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Sphingosine-1-phosphate receptor modulator

Ozanimod de-escalation of anti-CD20 treatment for Multiple Sclerosis

Phase 1 & 2
Waitlist Available
Led By Enrique Alvarez, MD/PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participants have been diagnosed with relapsing forms of MS and have had multiple sclerosis related symptoms at least 3 years prior to baseline visit
* Male or female participants \> 18 years of age at the time of initiation of de-escalation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Summary

A multi-center pilot study to evaluate safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.

Eligible Conditions
  • Multiple Sclerosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
New T2 lesions count
Serious infections
Secondary study objectives
Adverse Events
Brain parenchymal and thalamic volume loss
IgG and IgM levels
+4 more
Other study objectives
25-foot walk speed
9-hole peg test
Changes in employment
+3 more

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734
49%
Influenza Like Illness
12%
Headache
11%
Nasopharyngitis
8%
Upper Respiratory Tract Infection
6%
Orthostatic Hypotension
6%
Pyrexia
5%
Alanine Aminotransferase Increased
4%
Urinary Tract Infection
3%
Hypertension
3%
Pharyngitis
2%
Gamma-Glutamyltransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Interferon Beta-1a
Ozanimod 0.5 mg
Ozanimod 1 mg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ozanimod de-escalation of anti-CD20 treatmentExperimental Treatment1 Intervention
Ozanimod will be started 6-12 months after the last anti-CD20 infusion or 30-180 days from their last ofatumumab injection. Ozanimod will be provided by the study.
Group II: Continued anti-CD20 treatmentActive Control1 Intervention
Patients will continue to receive anti-CD20. Propensity score matched to the experimental arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozanimod
2020
Completed Phase 3
~3510

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,776 Previous Clinical Trials
2,775,041 Total Patients Enrolled
21 Trials studying Multiple Sclerosis
2,767 Patients Enrolled for Multiple Sclerosis
Enrique Alvarez, MD/PhDPrincipal InvestigatorUniversity of Colorado, Denver
~32 spots leftby Aug 2028
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