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Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA

NCT04247815 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-03-29

Study results available
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Summary

This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA.

Conditions

Interventions

DRUG

ATI-450

Oral, small molecule MK2 inhibitor

DRUG

Placebo oral tablet

Placebo tablet manufactured to match ATI-450 in appearance

DRUG

Methotrexate

7.5 mg to 25 mg weekly

Sponsors & Collaborators

  • Aclaris Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Gordon · Aclaris Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-16
Primary Completion
2021-02-04
Completion
2021-02-04
FDA Drug
Yes

Countries

  • United States

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 NCT04247815 on ClinicalTrials.gov