermatology Research Associates - Los Angeles- Site Number : 8401092	Los Angeles90045	NCT06241118	Map
CA	Keck School of Medicine at USC Medical Center	Los Angeles90033	NCT06195072	Map
CA	LA Universal Research Center- Site Number : 8401064	Los Angeles90057	NCT06241118	Map
CA	University Dermatology Trials- Site Number : 8401339	Newport Beach92660	NCT06241118	Map
CA	Stanford University Medical Center	Palo Alto94305	NCT06195072	Map
CA	Rady Children's Hospital- Site Number : 8401291	San Diego92123	NCT06241118	Map
CA	Therapeutics Clinical Research- Site Number : 8401283	San Diego92123	NCT06241118	Map
CO	Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245	Wheat Ridge80033	NCT06241118	Map
DC	Georgetown University Medical Center - Department of Rheumatology	Washington D.C.20007	NCT06195072	Map
FL	Encore Medical Research of Boynton Beach- Site Number : 8401030	Boynton Beach33436	NCT06241118	Map
FL	St. Jude Clinical Research- Site Number : 8401287	Doral33172	NCT06241118	Map
FL	Apex Clinical Research - Jacksonville- Site Number : 8401332	Jacksonville32256	NCT06241118	Map
FL	Global Clinical Professionals (GCP)- Site Number : 8401045	St. Petersburg33714	NCT06241118	Map
FL	Avita Clinical Research- Site Number : 8401073	Tampa33613	NCT06241118	Map
GA	Emory University School of Medicine	Atlanta30322	NCT06195072	Map
IL	Northwestern University	Chicago60611	NCT06195072	Map
IL	Northwestern University- Site Number : 8401285	Chicago60611	NCT06241118	Map
IL	The University of Chicago Medical Center (UCMC)	Chicago60637	NCT06195072	Map
IL	NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038	Skokie60077	NCT06241118	Map
IN	Dawes Fretzin Clinical Research- Site Number : 8401015	Indianapolis46256	NCT06241118	Map
KS	University of Kansas School of Medicine	Kansas City66160	NCT06195072	Map
KY	Equity Medical - Bowling Green- Site Number : 8401296	Bowling Green42104	NCT06241118	Map
LA	Tandem Clinical Research - Metairie- Site Number : 8401187	Metairie70006	NCT06241118	Map
MD	Johns Hopkins University School of Medicine	Baltimore21224	NCT06195072	Map
MA	Boston University (BU)	Boston02215	NCT06195072	Map
MA	Massachusetts General Hospital	Boston02114	NCT06195072	Map
MI	University of Michigan	Ann Arbor48109-0370	NCT06195072	Map
MI	University of Michigan Health System - Ann Arbor- Site Number : 8401290	Ann Arbor48109	NCT06241118	Map
MI	MI Skin Center- Site Number : 8401307	Northville48167	NCT06241118	Map
MN	Mayo Clinic	Rochester55905	NCT06195072	Map
NE	Skin Specialists- Site Number : 8401068	Omaha68144	NCT06241118	Map
NJ	Schweiger Dermatology Group - East Windsor- Site Number : 8401338	East Windsor08520	NCT06241118	Map
NJ	Robert Wood Johnson Medical School	New Brunswick08901	NCT06195072	Map
NM	The University of New Mexico- Site Number : 8401263	Albuquerque87106	NCT06241118	Map
NY	Northwell Health	Great Neck11021	NCT06195072	Map
NY	Columbia University Medical Center	New York10032	NCT06195072	Map
NY	Equity Medical- Site Number : 8401239	New York10023	NCT06241118	Map
NY	Hospital for Special Surgery	New York10021	NCT06195072	Map
NY	Sadick Research Group - New York - Park Avenue- Site Number : 8401050	New York10075	NCT06241118	Map
NC	Duke University Medical Center	Durham27710	NCT06195072	Map
OH	Cincinnati Children's Hospital Medical Center- Site Number : 8401279	Cincinnati45229	NCT06241118	Map
OR	Oregon Health & Science University (OHSU)- Site Number : 8401247	Portland97239	NCT06241118	Map
OR	Oregon Health & Science University (OHSU)	Portland97239	NCT06195072	Map
PA	Clinical Research of Philadelphia- Site Number : 8401193	Philadelphia19114	NCT06241118	Map
PA	Paddington Testing Company- Site Number : 8401041	Philadelphia19103	NCT06241118	Map
PA	Thomas Jefferson University Hospital	Philadelphia19107	NCT06195072	Map
PA	University of Pennsylvania	Philadelphia19104	NCT06195072	Map
SC	Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282	Charleston29425	NCT06241118	Map
SC	Medical University of South Carolina (MUSC)	Charleston29404	NCT06195072	Map
TX	Arlington Research Center- Site Number : 8401248	Arlington76011	NCT06241118	Map
TX	McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288	Bellaire77401	NCT06241118	Map
TX	Reveal Research Institute - Dallas- Site Number : 8401219	Dallas75235	NCT06241118	Map
TX	University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics	Houston77030	NCT06195072	Map
UT	Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057	Ogden84405	NCT06241118	Map
VA	Virginia Dermatology & Skin Cancer Center- Site Number : 8401047	Norfolk23502	NCT06241118	Map
WA	North Sound Dermatology- Site Number : 8401280	Mill Creek98012	NCT06241118	Map
WI	Children's Wisconsin- Site Number : 8401246	Milwaukee53226	NCT06241118	Map
WI	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee53226	NCT06195072	Map
WY	Cheyenne Skin Clinic- Site Number : 8401234	Cheyenne82009	NCT06241118	Map

Amlitelimab clinical trials at a glance: phase × recruitment status

Phase	recruiting	active not recruiting	enrolling by invitation	completed	terminated	Total
P1				2		2
P2	1	3		3	2	9
P2/P3			1			1
P3	1	1		3		5

Recruiting Amlitelimab clinical trials (3)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT ID	Title	Phase	Indication	Enrollment	Started
NCT05492578	RIVER-ADLong-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials	P2/P3	Dermatitis Atopic	1,663	Aug 2022
NCT06241118	AQUAA 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	P3	Dermatitis Atopic	636	Feb 2024
NCT06195072	CONQUESTPlatform Clinical Study for Conquering Scleroderma	P2	Interstitial Lung Disease Due to Systemic Disease	400	Apr 2024

Amlitelimab clinical trials by indication

Dermatitis Atopic (9)

NCT	Acronym	Phase	Status	Title
NCT05769777	ATLANTIS	P2	active not recruiting	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
NCT05492578	RIVER-AD	P2/P3	enrolling by invitation	Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
NCT06241118	AQUA	P3	recruiting	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
NCT06407934	ESTUARY	P3	active not recruiting	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
NCT06686628	—	P1	completed	An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates
NCT06181435	COAST 2	P3	completed	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)
NCT06015308	HYDRO	P2	completed	A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
NCT06130566	COAST 1	P3	completed	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
+ 1 more, see All trials below.

Asthma (2)

NCT	Acronym	Phase	Status	Title
NCT06033833	RIVER-ASTHMA	P2	active not recruiting	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
NCT05421598	TIDE-asthma	P2	completed	Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

Coeliac Disease (1)

NCT	Acronym	Phase	Status	Title
NCT06557772	—	P2	active not recruiting	A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease

Alopecia Areata (1)

NCT	Acronym	Phase	Status	Title
NCT06444451	—	P2	terminated	A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata

Interstitial Lung Disease Due to Systemic Disease (1)

NCT	Acronym	Phase	Status	Title
NCT06195072	CONQUEST	P2	recruiting	Platform Clinical Study for Conquering Scleroderma

Hidradenitis (1)

NCT	Acronym	Phase	Status	Title
NCT06118099	—	P2	terminated	Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Healthy Volunteers (1)

NCT	Acronym	Phase	Status	Title
NCT05796479	—	P1	completed	A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants

Eczema (1)

NCT	Acronym	Phase	Status	Title
NCT05131477	STREAM-AD	P2	completed	Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

Amlitelimab pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

Acronym	NCT	Phase	Status	Indication	Enrollment	PubMed
AQUA	NCT06241118	P3	recruiting	Dermatitis Atopic	636	—
ESTUARY	NCT06407934	P3	active not recruiting	Dermatitis Atopic	1,541	—
COAST 2	NCT06181435	P3	completed	Dermatitis Atopic	589	—
COAST 1	NCT06130566	P3	completed	Dermatitis Atopic	601	—
SHORE	NCT06224348	P3	completed	Dermatitis Atopic	643	—
ATLANTIS	NCT05769777	P2	active not recruiting	Dermatitis Atopic	999	—
CONQUEST	NCT06195072	P2	recruiting	Interstitial Lung Disease Due to Systemic Disease	400	PMID 39544897
RIVER-ASTHMA	NCT06033833	P2	active not recruiting	Asthma	335	—
HYDRO	NCT06015308	P2	completed	Dermatitis Atopic	224	—
TIDE-asthma	NCT05421598	P2	completed	Asthma	437	—
STREAM-AD	NCT05131477	P2	completed	Eczema	390	PMID 39522654

Terminated and withdrawn Amlitelimab trials (2)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

NCT06444451terminatedA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
NCT06118099terminatedProof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

All Amlitelimab trials (17)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT ID	Acronym	Title	Phase	Status	Enrollment	Sponsor	Started
NCT05769777	ATLANTIS	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	P2	active not recruiting	999	Sanofi	Apr 2023
NCT06557772		A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease	P2	active not recruiting	229	Sanofi	Aug 2024
NCT05492578	RIVER-AD	Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials	P2/P3	enrolling by invitation	1,663	Sanofi	Aug 2022
NCT06241118	AQUA	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	P3	recruiting	636	Sanofi	Feb 2024
NCT06407934	ESTUARY	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	P3	active not recruiting	1,541	Sanofi	May 2024
NCT06195072	CONQUEST	Platform Clinical Study for Conquering Scleroderma	P2	recruiting	400	Scleroderma Research Foundation, Inc.	Apr 2024
NCT06033833	RIVER-ASTHMA	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	P2	active not recruiting	335	Sanofi	Sep 2023
NCT06444451		A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata	P2	terminated	166	Sanofi	Jun 2024
NCT06686628		An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates	P1	completed	23	Sanofi	Nov 2024
NCT06181435	COAST 2	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)	P3	completed	589	Sanofi	Dec 2023
NCT06015308	HYDRO	A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo	P2	completed	224	Sanofi	Oct 2023
NCT06130566	COAST 1	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	P3	completed	601	Sanofi	Nov 2023
NCT06224348	SHORE	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	P3	completed	643	Sanofi	Jan 2024
NCT06118099		Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa	P2	terminated	90	Sanofi	Nov 2023
NCT05421598	TIDE-asthma	Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma	P2	completed	437	Sanofi	Jun 2022
NCT05131477	STREAM-AD	Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study	P2	completed	390	Kymab Limited	Dec 2021
NCT05796479		A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants	P1	completed	32	Sanofi	Apr 2022

Amlitelimab clinical trials: frequently asked questions

How many Amlitelimab clinical trials are there?: 17 Amlitelimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 3 are actively recruiting participants. 8 are marked completed.
Are Amlitelimab clinical trials recruiting in 2026?: Yes — 3 Amlitelimab trials are actively recruiting in 2026, with 67 U.S. sites across 32 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Amlitelimab being studied for?: Amlitelimab is being studied for Dermatitis Atopic, Asthma, Celiac Disease, Coeliac Disease, Eczema and 6 more. The trials are grouped by indication on this page.
What phase is Amlitelimab in?: Amlitelimab clinical trials span 5 Phase 3, 9 Phase 2, 2 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Amlitelimab clinical trials?: The lead sponsor across the most Amlitelimab trials is Sanofi, with 2 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Amlitelimabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

Last refreshed June 12, 2026.

Related pages on Hipa.ai:

Amlitelimab overview Amlitelimab evidence & publications