ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)
NCT ID: NCT05279417
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
251 participants
INTERVENTIONAL
2022-02-01
2023-10-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA
NCT04247815
A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
NCT00847613
Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis
NCT02504671
A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis
NCT00458146
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
NCT00316771
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ATI-450 20 mg BID plus Methotrexate
ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks
Methotrexate
15 mg to 25 mg weekly
ATI-450 20 mg oral tablet BID
Oral, small molecule MK2 inhibitor
ATI-450 50 mg BID plus Methotrexate
ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
ATI-450 50 mg oral tablet BID
Oral, small molecule MK2 inhibitor
Methotrexate
15 mg to 25 mg weekly
Placebo plus Methotrexate
Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
Placebo oral tablet
Placebo tablet manufactured to match ATI-450 in appearance
Methotrexate
15 mg to 25 mg weekly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
* Have active moderate to severe RA at Screening.
* A minimum of 12 weeks on MTX with a stable MTX dose.
Exclusion Criteria
* Uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results (eg, previous malignancy, recurrent infection, previous venous thromboembolism).
* Participant has experience with \> 2 biologics, \> 1 JAK inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
* Currently receiving corticosteroids at doses \> 10 mg/day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aclaris Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ajay Aggarwal
Role: STUDY_DIRECTOR
Aclaris Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-002860-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ATI-450-RA-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.