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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03650114




Registration number
NCT03650114
Ethics application status
Date submitted
17/08/2018
Date registered
28/08/2018
Date last updated
20/11/2024

Titles & IDs
Public title
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Scientific title
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
Secondary ID [1] 0 0
COMB157G2399
Universal Trial Number (UTN)
Trial acronym
ALITHIOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ofatumumab
Treatment: Other - Tetanus toxoid (TT) containing vaccine (Td, Tdap)
Treatment: Other - 13-valent pneumococcal conjugate vaccine (13-PCV)
Treatment: Other - 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Treatment: Other - Seasonal Quadrivalent influenza vaccine
Treatment: Other - Keyhole limpet hemocyanin (KLH) neo-antigen

Experimental: Ofatumumab - Subcutaneous injection


Treatment: Other: Ofatumumab
subcutaneous injection of 20 mg ofatumumab every 4 weeks

Treatment: Other: Tetanus toxoid (TT) containing vaccine (Td, Tdap)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid

Treatment: Other: 13-valent pneumococcal conjugate vaccine (13-PCV)
0.5mL Vial/Syringe

Treatment: Other: 23-valent pneumococcal polysaccharide vaccine (23-PPV)
0.5mL Vial/Syringe

Treatment: Other: Seasonal Quadrivalent influenza vaccine
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)

Treatment: Other: Keyhole limpet hemocyanin (KLH) neo-antigen
1mg Vial
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
Timepoint [1] 0 0
Up to 8 years
Secondary outcome [1] 0 0
Number of relapse rates per year
Timepoint [1] 0 0
Data from the core studies through the first 5 years in this study.
Secondary outcome [2] 0 0
Patients with confirmed 3 and 6 month disability worsening
Timepoint [2] 0 0
During the first 5 years of treatment in the study.
Secondary outcome [3] 0 0
Patients with confirmed 6, 12, and 24 month disability improvement and improvement during the first 5 years of the study.
Timepoint [3] 0 0
During the first 5 years of treatment in the study.
Secondary outcome [4] 0 0
Patients with changes in Expanded Disability Status Scale (EDSS) scores
Timepoint [4] 0 0
Data from the core studies through the first 5 years in this study, (depending on if first dose was in the core or in this extension study or comparator randomization)
Secondary outcome [5] 0 0
Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores
Timepoint [5] 0 0
During the first 5 years of the study.
Secondary outcome [6] 0 0
Changes in the Magnetic Resonance Image (MRI) related to brain volume loss
Timepoint [6] 0 0
Data from the core studies through the first 5 years in this study.
Secondary outcome [7] 0 0
Changes in the Magnetic Resonance Image (MRI) related to T2 lesions
Timepoint [7] 0 0
Data from the core studies through the first 5 years in this study.
Secondary outcome [8] 0 0
Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions
Timepoint [8] 0 0
Data from the core studies through the first 5 years in this study.
Secondary outcome [9] 0 0
Changes in neurofilament light change serum concentration
Timepoint [9] 0 0
Data from the core studies through the first 5 years in this study.

Eligibility
Key inclusion criteria
1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
2. Written informed consent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2028
Actual
Sample size
Target
2060
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Novartis Investigative Site - St Leonards
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03650114
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03650114