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Study of PTC844 in Participants With Active Rheumatoid Arthritis

RecruitingPhase 2

A Phase 2A, Proof-of-Concept, Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PTC844 in Participants With Active Rheumatoid Arthritis

Who can join

Ages 18 to 70 · All sexes

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: PTC Therapeutics · Participants: 75 · Started: Sep 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07779616

Locations in the U.S.

ArizonaAARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Chandler, Chandler
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff, Flagstaff (Not yet recruiting)
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix, Phoenix (Not yet recruiting)
CaliforniaMillennium Clinical Trials, Westlake Village
FloridaNouvelle Clinical Research LLC, Cutler Bay
Millennium Medical Research, LLC., Miami
Vitaly Clinical Research, LLC, Miami (Not yet recruiting)
Suncoast Clinical Research, Inc. - New Port Richey, New Port Richey (Not yet recruiting)
Conquest Research, Winter Park
IllinoisChicago Arthritis and Regenerative Medicine, Chicago (Not yet recruiting)
North CarolinaDJL Clinical Research PLLC, Charlotte (Not yet recruiting)
PennsylvaniaRheumatology Specialty Center, Willow Grove (Not yet recruiting)
TexasPrecision Comprehensive Clinical Research Solutions - Irving, Irving
VirginiaArthritis & Rheumatism Associates - Fairfax, Fairfax (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.