Ulcerative Colitis Clinical Trial
— LUCENT-URGEOfficial title:
A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
| Status | Recruiting |
| Enrollment | 160 |
| Est. completion date | March 31, 2025 |
| Est. primary completion date | December 9, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Have an established diagnosis of UC for =3 months - Have confirmed diagnosis of moderately for severely active UC - Have current bowel urgency - Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC. Exclusion Criteria: - Have Crohn's disease (CD) - Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or - Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge. - Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation - Have any history or current evidence of cancer of the gastrointestinal tract - Have active tuberculosis - Have HIV infection. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Universitair Ziekenhuis Gent - Gastro IBD | Gent | |
| Belgium | UZ Leuven - E507 Studies IBD tav Tine Hermans | Leuven | |
| Czechia | SurGal clinic s.r.o. | Brno | |
| Czechia | Vojenska nemocnice Brno, Interni oddeleni | Brno | Czech Republic |
| Czechia | Hepato-gastroenterologie HK, s.r.o. | Hradec Kralove | Hradec Králové |
| Czechia | GastroJeka s.r.o | Klatovy | Czech Republic |
| Czechia | MUDr. Gregar, s.r.o. | Olomouc | Olomoucký Kraj |
| Czechia | PreventaMed, s.r.o. | Olomouc | |
| Czechia | FN Ostrava, Interní Klinika | Ostrava | Czech Republic |
| France | Chu Besancon | Besancon | |
| France | CHU de LILLE - Bureau des ARCs Gastro - HPDD | Lille Cedex | |
| France | Hospices Civils de Lyon - Hôpital Lyon Sud - ARC HGE bâtiment 3I | Lyon - Pierre Benite | |
| France | Hôpital Saint-Eloi Pôle Digestif ,APEMAD - Recherche clinique | Montpellier | |
| France | Clinique Jules Verne | Nantes | |
| France | CHU Nantes | Nantes Cedex 1 | |
| France | Unité de Recherche Clinique (4èmeB) | Nice Cedex 3 | |
| France | Centre Hospitalier de Pau | Pau | Pyrénées-Atlantiques |
| France | CHU Bordeaux - Hôpital Haut-Lévêque | Pessac | Gironde |
| France | Chu de Reims - Hôpital Robert Debré | Reims Cedex | |
| France | CHU Rennes - Hôpital Pontchaillou | Rennes cedex 09 | Ille Et Vilaine |
| France | CHU de Saint-Etienne | Saint Etienne Cedex 02 | |
| France | Chru Nancy Brabois | Vandoeuvre les Nancy | |
| Germany | DRK Kliniken Berlin Westend, Gastroenterologie, Studienbüro | Berlin | |
| Germany | Praxis Dr. M. Mross - Gastroenterologie | Berlin | |
| Germany | Universitätsklinikum Leipzig, Med. Klinik II | Leipzig | |
| Hungary | Clinepert kft | Budapest | |
| Hungary | Pannónia Magánorvosi Centrum | Budapest | |
| Hungary | Semmelweis Egyetem, Belgyógyászati es Hematológiai Klinika | Budapest | |
| Hungary | Bugat Pal Korhaz | Gyongyos | Heves |
| Hungary | Clinfan Ltd. Gastroenterology Clinic | Szekszard | |
| Italy | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Brescia | |
| Italy | IRCCS Saverio de Bellis, National Institute of Gastroenterology | Castellana Grotte | |
| Italy | Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Irccs Ospedale San Raffaele, Gastroenterologia/Ibd Unit, Settore G Piano -1 | Milano | |
| Italy | Fondazione Policlinico Agostino Gemelli IRCCS_ CEMAD | Roma | |
| Italy | Uoc Gastroenterologia - Policlinico Tor Vergata | Roma | |
| Italy | IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali | Rozzano | |
| Italy | A.O.Ordine Mauriziano, SC Gastroenterologia, ambulatorio endoscopia digestiva | Torino | |
| Poland | NZOZ Centrum Medyczne KERmed | Bydgoszcz | |
| Poland | Vitamed Galaj I Cichomski sp.j. | Bydgoszcz | |
| Poland | MZ Badania Slowik Zymla Sp.j. | Knurów | Slaskie |
| Poland | Centrum Medyczne Plejady | Krakow | |
| Poland | KRAKOWSKIE CENTRUM MEDYCZNE Sp. z o.o | Krakow | |
| Poland | Topolowa Medicenter Ryszawa & Wspólnicy Sp.j. | Krakow | |
| Poland | AmiCare Sp. z o.o. Sp. K. | Lodz | |
| Poland | Bonifraterskie Centrum Medyczne sp. z o.o | Lodz | |
| Poland | IP Clinic | Lodz | |
| Poland | Med-GASTR SP. Z O.O., SP.K. | Lodz | |
| Poland | Allmedica Badania Kliniczne Sp. z o.o. Sp. k. | Nowy Targ | |
| Poland | Twoja Przychodnia Opolskie Centrum Medyczne | Opole | |
| Poland | Solumed Centrum Medyczne | Poznan | Wielkopolskie |
| Poland | Centrum Medyczne Medyk | Rzeszow | Subcarpathian |
| Poland | Nowe Zdrowie-Ck, Kieltucki I Wspólnicy Sp. J. | Staszów | |
| Poland | DC-MED Sp. z o.o. s.k. | Swidnica | |
| Poland | Sonomed Sp. z o.o. | Szczecin | |
| Poland | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | |
| Poland | NZOZ FOR MED sp. z o.o. | Wadowice | |
| Poland | Centrum Medyczne Oporow | Wroclaw | |
| Poland | FutureMeds sp. z o. o. | Wroclaw | |
| Poland | PlanetMed Sp.z o.o. | Wroclaw | |
| Poland | Centrum Medyczne Kuba Med 2 Sp. z o.o. ETG Zamosc | Zamosc | |
| Slovakia | Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica gastroenterologická ambulancia, II. Interná klinika SZU | Banska Bystrica | Slovak Republic |
| Slovakia | ALIAN s.r.o. | Bardejov | Slovak Republic |
| Slovakia | CLINIQ, s.r.o | Bratislava | Slovak Republic |
| Slovakia | GASTRO AMBULANCIA, poliklinika Tahanovce | Kosice | Slovak Republic |
| Slovakia | Fakultna nemocnica Nitra, Interna klinika | Nitra | Slovak Republic |
| Slovakia | KM Management, spol. s.r.o | Nitra Stare Mesto | Slovak Republic |
| Slovakia | Accout Center s.r.o. | Sahy | Slovak Republic |
| United Kingdom | Fairfield General Hospital | Bury | Great Britain |
| United Kingdom | King's College Hospital NHS Foundation Trust | London | |
| United Kingdom | Clinical Research Unit, Royal Liverpool University Hospital | Waltham Forest | |
| United States | Digestive Health Partners - Research Department | Asheville | North Carolina |
| United States | Digestive Healthcare of Georgia | Atlanta | Georgia |
| United States | Washington Gastroenterology | Bellevue | Washington |
| United States | NY Scientific | Brooklyn | New York |
| United States | Charlotte Gastroenterolgy & Hepatology | Charlotte | North Carolina |
| United States | Charlottesville Medical Research | Charlottesville | Virginia |
| United States | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan |
| United States | Chevy Chase Clinical Research | Chevy Chase | Maryland |
| United States | Central Florida Gastro Research | Clearwater | Florida |
| United States | Optimed Research, LTD | Columbus | Ohio |
| United States | Gastro One | Cordova | Tennessee |
| United States | Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia |
| United States | Medical Research Center of Connecticut, LLC | Hamden | Connecticut |
| United States | Biopharma Informatic, LLC | Houston | Texas |
| United States | Clinical Trial Network | Houston | Texas |
| United States | Houston Endoscopy And Research Center, LLC | Houston | Texas |
| United States | Grand Teton Research Group, PLLC | Idaho Falls | Idaho |
| United States | IU Health University Hospital | Indianapolis | Indiana |
| United States | Encore Borland-Groover Clinical Research | Jacksonville | Florida |
| United States | Citrine Institute for Research and Wellness | Katy | Texas |
| United States | Tri-Cities Gastroenterology | Kingsport | Tennessee |
| United States | Om Research, LLC | Lancaster | California |
| United States | Dedicated Clinical Research | Litchfield Park | Arizona |
| United States | AngioCardiac Care of Texas, PA | McAllen | Texas |
| United States | GI Alliance/ Metairie | Metairie | Louisiana |
| United States | Advanced Research Associates, LLC | Miami | Florida |
| United States | Research Associates of South Florida | Miami | Florida |
| United States | Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio |
| United States | Delta Research Partners | Monroe | Louisiana |
| United States | Gastroenterology Health Partners | New Albany | Indiana |
| United States | Central Sooner Research | Norman | Oklahoma |
| United States | California Medical Research Associates, Inc. | Northridge | California |
| United States | Care Access Research - Ogden | Ogden | Utah |
| United States | Digestive System Healthcare | Pasadena | Texas |
| United States | LinQ Research, LLC | Pearland | Texas |
| United States | University Gastroenterology | Providence | Rhode Island |
| United States | Gastroenterology Research of San Antonio | San Antonio | Texas |
| United States | Southern Star Research Institute, LLC | San Antonio | Texas |
| United States | Clinical Applications Laboratories, Inc. | San Diego | California |
| United States | Gastroenterology Associates of Texas - Denise Rodriguez | Sugar Land | Texas |
| United States | Arizona Digestive Health - Sun City | Sun City | Arizona |
| United States | Washington Gastroenterology dba GI Alliance | Tacoma | Washington |
| United States | GCP Clinical Research, LLC | Tampa | Florida |
| United States | International Center for Research LLC | Tampa | Florida |
| United States | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas |
| United States | Tyler Research Institute, LLC | Tyler | Texas |
| United States | GI Alliance Research Webster | Webster | Texas |
| United States | Innovo Research:Wilmington Health | Wilmington | North Carolina |
| United States | West Michigan Clinical Research Center | Wyoming | Wyoming |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Slovakia, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Bowel Urgency Severity Urgency Numeric Rating Score (UNRS) | Baseline, Week 12 | ||
| Secondary | Change from Baseline in Bowel Urgency Frequency | Baseline, Week 12 | ||
| Secondary | Percentage of Participants Achieving Clinically Meaningful Improvement in Bowel Urgency Frequency | Baseline to Week 12 | ||
| Secondary | Change from Baseline in Stool Deferral Time | Baseline, Week 12 | ||
| Secondary | Percentage of Participants Achieving Clinically Meaningful Improvement of Stool Deferral Time | Week 12 | ||
| Secondary | Percentage of Participants achieving Both Clinical Remission, Based on the modified Mayo Score and a UNRS score of =1 | Week 12 | ||
| Secondary | Percentage of Participants achieving Both Clinical Response, Based on the modified Mayo Score and a UNRS score =3 Points of Improvement from Baseline | Week 12 | ||
| Secondary | Pairwise Correlations between the UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures | Baseline to Week 12 | ||
| Secondary | Pairwise Correlations between Change in UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures | Baseline to Week 12 | ||
| Secondary | Correlation between the UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures, with Quality of Life (QoL)/Functional Outcome Measures and Ulcerative Colitis (UC) Symptom Measures | Baseline to Week 12 | ||
| Secondary | Correlation between Change in UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures, with Change in QoL/Functional Outcome Measures and UC Symptom Measures | Baseline to Week 12 |
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