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

Aclaris Therapeutics

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo oral tablet

Drug: ATI-450

Drug: Methotrexate

Study type

Interventional

Funder types

Industry

Identifiers

NCT04247815

ATI-450-RA-201

Details and patient eligibility

About

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.

Full description

This is a Phase 2, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA with inadequate response to methotrexate. All subjects will be required to complete a safety follow up visit 30 days post last study medication administration.

Enrollment

25 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.