Crohn's Disease Clinical Trials

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A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Status: Recruiting
Location: See all (72) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.

• For UC:

⁃ Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.

• For CD:

⁃ Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization

• Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD

• Have screening laboratory test results within the protocol specified parameters.

Locations
United States
Arizona
Mayo Clinic in Arizona - Scottsdale
NOT_YET_RECRUITING
Scottsdale
California
Biopharma Informatic, LLC
RECRUITING
Los Angeles
Om Research LLC
NOT_YET_RECRUITING
Oxnard
Colorado
South Denver Gastroenterology
NOT_YET_RECRUITING
Englewood
Florida
Gastro Health Research - Miami
NOT_YET_RECRUITING
Miami
Ezy Medical Research
RECRUITING
Miami Lakes
Georgia
Atlanta Gastroenterology Associates - Peachtree Dunwoody
RECRUITING
Atlanta
Illinois
Rush University Medical Center
NOT_YET_RECRUITING
Chicago
Kansas
Cotton O'Neil Digestive Health Center
RECRUITING
Topeka
Michigan
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
RECRUITING
Wyoming
Missouri
KAD Clinical Research
NOT_YET_RECRUITING
St Louis
North Carolina
Innovo Research - Wilmington Gastroenterology Associates
NOT_YET_RECRUITING
Wilmington
Nevada
Vector Clinical Trials
RECRUITING
Las Vegas
Texas
One of a Kind Clinical Research Center - Kingwood
NOT_YET_RECRUITING
Kingwood
Southern Star Research Institute
RECRUITING
San Antonio
Other Locations
Belgium
AZ Maria Middelares
NOT_YET_RECRUITING
Ghent
UZ Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
AZ Delta vzw
NOT_YET_RECRUITING
Roeselare
Brazil
Loema Instituto de Pesquisa Clinica
NOT_YET_RECRUITING
Campinas
Fundação Universidade de Caxias do Sul (FUCS)
NOT_YET_RECRUITING
Caxias Do Sul
Centro Digestivo de Curitiba
NOT_YET_RECRUITING
Curitiba
Centro de Pesquisa Clínica de Marília - CPCLIM
NOT_YET_RECRUITING
Marília
BR Trials - Ensaios Clinicos e Consultoria
NOT_YET_RECRUITING
São Paulo
Clínica Hepatogastro JK
NOT_YET_RECRUITING
São Paulo
CPCLIN
NOT_YET_RECRUITING
São Paulo
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
NOT_YET_RECRUITING
São Paulo
Solare Trials
NOT_YET_RECRUITING
São Paulo
CEDOES
NOT_YET_RECRUITING
Vitória
Canada
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)
NOT_YET_RECRUITING
Lethbridge
London Digestive Disease Institute
NOT_YET_RECRUITING
London
Tdda Inc.
NOT_YET_RECRUITING
Vaughan
China
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Changzhou Second People's Hospital
NOT_YET_RECRUITING
Changzhou
The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated hospital of Zhejiang University school of medicine
NOT_YET_RECRUITING
Hangzhou
Huizhou Central People's Hospital
NOT_YET_RECRUITING
Huizhou
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
NOT_YET_RECRUITING
Wenzhou
Zhongshan Hospital Affiliated to Xiamen University
NOT_YET_RECRUITING
Xiamen
Affiliated Hospital of Jiangsu University
NOT_YET_RECRUITING
Zhenjiang
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
NOT_YET_RECRUITING
Berlin
Studienzentrum MVZ Dachau
NOT_YET_RECRUITING
Dachau
Studiengesellschaft BSF Unternehmergesellschaft
NOT_YET_RECRUITING
Halle
St. Marien- und St. Annastiftskrankenhaus
NOT_YET_RECRUITING
Ludwigshafen
Universitaetsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Hungary
Geomedical Egészségügyi Központ
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
NOT_YET_RECRUITING
Tatabánya
Israel
Assuta Ashdod Medical Center
NOT_YET_RECRUITING
Ashdod
Rambam Health Care Campus
NOT_YET_RECRUITING
Haifa
Hadassah Medical Center
NOT_YET_RECRUITING
Jerusalem
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Rabin Medical Center
NOT_YET_RECRUITING
Petah Tikva
Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Yitzhak Shamir Medical Center
NOT_YET_RECRUITING
Ẕerifin
Italy
Azienda Ospedaliera Universitaria Careggi
NOT_YET_RECRUITING
Florence
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
Ospedale Sacro Cuore Don G. Calabria
NOT_YET_RECRUITING
Negrar
Fondazione Policlinico Universitario Agostino Gemelli
NOT_YET_RECRUITING
Roma
Humanitas
NOT_YET_RECRUITING
Rozzano
Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
NOT_YET_RECRUITING
Katowice
Oslomed Centrum Medyczne
NOT_YET_RECRUITING
Krakow
Medrise Sp. z o.o.
NOT_YET_RECRUITING
Lublin
Twoja Przychodnia PCM
NOT_YET_RECRUITING
Poznan
ETG Siedlce
NOT_YET_RECRUITING
Siedlce
Sonomed Sp. z o. o.
NOT_YET_RECRUITING
Szczecin
Twoja Przychodnia SCM
NOT_YET_RECRUITING
Szczecin
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
NOT_YET_RECRUITING
Warsaw
WSD MEDI
NOT_YET_RECRUITING
Warsaw
ETG Zamość
NOT_YET_RECRUITING
Zamość
Contact Information
Primary
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
clinical_inquiry_hub@lilly.com
1-317-615-4559
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2028-03
Participants
Target number of participants: 60
Treatments
Active_comparator: Mirikizumab
Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Experimental: LY4395089 and Mirikizumab Co-Administration
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov