NCT04247815

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

A Phase 2a, Randomized, Investigator and Patient-blind, Sponsor-unblinded, Parallel Group, Placebo-controlled Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	ATI-450	Oral, small molecule MK2 inhibitor
DRUG	Placebo oral tablet	Placebo tablet manufactured to match ATI-450 in appearance
DRUG	Methotrexate	7.5 mg to 25 mg weekly

Timeline

• Start date: 2020-03-16
• Primary completion: 2021-02-04
• Completion: 2021-02-04
• First posted: 2020-01-30
• Last updated: 2023-03-29
• Results posted: 2023-03-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study