PTC844 in people with active rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates the safety, pharmacokinetics, and biomarker effects of PTC844 versus placebo in adults with active rheumatoid arthritis. Participants must have a confirmed RA diagnosis, moderate or higher disease activity, and stable background DMARDs unless inadequate response or intolerance justifies changes. The study will monitor how the drug is absorbed, distributed, metabolized, and excreted, along with biomarker signals related to disease activity. Enrollment is at multiple sites in Arizona and includes adults who meet inclusion and exclusion criteria related to disease activity and health status.

Why it matters

Who can join: the full rules

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.

Where it's running

• AARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Chandler
  Chandler, Arizona, United States Recruiting
• Millennium Clinical Trials
  Westlake Village, California, United States Recruiting
• Nouvelle Clinical Research LLC
  Cutler Bay, Florida, United States Recruiting
• Millennium Medical Research, LLC.
  Miami, Florida, United States Recruiting
• Conquest Research
  Winter Park, Florida, United States Recruiting
• Precision Comprehensive Clinical Research Solutions - Irving
  Irving, Texas, United States Recruiting

Study contacts

• Study coordinator: Patient Advocacy
• Email: medinfo@ptcbio.com
• Phone: 1-866-562-4620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.