[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06636656":3,"trial-entities:NCT06636656":473,"trial-summary:NCT06636656":476},{"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":37,"secondary_outcomes":42,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":80,"locations":83,"central_contacts":463,"overall_officials":467,"references":468,"see_also_links":469},"NCT06636656","1486-0006","A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis","Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis","RECRUITING","2029-07-30","2026-08","2026-08-21","2024-12-11","Boehringer Ingelheim","INDUSTRY",false,"Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis.\n\nThis study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years.\n\nParticipants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body.\n\nThe doctors also regularly check participants' health and take note of any unwanted effects.",null,[19],"Ulcerative Colitis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},80,"ESTIMATED",[29,34],{"type":30,"name":31,"description":31,"armGroupLabels":32},"DRUG","BI 3032950 intravenous (Part A)",[33],"All participants",{"type":30,"name":35,"description":35,"armGroupLabels":36},"BI 3032950 subcutaneous (Part B)",[33],[38],{"measure":39,"description":40,"timeFrame":41},"Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1","The modified Mayo score (mMS) consists of 3 components\n\n1. Stool frequency subscore (SFS)\n2. Rectal bleeding subscore (RBS)\n3. Endoscopy subscore (ESS) Each component is graded from 0 = none to 3 = severe. The overall range of the mMS is from 0 to 9 with a higher score indicating a worsening of the symptoms.","Up to Week 12",[43,46,48,50,52,55,58],{"measure":44,"description":45,"timeFrame":41},"Endoscopic remission (defined as centrally-read ESS of 0)","The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.",{"measure":47,"description":40,"timeFrame":41},"Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1)",{"measure":49,"description":45,"timeFrame":41},"Endoscopic improvement (defined as centrally-read ESS of 0 or 1)",{"measure":51,"description":40,"timeFrame":41},"Modified Mayo Score change from baseline",{"measure":53,"description":54,"timeFrame":41},"Stool frequency subscore of 0 or 1","The stool frequency (SFS) is graded from 0 = none to 3 = severe. The SFS is part of the modified Mayo score.",{"measure":56,"description":57,"timeFrame":41},"Rectal bleeding subscore of 0","The rectal bleeding subscore (RBS) is graded from 0 = none to 3 = severe. The RBS is part of the modified Mayo score.",{"measure":59,"timeFrame":60},"Occurrence of treatment-emergent adverse events (AEs)","Up to Week 12 and up to Week 104","ALL","18 Years","80 Years",{"inclusion":65,"exclusion":70,"raw_text":79},[66,67,68,69],"Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,","Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,","Inadequate response, loss of response, or intolerance to treatment with biologic\u002Ftargeted therapy or termination of treatment with biologic\u002Ftargeted therapy for any other reason,","Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,",[71,72,73,74,75,76,77,78],"Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),","Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),","Evidence of colonic moderate\u002Fsevere mucosal dysplasia or colonic adenomas, unless properly removed,","Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,","Evidence of fulminant colitis or toxic megacolon at screening,","Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,","Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),","Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,","Inclusion criteria\n\n* Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,\n* Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,\n* Inadequate response, loss of response, or intolerance to treatment with biologic\u002Ftargeted therapy or termination of treatment with biologic\u002Ftargeted therapy for any other reason,\n* Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,\n* Further inclusion criteria apply.\n\nExclusion criteria\n\n* Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),\n* Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),\n* Evidence of colonic moderate\u002Fsevere mucosal dysplasia or colonic adenomas, unless properly removed,\n* Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,\n* Evidence of fulminant colitis or toxic megacolon at screening,\n* Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,\n* Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),\n* Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,\n* Further exclusion criteria apply.",[81,82],"ADULT","OLDER_ADULT",[84,99,109,119,128,137,143,153,163,172,182,192,201,211,220,232,241,253,262,274,283,292,301,307,316,325,334,343,352,358,367,373,382,391,403,409,415,424,436,445,454],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":96},"One of a Kind Clinical Research 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Rch","34211",[124],{"name":13,"role":93,"phone":94,"email":95},{"lat":126,"lon":127},27.3863,-82.4332,{"facility":129,"status":8,"city":130,"state":112,"zip":131,"country":90,"contacts":132,"geoPoint":134},"University of Miami","Miami","33136",[133],{"name":13,"role":93,"phone":94,"email":95},{"lat":135,"lon":136},25.77427,-80.19366,{"facility":138,"status":8,"city":130,"state":112,"zip":139,"country":90,"contacts":140,"geoPoint":142},"Reliant Medical Research","33165-3639",[141],{"name":13,"role":93,"phone":94,"email":95},{"lat":135,"lon":136},{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":90,"contacts":148,"geoPoint":150},"Illinois Gastroenterology Group - Gurnee","Gurnee","Illinois","60031",[149],{"name":13,"role":93,"phone":94,"email":95},{"lat":151,"lon":152},42.3703,-87.90202,{"facility":154,"status":8,"city":155,"state":156,"zip":157,"country":90,"contacts":158,"geoPoint":160},"University of Kansas Medical Center","Kansas City","Kansas","66103-2937",[159],{"name":13,"role":93,"phone":94,"email":95},{"lat":161,"lon":162},39.11417,-94.62746,{"facility":164,"status":86,"city":165,"state":165,"zip":166,"country":90,"contacts":167,"geoPoint":169},"Columbia University Medical Center","New York","10032-3725",[168],{"name":13,"role":93,"phone":94,"email":95},{"lat":170,"lon":171},40.71427,-74.00597,{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":90,"contacts":177,"geoPoint":179},"Atrium Health Gastroenterology and Hepatology","Charlotte","North Carolina","28204-2963",[178],{"name":13,"role":93,"phone":94,"email":95},{"lat":180,"lon":181},35.22709,-80.84313,{"facility":183,"status":8,"city":184,"state":185,"zip":186,"country":90,"contacts":187,"geoPoint":189},"Texas Digestive Disease Consultants","Cedar Park","Texas","78613",[188],{"name":13,"role":93,"phone":94,"email":95},{"lat":190,"lon":191},30.5052,-97.82029,{"facility":193,"status":8,"city":194,"state":185,"zip":195,"country":90,"contacts":196,"geoPoint":198},"Baylor College of Medicine","Houston","77030",[197],{"name":13,"role":93,"phone":94,"email":95},{"lat":199,"lon":200},29.76328,-95.36327,{"facility":202,"status":86,"city":203,"state":204,"zip":205,"country":90,"contacts":206,"geoPoint":208},"University of Washington","Seattle","Washington","98195-0001",[207],{"name":13,"role":93,"phone":94,"email":95},{"lat":209,"lon":210},47.60621,-122.33207,{"facility":212,"status":8,"city":213,"state":204,"zip":214,"country":90,"contacts":215,"geoPoint":217},"Digestive Health Specialists","Tacoma","98405-2318",[216],{"name":13,"role":93,"phone":94,"email":95},{"lat":218,"lon":219},47.25288,-122.44429,{"facility":221,"status":8,"city":222,"zip":223,"country":224,"contacts":225,"geoPoint":229},"UZ Leuven","Leuven","3000","Belgium",[226],{"name":13,"role":93,"phone":227,"email":228},"080049616","belgique@bitrialsupport.com",{"lat":230,"lon":231},50.87959,4.70093,{"facility":233,"status":8,"city":234,"zip":235,"country":224,"contacts":236,"geoPoint":238},"CHC MontLegia","Liège","4000",[237],{"name":13,"role":93,"phone":227,"email":228},{"lat":239,"lon":240},50.63373,5.56749,{"facility":242,"status":86,"city":243,"zip":244,"country":245,"contacts":246,"geoPoint":250},"Hepato-Gastroenterologie HK, s.r.o.","Hradec Králové","500 12","Czechia",[247],{"name":13,"role":93,"phone":248,"email":249},"800142046","cesko@bitrialsupport.com",{"lat":251,"lon":252},50.20923,15.83277,{"facility":254,"status":8,"city":255,"zip":256,"country":245,"contacts":257,"geoPoint":259},"ISCARE a.s.","Prague","190 00",[258],{"name":13,"role":93,"phone":248,"email":249},{"lat":260,"lon":261},50.08804,14.42076,{"facility":263,"status":8,"city":264,"zip":265,"country":266,"contacts":267,"geoPoint":271},"Centrum Medyczne Plejady","Krakow","30-363","Poland",[268],{"name":13,"role":93,"phone":269,"email":270},"008001218830","polska@bitrialsupport.com",{"lat":272,"lon":273},50.06143,19.93658,{"facility":275,"status":8,"city":276,"zip":277,"country":266,"contacts":278,"geoPoint":280},"Medrise Sp. z o.o.","Lublin","20-582",[279],{"name":13,"role":93,"phone":269,"email":270},{"lat":281,"lon":282},51.25058,22.57009,{"facility":284,"status":8,"city":285,"zip":286,"country":266,"contacts":287,"geoPoint":289},"Eskulap Pabianice Sp. z o.o.","Pabianice","95-200",[288],{"name":13,"role":93,"phone":269,"email":270},{"lat":290,"lon":291},51.66446,19.35473,{"facility":293,"status":8,"city":294,"zip":295,"country":266,"contacts":296,"geoPoint":298},"EMC Instytut Medyczny S.A. - Poznan 70-304","Poznan","60-309",[297],{"name":13,"role":93,"phone":269,"email":270},{"lat":299,"lon":300},52.40692,16.92993,{"facility":302,"status":8,"city":294,"zip":303,"country":266,"contacts":304,"geoPoint":306},"Clinical Research Center Sp. z o.o. Medic-R sp.k.","61-731",[305],{"name":13,"role":93,"phone":269,"email":270},{"lat":299,"lon":300},{"facility":308,"status":8,"city":309,"zip":310,"country":266,"contacts":311,"geoPoint":313},"Centrum Medyczne Medyk Sp. z o.o.","Rzeszów","35-326",[312],{"name":13,"role":93,"phone":269,"email":270},{"lat":314,"lon":315},50.04132,21.99901,{"facility":317,"status":8,"city":318,"zip":319,"country":266,"contacts":320,"geoPoint":322},"Endoskopia Sp. z o.o.","Sopot","81-756",[321],{"name":13,"role":93,"phone":269,"email":270},{"lat":323,"lon":324},54.4418,18.56003,{"facility":326,"status":8,"city":327,"zip":328,"country":266,"contacts":329,"geoPoint":331},"Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.","Szczecin","71-434",[330],{"name":13,"role":93,"phone":269,"email":270},{"lat":332,"lon":333},53.42894,14.55302,{"facility":335,"status":8,"city":336,"zip":337,"country":266,"contacts":338,"geoPoint":340},"Gastromed Sp. z o.o.","Torun","87-100",[339],{"name":13,"role":93,"phone":269,"email":270},{"lat":341,"lon":342},53.01375,18.59814,{"facility":344,"status":8,"city":345,"zip":346,"country":266,"contacts":347,"geoPoint":349},"Synexus Polska Sp. z o.o.","Warsaw","02-672",[348],{"name":13,"role":93,"phone":269,"email":270},{"lat":350,"lon":351},52.22977,21.01178,{"facility":353,"status":8,"city":345,"zip":354,"country":266,"contacts":355,"geoPoint":357},"NZOZ VIVAMED Jadwiga Miecz","03-580",[356],{"name":13,"role":93,"phone":269,"email":270},{"lat":350,"lon":351},{"facility":359,"status":8,"city":360,"zip":361,"country":266,"contacts":362,"geoPoint":364},"PlanetMed Sp. z o.o.","Wroclaw","52-210",[363],{"name":13,"role":93,"phone":269,"email":270},{"lat":365,"lon":366},51.10286,17.03006,{"facility":368,"status":8,"city":360,"zip":369,"country":266,"contacts":370,"geoPoint":372},"EMC Instytut Medyczny S.A. - Wroclaw","54-239",[371],{"name":13,"role":93,"phone":269,"email":270},{"lat":365,"lon":366},{"facility":374,"status":8,"city":375,"zip":376,"country":266,"contacts":377,"geoPoint":379},"Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.","Włocławek","87-800",[378],{"name":13,"role":93,"phone":269,"email":270},{"lat":380,"lon":381},52.64817,19.0678,{"facility":383,"status":8,"city":384,"zip":385,"country":266,"contacts":386,"geoPoint":388},"Pro Life Medica Sp. z o.o.","Zamość","22-400",[387],{"name":13,"role":93,"phone":269,"email":270},{"lat":389,"lon":390},50.72314,23.25196,{"facility":392,"status":8,"city":393,"zip":394,"country":395,"contacts":396,"geoPoint":400},"Clinical Hospital Center Zvezdara","Belgrade","11000","Serbia",[397],{"name":13,"role":93,"phone":398,"email":399},"0800800636","srbija@bitrialsupport.com",{"lat":401,"lon":402},44.80401,20.46513,{"facility":404,"status":86,"city":393,"zip":405,"country":395,"contacts":406,"geoPoint":408},"Military Medical Academy","11040",[407],{"name":13,"role":93,"phone":398,"email":399},{"lat":401,"lon":402},{"facility":410,"status":86,"city":393,"zip":411,"country":395,"contacts":412,"geoPoint":414},"Clinical Center Zemun","11080",[413],{"name":13,"role":93,"phone":398,"email":399},{"lat":401,"lon":402},{"facility":416,"status":8,"city":417,"zip":418,"country":395,"contacts":419,"geoPoint":421},"General Hospital - Djordje Joanovic","Zrenjanin","23101",[420],{"name":13,"role":93,"phone":398,"email":399},{"lat":422,"lon":423},45.38361,20.38194,{"facility":425,"status":8,"city":426,"zip":427,"country":428,"contacts":429,"geoPoint":433},"F D Roosevelt University General Hospital Of Banska Bystrica","Banská Bystrica","975 17","Slovakia",[430],{"name":13,"role":93,"phone":431,"email":432},"0800002662","slovensko@bitrialsupport.com",{"lat":434,"lon":435},48.73947,19.14932,{"facility":437,"status":8,"city":438,"zip":439,"country":428,"contacts":440,"geoPoint":442},"ENDOMED s.r.o.","Košice","040 13",[441],{"name":13,"role":93,"phone":431,"email":432},{"lat":443,"lon":444},48.71441,21.25802,{"facility":446,"status":8,"city":447,"zip":448,"country":428,"contacts":449,"geoPoint":451},"KM Management, spol. s.r.o.","Nitra","949 01",[450],{"name":13,"role":93,"phone":431,"email":432},{"lat":452,"lon":453},48.30763,18.08453,{"facility":455,"status":8,"city":456,"zip":457,"country":428,"contacts":458,"geoPoint":460},"Gastro I., s.r.o","Prešov","080 01",[459],{"name":13,"role":93,"phone":431,"email":432},{"lat":461,"lon":462},48.99923,21.2355,[464],{"name":13,"role":93,"phone":465,"email":466},"1-800-243-0127","clintriage.rdg@boehringer-ingelheim.com",[],[],[470],{"label":471,"url":472},"Related Info","https:\u002F\u002Fwww.clinicalstudies.boehringer-ingelheim.com\u002Fmsw\u002Fdatatransparency",{"nct_id":4,"conditions":474,"biomarkers":475},[19],[],{"nct_id":4,"found":477,"summary":478,"prompt_version":487},true,{"design":479,"status":480,"heading":6,"summary":481,"follow_up":482,"word_count":483,"commitments":484,"compensation":485,"drugs_mentioned":486},"This is an interventional study planning to enroll 80 participants. It involves two parts where BI 3032950 is given either intravenously or subcutaneously.","completed","This study is for adults aged 18 to 80 who have ulcerative colitis (a chronic inflammatory bowel disease) and whose previous treatments haven't worked well or were stopped. We are testing a drug called BI 3032950 to see if it can help improve symptoms. The study has two parts. In Part A, you would receive BI 3032950 intravenously (through a vein) every four weeks. After 12 weeks, doctors will check if your symptoms have improved. You would then move to Part B, where BI 3032950 is given as an injection under the skin. If your symptoms show improvement after 12 weeks, you may continue receiving BI 3032950. The main goal is to see how many people achieve clinical remission (a significant reduction in symptoms) by week 12.","The primary outcome for symptom improvement is measured up to Week 12.",127,"In Part A, participants receive BI 3032950 intravenously every 4 weeks. After 12 weeks, participants move to Part B and receive BI 3032950 as an injection under the skin.","Not stated in the trial record.",[],"v2"]