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NCT04247815 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Aclaris Therapeutics.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target

NCT04247815: Completed Phase 2 study, sponsored by Aclaris Therapeutics.

NCT04247815 is a Phase 2 study that has completed, run by Aclaris Therapeutics. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04247815, a Phase 2 study, has completed, sponsored by Aclaris Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study 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.

Primary Outcome

Safety and tolerability reported as Adverse Events (AEs). AEs will be coded with the Medical Dictionary for Regulatory Activities (MedDRA) version 23.0. AEs will be presented by system organ class and preferred term in frequency tables.

Interventions

  • DRUG Placebo oral tablet
  • DRUG Methotrexate
  • DRUG ATI-450

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-03-16
Est. Completion 2021-02-04
Phase Phase 2
Aclaris Therapeutics

33 total trials

What the finished NCT04247815 record still lists

NCT04247815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo oral tablet is the first listed.

NCT04247815 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04247815 about?

NCT04247815 is a clinical study titled "Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA". 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.

What is the current status of trial NCT04247815?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-03-16. Estimated completion is 2021-02-04.

What interventions are being tested in trial NCT04247815?

The interventions under investigation include: Placebo oral tablet (DRUG), Methotrexate (DRUG), ATI-450 (DRUG).

Who is sponsoring clinical trial NCT04247815?

This trial is sponsored by Aclaris Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04247815's enrollment target sits among peer trials

25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04247815, the US trial registry maintained by the National Library of Medicine. NCT04247815 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.