ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)
Public ClinicalTrials.gov record NCT05279417. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2b, Randomized, Multicenter, Double-blind, Parallel Group, Placebo Controlled, Dose Ranging Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone
Study identification
- NCT ID
- NCT05279417
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Industry
- Enrollment
- 251 participants
Conditions and interventions
Conditions
Interventions
- ATI-450 20 mg oral tablet BID Drug
- ATI-450 50 mg oral tablet BID Drug
- Methotrexate Drug
- Placebo oral tablet Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2022
- Primary completion
- Sep 4, 2023
- Completion
- Oct 10, 2023
- Last update posted
- Sep 4, 2024
2022 – 2023
United States locations
- U.S. sites
- 11
- U.S. states
- 6
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Aclaris Investigational Site | El Cajon | California | 92020 | — |
| Aclaris Investigational Site | Encino | California | 91436 | — |
| Aclaris Investigational Site | La Jolla | California | 92093 | — |
| Aclaris Investigational Site | Palm Desert | California | 92260 | — |
| Aclaris Investigational Site | Tampa | Florida | 33613 | — |
| Aclaris Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| Aclaris Investigational Site | Duncansville | Pennsylvania | 16635 | — |
| Aclaris Investigational Site | Jackson | Tennessee | 38305 | — |
| Aclaris Investigational Site | Cypress | Texas | 77429 | — |
| Aclaris Investigational Site | Mesquite | Texas | 75150 | — |
| Aclaris Investigational Site | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05279417, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 4, 2024 · Synced May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05279417 live on ClinicalTrials.gov.