Amlitelimab Clinical Trials (2026): 17 Studies for Dermatitis Atopic & Asthma
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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17 Amlitelimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 8 indications (including Dermatitis Atopic & Asthma) and 9,019 total planned enrollment. 5 Phase 3 Amlitelimab trials and 9 Phase 2 are listed. 1 Amlitelimab clinical trial is actively recruiting at 23 U.S. sites across 17 states. Most recent activity: NCT05769777 (Jun 2031).
Where to Participate: All Amlitelimab Trial Sites in the U.S. (23 sites across 17 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 |
| CA | Cedars-Sinai Medical Center | Los Angeles90048 | NCT06195072 | Map |
| CA | Keck School of Medicine at USC Medical Center | Los Angeles90033 | NCT06195072 | Map |
| CA | Stanford University Medical Center | Palo Alto94305 | NCT06195072 | Map |
| DC | Georgetown University Medical Center - Department of Rheumatology | Washington D.C.20007 | NCT06195072 | Map |
| IL | The University of Chicago Medical Center (UCMC) | Chicago60637 | NCT06195072 | Map |
| KS | University of Kansas School of Medicine | Kansas City66160 | NCT06195072 | 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 |
| MN | Mayo Clinic | Rochester55905 | NCT06195072 | Map |
| NJ | Robert Wood Johnson Medical School | New Brunswick08901 | NCT06195072 | Map |
| NY | Northwell Health | Great Neck11021 | NCT06195072 | Map |
| NY | Columbia University Medical Center | New York10032 | NCT06195072 | Map |
| NY | Hospital for Special Surgery | New York10021 | NCT06195072 | Map |
| NC | Duke University Medical Center | Durham27710 | NCT06195072 | Map |
| OR | Oregon Health & Science University (OHSU) | Portland97239 | NCT06195072 | Map |
| PA | Thomas Jefferson University Hospital | Philadelphia19107 | NCT06195072 | Map |
| PA | University of Pennsylvania | Philadelphia19104 | NCT06195072 | Map |
| SC | Medical University of South Carolina (MUSC) | Charleston29404 | NCT06195072 | Map |
| TX | University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics | Houston77030 | NCT06195072 | Map |
| WI | Froedtert Hospital and the Medical College of Wisconsin | Milwaukee53226 | NCT06195072 | Map |
Amlitelimab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | Total |
|---|---|---|---|---|---|
| P1 | 2 | 2 | |||
| P2 | 1 | 3 | 3 | 2 | 9 |
| P2/P3 | 1 | 1 | |||
| P3 | 2 | 3 | 5 |
Recruiting Amlitelimab clinical trials (1)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| 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 | active not recruiting | Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials |
| NCT06241118 | AQUA | P3 | active not 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 | active not recruiting | Dermatitis Atopic | 464 | — |
| 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 | active not recruiting | 1,856 | 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 | active not recruiting | 464 | 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. 1 is actively recruiting participants. 8 are marked completed.
- Are Amlitelimab clinical trials recruiting in 2026?
- Yes — 1 Amlitelimab trial is actively recruiting in 2026, with 23 U.S. sites across 17 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.
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