{"commentary":{"count":39,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":23,"podcast":13,"x_thread":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03952039\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"FREEDOM2","nct_id":"NCT03952039","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=freedom2-nct03952039. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"FREEDOM2","arms":[{"description":"Will include up to 128 subjects receiving fedratinib 400 mg self-administered Investigational Product (IP) on an outpatient basis, once daily preferably together with food during an evening meal at the same time each day in consecutive 4-week (28-day) cycles.","label":"Fedratinib 400mg/day","type":"EXPERIMENTAL"},{"description":"Best-available Investigator-selected therapy included a number of available compounds to treat MF and/or its symptoms and was chosen by the investigator for each subject. Therapy changed at different times during the treatment period. No investigational agents (e.g. not approved for the treatment of any indication) were allowed. BAT also included the choice of no treatment.","label":"Best Available Therapy (BAT)","type":"ACTIVE_COMPARATOR"}],"collaborators":["Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation"],"completion_date":{"date":"2025-07-28","type":"ACTUAL"},"conditions":["Primary Myelofibrosis","Post-Polycythemia Vera","Myelofibrosis"],"enrollment":{"count":202,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"FEDRATINIB","type":"DRUG"},{"name":"Best Available Therapy (BAT)","type":"DRUG"}],"last_update":"2025-08-28","lead_sponsor":"Celgene","official_title":"A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-12-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Spleen Volume Response Rate (RR)","timeFrame":"From Screening to end of Cycle 6 (1 cycle = 28 days), approximately 196 days"}],"references":[{"citation":"Harrison CN, Mesa R, Talpaz M, Al-Ali HK, Xicoy B, Passamonti F, Palandri F, Benevolo G, Vannucchi AM, Mediavilla C, Iurlo A, Kim I, Rose S, Brown P, Hernandez C, Wang J, Kiladjian JJ. Efficacy and safety of fedratinib in patients with myelofibrosis previously treated with ruxolitinib (FREEDOM2): results from a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Haematol. 2024 Oct;11(10):e729-e740. doi: 10.1016/S2352-3026(24)00212-6. Epub 2024 Sep 9.","pmid":"39265613","type":"DERIVED"}],"start_date":{"date":"2019-09-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib","url":"https://clinicaltrials.gov/study/NCT03952039"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/freedom2-nct03952039"}