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

Sponsor
Aclaris Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05279417
Collaborator
(none)
195
Enrollment
9
Locations
3
Arms
14.9
Anticipated Duration (Months)
21.7
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: ATI-450 50mg oral tablet BID
  • Drug: Placebo oral tablet
  • Drug: Methotrexate
  • Drug: ATI-450 20mg oral tablet BID
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
195 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Alone
Actual Study Start Date :
Feb 2, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ATI-450 20mg BID plus Methotrexate

ATI-450 20mg oral tablet BID with a stable weekly dose of Methotrexate

Drug: ATI-450 50mg oral tablet BID
Oral, small molecule MK2 inhibitor
Other Names:
  • zunsemetinib

    • Drug: Methotrexate
    15 mg to 25 mg weekly
    Experimental: ATI-450 50mg BID plus Methotrexate

    ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate

    Drug: Methotrexate
    15 mg to 25 mg weekly

    Drug: ATI-450 20mg oral tablet BID
    Oral, small molecule MK2 inhibitor
    Other Names:
  • zunsemetinib

    		•
    Placebo Comparator: Placebo plus Methotrexate

    Placebo oral tablet BID with a stable weekly dose of Methotrexate

    Drug: Placebo oral tablet
    Placebo tablet manufactured to match ATI-450 in appearance

    Drug: Methotrexate
    15 mg to 25 mg weekly

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients achieving ACR20 at Week 12 [Baseline to Week 12]

    Secondary Outcome Measures

    1. Proportion of patients achieving ACR50/70 at Week 12 [Baseline to Week 12]

    2. Proportion of patients achieving ACR20/50/70 over time [Up to 12 Weeks]

    3. Mean change from baseline in DAS28-CRP over time [Up to 12 Weeks]

    4. Proportion of patients achieving DAS28-CRP remission (score < 2.6) over time [Up to 12 Weeks]

    5. Proportion of patients achieving DAS28-CRP low disease activity (score ≤ 3.2) over time [Up to 12 Weeks]

    6. Mean change from baseline in CDAI over time [Up to 12 Weeks]

    7. Proportion of patients achieving CDAI remission (score ≤ 2.8) over time [Up to 12 Weeks]

    8. Percent change from baseline in hsCRP level over time [Up to 30 days after 12 weeks of treatment]

    9. HAQ-DI score over time [Up to 12 Weeks]

    10. SF-36v2 score over time [Up to 12 Weeks]

    11. FACIT-Fatigue score over time [Up to 12 Weeks]

    12. Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities [Baseline to Week 12]

    13. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Aclaris Investigational Site Tampa Florida United States 33613
    6 Aclaris Investigational Site Oklahoma City Oklahoma United States 73103
    7 Aclaris Investigational Site Duncansville Pennsylvania United States 16635
    8 Aclaris Investigational Site Houston Texas United States 77429
    9 Aclaris Investigational Site Mesquite Texas United States 75150

    Sponsors and Collaborators

    • Aclaris Therapeutics, Inc.

    Investigators

    • Study Director: Ajay Aggarwal, Aclaris Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aclaris Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT05279417
    Other Study ID Numbers:
    • ATI-450-RA-202
    First Posted:
    Mar 15, 2022
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aclaris Therapeutics, Inc.
    Rheumatoid
    Arthritis
    RA
    Additional relevant MeSH terms:
    Arthritis
    Methotrexate

    Study Results

    No Results Posted as of Mar 15, 2022