CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
ATI-450 +2 moredrug
Likely dose
Methotrexate 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04247815
NCT04247815Phase 2Completed

A Phase 2a, Randomized, Investigator and Patient-blind, Sponsor-unblinded, Parallel Group, Placebo-controlled Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe Active Rheumatoid Arthritis

Aclaris Therapeutics, Inc.·interventional·Posted Jan 30, 2020·Updated Mar 29, 2023

In Brief

A Phase 2 clinical trial evaluating ATI-450, Placebo oral tablet, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 25 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 30, 2020
Enrollment StartMar 16, 2020
Primary CompletionFeb 4, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.4 years ago

Interventions

ATI-450drug

Oral, small molecule MK2 inhibitor

Placebo oral tabletdrug

Placebo tablet manufactured to match ATI-450 in appearance

Methotrexatedrug

7.5 mg to 25 mg weekly