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Center for Global Research Data

Mapping of components of the complete blood count and comprehensive metabolic profile to disease-specific clinical and endoscopy endpoints in phase 2 and 3 clinical trials of ulcerative colitis and Crohn’s disease 

Lead InvestigatorKlaus GottliebEli Lilly USA
Title of Proposal Research:Mapping of components of the complete blood count and comprehensive metabolic profile to disease-specific clinical and endoscopy endpoints in phase 2 and 3 clinical trials of ulcerative colitis and Crohn’s disease 
Vivli Data Request: 3328
Funding Source:Commercial FundingThe work will be conducted by full-time employees of Eli Lilly and company, the applicant.
Potential Conflicts of Interest: Eli Lilly is involved in research and development of drugs for autoimmune diseases, including inflammatory bowel disease. Research findings will be made public.

Summary of the Proposed Research: 

If successful, this machine learning research project will lead to a better understanding of how routinely obtained reported laboratory values can be used to predict endoscopic outcomes of patients with ulcerative colitis and Crohn’s disease. Endoscopic improvement is a prerequisite of healing and getting better. Endoscopic improvement and related outcomes are measured by endoscopic evaluations and multi-component clinical endpoints, such as Crohn’s Disease Activity Index (CDAI) and Mayo score. Given an invasive nature of endoscopic evaluations and the complex nature of clinical trial endpoints, an ability to evaluate patient outcomes using alternative non-invasive and commonly performed tests would be greatly beneficial to patients in both clinical practice and clinical drug development. 

Requested Studies:
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn’s Disease (GEMINI II) 

Sponsor: Takeda 
Study ID: NCT00783692
Sponsor ID: C13007 

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease (GEMINI III) 

Sponsor: Takeda
Study ID: NCT01224171
Sponsor ID: C13011 

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis (GEMINI I) 

Sponsor: Takeda
Study ID:  NCT00783718
Sponsor ID: C13006 

Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Examine the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Patients With Moderately or Severely Active Ulcerative Colitis 

Sponsor: Takeda
Study ID:  NCT02039505
Sponsor ID: MLN0002/CCT-101 

Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn’s Disease 

Sponsor: Takeda
Study ID:  NCT00655135
Sponsor ID: L299-016 

A Phase II, Randomized, Placebo-Controlled, Double Blind, Parallel Group, Multicenter Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients with Mildly to Moderately Active Ulcerative Colitis 

Sponsor: Takeda
Study ID:  N/A
Sponsor ID: M200-022