An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC)

Phase 1

• Conditions: secondary progressive multiple sclerosis (SPMS); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-005752-38-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-19
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study.
2. One of the following MS treatments as part of clinical routine:
a. Cohort 1: Siponimod treatment according to EU SmPC without interrupting daily dosing for the purpose of vaccination with SARS-CoV-2 modRNA
b. Cohort 2: Siponimod treatment according to EU SmPC interrupting daily dosing for the purpose of vaccination with SARS-CoV-2 modRNA
c. Cohort 3: Dimethylfumarate, glatirameracetate, interferon, teriflunomode as per respective EU SmPC or no current treatment with diagnosis of SPMS or with RRMS at risk to develop SPMS (at the discretion of the treating physician)
3. Planning to receive a SARS-CoV-2 modRNA vaccination as part of clinical routine
4.No change regarding DMT within 4 weeks prior to inclusion to AMA-VACC, i.e. stable on current DMT according to dosing within label, no interruption, start or withdrawal of DMT in this period of time and no planned switch of DMT within following 2 months
5.Patients willing and eligible to receive a modRNA vaccine against COVID-19 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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. History of COVID-19
2. SARS-CoV-2 antibodies at screening
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 and who are therefore not able to comply with the requirements of the study and capable of giving informed consent
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. Known or suspected clinically relevant allergy, intolerance or hypersensitivity to peanuts, soya (only cohort 1 and 2) or to any of the study treatments designated for the individual subject (DMTs or mRNA vaccines) or drugs of similar chemical classes (active substance or excipients)
9. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 10 days of study treatment after stopping medication.
10. For cohort 3: patients with contraindications for their current MS medication according to the respective EU SmPC

Study & Design

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