Ozanimod for Colitis, Ulcerative

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
OM Research, Lancaster, CA
Colitis, Ulcerative+2 More
Ozanimod - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to explore the safety, efficacy, quality of life, and biomarker response in participants with moderate to severe ulcerative colitis in clinical practice.

Eligible Conditions

  • Colitis, Ulcerative

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Colitis, Ulcerative

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Up to approximately 3 years

Week 156
Clinical remission by partial Mayo score
Clinical response by partial Mayo score
Corticosteroid-free clinical remission by partial Mayo
Week 26
Clinical remission as measured by modified Mayo score
Clinical response as measured by modified Mayo score
Corticosteroid-free clinical remission as measured by modified Mayo score
Proportion of participants who achieve endoscopic improvement
Proportion of participants who achieve endoscopic remission
Proportion of participants who achieve endoscopic response
Proportion of participants who achieve histological improvement
Proportion of participants who achieve histological remission
Proportion of participants with IBDQ remission with total score of ≥ 170 points
Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline
Proportion of participants with change in total score (≥ 16 points) of IBDQ response from baseline
Proportion of participants with histo-endoscopic mucosal improvement
Year 3
Proportion of participants with AEs leading to discontinuation
Proportion of participants with AEs of interest (AEI)
Proportion of participants with Adverse Events (AEs)
Proportion of participants with Serious Adverse Events (SAEs)
Proportion of participants with clinical laboratory abnormalities

Trial Safety

Safety Progress

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

Other trials for Colitis, Ulcerative

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

Cohort 1 - Advanced therapy-naive
1 of 2
Cohort 2 - Advanced therapy-exposed
1 of 2
Experimental Treatment

580 Total Participants · 2 Treatment Groups

Primary Treatment: Ozanimod · No Placebo Group · Phase 4

Cohort 1 - Advanced therapy-naive
Drug
Experimental Group · 1 Intervention: Ozanimod · Intervention Types: Drug
Cohort 2 - Advanced therapy-exposed
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: up to approximately 3 years
Closest Location: OM Research · Lancaster, CA
Photo of california 1Photo of california 2Photo of california 3
2020First Recorded Clinical Trial
3 TrialsResearching Colitis, Ulcerative
2 CompletedClinical Trials

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,463 Previous Clinical Trials
3,907,324 Total Patients Enrolled
12 Trials studying Colitis, Ulcerative
2,238 Patients Enrolled for Colitis, Ulcerative

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration.
You have moderate to severely active UC disease activity defined as a modified Mayo score of 5 through 9, inclusive.

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.