The main purpose of this study is to see how the safety and how well it works of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.
Official registry: https://clinicaltrials.gov/study/NCT07483099 · Eli Lilly and Company · enrollment listed as 60
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are LY4395089, Mirikizumab - Intravenous (IV), or Mirikizumab - Subcutaneous (SC). The registry lists allocation as randomized. The main purpose of this study is to see how the safety and how well it works of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD).
They plan to enroll about 60 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease
Interventions: LY4395089, Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC)
Primary outcome (registry wording): Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response
There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
clinical_inquiry_hub@lilly.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 57 sites outside the US on the same record
Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.
NCT02421705 · Official ClinicalTrials.gov record · KU Leuven
Background: Crohn s disease (CD) is an inflammatory bowel disease. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition.
NCT03167437 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)
This study wants to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).
NCT04372108 · Official ClinicalTrials.gov record · Janssen Scientific Affairs, LLC
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary