ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)

NCT05279417 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: ATI-450-RA-2022021-002860-31
• Study Type: interventional
• Target: 251
• Locations: 4 countries
• Sites: 50

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid; Arthritis; RA

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving ACR20 at Week 12

  Baseline to Week 12

Secondary Outcomes (13)

• 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 remission (score < 2.6) over time

  Up to 12 Weeks

• Proportion of patients achieving DAS28-CRP low disease activity (score ≤ 3.2) over time

  Up to 12 Weeks

Study Arms (3)

ATI-450 20 mg BID plus Methotrexate

EXPERIMENTAL

ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks

Drug: Methotrexate; Drug: ATI-450 20 mg oral tablet BID

ATI-450 50 mg BID plus Methotrexate

EXPERIMENTAL

ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks

Drug: ATI-450 50 mg oral tablet BID; Drug: Methotrexate

Placebo plus Methotrexate

PLACEBO COMPARATOR

Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks

Drug: Placebo oral tablet; Drug: Methotrexate

Interventions

ATI-450 50 mg oral tablet BID DRUG

Oral, small molecule MK2 inhibitor

Also known as: zunsemetinib

ATI-450 50 mg BID plus Methotrexate

Placebo oral tablet DRUG

Placebo tablet manufactured to match ATI-450 in appearance

Placebo plus Methotrexate

Methotrexate DRUG

15 mg to 25 mg weekly

ATI-450 20 mg BID plus Methotrexate; ATI-450 50 mg BID plus Methotrexate; Placebo plus Methotrexate

ATI-450 20 mg oral tablet BID DRUG

Oral, small molecule MK2 inhibitor

Also known as: zunsemetinib

ATI-450 20 mg BID plus Methotrexate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (50)

Aclaris Investigational Site

El Cajon, California, 92020, United States

Location

Aclaris Investigational Site

Encino, California, 91436, United States

Location

Aclaris Investigational Site

La Jolla, California, 92093, United States

Location

Aclaris Investigational Site

Palm Desert, California, 92260, United States

Location

Aclaris Investigational Site

Tampa, Florida, 33613, United States

Location

Aclaris Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Aclaris Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Aclaris Investigational Site

Jackson, Tennessee, 38305, United States

Location

Aclaris Investigational Site

Cypress, Texas, 77429, United States

Location

Aclaris Investigational Site

Mesquite, Texas, 75150, United States

Location

Aclaris Investigational Site

San Antonio, Texas, 78229, United States

Location

Aclaris Investigational Site

Pleven, 5800, Bulgaria

Location

Aclaris Investigational Site

Plovdiv, 4000, Bulgaria

Location

Aclaris Investigational Site

Plovdiv, 4001, Bulgaria

Location

Aclaris Investigational Site

Plovdiv, 4002, Bulgaria

Location

Aclaris Investigational Site

Plovdiv, 4004, Bulgaria

Location

Aclaris Investigational Site

Sofia, 1336, Bulgaria

Location

Aclaris Investigational Site

Sofia, 1431, Bulgaria

Location

Aclaris Investigational Site

Sofia, 1606, Bulgaria

Location

Aclaris Investigational Site

Varna, 9000, Bulgaria

Location

Aclaris Investigational Site

Brno, 615 00, Czechia

Location

Aclaris Investigational Site

Hlučín, 748 01, Czechia

Location

Aclaris Investigational Site

Ostrava, 702 00, Czechia

Location

Aclaris Investigational Site

Pardubice, 530 02, Czechia

Location

Aclaris Investigational Site

Prague, 128 50, Czechia

Location

Aclaris Investigational Site

Prague, 140 00, Czechia

Location

Aclaris Investigational Site

Uherské Hradiště, 686 01, Czechia

Location

Aclaris Investigational Site

Krakow, Lesser Poland Voivodeship, 30-002, Poland

Location

Aclaris Investigational Site

Tomaszów Lubelski, Lubelski, 22-600, Poland

Location

Aclaris Investigational Site

Lublin, Lublin Voivodeship, 20-362, Poland

Location

Aclaris Investigational Site

Nadarzyn, Masovian Voivodeship, 05-830, Poland

Location

Aclaris Investigational Site

Grodzisk Mazowiecki, Mzowieckie, 05-825, Poland

Location

Aclaris Investigational Site

Bialystok, Podlaskie Voivodeship, 15-351, Poland

Location

Aclaris Investigational Site

Katowice, Silesian Voivodeship, 40-282, Poland

Location

Aclaris Investigational Site

Elblag, Warm.Maz., 82-300, Poland

Location

Aclaris Investigational Site

Olsztyn, Warmińsko-Mazurskien, 10-117, Poland

Location

Aclaris Investigational Site

Poznan, Wielkopolska, 61-113, Poland

Location

Aclaris Investigational Site

Bialystok, 15-297, Poland

Location

Aclaris Investigational Site

Bialystok, 15-879, Poland

Location

Aclaris Investigational Site

Dąbrówka, 62-069, Poland

Location

Aclaris Investigational Site

Krakow, 30-363, Poland

Location

Aclaris Investigational Site

Lublin, 20-607, Poland

Location

Aclaris Investigational Site

Nowa Sól, 67-100, Poland

Location

Aclaris Investigational Site

Poznan, 60-218, Poland

Location

Aclaris Investigational Site

Poznan, 60-446, Poland

Location

Aclaris Investigational Site

Poznan, 61-397, Poland

Location

Aclaris Investigational Site

Sochaczew, 96-500, Poland

Location

Aclaris Investigational Site

Torun, 87-100, Poland

Location

Aclaris Investigational Site

Warsaw, 04-141, Poland

Location

Aclaris Investigational Site

Wroclaw, 52-442, Poland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ajay Aggarwal

  Aclaris Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 15, 2022
• Study Start: February 1, 2022
• Primary Completion: September 5, 2023
• Study Completion: October 11, 2023
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

PL (23); CZ (7); BU (9); US (11)