A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Ulcerative ColitisUlcerative Colitis Chronic
- Interventions
- Registration Number
- NCT05767021
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mirikizumab Mirikizumab Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Change from Baseline in Bowel Urgency Severity Urgency Numeric Rating Score (UNRS) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Change from Baseline in Bowel Urgency Frequency Baseline, Week 12 Percentage of Participants Achieving Clinically Meaningful Improvement in Bowel Urgency Frequency Baseline to Week 12 Change from Baseline in Stool Deferral Time Baseline, Week 12 Percentage of Participants Achieving Clinically Meaningful Improvement of Stool Deferral Time Week 12 Percentage of Participants achieving Both Clinical Remission, Based on the modified Mayo Score and a UNRS score of ≤1 Week 12 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 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 Pairwise Correlations between the UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures Baseline to Week 12 Pairwise Correlations between Change in UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures Baseline to Week 12 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
Trial Locations
- Locations (120)
Advanced Research Associates, LLC
🇺🇸Miami, Florida, United States
Gastroenterology Research of San Antonio
🇺🇸San Antonio, Texas, United States
Southern Star Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Dedicated Clinical Research
🇺🇸Litchfield Park, Arizona, United States
Arizona Digestive Health - Sun City
🇺🇸Sun City, Arizona, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Om Research, LLC
🇺🇸Lancaster, California, United States
California Medical Research Associates, Inc.
🇺🇸Northridge, California, United States
Clinical Applications Laboratories, Inc.
🇺🇸San Diego, California, United States
Research Associates of South Florida
🇺🇸Miami, Florida, United States
Central Florida Gastro Research
🇺🇸Clearwater, Florida, United States
Encore Borland-Groover Clinical Research
🇺🇸Jacksonville, Florida, United States
Atlanta Center for Gastroenterology, P.C.
🇺🇸Decatur, Georgia, United States
Grand Teton Research Group, PLLC
🇺🇸Idaho Falls, Idaho, United States
IU Health University Hospital
🇺🇸Indianapolis, Indiana, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
GI Alliance/ Metairie
🇺🇸Metairie, Louisiana, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
🇺🇸Topeka, Kansas, United States
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
West Michigan Clinical Research Center
🇺🇸Wyoming, Michigan, United States
NY Scientific
🇺🇸Brooklyn, New York, United States
Charlotte Gastroenterolgy & Hepatology
🇺🇸Charlotte, North Carolina, United States
Optimed Research, LTD
🇺🇸Columbus, Ohio, United States
Paramount Medical Research & Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
Tri-Cities Gastroenterology
🇺🇸Kingsport, Tennessee, United States
Gastro One
🇺🇸Cordova, Tennessee, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Houston Endoscopy And Research Center, LLC
🇺🇸Houston, Texas, United States
Citrine Institute for Research and Wellness
🇺🇸Katy, Texas, United States
AngioCardiac Care of Texas, PA
🇺🇸McAllen, Texas, United States
Digestive System Healthcare
🇺🇸Pasadena, Texas, United States
Care Access Research - Ogden
🇺🇸Ogden, Utah, United States
LinQ Research, LLC
🇺🇸Pearland, Texas, United States
GI Alliance Research Webster
🇺🇸Webster, Texas, United States
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Washington Gastroenterology dba GI Alliance
🇺🇸Tacoma, Washington, United States
Washington Gastroenterology
🇺🇸Bellevue, Washington, United States
Universitair Ziekenhuis Gent - Gastro IBD
🇧🇪Gent, Belgium
UZ Leuven - E507 Studies IBD tav Tine Hermans
🇧🇪Leuven, Belgium
GastroJeka s.r.o
🇨🇿Klatovy, Czech Republic, Czechia
Hepato-gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Hradec Králové, Czechia
SurGal clinic s.r.o.
🇨🇿Brno, Czechia
CHU Bordeaux - Hôpital Haut-Lévêque
🇫🇷Pessac, Gironde, France
CHU Rennes - Hôpital Pontchaillou
🇫🇷Rennes cedex 09, Ille Et Vilaine, France
Centre Hospitalier de Pau
🇫🇷Pau, Pyrénées-Atlantiques, 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
CHU Nantes
🇫🇷Nantes Cedex 1, France
Chu de Reims - Hôpital Robert Debré
🇫🇷Reims Cedex, France
CHU de Saint-Etienne
🇫🇷Saint Etienne Cedex 02, France
Chru Nancy Brabois
🇫🇷Vandoeuvre les Nancy, France
Universitätsklinikum Leipzig, Med. Klinik II
🇩🇪Leipzig, Germany
Praxis Dr. M. Mross - Gastroenterologie
🇩🇪Berlin, Germany
DRK Kliniken Berlin Westend, Gastroenterologie, Studienbüro
🇩🇪Berlin, Germany
Clinepert kft
🇭🇺Budapest, Hungary
Clinfan Ltd. Gastroenterology Clinic
🇭🇺Szekszard, Hungary
IRCCS Saverio de Bellis, National Institute of Gastroenterology
🇮🇹Castellana Grotte, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Fondazione Policlinico Agostino Gemelli IRCCS_ CEMAD
🇮🇹Roma, Italy
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
🇮🇹Rozzano, Italy
A.O.Ordine Mauriziano, SC Gastroenterologia, ambulatorio endoscopia digestiva
🇮🇹Torino, Italy
Uoc Gastroenterologia - Policlinico Tor Vergata
🇮🇹Roma, Italy
Irccs Ospedale San Raffaele, Gastroenterologia/Ibd Unit, Settore G Piano -1
🇮🇹Milano, Italy
Centrum Medyczne Medyk
🇵🇱Rzeszow, Subcarpathian, Poland
Solumed Centrum Medyczne
🇵🇱Poznań, Wielkopolskie, Poland
NZOZ Centrum Medyczne KERmed
🇵🇱Bydgoszcz, Poland
Vitamed Galaj I Cichomski sp.j.
🇵🇱Bydgoszcz, Poland
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
Med-GASTR SP. Z O.O., SP.K.
🇵🇱Lodz, Poland
AmiCare Sp. z o.o. Sp. K.
🇵🇱Lodz, Poland
Bonifraterskie Centrum Medyczne sp. z o.o
🇵🇱Lodz, Poland
Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
🇵🇱Nowy Targ, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
🇵🇱Opole, Poland
DC-MED Sp. z o.o. s.k.
🇵🇱Swidnica, Poland
Sonomed Sp. z o.o.
🇵🇱Szczecin, Poland
NZOZ FOR MED sp. z o.o.
🇵🇱Wadowice, Poland
PlanetMed Sp.z o.o.
🇵🇱Wroclaw, Poland
FutureMeds sp. z o. o.
🇵🇱Wroclaw, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Centrum Medyczne Kuba Med 2 Sp. z o.o. ETG Zamosc
🇵🇱Zamosc, Poland
MZ Badania Słowik Zymła Sp.j.
🇵🇱Knurów, Śląskie, Poland
ALIAN s.r.o.
🇸🇰Bardejov, Slovak Republic, Slovakia
Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica gastroenterologická ambulancia, II. Interná klinika SZU
🇸🇰Banska Bystrica, Slovak Republic, Slovakia
CLINIQ, s.r.o
🇸🇰Bratislava, Slovak Republic, Slovakia
GASTRO AMBULANCIA, poliklinika Ťahanovce
🇸🇰Kosice, Slovak Republic, Slovakia
KM Management, spol. s.r.o
🇸🇰Nitra Stare Mesto, Slovak Republic, Slovakia
Fakultna nemocnica Nitra, Interna klinika
🇸🇰Nitra, Slovak Republic, Slovakia
Clinical Research Unit, Royal Liverpool University Hospital
🇬🇧Waltham, Waltham Forest, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Fairfield General Hospital
🇬🇧Bury, Great Britain, United Kingdom
PreventaMed, s.r.o.
🇨🇿Olomouc, Czechia
Innovo Research:Wilmington Health
🇺🇸Wilmington, North Carolina, United States
GCP Clinical Research, LLC
🇺🇸Tampa, Florida, United States
International Center for Research LLC
🇺🇸Tampa, Florida, United States
Chu Besancon
🇫🇷Besancon, France
Gastroenterology Health Partners
🇺🇸New Albany, Indiana, United States
Digestive Health Partners - Research Department
🇺🇸Asheville, North Carolina, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Gastroenterology Associates of Texas - Denise Rodriguez
🇺🇸Sugar Land, Texas, United States
Vojenska nemocnice Brno, Interni oddeleni
🇨🇿Brno, Czech Republic, Czechia
MUDr. Gregar, s.r.o.
🇨🇿Olomouc, Olomoucký Kraj, Czechia
FN Ostrava, Interní Klinika
🇨🇿Ostrava, Czech Republic, Czechia
CHU de LILLE - Bureau des ARCs Gastro - HPDD
🇫🇷Lille Cedex, France
Unité de Recherche Clinique (4èmeB)
🇫🇷Nice Cedex 3, France
Clinique Jules Verne
🇫🇷Nantes, France
Bugat Pal Korhaz
🇭🇺Gyongyos, Heves, Hungary
Pannónia Magánorvosi Centrum
🇭🇺Budapest, Hungary
Semmelweis Egyetem, Belgyógyászati es Hematológiai Klinika
🇭🇺Budapest, Hungary
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
🇮🇹Brescia, Italy
KRAKOWSKIE CENTRUM MEDYCZNE Sp. z o.o
🇵🇱Krakow, Poland
Nowe Zdrowie-Ck, Kiełtucki I Wspólnicy Sp. J.
🇵🇱Staszów, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Accout Center s.r.o.
🇸🇰Sahy, Slovak Republic, Slovakia
Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
🇵🇱Krakow, Poland
IP Clinic
🇵🇱Lodz, Poland
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