Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod (COAST: CD20 and Ozanimod Sequencing Trial)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Participants received their last anti-CD20 infusion, including ocrelizumab subcutaneous injection, within 6-12 months or received their last ofatumumab injection within 30 -180 days from Day 1

• Participants must provide written informed consent and be able to comply with the visit schedule and study related assessments

• Participants must be able to undergo a brain MRI without anesthesia

• Woman of Childbearing Potential must agree to practice a highly effective method of contraception throughout the study until completion and willing to follow pregnancy precautions.

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Nevada
Cleveland Clinic
RECRUITING
Las Vegas
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Enrique Alvarez, MD/PhD
enrique.alvarez@cuanschutz.edu
303-724-8249
Backup
Lilli Farrell, BS
lillian.farrell@cuanschutz.edu
Time Frame
Start Date: 2024-07-29
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 100
Treatments
Experimental: Ozanimod de-escalation of anti-CD20 treatment
Ozanimod will be started 6-12 months after the last anti-CD20 infusion, including ocrelizumab subcutaneous injection, or 30-180 days from their last ofatumumab injection. Ozanimod will be provided by the study.
No_intervention: Continued anti-CD20 treatment
Patients will continue to receive anti-CD20. Propensity score matched to the experimental arm.
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

Similar Clinical Trials