NCT05279417

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

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 Methotrexate (MTX) Versus Placebo Plus MTX in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	ATI-450 50 mg oral tablet BID	Oral, small molecule MK2 inhibitor
DRUG	Placebo oral tablet	Placebo tablet manufactured to match ATI-450 in appearance
DRUG	Methotrexate	15 mg to 25 mg weekly
DRUG	ATI-450 20 mg oral tablet BID	Oral, small molecule MK2 inhibitor

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-09-05
• Completion: 2023-10-11
• First posted: 2022-03-15
• Last updated: 2024-09-05

Locations

50 sites across 4 countries: United States, Bulgaria, Czechia, Poland

Regulatory

• FDA-regulated drug study