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Recruiting Phase 2

Study of PTC844 in Participants With Active Rheumatoid Arthritis

NCT07779616 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-09-24
Last updated
2026-11-06

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

PTC844Placebo

PTC844: PTC844 will be administered per schedule specified in the arm description.

Placebo: Placebo matching to PTC844 will be administered per schedule specified in the arm description.

Study summary

This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to placebo in participants with active rheumatoid arthritis (RA).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Key Inclusion Criteria: * Historical diagnosis of RA as per the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) diagnostic criteria. * Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-CRP (score of ≥3.2) at screening. * Naïve to disease-modifying treatments for RA or have had an inadequate response to background treatment for RA and/or inability to tolerate disease-modifying antirheumatic drugs, as per investigator's discretion. * Disease-modifying antirheumatic drugs should be stable and unchanged from 30 days prior to the start of the Screening Period and intend to remain stable and unchanged throughout the course of the study. * CRP of ≥5 milligrams (mg)/liter (L) at screening. Key Exclusion Criteria: * Presence of any clinically significant abnormality at screening, or prior or ongoing medical condition (for example, concomitant illness, psychiatric condition), surgical procedure, medical history, or physical findings that, in the investigator's opinion, could adversely affect the safety of the participant or could impair the assessment of study results. * Participants with Class IV RA. * Past medical history of blood dyscrasia, bone marrow abnormality and/or suppression, drug induced thrombocytopenia or idiopathic thrombocytopenia, or bleeding diathesis. * Past medical history of inflammatory joint disease other than RA or fibromyalgia. * Rheumatoid arthritis onset at \<17 years of age. * Past medical history of malignancy within 5 years prior to screening, except for nonmelanoma skin cancers cursed via local resection. * Participant has a known hypersensitivity to any of the ingredients of PTC844 or to any excipients of the study drug. * Use or intended use of any prescribed disease-modifying treatments for RA within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit, except for methotrexate, low dose prednisone (\<10 mg/day), hydroxychloroquine, or sulfasalazine, which are permitted as established background single-therapy medications. * Use or intended use of a combination of methotrexate, low dose prednisone (\<10 mg/day), hydroxychloroquine, or sulfasalazine within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) — Baseline up to Week 16
  • Change From Baseline to Week 2 in Dihydroorotate (DHO) — Baseline, Week 2

Trial sites (26)

FacilityCityRegionStatus
AARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Chandler Chandler Arizona Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff Flagstaff Arizona Not Yet Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix Phoenix Arizona Not Yet Recruiting
Millennium Clinical Trials Westlake Village California Recruiting
Nouvelle Clinical Research LLC Cutler Bay Florida Recruiting
Vitaly Clinical Research, LLC Miami Florida Not Yet Recruiting
Millennium Medical Research, LLC. Miami Florida Recruiting
Suncoast Clinical Research, Inc. - New Port Richey New Port Richey Florida Not Yet Recruiting
Conquest Research Winter Park Florida Recruiting
Chicago Arthritis and Regenerative Medicine Chicago Illinois Not Yet Recruiting
DJL Clinical Research PLLC Charlotte North Carolina Not Yet Recruiting
Rheumatology Specialty Center Willow Grove Pennsylvania Not Yet Recruiting
Precision Comprehensive Clinical Research Solutions - Irving Irving Texas Recruiting
Arthritis & Rheumatism Associates - Fairfax Fairfax Virginia Not Yet Recruiting
Aversi Clinic LLC Tbilisi Georgia Not Yet Recruiting
JSC Jerarsi Tbilisi Georgia Not Yet Recruiting
JSC Vian - Iv. Bokeria University Hospital Tbilisi Georgia Not Yet Recruiting
JSC VIAN Caraps Medline Tbilisi Georgia Not Yet Recruiting
LTD Caucasus Medical Centre Tbilisi Georgia Not Yet Recruiting
LTD Innova Tbilisi Georgia Not Yet Recruiting
The First Medical Center LLC Tbilisi Georgia Not Yet Recruiting
CAP Research ltd Quatre Bornes Mauritius Not Yet Recruiting
Arthritis Clinical Research Trials CC Cape Town South Africa Not Yet Recruiting
Dr IC Louw Cape Town South Africa Not Yet Recruiting
Clinresco Centres (Pty) Ltd Kempton Park South Africa Not Yet Recruiting
Clinical Trials Network - Helderberg Somerset West South Africa Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07779616 on ClinicalTrials.gov ↗ ← All trials in the USA