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ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)
Sponsor: Aclaris Therapeutics, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
251
Start Date
2022-02-01
Completion Date
2023-10-11
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
ATI-450 50 mg oral tablet BID
Oral, small molecule MK2 inhibitor
Placebo oral tablet
Placebo tablet manufactured to match ATI-450 in appearance
Methotrexate
15 mg to 25 mg weekly
ATI-450 20 mg oral tablet BID
Oral, small molecule MK2 inhibitor
Locations (50)
Aclaris Investigational Site
El Cajon, California, United States
Aclaris Investigational Site
Encino, California, United States
Aclaris Investigational Site
La Jolla, California, United States
Aclaris Investigational Site
Palm Desert, California, United States
Aclaris Investigational Site
Tampa, Florida, United States
Aclaris Investigational Site
Oklahoma City, Oklahoma, United States
Aclaris Investigational Site
Duncansville, Pennsylvania, United States
Aclaris Investigational Site
Jackson, Tennessee, United States
Aclaris Investigational Site
Cypress, Texas, United States
Aclaris Investigational Site
Mesquite, Texas, United States
Aclaris Investigational Site
San Antonio, Texas, United States
Aclaris Investigational Site
Pleven, Bulgaria
Aclaris Investigational Site
Plovdiv, Bulgaria
Aclaris Investigational Site
Plovdiv, Bulgaria
Aclaris Investigational Site
Plovdiv, Bulgaria
Aclaris Investigational Site
Plovdiv, Bulgaria
Aclaris Investigational Site
Sofia, Bulgaria
Aclaris Investigational Site
Sofia, Bulgaria
Aclaris Investigational Site
Sofia, Bulgaria
Aclaris Investigational Site
Varna, Bulgaria
Aclaris Investigational Site
Brno, Czechia
Aclaris Investigational Site
Hlučín, Czechia
Aclaris Investigational Site
Ostrava, Czechia
Aclaris Investigational Site
Pardubice, Czechia
Aclaris Investigational Site
Prague, Czechia
Aclaris Investigational Site
Prague, Czechia
Aclaris Investigational Site
Uherské Hradiště, Czechia
Aclaris Investigational Site
Krakow, Lesser Poland Voivodeship, Poland
Aclaris Investigational Site
Tomaszów Lubelski, Lubelski, Poland
Aclaris Investigational Site
Lublin, Lublin Voivodeship, Poland
Aclaris Investigational Site
Nadarzyn, Masovian Voivodeship, Poland
Aclaris Investigational Site
Grodzisk Mazowiecki, Mzowieckie, Poland
Aclaris Investigational Site
Bialystok, Podlaskie Voivodeship, Poland
Aclaris Investigational Site
Katowice, Silesian Voivodeship, Poland
Aclaris Investigational Site
Elblag, Warm.Maz., Poland
Aclaris Investigational Site
Olsztyn, Warmińsko-Mazurskien, Poland
Aclaris Investigational Site
Poznan, Wielkopolska, Poland
Aclaris Investigational Site
Bialystok, Poland
Aclaris Investigational Site
Bialystok, Poland
Aclaris Investigational Site
Dąbrówka, Poland
Aclaris Investigational Site
Krakow, Poland
Aclaris Investigational Site
Lublin, Poland
Aclaris Investigational Site
Nowa Sól, Poland
Aclaris Investigational Site
Poznan, Poland
Aclaris Investigational Site
Poznan, Poland
Aclaris Investigational Site
Poznan, Poland
Aclaris Investigational Site
Sochaczew, Poland
Aclaris Investigational Site
Torun, Poland
Aclaris Investigational Site
Warsaw, Poland
Aclaris Investigational Site
Wroclaw, Poland