ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate; Drug: ATI-450 50 mg oral tablet BID; Drug: Placebo oral tablet; Drug: ATI-450 20 mg oral tablet BID

• Registration Number: NCT05279417
• Lead Sponsor: Aclaris Therapeutics, Inc.

Brief Summary

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

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 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

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-15
• Primary Completion: 2023-09-05
• Study Completion: 2023-10-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• Able to comprehend and be willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient 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.

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Exclusion Criteria

• 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 patient at increased risk during the study or impact the interpretation of results (eg, previous malignancy, recurrent infection, previous venous thromboembolism).
• Patient 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATI-450 20 mg BID plus Methotrexate	Methotrexate	ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks
ATI-450 20 mg BID plus Methotrexate	ATI-450 20 mg oral tablet BID	ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks
ATI-450 50 mg BID plus Methotrexate	ATI-450 50 mg oral tablet BID	ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
Placebo plus Methotrexate	Placebo oral tablet	Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
Placebo plus Methotrexate	Methotrexate	Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
ATI-450 50 mg BID plus Methotrexate	Methotrexate	ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving ACR20 at Week 12	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in CDAI over time	Up to 12 Weeks
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) score over time	Up to 12 Weeks
Proportion of patients achieving DAS28-CRP remission (score < 2.6) over time	Up to 12 Weeks
Proportion of patients achieving ACR50/70 at Week 12	Baseline to Week 12
Proportion of patients achieving ACR20/50/70 over time	Up to 12 Weeks
Mean change from baseline in DAS28-CRP over time	Up to 12 Weeks
Proportion of patients achieving DAS28-CRP low disease activity (score ≤ 3.2) over time	Up to 12 Weeks
Proportion of patients achieving CDAI remission (score ≤ 2.8) over time	Up to 12 Weeks
Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities	Baseline to Week 12
Percent change from baseline in hsCRP level over time	Up to 30 days after 12 weeks of treatment
Health Assessment Questionnaire-Disability Index (HAQ-DI) score over time	Up to 12 Weeks
Short Form Health Survey version-2.0 (SF-36v2) score over time	Up to 12 Weeks
Trough ATI-450 and metabolite (CDD-2164) concentrations at clinic visits (trough and 2-hour post dose will be collected).	Study Days 1, 8, and 85

Trial Locations

Locations (1)

Aclaris Investigational Site; 🇵🇱 Wrocław, Poland