Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

Novartis

Status and phase: Enrolling; Phase 3

Conditions: Relapsing Multiple Sclerosis

Treatments: Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV); Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap); Biological: Ofatumumab; Biological: 13-valent pneumococcal conjugate vaccine (13-PCV); Biological: Seasonal Quadrivalent influenza vaccine; Biological: Keyhole limpet hemocyanin (KLH) neo-antigen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03650114

COMB157G2399

Details and patient eligibility

About

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

COVID-19 sub-study:

The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Enrollment: 2,060 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
2. Written informed consent

Exclusion criteria

• Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
• Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
• Subjects taking medications prohibited by the protocol
• Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

1. Informed consent
2. Actively enrolled in the COMB157G2399 Study
3. 12 weeks of continuous treatment within the COMB157G2399 Study
4. prior vaccination history as per protocol-defined

Exclusion criteria

• known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
• allergies to egg or shellfish
• any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
• any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,060 participants in 1 patient group

Ofatumumab

Experimental group

Description:

Subcutaneous injection

Treatment:

Biological: Keyhole limpet hemocyanin (KLH) neo-antigen

Biological: Seasonal Quadrivalent influenza vaccine

Biological: 13-valent pneumococcal conjugate vaccine (13-PCV)

Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap)

Biological: Ofatumumab

Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV)