ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This study evaluates ATI-450 plus MTX versus placebo plus MTX in participants with moderate to severe active RA who have had an inadequate response to MTX alone.

Key facts

Study ID

NCT05279417

Run by

Aclaris Therapeutics, Inc.

People needed

251

Starts

2022-02-01

Expected to finish

2023-10-11

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to comprehend and be willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved participant ICF prior to administration of any study-related procedures.
• Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
• Have active moderate to severe RA at Screening.
• A minimum of 12 weeks on MTX with a stable MTX dose.

You may not qualify if…

• Current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
• Uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results (eg, previous malignancy, recurrent infection, previous venous thromboembolism).
• Participant has experience with > 2 biologics, > 1 JAK inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
• Currently receiving corticosteroids at doses > 10 mg/day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening.

Where it is running

• Aclaris Investigational Site — Lublin, Poland
• Aclaris Investigational Site — Krakow, Poland
• Aclaris Investigational Site — El Cajon, California, United States
• Aclaris Investigational Site — Encino, California, United States
• Aclaris Investigational Site — La Jolla, California, United States
• Aclaris Investigational Site — Palm Desert, California, United States
• Aclaris Investigational Site — Tampa, Florida, United States
• Aclaris Investigational Site — Oklahoma City, Oklahoma, United States
• Aclaris Investigational Site — Duncansville, Pennsylvania, United States
• Aclaris Investigational Site — Jackson, Tennessee, United States
• Aclaris Investigational Site — Cypress, Texas, United States
• Aclaris Investigational Site — Mesquite, Texas, United States
• Aclaris Investigational Site — San Antonio, Texas, United States
• Aclaris Investigational Site — Pleven, Bulgaria
• Aclaris Investigational Site — Plovdiv, Bulgaria
• Aclaris Investigational Site — Plovdiv, Bulgaria
• Aclaris Investigational Site — Plovdiv, Bulgaria
• Aclaris Investigational Site — Plovdiv, Bulgaria
• Aclaris Investigational Site — Sofia, Bulgaria
• Aclaris Investigational Site — Sofia, Bulgaria
• Aclaris Investigational Site — Sofia, Bulgaria
• Aclaris Investigational Site — Varna, Bulgaria
• Aclaris Investigational Site — Brno, Czechia
• Aclaris Investigational Site — Hlučín, Czechia
• Aclaris Investigational Site — Ostrava, Czechia

Full record on ClinicalTrials.gov

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