[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epp2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epp2":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100655993","phase-2-a-study-to-investigate-port-77-oral-dosing-compared-with-placebo-in-participants-with-erythropoietic-protoporphyria-epp-or-x-linked-protoporphyria-xlp-100655993",false,"NCT07820085","A Study to Investigate PORT-77 Oral Dosing Compared With Placebo in Participants With Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP)","A Phase 2b\u002F3, Quadruple-Blinded, Randomized, Placebo-Controlled Study of PORT-77 Administered Orally to Adults and Adolescents With Erythropoietic Protoporphyria or X-Linked Protoporphyria and an Open-Label Extension","PATHWAY","Inclusion Criteria:\n\n* Aged 12 years or older.\n* Clinical history of EPP, XLP, or EPP2 supported by genetic confirmation or historical laboratory test results\n* History of consistent, non-painful prodrome within approximately 45 minutes of sunlight exposure and prior to phototoxic attacks\n* Demonstrates ≥85% compliance with daily symptom diary during run-in period.\n* Body weight or BMI at Screening as follows:\n\n  1. For participants aged 12 to \\\u003C18 years: body weight ≥32 kg\n  2. For participants aged ≥18 years: BMI ≥18.5 kg\u002Fm2\n* AST and ALT \\\u003C3 × ULN and total bilirubin \\\u003C2 × ULN (unless documented Gilbert syndrome) at Screening\n* Willing and able to provide informed consent and\u002For assent for the study.\n* Willing and able to comply with study visits, study procedures, and contraception guidance\n* Intends to remain in the same approximate geographic latitude for the duration of the placebo-controlled period, with no more than 14 days spent outside this region.\n\nExclusion Criteria:\n\n* Diagnosis of another porphyria or another photodermatosis that may confound the evaluation of PORT-77\n* Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory assessments\n* Major surgery within 8 weeks before Screening, incomplete recovery from any previous surgery, or major surgery planned to occur during the study\n* History of, or anticipated need for, liver transplantation or history of bone marrow transplantation\n* Active infection with hepatitis B or C\n* Unable to swallow tablets or has a disease that significantly affects gastrointestinal function\n* Any other disease, condition, or circumstance that, at the discretion of the Investigator or Sponsor, would interfere with the evaluation of PORT-77 or study participation, or would make study participation not in the best interest of the participant\n* History of drug or alcohol abuse within the last 12 months, or current or planned use of prohibited or illegal substances\n* Has taken any medication, vitamin, or supplement that alters sensitivity to light exposure (eg, afamelanotide, melanotan, beta carotene, dersimelagon) within 90 days of Day 1; or has taken bitopertin within 120 days of Day 1; or has taken iron within 30 days of Day 1\n* Drugs or supplements that may impact or be impacted by PORT-77\n* Concurrent or anticipated participation in an interventional clinical trial during the study period.\n* Received another investigational therapy within 5 half-lives, if the half-life is known, or within 30 days, if the half-life is unknown, prior to Day 1.\n* Known hypersensitivity to PORT-77 or excipients\n* Female who has a positive pregnancy test at Screening or Day 1 or is breastfeeding","ALL","12 Years",{"count":20,"type":21},225,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","PATHWAY is a Phase 2b\u002F3 clinical study with an Open-Label Extension (OLE). It tests PORT-77 in patients with EPP, EPP2, and XLP.\n\nThe study has three parts:\n\nPart 1: Phase 2b\n\n* Find the right dose of PORT-77 to lower PPIX levels in the blood\n* Test if PORT-77 lowers PPIX levels better than placebo\n* Check the safety of each dose\n\nPart 2: Phase 3\n\n* Test if PORT-77 lowers PPIX levels better than placebo\n* Test if PORT-77 increases the amount of time patients spend in sunlight each day without pain compared to placebo\n* Check the safety of PORT-77\n\nPart 3: Open-Label Extension (OLE)\n\n* Test the long-term effect of PORT-77 on PPIX levels and time in sun\n* Monitor long-term safety",[28,29,30],"Erythropoietic Protoporphyria (EPP)","X-Linked Protoporphyria (XLP)","EPP2",[32,33,34,35,36,30],"PORT-77","EPP","X-linked protoporphyria","Erythropoietic Protoporphyria","XLP","RECRUITING","2026-09-10",{"date":40,"type":41},"2026-09-15","ACTUAL",{"date":43,"type":21},"2026-09",{"date":45,"type":21},"2029-09",{"name":47,"class":48},"Portal Therapeutics, Inc.","INDUSTRY",2]