Study of PTC844 in Participants With Active Rheumatoid Arthritis

Sponsor
PTC Therapeutics
Study ID
NCT07779616
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • PTC844 — DRUG
    PTC844 will be administered per schedule specified in the arm description.
  • Placebo — DRUG
    Placebo matching to PTC844 will be administered per schedule specified in the arm description.

Study Details

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).

Key Dates

First listed
Aug 21, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Oct 29, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PTC844 Low Dose
    Participants will receive PTC844 at a low dose once daily (QD) orally for 12 weeks.
  • Experimental: PTC844 High Dose
    Participants will receive PTC844 at a high dose QD orally for 12 weeks.
  • Placebo Comparator: Placebo
    Participants will receive placebo matching to PTC844 QD orally for 12 weeks.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Week 16 ]

Central Contacts

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