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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
251
Oral, small molecule MK2 inhibitor
Placebo tablet manufactured to match ATI-450 in appearance
15 mg to 25 mg weekly
Proportion of patients achieving ACR20 at Week 12
Time frame: Baseline to Week 12
Proportion of patients achieving ACR50/70 at Week 12
Time frame: Baseline to Week 12
Proportion of patients achieving ACR20/50/70 over time
Time frame: Up to 12 Weeks
Mean change from baseline in DAS28-CRP over time
Time frame: Up to 12 Weeks
Proportion of patients achieving DAS28-CRP remission (score < 2.6) over time
Time frame: Up to 12 Weeks
Proportion of patients achieving DAS28-CRP low disease activity (score ≤ 3.2) over time
Time frame: Up to 12 Weeks
Mean change from baseline in CDAI over time
Time frame: Up to 12 Weeks
Proportion of patients achieving CDAI remission (score ≤ 2.8) over time
Time frame: Up to 12 Weeks
Percent change from baseline in hsCRP level over time
Time frame: Up to 30 days after 12 weeks of treatment
Health Assessment Questionnaire-Disability Index (HAQ-DI) score over time
Time frame: Up to 12 Weeks
Short Form Health Survey version-2.0 (SF-36v2) score over time
Time frame: Up to 12 Weeks
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Oral, small molecule MK2 inhibitor
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
...and 40 more locations
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) score over time
Time frame: Up to 12 Weeks
Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities
Time frame: Baseline to Week 12
Trough ATI-450 and metabolite (CDD-2164) concentrations at clinic visits (trough and 2-hour post dose will be collected).
Time frame: Study Days 1, 8, and 85