[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"familial-adenomatous-polyposis-fap\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:familial-adenomatous-polyposis-fap":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,64,94,125,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":42,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100509886","phase-1-fog-001-in-locally-advanced-or-metastatic-solid-tumors-100509886",false,"NCT05919264","FOG-001 in Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and marrow function.\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs).\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic non-MSI-H or non-dMMR CRC.\n* At least one lesion that is suitable for a core needle biopsy.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):\n\n* Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):\n\n* Desmoid tumor (aggressive fibromatosis)\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n* One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab\n\n* Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.\n* MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1\u002FPD-L1\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine\u002FTipiracil + Bevacizumab\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n\nMonotherapy Dose Optimization (Part 1i): FAP\n\n* Diagnosis of phenotypic classical FAP with a documented APC mutation\n* Post-colectomy \\>6 months prior to first dose of study drug administration with measurable duodenal polyp burden\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2a):\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2b):\n\n* Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence\n\nExclusion Criteria:\n\n* Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC. For participants with FAP, osteomas are allowed.\n* Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.\n* Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.\n* Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)\n* Unstable\u002Finadequate cardiac function.\n* Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.\n* Pregnant, lactating, or planning to become pregnant.\n* Complete colectomy within 6 months of the first dose of study drug administration.","ALL","18 Years",{"count":19,"type":20},619,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Cancer","Colorectal Cancer","Solid Tumor","Locally Advanced Solid Tumor","Metastatic Cancer","WNT Pathway","HCC","Desmoid","Microsatellite Stable Colorectal Cancer","Metastatic Castration-resistant Prostate Cancer","Familial Adenomatous Polyposis (FAP)","Endometrial Carcinoma","Prostate Cancer","Microsatellite Instability-High Colorectal Cancer","Adamantinomatous Craniopharyngioma",[27,29,30,31,43,44,45,34,46,47,48,49,50],"WNT Pathway Activating Mutation (WPAM)","Colorectal Cancer (CRC)","Microsatellite Stable (MSS)","Hepatocellular Carcinoma (HCC)","Adenomatous Polyposis Coli (APC)","β-catenin","Beta-catenin","CTNNB1","RECRUITING","2026-08-13",{"date":54,"type":55},"2026-08-17","ACTUAL",{"date":57,"type":55},"2023-05-23",{"date":59,"type":20},"2027-08-31",{"name":61,"class":62},"Parabilis Medicines, Inc.","INDUSTRY",33,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100648936","phase-1-a-safety-study-of-st316-in-participants-with-familial-adenomatous-polyposis-fap-100648936","NCT07729371","A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP).","An Open-Label, Phase 1b Trial to Assess the Safety and Efficacy of ST316 in Participants With Familial Adenomatous Polyposis (FAP)","FAP","Inclusion Criteria:\n\n1. Male or female participants aged 18 years or older at the time of informed consent.\n2. Ability to understand and willingness to sign a written informed consent document, prior to undertaking any study-related procedures.\n3. Confirmed Familial Adenomatous Polyposis (FAP) by molecular genetic testing and at least six polyps of 5-9 mm. Patients with FAP that present thyroid nodule and\u002F or desmoid tumors are eligible.\n4. History of prophylactic colectomy with either ileo-rectal anastomosis (IRA) or ileal pouch-anal anastomosis (IPAA), performed at least 12 months prior to screening, and without ongoing surgical complications.\n5. Presence of rectal\u002Fpouch polyps at baseline; polyps must be \\\u003C10 mm in size. If polyps ≥10 mm are identified during the baseline colonoscopy, they must be endoscopically removed at the time of the baseline colonoscopy before first dose of ST316.\n6. Willingness to forgo concurrent use of supplements containing, turmeric, omega-3 fatty acids, oral corticosteroids, NSAIDs, or other FAP-directed drug therapy for the duration of the study. Low-dose aspirin (80-100 mg daily) for cardioprotective indications will be permitted.\n7. Adequate organ function as defined by ALL of the following laboratory criteria (obtained within 28 days prior to first dose):\n\n   Total bilirubin ≤1.5 × institutional ULN (unless Gilbert's syndrome). Alkaline phosphatase ≤1.5 × institutional ULN. AST (SGOT) ≤1.5 × institutional ULN. ALT (SGPT) ≤1.5 × institutional ULN. Serum creatinine ≤1.5 × institutional ULN.\n8. Women of childbearing potential (WOCBP) and male participants who are sexually active with WOCBP must agree to use highly effective contraception from screening throughout study duration and for at least 90 days after last dose.\n9. Not currently breastfeeding. Women must agree not to breastfeed from first dose through 90 days after last dose.\n\nExclusion Criteria:\n\n1. Use of any other investigational agent or participation in an interventional clinical trial within 12 weeks prior to first dose of ST316.\n2. Receipt of systemic oral corticosteroids within 30 days prior to first dose of ST316.\n3. Uncontrolled intercurrent illness or recent (within 4 weeks) major surgical procedure (excluding disease-related surgery, which should be \\>12 months from screening) that would limit compliance or pose undue risk to the participant.\n4. History of invasive malignancy within 3 years prior to screening (exceptions: carcinoma of the cervix in situ, carcinoma in situ of any site, or basal\u002Fsquamous cell carcinoma of the skin that has been completely excised).\n5. Concurrent use of anticoagulants with a risk of bleeding that may preclude study-related procedures (i.e., endoscopy and biopsies).\n6. Use of other NSAIDs (e.g., ibuprofen) exceeding 4 days per month, within 6 weeks prior to first dose of ST316.\n7. Regular use of aspirin at doses exceeding 700 mg per week.\n8. Treatment with other FAP-directed drug therapy (including sulindac, celecoxib, or fish oil) within 4 weeks prior to first dose of ST316.\n9. Any of the following findings on baseline biopsy obtained during screening colonoscopy:\n\n   1. Colorectal cancer on biopsy.\n   2. Duodenal cancer on biopsy.\n   3. High-grade dysplasia found on polyp biopsy where the polyp has not been completely removed.\n   4. A large polyp (\\>1 cm) not completely removed at baseline colonoscopy.\n10. QTcF \\>480 ms before first dose of ST316.\n11. Significant medical or psychiatric disorder that would preclude study participation or informed consent capacity.\n12. Known hypersensitivity to ST316 or any of its excipients.\n13. Currently pregnant, breastfeeding, or planning to conceive during the projected duration of the study (including 90 days post-last dose).",{"count":73,"type":20},40,[23],"This is a Phase 1b, open- label, dose-optimization study evaluating ST316 in adult participants with familial adenomatous polyposis (FAP) who have undergone colectomy and have recurrent polyps. This study uses a three-cohorts, sequential adaptive design to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ST316, as well as its preliminary efficacy in reducing polyp recurrence.",[37],[78,70,79,80,81,82,83],"Familial adenomatous polyposis","Polyp recurrence","Colorectal polyps","Colectomy","Hereditary colorectal cancer","Desmoid tumors","NOT_YET_RECRUITING","2026-08-10",{"date":87,"type":55},"2026-08-12",{"date":89,"type":20},"2027-01-04",{"date":91,"type":20},"2029-12-31",{"name":93,"class":62},"Sapience Therapeutics",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100648675","evaluation-of-the-ileo-anal-pouch-in-fap-endopol-100648675","NCT07726771","Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL)","ENDOPOL: Dye chromoENDOscopy Versus Virtual Chromoendoscopy for Assessment of the Ileo-anal Pouch in Patients With Familial Adenomatous POLyposis: a Randomized Controlled Trial","ENDOPOL","Inclusion Criteria:\n\nALL of the following:\n\n1. Diagnosis of FAP i.e., at least one of following:\n\n   * Genetic diagnosis: proven APC germline mutation OR\n   * Clinical diagnosis: \\>100 colorectal adenomas in combination with a positive family history of FAP\n2. Have an ileal-pouch anal anastomosis (IPAA), either after primary proctocolectomy or secondary proctectomy after initial colectomy and ileorectal or ileosigmoidal anastomosis (IRA\u002FISA)\n3. Age ≥ 18 years\n\nExclusion Criteria:\n\nANY of the following\n\n1. Diagnosis of FAP i.e., at least one of following:\n\n   * Genetic diagnosis: proven APC germline mutation OR\n   * Clinical diagnosis: \\>100 colorectal adenomas in combination with a positive family history of FAP\n2. Have an ileal-pouch anal anastomosis (IPAA), either after primary proctocolectomy or secondary proctectomy after initial colectomy and ileorectal or ileosigmoidal anastomosis (IRA\u002FISA)\n3. Age ≥ 18 years",{"count":103,"type":20},50,[105],"NA","This international, multi-centre randomised controlled trial will compare dye-based chromoendoscopy with virtual chromoendoscopy, using NBI\u002FBLI, for adenoma detection during routine surveillance pouchoscopy in adults with familial adenomatous polyposis (FAP) and an ileal pouch-anal anastomosis (IPAA). The estimated study duration is 2 years. Participants will undergo their usual scheduled pouchoscopy, performed by endoscopists experienced in FAP. Before the procedure, they will be randomised 1:1 to dye-based or virtual chromoendoscopy. Adenomas requiring endoscopic treatment will be removed during the same procedure according to standard practice.\n\nTo our knowledge, no previous study has directly compared these techniques in this setting. Current guidelines recommend surveillance in patients with FAP and a pouch and permit dye-spray chromoendoscopy, but do not specify whether dye-based or virtual chromoendoscopy should be preferred. Practice varies between centres: virtual chromoendoscopy is commonly used at St Mark's Hospital, while some European centres primarily use dye-based chromoendoscopy. This study therefore aims to standardise practice and generate evidence to inform future surveillance strategies.\n\nEligible patients will be adults aged ≥18 years with FAP, defined by a proven APC germline mutation or a clinical diagnosis of \\>100 colorectal adenomas with a positive family history, and who have undergone IPAA after primary proctocolectomy or secondary proctectomy following IRA\u002FISA. Patients will be identified through routine endoscopy booking systems. Those who have consented to email communication from the Polyposis Registry team will receive a Participant Information Sheet in advance. They will be approached again on the day of their procedure, given the opportunity to ask questions, and consented before randomisation. Patients who do not consent will undergo their planned pouchoscopy as normal, without study randomisation. Patients lacking capacity to consent will not be approached.\n\nRandomisation will be performed using an independent computer-generated programme within Castor EDC, with allocation in a 1:1 ratio. Block randomisation will ensure balanced distribution between arms within each centre, and stratification by centre will account for differences in patient characteristics and local practice. Blinding is not feasible because dye-based and virtual chromoendoscopy have visually distinct appearances.\n\nDuring pouchoscopy, the pre-pouch ileum, pouch body and rectal cuff will be carefully inspected. In the dye-based arm, indigo carmine will be applied using a spray catheter before withdrawal and mucosal inspection. In the virtual chromoendoscopy arm, inspection will be performed using NBI\u002FBLI according to local platform availability. The endoscope will be advanced to the pre-pouch ileum, followed by systematic withdrawal and spiral mucosal inspection. Lesions will be documented by size and location, including pouch body and rectal remnant\u002Frectal cuff, using a polyp burden scoring table. Retroflexion will be performed to assess the rectal cuff. Polyp size will be estimated in millimetres, supported where appropriate by biopsy forceps of known size. Adenomas will be resected using standard polypectomy techniques where indicated, including polyps \\>5 mm in the pouch body, \\>2 mm in the rectal cuff, or lesions suspicious for high-grade dysplasia or early cancer.\n\nBecause assessment of small polyps can vary between endoscopists, particularly for lesions \\\u003C5 mm, endoscopic images will be used to assess inter-rater and intra-rater reliability for polyp burden and size. If reliability is acceptable, smaller polyps will be included and reported.\n\nQuality parameters will be collected for each procedure, including adjusted Boston Bowel Preparation Scale assessment for the pouch and total procedural time. Procedural time will include scope introduction, irrigation, dye application where applicable, withdrawal and inspection, retroflexion, and removal and retrieval of polyps.\n\nPost-procedure follow-up will follow routine care. Patients will be asked to monitor for adverse events after pouchoscopy and contact the hospital if needed. Future surveillance will be scheduled according to each centre's usual policy.\n\nStudy data will be held in routine hospital systems accessible to the patient's usual clinical team and in a study file. Participants will be assigned a study number. No identifiable patient information will leave the Trust or be accessible to anyone outside the usual care team. Anonymised data will be entered into Castor EDC. Pseudonymised data will be transferred to the central study team at Amsterdam University Medical Center under an existing data transfer agreement for pooled analysis.\n\nThe study does not expose participants to risks beyond routine surveillance pouchoscopy. There is no direct individual benefit but findings may benefit future patients with FAP and families by improving evidence.",[37,108],"Pouches, Ileoanal",[70,110,111,112,113],"Endoscopy","Chromoendoscopy","Dye spray","Pouch","2026-07-21",{"date":116,"type":55},"2026-07-24",{"date":118,"type":55},"2026-07-09",{"date":120,"type":20},"2031-07-09",{"name":122,"class":123},"London North West Healthcare NHS Trust","OTHER",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":145,"locationsCount":4},"100646469","expanded-access-to-05-mg-erapa-for-familial-adenomatous-polyposis-100646469","NCT07689942","Expanded Access to 0.5 mg eRapa for Familial Adenomatous Polyposis","Expanded Access Program for 0.5 mg eRapa in Familial Adenomatous Polyposis","eRapa-FAP","Inclusion Criteria:\n\n1. Patient is post pubertal and reached full adult height\n2. Patient has FAP confirmed by APC genotype mutation tesing or a history of FAP in one of the parents. Genetic mosaics or Attenuated (as well as classical) FAP may participate\n3. Patient has significant colorectal and\u002For duodenal FAP disease burden.\n\nExclusion Criteria:\n\n1. Patient has existing carcinoma or high-grade dysplasia in the GI tract and\u002For requires imminent definitive surgical intervention (either partial or complete colectomy or duodenectomy).\n2. Patient with an acquired or congenital immunodeficiency, active and clinically significant tuberculosis, bacterial, fungal, or viral infections, including HIV.\n3. Patient has clinically significant elevations of hepatic enzymes or bilirubin, or other evidence of active hepatitis.\n4. Patient has clinically significant impairment of renal function.\n5. Patient has a history or evidence of clinically significant hyperlipoproteinemia or hypertriglyceridemia.\n6. Patient has active or recurrent bouts of pancreatitis, or clinically significant elevations of lipase or amylase.\n7. Patient is taking medications that are considered strong inducers or inhibitors of cytochrome P450 (CYP) 3A4\u002F5 or strong inducers or inhibitors of P-glycoprotein 1 (P-gp1) that cannot be discontinued at least 1 week prior to first dose of treatment intervention and for the duration of the treatment.\n8. Patients with known hypersensitivity to rapamycin (sirolimus) or any of the excipients in eRapa.\n9. Sexually active patients who are unwilling to use a highly effective contraceptive method and to refrain from donating gametes (sperm or oocytes) throughout the time they are receiving eRAPA and for 12 weeks beyond that time, and to refrain from breast-feeding their children while on treatment.\n10. Patients who are pregnant or who are trying to become pregnant while taking eRapa.\n11. Patients unwilling or unable to undergo continued endoscopic surveillance in accordance with standards of care while taking eRapa.\n12. Patient has Mutations in the MUTYH gene.","EXPANDED_ACCESS","This expanded access program provides 0.5 mg eRapa (encapsulated rapamycin) to patients with familial adenomatous polyposis (FAP) who have no satisfactory alternative treatment options and are not eligible to participate in a clinical trial. The objective is to provide access to eRapa based on the treating physician's assessment that the potential benefits outweigh the potential risks, with appropriate clinical monitoring for safety and tolerability.",[37],[137,70,138,139,140],"rapamycin","eRapa","Expanded Access","Compassionate Use","AVAILABLE","2026-06-30",{"date":144,"type":55},"2026-07-08",{"name":146,"class":62},"Biodexa Pharmaceuticals",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100589128","phase-3-phase-3-trial-of-erapa-in-patients-with-familial-adenomatous-polyposis-100589128","NCT06950385","Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis","A Phase 3, Multi-Site, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of eRapa to Improve Clinical Outcomes in Patients With Familial Adenomatous Polyposis","SERENTA","Inclusion Criteria:\n\n1. Participant must be ≥18 years of age inclusive.\n2. Participant must have documented FAP, confirmed by adenomatous polyposis coli genotype mutation testing.\n3. Participant must have at least 1 of the following high-risk features: \\>100 polyps but ≤500 polyps in the colon, or ≥10 polyps in the retained rectum\u002Fsigmoid or ileal pouch (≥3 mm in size), or Spigelman stage 3 or 4 with at least 1 polyp ≥10 mm to be removed at baseline or on endoscopy performed within 18 months of screening.\n4. Contraceptive use by participants or participant partners until at at least 12 weeks after stopping study treatment.\n5. Agree not to donate gametes for the purpose of reproduction until at at least 12 weeks after stopping study treatment.\n6. Willing to undergo endoscopic evaluation.\n\nExclusion Criteria:\n\n1. Participant has unresected or incompletely resected high-grade dysplasia or cancer within the duodenum, colon, rectum, or ileal pouch at screening endoscopy.\n2. Participant has any polyps ≥8 mm in the duodenum, colon, rectum, or ileal pouch remaining after screening endoscopy (polyps ≥8 mm are to be resected during screening endoscopy).\n3. Participant has had surgery within 6 weeks of the trial.\n4. Participant has active malignancy or history of malignancy diagnosed within 24 months of first dose of trial intervention.\n5. Participant has a history of, or currently has, an acquired or primary (congenital) immunodeficiency.\n6. Participant has active and clinically significant tuberculosis (positive Quantiferon Gold test), bacterial, fungal, or viral infection, including human immunodeficiency virus (HIV).\n7. Participant has any medical or social condition that, in the opinion of the Investigator, might increase participant risk if enrolled, prevent participant compliance to trial procedures, or present an unacceptable confound to safety or clinical trial data.",{"count":156,"type":20},168,[158],"PHASE3","The main goal of this clinical trial is to learn if the drug eRapa works to slow down the progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP). Researchers will compare eRapa to Placebo. The questions to be answered by this trial are:\n\n* Does taking eRapa help to slow down the progression of the disease in patients with FAP?\n* Is eRapa a safe treatment for patients diagnosed with FAP?\n* What is the effect of eRapa on the number of polyps found in GI tract of patients diagnosed with FAP?\n* How does treatment with eRapa affect a patient's quality of life?\n\nParticipants will:\n\n* Take eRapa or placebo once per day every other week until disease progresses (gets worse), stops taking part in the trial or dies.\n* Visit the clinic once every 3 months for check ups and tests.\n* Have an endoscopy at the start of the trial and then every 6 months to check on whether the disease is getting better or worse.",[37],[70,162,163,164],"Polyposis","Polyps","ileal pouch","2026-06-01",{"date":167,"type":55},"2026-06-02",{"date":169,"type":55},"2025-07-18",{"date":171,"type":20},"2031-01",{"name":173,"class":62},"Rapamycin Holdings Inc.",29]