Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05279417 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Aclaris Therapeutics.

Completed
Registry status
Phase 2
Development phase
251
Enrollment target

NCT05279417: Completed Phase 2 study, sponsored by Aclaris Therapeutics.

NCT05279417 is a Phase 2 study that has completed, run by Aclaris Therapeutics. The registered enrollment target is 251 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05279417, a Phase 2 study, has completed, sponsored by Aclaris Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
251 participants
Enrollment target

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.

Interventions

  • DRUG Placebo oral tablet
  • DRUG Methotrexate
  • DRUG ATI-450 50 mg oral tablet BID
  • DRUG ATI-450 20 mg oral tablet BID

Trial Details

FieldValue
Enrollment Target 251 participants
Start Date 2022-02-01
Est. Completion 2023-10-11
Phase Phase 2
Aclaris Therapeutics

33 total trials

What the finished NCT05279417 record still lists

NCT05279417 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo oral tablet is the first listed.

NCT05279417 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05279417 about?

NCT05279417 is a clinical study titled "ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)". 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.

What is the current status of trial NCT05279417?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 251 participants. The study started on 2022-02-01. Estimated completion is 2023-10-11.

What interventions are being tested in trial NCT05279417?

The interventions under investigation include: Placebo oral tablet (DRUG), Methotrexate (DRUG), ATI-450 50 mg oral tablet BID (DRUG), ATI-450 20 mg oral tablet BID (DRUG).

Who is sponsoring clinical trial NCT05279417?

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 NCT05279417's enrollment target sits among peer trials

251 222nd of 2000 higher than 1,779 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT06043817 · 251 participants · Phase 1

    First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations

  • NCT02314988 · 252 participants · Phase 2

    Tranexamic Acid to Reduce Blood Loss in Spine Surgery

  • NCT03941756 · 252 participants · NA

    Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma

  • NCT05219617 · 252 participants · Phase 3

    Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT05279417, the US trial registry maintained by the National Library of Medicine. NCT05279417 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.