Clinical trial NCT05767021: A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis
Ulcerative Colitis Chronic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-03-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Bowel Urgency Severity Urgency Numeric Rating Score (UNRS)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change from Baseline in Bowel Urgency Frequency
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving Clinically Meaningful Improvement in Bowel Urgency Frequency
timeFrame: Baseline to Week 12
measure: Change from Baseline in Stool Deferral Time
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving Clinically Meaningful Improvement of Stool Deferral Time
timeFrame: Week 12
measure: Percentage of Participants achieving Both Clinical Remission, Based on the modified Mayo Score and a UNRS score of ≤1
timeFrame: Week 12
measure: Percentage of Participants achieving Both Clinical Response, Based on the modified Mayo Score and a UNRS score ≥3 Points of Improvement from Baseline
timeFrame: Week 12
measure: Pairwise Correlations between the UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures
timeFrame: Baseline to Week 12
measure: Pairwise Correlations between Change in UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures
timeFrame: Baseline to Week 12
measure: 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
timeFrame: Baseline to Week 12
measure: 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
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Sun City
country: United States
facility: Arizona Digestive Health - Sun City
state: Arizona
city: Lancaster
country: United States
facility: Om Research, LLC
state: California
city: Northridge
country: United States
facility: California Medical Research Associates, Inc.
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Central Florida Gastro Research
state: Florida
city: Jacksonville
country: United States
facility: Encore Borland-Groover Clinical Research
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida
state: Florida
city: Miami
country: United States
facility: Advanced Research Associates, LLC
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: International Center for Research LLC
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLLC
state: Idaho
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: New Albany
country: United States
facility: Gastroenterology Health Partners
state: Indiana
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Metairie
country: United States
facility: GI Alliance/ Metairie
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Brooklyn
country: United States
facility: NY Scientific
state: New York
city: Asheville
country: United States
facility: Digestive Health Partners - Research Department
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterolgy & Hepatology
state: North Carolina
city: Wilmington
country: United States
facility: Innovo Research:Wilmington Health
state: North Carolina
city: Columbus
country: United States
facility: Optimed Research, LTD
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Cordova
country: United States
facility: Gastro One
state: Tennessee
city: Kingsport
country: United States
facility: Tri-Cities Gastroenterology
state: Tennessee
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy And Research Center, LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Katy
country: United States
facility: Citrine Institute for Research and Wellness
state: Texas
city: McAllen
country: United States
facility: AngioCardiac Care of Texas, PA
state: Texas
city: Pasadena
country: United States
facility: Digestive System Healthcare
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC
state: Texas
city: Sugar Land
country: United States
facility: Gastroenterology Associates of Texas - Denise Rodriguez
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Webster
country: United States
facility: GI Alliance Research Webster
state: Texas
city: Ogden
country: United States
facility: Care Access Research - Ogden
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology
state: Washington
city: Tacoma
country: United States
facility: Washington Gastroenterology dba GI Alliance
state: Washington
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent - Gastro IBD
city: Leuven
country: Belgium
facility: UZ Leuven - E507 Studies IBD tav Tine Hermans
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno, Interni oddeleni
state: Czech Republic
city: Klatovy
country: Czechia
facility: GastroJeka s.r.o
state: Czech Republic
city: Ostrava
country: Czechia
facility: FN Ostrava, Interní Klinika
state: Czech Republic
city: Hradec Kralove
country: Czechia
facility: Hepato-gastroenterologie HK, s.r.o.
state: Hradec Králové
city: Olomouc
country: Czechia
facility: MUDr. Gregar, s.r.o.
state: Olomoucký Kraj
city: Brno
country: Czechia
facility: SurGal clinic s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed, s.r.o.
city: Pessac
country: France
facility: CHU Bordeaux - Hôpital Haut-Lévêque
state: Gironde
city: Rennes cedex 09
country: France
facility: CHU Rennes - Hôpital Pontchaillou
state: Ille Et Vilaine
city: Pau
country: France
facility: Centre Hospitalier de Pau
state: Pyrénées-Atlantiques
city: Besancon
country: France
facility: Chu Besancon
city: Lille Cedex
country: France
facility: CHU de LILLE - Bureau des ARCs Gastro - HPDD
city: Lyon - Pierre Benite
country: France
facility: Hospices Civils de Lyon - Hôpital Lyon Sud - ARC HGE bâtiment 3I
city: Montpellier
country: France
facility: Hôpital Saint-Eloi Pôle Digestif ,APEMAD - Recherche clinique
city: Nantes Cedex 1
country: France
facility: CHU Nantes
city: Nantes
country: France
facility: Clinique Jules Verne
city: Nice Cedex 3
country: France
facility: Unité de Recherche Clinique (4èmeB)
city: Reims Cedex
country: France
facility: Chu de Reims - Hôpital Robert Debré
city: Saint Etienne Cedex 02
country: France
facility: CHU de Saint-Etienne
city: Vandoeuvre les Nancy
country: France
facility: Chru Nancy Brabois
city: Berlin
country: Germany
facility: Praxis Dr. M. Mross - Gastroenterologie
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend, Gastroenterologie, Studienbüro
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Med. Klinik II
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
state: Heves
city: Budapest
country: Hungary
facility: Clinepert kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Belgyógyászati es Hematológiai Klinika
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum
city: Szekszard
country: Hungary
facility: Clinfan Ltd. Gastroenterology Clinic
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
city: Castellana Grotte
country: Italy
facility: IRCCS Saverio de Bellis, National Institute of Gastroenterology
city: Milano
country: Italy
facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele, Gastroenterologia/Ibd Unit, Settore G Piano -1
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS_ CEMAD
city: Roma
country: Italy
facility: Uoc Gastroenterologia - Policlinico Tor Vergata
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
city: Torino
country: Italy
facility: A.O.Ordine Mauriziano, SC Gastroenterologia, ambulatorio endoscopia digestiva
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
state: Subcarpathian
city: Poznań
country: Poland
facility: Solumed Centrum Medyczne
state: Wielkopolskie
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj I Cichomski sp.j.
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: KRAKOWSKIE CENTRUM MEDYCZNE Sp. z o.o
city: Krakow
country: Poland
facility: Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
city: Lodz
country: Poland
facility: IP Clinic
city: Lodz
country: Poland
facility: Med-GASTR SP. Z O.O., SP.K.
city: Lodz
country: Poland
facility: AmiCare Sp. z o.o. Sp. K.
city: Lodz
country: Poland
facility: Bonifraterskie Centrum Medyczne sp. z o.o
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
city: Opole
country: Poland
facility: Twoja Przychodnia Opolskie Centrum Medyczne
city: Staszów
country: Poland
facility: Nowe Zdrowie-Ck, Kiełtucki I Wspólnicy Sp. J.
city: Swidnica
country: Poland
facility: DC-MED Sp. z o.o. s.k.
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Wadowice
country: Poland
facility: NZOZ FOR MED sp. z o.o.
city: Wroclaw
country: Poland
facility: FutureMeds sp. z o. o.
city: Wroclaw
country: Poland
facility: PlanetMed Sp.z o.o.
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Zamosc
country: Poland
facility: Centrum Medyczne Kuba Med 2 Sp. z o.o. ETG Zamosc
city: Knurów
country: Poland
facility: MZ Badania Słowik Zymła Sp.j.
state: Śląskie
city: Banska Bystrica
country: Slovakia
facility: Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica gastroenterologická ambulancia, II. Interná klinika SZU
state: Slovak Republic
city: Bardejov
country: Slovakia
facility: ALIAN s.r.o.
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: CLINIQ, s.r.o
state: Slovak Republic
city: Kosice
country: Slovakia
facility: GASTRO AMBULANCIA, poliklinika Ťahanovce
state: Slovak Republic
city: Nitra Stare Mesto
country: Slovakia
facility: KM Management, spol. s.r.o
state: Slovak Republic
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra, Interna klinika
state: Slovak Republic
city: Sahy
country: Slovakia
facility: Accout Center s.r.o.
state: Slovak Republic
city: Bury
country: United Kingdom
facility: Fairfield General Hospital
state: Great Britain
city: Waltham
country: United Kingdom
facility: Clinical Research Unit, Royal Liverpool University Hospital
state: Waltham Forest
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: