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

Aclaris Therapeutics

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: ATI-450 20 mg oral tablet BID; Drug: ATI-450 50 mg oral tablet BID; Drug: Methotrexate; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05279417

2021-002860-31 (EudraCT Number)

ATI-450-RA-202

Details and patient eligibility

About

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.

Full description

This is a Phase 2b, randomized, multicenter, double-blind, parallel group, placebo controlled, dose ranging study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of 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.

Enrollment: 251 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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251 participants in 3 patient groups, including a placebo group

ATI-450 20 mg BID plus Methotrexate

Experimental group

Description:

ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks

Treatment:

Drug: Methotrexate

Drug: ATI-450 20 mg oral tablet BID

ATI-450 50 mg BID plus Methotrexate

Experimental group

Description:

ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks

Treatment:

Drug: Methotrexate

Drug: ATI-450 50 mg oral tablet BID

Placebo plus Methotrexate

Placebo Comparator group

Description:

Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks

Treatment:

Drug: Placebo oral tablet

Drug: Methotrexate