Ozanimod for Ileocolitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Local Institution - 0062, Liege, Belgium
Ileocolitis
Ozanimod - Drug
Eligibility
< 18
All Sexes
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Study Summary

The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Ileocolitis

Study Objectives

2 Primary · 20 Secondary · Reporting Duration: At week 12, week 64, and up to 81 weeks

At week 12
Proportion of participants achieving SES-CD ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point
Proportion of participants who achieve PCDAI < 10
Week 64
Proportion of adolescents who achieve CDAI reduction from Baseline of ≥ 100 points or CDAI score < 150
Proportion of adolescents who achieve Crohn's Disease Activity Index (CDAI) score < 150
Proportion of adolescents who achieve an average daily abdominal pain score ≤ 1 point
Proportion of adolescents who achieve an average daily stool frequency ≤ 3 points with abdominal pain
Proportion of adolescents who achieve stool frequency no worse than Baseline
Proportion of participants who achieve SES-CD decrease from Baseline of ≥ 50% (ER-50)
Proportion of participants who achieve reduction in PCDAI score ≥ 12.5
Proportion of participants who achieve total PCDAI score of < 30 points
Week 81
Absolute change from Baseline in absolute lymphocyte count (ALC)
Percent change from Baseline in ALC
Week 81
Steady state systemic exposures of CC112273
Steady state systemic exposures of ozanimod
At week 64
Proportion of participants achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point
Proportion of participants who achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10
Proportion of participants who achieve a CDAI score < 150 while remaining corticosteroid free in the prior 12 weeks (adolescents only)
Proportion of participants who achieve a PCDAI score < 10 while remaining corticosteroid free in the prior 12 weeks
Up to 81 weeks
Change from Baseline in stool frequency score over time
Change from baseline in abdominal pain over time measured by Pediatric Crohn's Disease Activity Index (graded from 0-10)
Number of participants with Adverse Events (AEs)
Number of participants with Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Ileocolitis

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
0%Chronic Sinusitis
0%Goitre
0%Large Intestine Polyp
0%Umbilical Hernia
0%Abdominal Wall Haematoma
0%Fatigue
0%Cholecystitis Chronic
0%Pyelonephritis Acute
0%Acute Hepatitis B
0%Diverticulitis
0%Ankle Fracture
0%Comminuted Fracture
0%Hepatic Enzyme Increased
0%Osteitis
0%Carbon Monoxide Poisoning
0%Ligament Sprain
0%Invasive Breast Carcinoma
0%Intentional Overdose
0%Jaw Fracture
0%Traumatic Fracture
0%Intervertebral Disc Disorder
0%Pseudarthrosis
0%Medulloblastoma
0%Keratoacanthoma
0%Malignant Melanoma In Situ
0%Central Nervous System Lesion
0%Autonomic Nervous System Imbalance
0%Guillain-Barre Syndrome
0%Acoustic Neuritis
0%Cerebral Infarction
0%Epilepsy
0%Cervical Radiculopathy
0%Generalised Tonic-Clonic Seizure
0%Metrorrhagia
0%Calculus Urinary
0%Multiple Sclerosis Relapse
0%Lumbar Radiculopathy
0%Sciatica
0%Uterine Polyp
0%Vanishing Twin Syndrome
0%Pulmonary Embolism
0%Endometriosis
0%Ovarian Cyst
0%Dysfunctional Uterine Bleeding
0%Urticaria
0%Skin Ulcer
0%Intervertebral Disc Protrusion
0%Sinus Tachycardia
0%Acute Myocardial Infarction
0%Atrial Fibrillation
0%Supraventricular Tachycardia
0%Keratoconus
0%Abdominal Pain
0%Drowning
0%Cyst
0%Cholelithiasis
0%Hyperplastic Cholecystopathy
0%Gastroenteritis
0%Appendicitis
0%Pneumonia
0%Lumbar Vertebral Fracture
0%Tonsillitis
0%Clavicle Fracture
0%Concussion
0%Seizure
0%Craniocerebral Injury
0%Joint Injury
0%Lower Limb Fracture
0%Cerebral Haemorrhage
0%Back Pain
0%Breast Cancer
0%Chronic Lymphocytic Leukaemia
0%Ovarian Fibroma
0%Neuralgia
0%Syncope
0%Speech Disorder
0%Foetal Growth Restriction
0%Placental Polyp
0%Chronic Kidney Disease
0%Suicide Attempt
0%Urethral Stenosis
0%Renal Colic
0%Breast Cyst
0%Cervical Polyp
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

Ozanimod Dose Level 1
1 of 2
Ozanimod Dose Level 2
1 of 2
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Ozanimod · No Placebo Group · Phase 2 & 3

Ozanimod Dose Level 1
Drug
Experimental Group · 1 Intervention: Ozanimod · Intervention Types: Drug
Ozanimod Dose Level 2
Drug
Experimental Group · 1 Intervention: Ozanimod · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozanimod
2020
Completed Phase 3
~3370

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at week 12, week 64, and up to 81 weeks
Closest Location: Local Institution - 0054 · Montréal, Canada
Photo of quebec 1Photo of quebec 2Photo of quebec 3
2022First Recorded Clinical Trial
0 TrialsResearching Ileocolitis
3 CompletedClinical Trials

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,463 Previous Clinical Trials
3,907,784 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 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.