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Last Updated: May 2, 2024

CLINICAL TRIALS PROFILE FOR ATI-450

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Clinical Trials for ATI-450

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT04247815 ↗	Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA	Completed	Aclaris Therapeutics, Inc.	Phase 2	This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA.
NCT04481685 ↗	A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19)	Completed	University of Kansas Medical Center	Phase 2	COVID-19 morbidity and mortality has been associated with Cytokine Release Syndrome (CRS) and Acute Respiratory Distress Syndrome (ARDS). ATI-450 is an oral small molecule MAPKAPK2 (MK2) inhibitor that potently inhibits multiple inflammatory cytokines. The investigator hypothesizes that MK2 pathway blockade during active COVID-19 infection in hospitalized participants will result in improvement in respiratory-failure free survival.
NCT04524858 ↗	Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS)	Terminated	Aclaris Therapeutics, Inc.	Phase 2	This is a Phase 2 study to investigate the safety and efficacy of ATI-450 for the Maintenance of Remission in Patients with Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed with Anti-IL-1 Therapy.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Summary

Clinical Trial Conditions for ATI-450

Condition Name

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Condition Name for
Intervention	Trials
Rheumatoid Arthritis	2
Breast Cancer	1
Cancer of Breast	1
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Condition MeSH

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Condition MeSH for
Intervention	Trials
Arthritis	3
Hidradenitis	1
Breast Neoplasms	1
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Clinical Trial Locations for ATI-450

Trials by Country

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Trials by Country for
Location	Trials
United States	35
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Trials by US State

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Trials by US State for
Location	Trials
Texas	4
Florida	4
Pennsylvania	4
California	3
Kansas	2
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Clinical Trial Progress for ATI-450

Clinical Trial Phase

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Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	6
Phase 1/Phase 2	1
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Clinical Trial Status

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Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	3
Completed	2
Terminated	1
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Clinical Trial Sponsors for ATI-450

Sponsor Name

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Sponsor Name for
Sponsor	Trials
Aclaris Therapeutics, Inc.	6
University of Kansas Medical Center	1
United States Department of Defense	1
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Sponsor Type

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Sponsor Type for
Sponsor	Trials
Industry	6
Other	2
U.S. Fed	1
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