[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658953":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":72,"studyPopulation":11,"armGroups":73,"interventions":106,"overallOfficials":11,"centralContacts":115,"locations":11,"responsibleParty":121,"collaborators":11,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":11,"enrollmentInfo":133,"targetDuration":11,"studyType":136,"phases":137,"briefSummary":140,"conditions":141,"keywords":11,"overallStatus":143,"whyStopped":11,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":11},{"fullName":5,"class":6},"Agios Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Phase 2 and Phase 3: Percentage of Subjects With No Phlebotomy and Absence of Phlebotomy Eligibility",null,"Week 13 Through Week 26",[14,17,20,22,25,28,30,32,34,36,38,40,42,44,47,49,51,53,55,57,59],{"measure":15,"description":11,"timeFrame":16},"Phase 2 and Phase 3: Number of Phlebotomies During the Double-blind Period","Up to Week 26",{"measure":18,"description":19,"timeFrame":16},"Phase 2: Percentage of Subjects Achieving Hematocrit (HCT) Response During the Double-blind Period","HCT response is defined as having at most one HCT assessment ≥45 percent (%) during the double-blind period.",{"measure":21,"description":11,"timeFrame":16},"Phase 2 and Phase 3: Time to First HCT ≥45%",{"measure":23,"description":11,"timeFrame":24},"Phase 2 and Phase 3: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","Up to Week 130",{"measure":26,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AG-236","Each dose occasion from Day 1 to Week 52",{"measure":29,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of AG-236",{"measure":31,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Maximum Observed Plasma Concentration (Cmax) of AG-236",{"measure":33,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Percentage of Area Under the Concentration-Time Curve due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of AG-236",{"measure":35,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Time to Last Measurable Concentration (tlast) of AG-236",{"measure":37,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Time to Reach Maximum Observed Plasma Concentration (tmax) of AG-236",{"measure":39,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Terminal Elimination Half-Life (t1\u002F2) of AG-236",{"measure":41,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Apparent Total Body Clearance (CL\u002FF) of AG-236",{"measure":43,"description":11,"timeFrame":27},"Phase 2 and Phase 3: Apparent Volume of Distribution (Vz\u002FF) of AG-236",{"measure":45,"description":11,"timeFrame":46},"Phase 3: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 8a T-score at Week 26","Baseline, Week 26",{"measure":48,"description":11,"timeFrame":46},"Phase 3: Change From Baseline in PROMIS Fatigue SF 8a T-score at Week 26 Among Those who Have Fatigue at Baseline",{"measure":50,"description":11,"timeFrame":46},"Phase 3: Percentage of Subjects With Improvement in the Patient Global Impression of Severity (PGIS) -Fatigue by at Least one Category at Week 26 Compared with Baseline or \"No Change\" if None or Mild Fatigue at Baseline",{"measure":52,"description":11,"timeFrame":46},"Phase 3: Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) -Fatigue at Week 26 or \"No Change\" if None or Mild Fatigue at Baseline",{"measure":54,"description":11,"timeFrame":46},"Phase 3: Change From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Total Symptom Score at Week 26",{"measure":56,"description":11,"timeFrame":46},"Phase 3: Change From Baseline in MFSAF v4.0 Total Symptom Score at Week 26 Among Those who Have Symptoms at Baseline",{"measure":58,"description":11,"timeFrame":46},"Phase 3: Percentage of Subjects With Improvement in the PGIS-PV Symptoms by at Least 1 Category at Week 26 Compared With Baseline or \"No Change\" if None or Mild PV Symptoms at Baseline",{"measure":60,"description":11,"timeFrame":46},"Phase 3: Percentage of Subjects With Improvement in the PGIC-PV Symptoms at Week 26 or \"No Change\" if None or Mild PV Symptoms at Baseline",{"allocation":62,"interventionModel":63,"interventionModelDescription":11,"primaryPurpose":64,"observationalModel":11,"timePerspective":11,"maskingInfo":65},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":66,"maskingDescription":11,"whoMasked":67},"QUADRUPLE",[68,69,70,71],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","AG-236 is a small interfering ribonucleic acid (siRNA) targeting transmembrane serine protease 6 (TMPRSS6) intended for the treatment of PV. The study aims to evaluate the efficacy and safety of treatment with AG-236 in subjects with PV. The study is a Phase 2\u002F3 study in which the recommended dose and dose regimen of AG-236 will be selected and further evaluated. The Phase 2 portion includes a 26-week randomized, placebo-controlled period in which subjects will be randomized in a 1:1:1:1:1 ratio to receive 1 of 3 dose levels of AG-236 in 1 of 2 dose regimens or placebo. The Phase 3 portion includes a 26-week randomized, placebo-controlled period in which subjects will be randomized in a 2:1 ratio to receive the recommended AG-236 dose level and dose regimen or placebo. Subjects who complete either the Phase 2 or Phase 3 portion will have the option to move into a 104-week open-label extension period to receive AG-236.",[74,81,85,89,93,98,102],{"label":75,"type":76,"description":77,"interventionNames":78},"Phase 2: AG-236 Dose X","EXPERIMENTAL","Subjects will receive AG-236 Dose X, administered subcutaneously (SC), according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period.",[79,80],"Drug: AG-236","Drug: Placebo",{"label":82,"type":76,"description":83,"interventionNames":84},"Phase 2: AG-236 Dose Y","Subjects will receive AG-236 Dose Y, administered SC, according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period.",[79,80],{"label":86,"type":76,"description":87,"interventionNames":88},"Phase 2: AG-236 Dose Z","Subjects will receive AG-236 Dose Z, administered SC, according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period.",[79,80],{"label":90,"type":76,"description":91,"interventionNames":92},"Phase 2: AG-236 Dose ZZ","Subjects will receive AG-236 Dose ZZ, administered SC, according to the assigned dosing regimen in the double-blind period, and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period.",[79],{"label":94,"type":95,"description":96,"interventionNames":97},"Phase 2: Placebo","PLACEBO_COMPARATOR","Subjects will receive placebo administered SC, according to the assigned dosing regimen in the double-blind period and will be randomized to receive AG-236 Dose X, Y, or Z if they opt to participate in the extension period.",[80],{"label":99,"type":76,"description":100,"interventionNames":101},"Phase 3: AG-236","Subjects will receive AG-236, administered SC at the dose and dose regimen selected for Phase 3 for 26 weeks in the double-blind period. Subjects who complete the double-blind period of the study will be eligible to continue receiving AG-236 in the open-label extension period.",[79],{"label":103,"type":95,"description":104,"interventionNames":105},"Phase 3: Placebo","Subjects will receive placebo administered SC at the dose and dose regimen selected for Phase 3 for 26 weeks in the double-blind period. Subjects who complete the double-blind period of the study will be eligible to continue receiving AG-236 in the open-label extension period.",[80],[107,112],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":11},"DRUG","AG-236","SC Injection",[75,82,86,90,99],{"type":108,"name":113,"description":110,"armGroupLabels":114,"otherNames":11},"Placebo",[75,82,86,94,103],[116],{"name":117,"role":118,"phone":119,"phoneExt":11,"email":120},"Agios Medical Affairs","CONTACT","08332288474","medinfo@agios.com",{"type":122,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658953","phase-2-a-study-to-investigate-ag-236-in-subjects-18-years-of-age-with-polycythemia-vera-100658953",false,"NCT07859423","A Study to Investigate AG-236 in Subjects ≥18 Years of Age With Polycythemia Vera","A Phase 2\u002F3, Double-blind, Randomized, Placebo-Controlled, Multicenter, Efficacy, Safety, and Pharmacokinetics Study of AG-236 in Subjects With Polycythemia Vera","PreVail","Key Inclusion Criteria:\n\n* PV diagnosis according to 2022 World Health Organization (WHO) criteria.\n* Phlebotomy requirements:\n\n  * At least 3 documented phlebotomies in the 6 months before randomization or at least 5 documented phlebotomies in the 12 months before randomization; and\n  * At least 1 documented phlebotomy within the 3 months before randomization.\n  * No phlebotomy within 6 days before randomization (not including the day of phlebotomy and the day of randomization in the 6-day count).\n* Cytoreductive therapy is allowed at randomization, but the subject must be on a stable regimen for at least 2 months prior (or at least 6 months with interferons) with no planned change in cytoreductive dose.\n* Subjects on phlebotomy alone and no cytoreductive therapy at randomization must have stopped prior treatment at least 2 months prior (at least 6 months for interferons).\n\nKey Exclusion Criteria:\n\n* Use of any investigational or marketed N-acetylgalactosamine (GalNAc) targeting product less than 48 weeks before randomization or not recovered from effects of prior administration of any investigational or marketed GalNAc targeting product taken more than 48 weeks before randomization.\n* Currently receiving treatment with a hepcidin mimetic; the last dose must have been administered ≥6 months before randomization.\n* Currently receiving treatment with or history of any use of TMPRSS6 targeting molecules (antisense oligonucleotide \\[ASO\\], siRNA, antibodies) before randomization.\n* Clinically significant, active and\u002For uncontrolled hepatobiliary, renal, cardiac, or pulmonary disease.\n* Prior malignancy in the last 5 years, except for curatively treated basal cell carcinoma or non-melanoma skin tumors, curatively treated carcinoma in situ of the cervix or breast, or localized prostate cancer.\n* Clinically significant thrombosis within 2 months before randomization.\n* Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":134,"type":135},245,"ESTIMATED","INTERVENTIONAL",[138,139],"PHASE2","PHASE3","This clinical trial is a Phase 2\u002F3 study that will determine the recommended dose and dose regimen of AG-236 and evaluate the efficacy, safety, and pharmacokinetics of AG-236 in polycythemia vera (PV) by testing how well AG-236 works compared to placebo to increase the number of subjects with no phlebotomy and absence of phlebotomy eligibility over a 13-week period. In addition, the long-term effect of AG-236 on efficacy and safety will be explored in an open-label extension portion.",[142],"Polycythemia Vera","NOT_YET_RECRUITING","2026-10-09",{"date":146,"type":147},"2026-10-13","ACTUAL",{"date":149,"type":135},"2026-11",{"date":151,"type":135},"2032-08",{"name":5,"class":6}]