RecruitingPhase 2interventionalRules rewrite

Phase 2: testing PTC844 for Rheumatoid Arthritis

Q: Is NCT07779616 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07779616?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07779616?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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

Official registry: https://clinicaltrials.gov/study/NCT07779616 · PTC Therapeutics · enrollment listed as 75

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are PTC844, or Placebo. The registry lists allocation as randomized. This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to dummy treatment (placebo) in participants with active rheumatoid arthritis (RA).

They plan to enroll about 75 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: PTC844, Placebo

Primary outcome (registry wording): Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
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-a blood inflammation marker (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
a blood inflammation marker (CRP) of ≥5 milligrams (mg)/liter (L) at screening

Who the registry excludes

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 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

Public study contact (from the registry)

Patient Advocacy

1-866-562-4620

medinfo@ptcbio.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

26 listed

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)

+ 12 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07779616 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07779616?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07779616?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary