Ozanimod for Ileocolitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ileocolitis
Ozanimod - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it can help people with Crohn's Disease.

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 29 Secondary · Reporting Duration: Week 12

Week 12
Assessment of circulating lymphocyte concentration
Assessment of gene expression
Severe Acute Respiratory Syndrome
Assessment of pharmacogenetics
Assessment of protein biomarker concentration
Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points
Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline
Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50%
Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points
Week 12
Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000)
Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores using the Global Histologic Disease Activity Score
Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150
Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 with SES-CD decrease from baseline of ≥ 50%
Proportion of participants with CDAI reduction from baseline of ≥ 70 points
Proportion of participants with CDAI score < 150 with SES-CD decrease from baseline of ≥ 50%
Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150
Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50%
Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50%
Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10%
Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50%
Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points
Proportion of participants with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline
Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150
Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50%
Proportion of subjects with CDAI reduction from baseline of ≥ 70 points
Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50%
Proportion of subjects with a CDAI score < 150
Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50%
Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50%
Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10%
Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ozanimod 0.5 mg
13%Nasopharyngitis
13%Headache
8%Upper Respiratory Tract Infection
7%Alanine Aminotransferase Increased
6%Influenza Like Illness
6%Orthostatic Hypotension
5%Urinary Tract Infection
5%Pharyngitis
5%Hypertension
4%Gamma-Glutamyltransferase Increased
3%Pyrexia
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02047734) in the Ozanimod 0.5 mg ARM group. Side effects include: Nasopharyngitis with 13%, Headache with 13%, Upper Respiratory Tract Infection with 8%, Alanine Aminotransferase Increased with 7%, Influenza Like Illness with 6%.

Trial Design

2 Treatment Groups

Administration of oral Ozanimod
1 of 2
Administration of Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

600 Total Participants · 2 Treatment Groups

Primary Treatment: Ozanimod · Has Placebo Group · Phase 3

Administration of oral Ozanimod
Drug
Experimental Group · 1 Intervention: Ozanimod · Intervention Types: Drug
Administration of Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozanimod
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12

Who is running the clinical trial?

CelgeneLead Sponsor
625 Previous Clinical Trials
172,526 Total Patients Enrolled
Kanthi Kollengode, MDStudy DirectorCelgene Corporation
3 Previous Clinical Trials
1,869 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,394 Previous Clinical Trials
3,306,909 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have Crohn's disease for at least 3 months on endoscopy and on histological exam.
Please confirm that you do *not* have ulcerative colitis?
Have you previously tried a treatment for Crohn's disease which didn't work?
Have you been diagnosed with Crohn's disease?

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
North Carolina62.5%
South Carolina25.0%
California12.5%
How old are they?
18 - 6587.5%
65+12.5%
What site did they apply to?
Galiz Research LLC25.0%
PMG Research of Charlotte LLC25.0%
PMG Research of Winston-Salem LLC50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria75.0%
Met criteria25.0%