Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA

• Status: Completed
• Trial end date: 2021-02-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aclaris Therapeutics, Inc.
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.

• DAS28-CRP ≥3.2 defined as moderate to high disease activity.

• Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints.

• hsCRP ≥5 mg/L at screening.

• Patients must have definitive intra-articular synovitis or osteitis defined as a score of 1 or greater on a Hand-Wrist MRI as assessed by central imaging reader (using RAMRIS).

• On a stable MTX dose and a stable dose of folic or folinic acid prior to the screening visit.

Exclusion Criteria:

• Patient has a current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.

• Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results.

• History or evidence of active or latent tuberculosis.

• Active infection requiring treatment with antibiotics.

• Blood pressure levels (in supine position after at least 5 minutes rest): <90 mmHg or >140 mmHg for systolic blood pressure or <40 mmHg or >90 mmHg for diastolic blood pressure.

• Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit.

• Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of the screening visit.

• Patients with history of stroke.

• Any joint procedure in the past 90 days prior to screening.