[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652898":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":30,"responsibleParty":40,"collaborators":30,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":30,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":30,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":66,"whyStopped":30,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":30},{"fullName":5,"class":6},"PTC Therapeutics","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"PTC844 Low Dose","EXPERIMENTAL","Participants will receive PTC844 at a low dose once daily (QD) orally for 12 weeks.",[13],"Drug: PTC844",{"label":15,"type":10,"description":16,"interventionNames":17},"PTC844 High Dose","Participants will receive PTC844 at a high dose QD orally for 12 weeks.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo matching to PTC844 QD orally for 12 weeks.",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","PTC844","PTC844 will be administered per schedule specified in the arm description.",[15,9],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"Placebo matching to PTC844 will be administered per schedule specified in the arm description.",[19],[35],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Patient Advocacy","CONTACT","1-866-562-4620","medinfo@ptcbio.com",{"type":41,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100652898","phase-2-study-of-ptc844-in-participants-with-active-rheumatoid-arthritis-100652898",false,"NCT07779616","Study of PTC844 in Participants With Active Rheumatoid Arthritis","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","Key Inclusion Criteria:\n\n* Historical diagnosis of RA as per the American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) diagnostic criteria.\n* Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-CRP (score of ≥3.2) at screening.\n* Naïve to disease-modifying treatments for RA or have had an inadequate response to background treatment for RA and\u002For inability to tolerate disease-modifying antirheumatic drugs, as per investigator's discretion.\n* 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.\n* CRP of ≥5 milligrams (mg)\u002Fliter (L) at screening.\n\nKey Exclusion Criteria:\n\n* 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.\n* Participants with Class IV RA.\n* Past medical history of blood dyscrasia, bone marrow abnormality and\u002For suppression, drug induced thrombocytopenia or idiopathic thrombocytopenia, or bleeding diathesis.\n* Past medical history of inflammatory joint disease other than RA or fibromyalgia.\n* Rheumatoid arthritis onset at \\\u003C17 years of age.\n* Past medical history of malignancy within 5 years prior to screening, except for nonmelanoma skin cancers cursed via local resection.\n* Participant has a known hypersensitivity to any of the ingredients of PTC844 or to any excipients of the study drug.\n* 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 (\\\u003C10 mg\u002Fday), hydroxychloroquine, or sulfasalazine, which are permitted as established background single-therapy medications.\n* Use or intended use of a combination of methotrexate, low dose prednisone (\\\u003C10 mg\u002Fday), hydroxychloroquine, or sulfasalazine within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","70 Years",{"count":53,"type":54},75,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","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).",[60],"Rheumatoid Arthritis",[62,63,64,27,65],"Immune-mediated disease","Autoimmune disease","Dihydroorotate dehydrogenase (DHODH) inhibitors","Rheumatoid arthritis","NOT_YET_RECRUITING","2026-08-18",{"date":69,"type":70},"2026-08-21","ACTUAL",{"date":72,"type":54},"2026-08-31",{"date":74,"type":54},"2027-10-29",{"name":5,"class":6}]