[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06985147":3,"trial-entities:NCT06985147":212,"trial-summary:NCT06985147":216},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":52,"sex":81,"minimum_age":82,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":83,"std_ages":87,"locations":90,"central_contacts":204,"overall_officials":205,"references":210,"see_also_links":211},"NCT06985147","DISC-3405-201","A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)","A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DISC-3405 in Participants With Polycythemia Vera (PV)","ACTIVE_NOT_RECRUITING","2029-02","2025-09","2026-07-31","2025-08-12","Disc Medicine, Inc","INDUSTRY",false,"This open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV).",null,[19],"Polycythemia Vera (PV)",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},60,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","DISC-3405","DISC-3405 is administered subcutaneously.",[34],"Within-participant dose escalation",[36,40,43,46,49],{"measure":37,"description":38,"timeFrame":39},"Number of participants with treatment-related adverse events as assessed by CTCAE","Proportion of participants with treatment-emergent adverse events","Up to 365 days",{"measure":41,"description":42,"timeFrame":39},"Incidence of clinically abnormal vital signs","Proportion of participants with changes in vital signs",{"measure":44,"description":45,"timeFrame":39},"Incidence of clinically abnormal physical exam","Proportion of participants with changes in physical examinations",{"measure":47,"description":48,"timeFrame":39},"Incidence of clinically abnormal electrocardiograms","Proportion of participants with changes in electrocardiograms (ECGs)",{"measure":50,"description":51,"timeFrame":39},"Incidence of abnormal laboratory test results","Proportion of participants with changes in clinical laboratory results",[53,55,57,59,61,63,65,67,69,71,73,75,77,79],{"measure":54,"timeFrame":39},"Proportion of participants achieving therapeutic response, defined as absence of phlebotomy eligibility, during the maintenance period",{"measure":56,"timeFrame":39},"Number of phlebotomies during the maintenance and optimization periods",{"measure":58,"timeFrame":39},"Proportion of participants achieving therapeutic response, defined as absence of phlebotomy eligibility, during the optimization period",{"measure":60,"timeFrame":39},"Proportion of participants with HCT values \u003C45% throughout the study",{"measure":62,"timeFrame":39},"Area under the plasma concentration versus time curve (AUC) following the first dose",{"measure":64,"timeFrame":39},"Peak plasma concentration (Cmax) following the first dose",{"measure":66,"timeFrame":39},"Elimination half-life (t½el) following the first dose",{"measure":68,"timeFrame":39},"Apparent clearance (CL\u002FF) following the first dose",{"measure":70,"timeFrame":39},"Maximum concentration at steady state (Cmax_ss) after repeating doses",{"measure":72,"timeFrame":39},"Pre-dose trough concentration (Ctrough) after repeating doses",{"measure":74,"timeFrame":39},"Change from baseline for HCT",{"measure":76,"timeFrame":39},"Change from baseline for serum hepcidin-25",{"measure":78,"timeFrame":39},"Change from baseline for serum iron",{"measure":80,"timeFrame":39},"Apparent volume of distribution (Vd\u002FF)","ALL","18 Years",{"inclusion":84,"exclusion":85,"raw_text":86},[],[],"Inclusion Criteria:\n\n1. Aged 18 years or older at the time of signing the informed consent form (ICF).\n2. Meet revised 2022 World Health Organization (WHO) criteria for the diagnosis of PV.\n3. Complete blood count values at Screening of HCT \\\u003C45% or HCT \\\u003C48% if followed by a phlebotomy within 2 weeks, white blood cells 4000\u002FμL to 20,000\u002FμL (inclusive), and platelets 100,000\u002FμL to 1,000,000\u002FμL (inclusive).\n4. At least 3 phlebotomies in 26 weeks before Screening or at least 5 phlebotomies in 52 weeks before Screening. At least 1 phlebotomy must be within the 12 weeks prior to Screening.\n5. Participants receiving cytoreductive therapy must have been taking for at least 6 months and be on a stable PV therapy regimen for at least 2 months for hydroxyurea, interferon or ruxolitinib with no anticipated need for dose adjustments during the study, or have decreasing dose (with medical monitor approval).\n6. Participants treated with phlebotomy alone must have stopped cytoreductive therapy 6 months before Screening.\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or with medical monitor approval, ECOG 2.\n8. If male with female sexual partner(s) of childbearing potential, agrees to use one of the following acceptable methods of contraception during the study and for at least 120 days after the last study drug dose:\n\n   1. Stable hormonal contraceptive (≥3 months; female partner) in conjunction with a barrier method (eg, condom or diaphragm \\[female partner\\])\n   2. Intrauterine device in place for at least 3 months (female partner)\n   3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner) in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm)\n   4. Confirmed successful vasectomy in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm)\n9. If female, then EITHER postmenopausal, defined as at least 12 months of natural, spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone \\>40 mIU\u002FmL at Screening, or at least 6 weeks following surgical menopause (bilateral oophorectomy with or without hysterectomy); surgically sterile, OR agreeable to use of highly effective contraception (listed below) on Day 1 (or earlier) and for at least 120 days after the last dose of study drug:\n\n   1. Stable hormonal contraceptive (≥3 months) in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm)\n   2. Intrauterine device in place for at least 3 months\n   3. Tubal ligation or single male partner with vasectomy in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm)\n10. Negative pregnancy test (females of childbearing potential).\n11. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n12. Able to comply with all study procedures.\n\nExclusion Criteria:\n\n1. Clinically significant laboratory abnormalities at Screening.\n2. Participants who require phlebotomy at HCT levels \\\u003C45%.\n3. Clinically significant thrombosis (eg, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to study treatment.\n4. Clinically significant active or chronic bleeding, considered meaningful in consultation with the medical monitor, within 6 months prior to study treatment.\n5. Significant renal dysfunction, evidenced by estimated glomerular filtration rate of \\\u003C30 mL\u002Fmin\u002F1.73 m2 at the Screening visit, as assessed locally.\n6. History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer, or other malignancies deemed acceptable by the Sponsor.\n7. Participants with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during Screening unless the cancer is adequately treated before study entry.\n8. Received busulfan, pipobroman, or phosphorus-32 within 7 months prior to Screening.\n9. Major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery.\n10. A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug.\n11. History of alcohol dependence or excessive alcohol consumption, as assessed by the Investigator.\n12. Active human immunodeficiency virus (HIV), hepatitis B or C. A positive hepatitis or HIV result should be discussed between the Investigator and Sponsor prior to enrollment.\n13. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study.\n14. Condition or concomitant medication that would confound the ability to interpret clinical data, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months.\n15. If female, pregnant or breastfeeding.\n16. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days (or 5 half-lives for drugs, whichever is longer) of Screening. Previous use of other hepcidin inducing agents that may impact TMPRSS6 expression are not allowed. Previous use of hepcidin mimetics may be allowed in discussion with the Sponsor.",[88,89],"ADULT","OLDER_ADULT",[91,100,108,112,119,127,135,143,151,158,165,173,180,188,196],{"facility":92,"city":93,"state":94,"zip":95,"country":96,"geoPoint":97},"Mayo Clinic in Arizona","Phoenix","Arizona","85054","United States",{"lat":98,"lon":99},33.44838,-112.07404,{"facility":101,"city":102,"state":103,"zip":104,"country":96,"geoPoint":105},"USC Norris Comprehensive Cancer Center","Los Angeles","California","90033",{"lat":106,"lon":107},34.05223,-118.24368,{"facility":109,"city":102,"state":103,"zip":110,"country":96,"geoPoint":111},"UCLA Health","90095",{"lat":106,"lon":107},{"facility":113,"city":114,"state":103,"zip":115,"country":96,"geoPoint":116},"Keck Medicine of USC - Cancer Clinic- Newport Beach","Newport Beach","92663",{"lat":117,"lon":118},33.61891,-117.92895,{"facility":120,"city":121,"state":122,"zip":123,"country":96,"geoPoint":124},"Mayo Clinic in Florida","Jacksonville","Florida","32224",{"lat":125,"lon":126},30.33218,-81.65565,{"facility":128,"city":129,"state":130,"zip":131,"country":96,"geoPoint":132},"Mayo Clinic in Minnesota","Rochester","Minnesota","55905",{"lat":133,"lon":134},44.02163,-92.4699,{"facility":136,"city":137,"state":138,"zip":139,"country":96,"geoPoint":140},"Siteman Cancer Center - Washington University St. Louis","St Louis","Missouri","63110",{"lat":141,"lon":142},38.62727,-90.19789,{"facility":144,"city":145,"state":146,"zip":147,"country":96,"geoPoint":148},"Atrium Health - Levine Cancer Center","Charlotte","North Carolina","28204",{"lat":149,"lon":150},35.22709,-80.84313,{"facility":152,"city":153,"state":146,"zip":154,"country":96,"geoPoint":155},"Duke University","Durham","27705",{"lat":156,"lon":157},35.99403,-78.89862,{"facility":159,"city":160,"state":146,"zip":161,"country":96,"geoPoint":162},"Atrium Health Wake Forest Baptist Medical Center","Winston-Salem","27157",{"lat":163,"lon":164},36.09986,-80.24422,{"facility":166,"city":167,"state":168,"zip":169,"country":96,"geoPoint":170},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":171,"lon":172},41.4995,-81.69541,{"facility":174,"city":175,"state":168,"zip":176,"country":96,"geoPoint":177},"Ohio State University","Columbus","43210",{"lat":178,"lon":179},39.96118,-82.99879,{"facility":181,"city":182,"state":183,"zip":184,"country":96,"geoPoint":185},"Oregon Health & Science University","Portland","Oregon","97239",{"lat":186,"lon":187},45.52345,-122.67621,{"facility":189,"city":190,"state":191,"zip":192,"country":96,"geoPoint":193},"MD Anderson Cancer Center","Houston","Texas","77030",{"lat":194,"lon":195},29.76328,-95.36327,{"facility":197,"city":198,"state":199,"zip":200,"country":96,"geoPoint":201},"University of Washington - Fred Hutchinson Cancer Research Center","Seattle","Washington","98109",{"lat":202,"lon":203},47.60621,-122.33207,[],[206],{"name":207,"affiliation":208,"role":209},"Will Savage, MD PhD","Disc Medicine","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":213,"biomarkers":215},[214],"Polycythemia Vera",[],{"nct_id":4,"found":217,"summary":218,"prompt_version":228},true,{"design":219,"status":220,"heading":221,"summary":222,"follow_up":223,"word_count":224,"commitments":225,"compensation":226,"drugs_mentioned":227},"This is an open-label study, meaning both you and the study team will know you are receiving DISC-3405. It will involve about 60 participants and will test up to two different dose levels of the drug.","completed","Phase 2 Study of DISC-3405 for Polycythemia Vera (PV)","This study is testing a new drug called DISC-3405 for people with Polycythemia Vera (PV), a blood disorder where your body makes too many red blood cells. DISC-3405 is given as a shot under the skin. Researchers want to see how safe DISC-3405 is, if it causes any side effects, and how well it works. To join, you must be 18 or older and meet specific blood count requirements, including having a hematocrit (HCT) below 45% (or 48% if you've had a recent blood draw). The study will look at side effects and changes in your vital signs and physical exam for up to 365 days. The current recruitment status is unclear.","Your safety will be monitored for up to 365 days after starting the treatment.",112,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]