Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS)

Phase 1

• Conditions: relapsing multiple sclerosis; MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000307-20-DE
• Lead Sponsor: ovartis Pharma Vertriebs GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-12
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study.
2. Patients eligible to start ofatumumab as per physician’s discretion and approved SmPC (exp. April, 2021; for cohort 2, patients may already be on ofatumumab, but most patients will start ofatumumab as part of this study).
3. Patients willing and eligible to receive a modRNA vaccine against SARS-CoV-2 as part of clinical routine
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of COVID-19 or current COVID-19 symptoms
2. Patients who previously received a BTK inhibitor or an antiCD20 therapy other than ofatumumab
3. Patients likely not being able or willing to complete the study
4. Use of other investigational drugs within 5 half-lives of enrollment/initiation of study treatment (e.g. small molecules) or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer
5. Patients with any medical or psychological condition that, in the investigators opinion, renders the patient unable to understand the nature, scope, and possible consequences of the study
6. No person directly associated with the administration of the study is allowed to participate as a study subject
7. No family member of the investigational study staff is allowed to participate in this study
8. No previous vaccination with a non-modRNA SARS-CoV-2 vaccine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified