Status:
COMPLETED
ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)
Lead Sponsor:
Aclaris Therapeutics, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 pharmacodynam...
Eligibility Criteria
Inclusion
- Able to comprehend and be willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved participant ICF prior to administration of any study-related procedures.
- 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
- Current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2023
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT05279417
Start Date
February 1 2022
End Date
October 11 2023
Last Update
September 5 2024
Active Locations (50)
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1
Aclaris Investigational Site
El Cajon, California, United States, 92020
2
Aclaris Investigational Site
Encino, California, United States, 91436
3
Aclaris Investigational Site
La Jolla, California, United States, 92093
4
Aclaris Investigational Site
Palm Desert, California, United States, 92260