Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod

ConditionRelapsing Multiple Sclerosis

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 > or = to 18 years of age at the time of initiation of de-escalation

Participants do not have evidence of new inflammatory disease activity (no new T2/contrast enhancing lesions, absence of relapses) for a minimum of two years prior to de-escalation

Participant is taking an anti-CD20 therapy as a DMT continuously for a minimum of two years (e.g., has received at least 3 courses of rituximab, ocrelizumab, ublituximab; 24 months of treatment with ofatumumab; or a combination of treatments whereby the patient has been deemed to be B-cell depleted for 2 years) prior to initiation of de-escalation

Disqualifiers

Any progression of neurological disability in the year prior to the screening visit that would be consistent with progressive MS

Participant has an EDSS >6.5

Participant has a history of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)

Participant is considering pregnancy in the short term, is pregnant, lactating or has a positive serum beta human chorionic gonadotropin (B-hCG) measured during screening.

Trial design

Design model

Parallel

Treatments tested in this trial

Ozanimod
Drug
De-escalation of anti-CD20 treatment using ozanimod.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Ozanimod de-escalation of anti-CD20 treatmentExperimental treatment 1 intervention

Group B: Continued anti-CD20 treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

New T2 lesions count

Number of new T2 lesions on MRI scans.

Time frame

36 months

Serious infections

Infections requiring hospitalization, intravenous antibiotic use, or prolonged antibiotic use for treatment of an infection for at least 30 days.

Time frame

36 months

Secondary outcomes

Relapses

Protocol and/or suspected relapses

Time frame

36 months

IgG and IgM levels

Time frame

36 months

Infections

All infections including opportunistic infections.

Time frame

36 months

No Evidence of Disease Activity (NEDA-3)

Not meeting any of the following criteria: 1. Evidence of Relapse activity - collected every 3 months via phone calls/clinic visits. 2. MRI disease activity - presence of new T2 lesions from MRI scans conducted at any timepoint. 3. 6 months Confirmed Disability progression (CDP6): measured by the EDSS assessed at baseline and every 6 months. CDP6 is defined as an increase in Expanded Disability Status Scale (EDSS) score of ≥1.5 if baseline EDSS was 0; or ≥1.0 points if baseline EDSS was ≥0.5-≤5.5; or by ≥0.5 points if baseline EDSS ≥6, sustained over two consecutive visits.

Time frame

36 months

Other outcomes

Symbol Digital Modalities Test

A 4 points or 10% change in cognition

Time frame

36 months

9-hole peg test

A 20% change in hand function

Time frame

36 months

25-foot walk speed

A 20% change in walking speed

Time frame

36 months

Multiple Sclerosis Functional Composite (MSFC)

A change in any of the above three criteria

Time frame

36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Source ClinicalTrials.gov

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