[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659630":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":48,"studyPopulation":20,"armGroups":49,"interventions":64,"overallOfficials":20,"centralContacts":76,"locations":20,"responsibleParty":82,"collaborators":20,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":20,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":20,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":109,"whyStopped":20,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":20},{"fullName":5,"class":6},"Forward Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants who achieved an American College of Rheumatology (ACR) 20 response at Week 12","The ACR20 response is defined as the proportion of participants with at least a 20% improvement in tender joint count (TJC) out of 68 joints, a 20% improvement in swollen joint count (SJC) out of 66 joints, and a 20% improvement in three of the following five criteria: participant pain, participant global assessment of disease, physician global assessment of disease, physical functioning assessment (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).","Week 12",[14,18,22,26,29,32,34],{"measure":15,"description":16,"timeFrame":17},"Incidence of TEAEs, SAEs, and clinically significant laboratory findings, vital signs, and 12-lead ECGs","Treatment-Emergent Adverse Events (TEAEs) are defined as adverse events (AEs) that occurred or worsened after the first dose of trial intervention. A Serious Adverse Event (SAE) is defined as an AE that results in death, is life-threatening, requires or prolongs a hospitalization, results in persistent or significant disability\u002Fincapacity, or is a congenital anomaly\u002Fbirth defect.","Baseline to Week 16",{"measure":19,"description":20,"timeFrame":21},"Proportion of participants with ACR20 response at Weeks 2, 4, and 8",null,"Baseline to Weeks 2, 4, and 8",{"measure":23,"description":24,"timeFrame":25},"Proportion of participants with ACR50 and ACR70 response at Weeks 2, 4, 8, and 12","ACR50 and ACR70 use the same criteria as ACR20 with improvement levels defined as 50% and 70%, respectively, versus 20% for ACR20.","Baseline to Weeks 2, 4, 8, and 12",{"measure":27,"description":28,"timeFrame":25},"Proportion of participants with MDA and VLDA at Weeks 2, 4, 8, and 12","Minimal Disease Activity (MDA) meets ≥5 of 7 and Very Low Disease Activity (VLDA) meets 7 of 7 of the following criteria: TJC ≤1; SJC ≤1; tender entheseal points ≤1; participant global visual analog scale (VAS) ≤20 mm; participant pain VAS ≤15 mm; HAQ ≤0.5; and Psoriasis Area and Severity Index (PASI) ≤1 or body surface area (BSA) involvement ≤3%.",{"measure":30,"description":31,"timeFrame":25},"Change from baseline to Weeks 2, 4, 8, and 12 in DAPSA score","Disease Activity in Psoriatic Arthritis (DAPSA) is calculated based on TJC out of 68 joints, SJC out of 66 joints, hsCRP, participant's assessment of rheumatic disease activity, and participant's assessment of pain severity.",{"measure":33,"description":20,"timeFrame":25},"Proportion of participants with DAPSA low disease activity (LDA) (≤14) and DAPSA remission (≤4) at Weeks 2, 4, 8, and 12",{"measure":35,"description":36,"timeFrame":25},"Proportion of participants with PASI 75 and PASI 90 response at Weeks 2, 4, 8, and 12 in participants with baseline BSA involvement ≥3%","Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response are binary outcomes indicating ≥75% and ≥90% improvement, respectively, in PASI from baseline. For each of four body regions, the area of involvement is scored from 0 to 6 and multiplied by the sum of three severity scores (erythema, induration, and desquamation, each scored 0 to 4). Each region is then weighted by its proportion of total body surface area: head = 0.1, upper extremities = 0.2, trunk = 0.3, lower extremities = 0.4. The total PASI is the sum of all four weighted regional scores.",{"allocation":38,"interventionModel":39,"interventionModelDescription":20,"primaryPurpose":40,"observationalModel":20,"timePerspective":20,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":20,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study consists of a 4-week screening period, 12-week treatment period, and a 4-week follow up period. Participants will be randomized 1:1:1 to Dose Regimen 1, Dose Regimen 2, or Placebo (\\~70 participants\u002Farm).",[50,55,59],{"label":51,"type":52,"description":20,"interventionNames":53},"Arm 1","EXPERIMENTAL",[54],"Drug: FT2109 Dosing Regimen 1",{"label":56,"type":52,"description":20,"interventionNames":57},"Arm 2",[58],"Drug: FT2109 Dosing Regimen 2",{"label":60,"type":61,"description":20,"interventionNames":62},"Arm 3","PLACEBO_COMPARATOR",[63],"Drug: Matching Placebo",[65,70,73],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":20},"DRUG","FT2109 Dosing Regimen 1","Administered daily for 12 weeks",[51],{"type":66,"name":71,"description":68,"armGroupLabels":72,"otherNames":20},"FT2109 Dosing Regimen 2",[56],{"type":66,"name":74,"description":68,"armGroupLabels":75,"otherNames":20},"Matching Placebo",[60],[77],{"name":78,"role":79,"phone":80,"phoneExt":20,"email":81},"Clinical Operations","CONTACT","857-285-4610","clinicaltrials@forward-tx.com",{"type":83,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100659630","phase-2-phase-2-trial-of-ft2109-for-the-treatment-of-psoriatic-arthritis-100659630",false,"NCT07869134","Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis","A Proof-of-Concept Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Two Dose Levels of FT2109 in Biologic Naïve and Biologic Experienced Participants With Active Psoriatic Arthritis (PsA)","Inclusion Criteria:\n\n* Age 18-75 years\n* Body mass index (BMI) within the range 18 to 40 kg\u002Fm2\n* Diagnosed with PsA for ≥6 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening\n* Have active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline and having hsCRP \\>0.3 mg\u002FdL (3 mg\u002FL)\n* Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis at screening\n* Biologic disease modifying anti-rheumatic drug (bDMARD) or targeted synthetic DMARD (tsDMARD) experienced participants can have received (a) up to one bDMARD (excluding TNF and IL-17 targeting therapies), and (b) up to one tsDMARD (excluding JAK targeting therapies)\n* bDMARD or tsDMARD naïve participants must have failed (a) at least one but no more than two csDMARDs AND\u002FOR (b) Apremilast\n\nExclusion Criteria:\n\n* Presence of other inflammatory or autoimmune conditions, including but not limited to rheumatoid arthritis, primary ankylosing spondylitis or non-radiographic axial spondyloarthritis without psoriasis, systemic lupus erythematosus, drug-induced dermatosis, inflammatory bowel disease, or Lyme disease\n* Current non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)\n* Use of \\>10mg\u002Fday prednisone equivalent or change in oral glucocorticoid dosage within 4 weeks prior to Baseline\n* Received targeted intra-articular, trigger point, tender point, intra-bursa, or intra-tendon sheath surgical or pharmacological treatment within 8 weeks of the Screening Visit\n* Undergone surgical treatment for PsA including synovectomy and arthroplasty in more than 3 joints and\u002For within the last 12 weeks prior to the Screening Visit.","ALL","18 Years","75 Years",{"count":95,"type":96},210,"ESTIMATED","INTERVENTIONAL",[99],"PHASE2","This study will investigate if the study medicine FT2109 can treat symptoms of active Psoriatic Arthritis (PsA). This study assesses the safety and efficacy of FT2109 in adult participants with active PsA who may or may not have been treated previously with advanced therapy and who may be on stable background therapy.\n\nIn this study, researchers will look at different doses of FT2109 compared to placebo (a treatment with no active study drug in it). Researchers will try to learn if at least one of the study doses of FT2109 works better than placebo to treat PsA symptoms.",[102],"Psoriatic Arthritis (PsA)",[104,102,105,106,107,108],"FT2109","Joint Diseases","Skin Diseases","Spondylarthropathies","Plaque Psoriasis","NOT_YET_RECRUITING","2026-10-06",{"date":112,"type":113},"2026-10-09","ACTUAL",{"date":115,"type":96},"2026-12",{"date":117,"type":96},"2027-11",{"name":5,"class":6}]