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

NCT05279417 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2024-09-05

No results posted yet for this study

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

Interventions

DRUG

ATI-450 50 mg oral tablet BID

Oral, small molecule MK2 inhibitor

DRUG

Placebo oral tablet

Placebo tablet manufactured to match ATI-450 in appearance

DRUG

Methotrexate

15 mg to 25 mg weekly

DRUG

ATI-450 20 mg oral tablet BID

Oral, small molecule MK2 inhibitor

Sponsors & Collaborators

  • Aclaris Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ajay Aggarwal · Aclaris Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-09-05
Completion
2023-10-11
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05279417 on ClinicalTrials.gov