Clinical trial NCT06598943: A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
Official title: An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Ulcerative Colitis Chronic
Keywords: CXCR1/2 Ligand receptor antagonist
IL-23 p19 antibody
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Colitis
Colitis, Ulcerative
Anti-Inflammatory Agents
Mirikizumab
Eltrekibart
Adult
Moderate to Severe
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

Detailed description: The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.

Eligibility criteria: Inclusion Criteria:

* Have had an established diagnosis of UC of ≥3 months in duration before baseline.
* Have moderately to severely active UC as assessed by the UC disease activity score.
* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
* Are on a stable dose of certain oral UC medications (including corticosteroids).
* Must meet contraception requirements.

Exclusion Criteria:

* Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
* Have experienced a thrombotic event within 24 weeks before baseline.
* Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
* Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
* Have a history of certain adenomas, dysplasia's, or malignancies.

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Response
timeFrame: Week 12
measure: Percentage of Participants Achieving Endoscopic Improvement
timeFrame: Week 12
measure: Percentage of Participants Achieving Endoscopic Remission
timeFrame: Week 12
measure: Percentage of Participants Achieving Clinical Remission
timeFrame: Week 52
measure: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
timeFrame: Week 12
measure: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
timeFrame: Baseline, Week 12
measure: Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart
timeFrame: Week 12
measure: PK: Ctrough ss of Mirikizumab
timeFrame: Week 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Coronado
country: United States
facility: Southern California GI and Liver Centers (SCLC)
state: California
city: Lancaster
country: United States
facility: Om Research, LLC
state: California
city: Los Alamitos
country: United States
facility: United Medical Doctors
state: California
city: Orange
country: United States
facility: Clinnova Research
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Miami
country: United States
facility: Well Pharma Medical Research Corp.
state: Florida
city: Orange Park
country: United States
facility: Digestive Disease Consultants DDCJAX
state: Florida
city: Orlando
country: United States
facility: Orlando Health Digestive Health Institute
state: Florida
city: Tampa
country: United States
facility: Nodal Medical Center
state: Florida
city: Tampa
country: United States
facility: Research Bay,Inc.
state: Florida
city: Tampa
country: United States
facility: International Center for Research LLC
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Oak Lawn
country: United States
facility: Avicenna Clinical Research - SW Gastroenterology
state: Illinois
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, P.L.C.
state: Michigan
city: Brooklyn
country: United States
facility: Ellipsis Research Group
state: New York
city: Jackson Heights
country: United States
facility: Smart Medical Research - Jackson Heights
state: New York
city: New York
country: United States
facility: Pioneer Clinical Research NY
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Edinburg
country: United States
facility: DHR Health Gastroenterology - Edinburg
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Intergrity Research
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute
state: Texas
city: Ogden
country: United States
facility: Care Access-Ogden
state: Utah
city: Ogden
country: United States
facility: Advanced Research Institute - South Ogden
state: Utah
city: Seattle
country: United States
facility: University of Washington School Medicine
state: Washington
city: Ciudad Autonoma De Buenos Air
country: Argentina
facility: Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
state: Buenos Aires
city: Munro
country: Argentina
facility: Clínica Privada Independencia
state: Buenos Aires
city: Quilmes
country: Argentina
facility: CER Instituto Medico
state: Buenos Aires
city: Caba
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aire
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
state: Santa Fe
city: SAN M. DE Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucumán
city: La Louviere
country: Belgium
facility: Chu Tivoli
city: Yvoir
country: Belgium
facility: CHU UCL Namur site Godinne
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal
state: Quebec
city: Zagreb
country: Croatia
facility: Poliklinika Solmed
state: Grad Zagreb
city: Bjelovar
country: Croatia
facility: General Hospital Dr Andjelko Visic Bjelovar
city: Osijek
country: Croatia
facility: Poliklinika Borzan
city: Rijeka
country: Croatia
facility: Special Hospital Medico
city: Brno
country: Czechia
facility: SurGal clinic s.r.o.
state: Czech Republic
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno p.o.
city: Slany
country: Czechia
facility: Etická komise Nemocnice Slaný
city: Zlín
country: Czechia
facility: Etická komise Krajské nemocnice T. Bati, a. s.
city: Kobenhavn NV
country: Denmark
facility: Bispebjerg Hospital
city: Grenoble
country: France
facility: CHU De Grenoble Hopital Albert Michallon
state: Cedex 09
city: Pierre Benite cedex
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
state: Rhone
city: La Roche-sur-Yon Cedex 9
country: France
facility: Centre Hospitalier Departemental (CHD) Vendee
city: Nice cedex 3
country: France
facility: CHU de Nice Hopital de L'Archet
city: Rouen
country: France
facility: Chu de Rouen Hopital Charles Nicolle
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg, III. Medizinische Klinik Studienzentrum
state: Bayern
city: München
country: Germany
facility: Klinikum Rechts der Isar der TU München
state: Bayern
city: Brandenburg an der Havel
country: Germany
facility: Universitätsklinikum Brandenburg GmbH
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt Goethe-Universität, Medizinische Klinik 1
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft
state: Sachsen-Anhalt
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Hamburg
country: Germany
facility: HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
city: Athens
country: Greece
facility: General Hospital of Athens Hippokratio
state: Attikí
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens
state: Attikí
city: Athens
country: Greece
facility: Alexandra Hospital
state: Attikí
city: Heraklion
country: Greece
facility: PAGNI-University General Hospital of Heraklion
state: Crete
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrád
city: Gyongyos
country: Hungary
facility: Bugát Pál Kórház
state: Heves
city: Budapest
country: Hungary
facility: Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Budapest
country: Hungary
facility: Semmelweis University
city: Szekesfehervar
country: Hungary
facility: Fejér Megyei Szent György Egyetemi Oktató Kórház
city: Dublin
country: Ireland
facility: Beaumont Hospital, Dublin
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna
state: BO
city: Monserrato
country: Italy
facility: Università di Cagliari - Presidio Policlinico Monserrato
state: Cagliari
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: FG
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
city: Segrate
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Milano
city: Fano
country: Italy
facility: AST Pesaro Urbino - Presidio Ospedaliero Santa Croce
state: PU
city: Rome
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
state: Roma
city: Gazzi - Messina
country: Italy
facility: A.O.U. Policlinico G. Martino
city: Milano
country: Italy
facility: Ospedale S. Paolo
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria
city: Padova
country: Italy
facility: Azienda Ospedale Università di Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Torino
country: Italy
facility: SC Farmacia AO Ordine Mauriziano
city: Hachinohe-shi
country: Japan
facility: Hachinohe City Hospital
state: Aomori
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki General Medical Center
state: Aomori
city: Kurume-shi
country: Japan
facility: Our Lady of the Snow St. Mary's Hospital
state: Fukuoka-Ken
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Kitakyushu-Shi
country: Japan
facility: JCHO Kyushu Hospital
state: Fukuoka
city: Koriyama-shi
country: Japan
facility: Hoshi General Hospital Foundation
state: Fukushima
city: Isesaki-shi
country: Japan
facility: Isesaki Municipal Hospital
state: Gumma
city: Hiroshima-city
country: Japan
facility: Hiroshima City North Medical Center Asa Citizens Hospital
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima
city: Sapporo Shi Chuo Ku
country: Japan
facility: Sapporo IBD Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Tokushukai Sapporo Tokushukai Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Shinjuku-ku
country: Japan
facility: JHCO Tokyo Yamate Medical Center
state: Jp-13
city: Kagoshima City
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic
state: Kagoshima
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Matsushima Hospital
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Nara-shi
country: Japan
facility: Nara Prefecture General Medical Center
state: Nara
city: Oita City
country: Japan
facility: Oita Red Cross Hospital
state: Oita-ken
city: Osaka-shi
country: Japan
facility: Infusion Clinic
state: Osaka
city: Sunto-gun
country: Japan
facility: National Hospital Organization Shizuoka Medical Center
state: Shizuoka
city: Koto-ku
country: Japan
facility: Showa University Koto Toyosu Hospital
state: Tokyo
city: Minato-Ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinagawa-KU
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoak
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Sumida-ku
country: Japan
facility: Tokyo Metro Bokutoh Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Gangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Kangwon-do
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univeristy Medical Center
state: Taegu-Kwangyǒkshi
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Liepaja
country: Latvia
facility: Liepaja Regional Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital
city: Wroclaw
country: Poland
facility: Melita Medical
state: Dolnośląskie
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
state: Mazowieckie
city: Bydgoszcz
country: Poland
facility: ManerMed Sp z o.o. Centrum Medyczne ,Medis
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Kermed Renata Bojata-Bronisz i Ewa Kowalińska Sp.j.
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady Magdalena Celińska-Löwenhoff, Michał Żołnowski sp.k
city: Krakow
country: Poland
facility: Centrum Nowoczesnych Terapii "Dobry Lekarz" sp. z o. o.
city: Krakow
country: Poland
facility: Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
city: Lodz
country: Poland
facility: Med-GASTR SP. Z O.O., SP.K.
city: Lublin
country: Poland
facility: Medrise Sp. z o.o
city: Opole
country: Poland
facility: Twoja Przychodnia Opolskie Centrum Medyczne
city: Poznan
country: Poland
facility: Twoja Przychodnia Pcm
city: Sopot
country: Poland
facility: Endoskopia Sp. z.o.o.
city: Torun
country: Poland
facility: Gastromed Sp. z o.o.
city: Wadowice
country: Poland
facility: NZOZ FOR MED sp. z o.o.
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporów
city: Wroclaw
country: Poland
facility: VISTAMED
city: Łódź
country: Poland
facility: Ip Clinic Sp. Z O. O.
city: Cluj-Napoca
country: Romania
facility: Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
state: Cluj
city: Ploiesti
country: Romania
facility: Valahia Medical Center SRL
state: Prahova
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Bucharest
country: Romania
facility: Emergency University Hospital
city: Bucuresti
country: Romania
facility: S.C. Centrul Medical Medicum SRL
city: Timisoara
country: Romania
facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
state: Beograd
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic"
state: Vojvodina
city: Belgrade
country: Serbia
facility: Clinical Center " Dr Dragisa Misovic Dedinje"
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Beograd
country: Serbia
facility: Military Medical Academy
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Pancevo
country: Serbia
facility: General Hospital Pancevo
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Las Palmas De GC
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: Las Palmas
city: Ciudad Real
country: Spain
facility: Hospital General Tomelloso
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia Comite Etico
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: CEIM Hospital Universitario y Politecnico la Fe
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Gazi Hospital
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Tıp Fakültesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty Hospital
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: