A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis

NCT ID: NCT04486716

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2024-10-21

Brief Summary

A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy

Detailed Description

This was a single-arm, multicenter, prospective, study in participants with relapsing multiple sclerosis (MS) who had been previously treated with intravenous (i.v.) anti-CD20 monoclonal antibody (aCD20 mAb) therapy and had received at least 2 consecutive courses of intravenously administered ocrelizumab or rituximab every 6 months, and the last dose was within 4 to 9 months before Baseline/Day 1. In this study, participants could have enrolled only if discontinuing i.v. aCD20 mAb therapy for reasons other than lack of efficacy or due to certain treatment-emergent adverse events (TEAEs). Reasons for switching could have included but were not limited to physician/participant preference, access to commercial drug (e.g. insurance coverage issues), or for other logistical reasons (e.g. geographical relocation, travel, etc.).

Eligible participants received open label ofatumumab 20 mg subcutaneous (s.c.) once monthly for 12 months following initial loading regimen of 20 mg s.c. doses on Days 1, 7, and 14. After the 12-Month Treatment Period there was a Telephone Safety Follow-up call 30 days after last dose of study treatment. The Core phase covered a 28-day Screening Period, 12-Month Treatment Period, and 30-Day Telephone Safety Follow-up.

Upon completing the study, participants could opt to continue ofatumumab therapy through commercial services. Participants who did not continue into the ofatumumab commercial patient services hub within 1 month of the end of study visit or who did not switch to another therapy had to continue into the Post-Treatment Safety Follow-up period, consisting of every 3 month visits including B cell monitoring, until they were able to start on commercial ofatumumab, until they switched to another therapy, or until their B cells were repleted (defined as a B cell concentration greater than the individual participant's baseline value prior to starting the i.v. aCD20 mAb or greater than the lower limit of normal).

Conditions

Relapsing Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ofatumumab

Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml) administered at baseline, Day 7, Day 14 and monthly thereafter

Group Type: EXPERIMENTAL

Ofatumumab

Intervention Type: DRUG

Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml)

Interventions

Ofatumumab

Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml)

Intervention Type: DRUG

Other Intervention Names

OMB157

Eligibility Criteria

Inclusion Criteria

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Written informed consent must be obtained before any assessment is performed.

2. Male or female participants aged 18 to 60 years (inclusive) at screening.

3. Diagnosis of relapsing MS (RMS) according to the 2017 Revised McDonald criteria (Thompson et al. 2018), including CIS, RRMS or SPMS with disease activity as defined by (Lublin et al. 2014).

4. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive).

5. Received at least 2 courses of intravenous aCD20 mAb (loading doses are considered 1 course):

• Participants currently treated with ocrelizumab must have received (meet all three criteria below):

1. 2 fully infused initial 300 mg ocrelizumab iv infusions 2. At least 1 fully infused 600 mg ocrelizumab iv infusions 6 months (+/- one month) 3. Last fully infused ocrelizumab dose must have occurred within 4-9 months prior to baseline

•Participants currently treated with rituximab must have received (meet both criteria below):

1. At least 2 fully infused courses of rituximab 500 mg - 1000 mg iv every 6 months (+/- one month).

1. Initial loading regimens of rituximab i.e. 500 mg - 1000 mg on day 1 and on day 15, are allowed but this is consider a single course and must be followed by additional infusion(s) every 6 months (+/- one month)

2. Last fully infused rituximab dose must have occurred within 4-9 months prior to baseline.

6. Participants discontinuing aCD20 therapy for reasons including, but not limited to: physician/participant preference, access to commercial drug (e.g. insurance coverage issues) or for other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study. 7. Neurologically stable within 1 month prior to first study drug administration.

8. Must be able to use a smart device or have a caregiver that can assist.

Exclusion Criteria

Participants meeting any of the following criteria are not eligible for inclusion in this study:

1. Participants that have demonstrated suboptimal response to aCD20 therapy to include:

a. Signs of MRI activity, defined as ≥ 2 active Gd+ T1 lesions, or any new or newly enlarging T2 lesions, documented within the past 6 months

• If a prior MRI within the last 6 months is not available, then new or newly enlarging T2 lesions should be considered "not documented" and the patient may continue screening b. Documented relapse while on stable, previous aCD20 treatment.
• Relapses during the first 3 months of intravenous aCD20 therapy are allowable if the participant is then relapse-free for the 12 months following the relapse while on intravenous aCD20 therapy c. Any signs of clinical worsening as measured by EDSS or any clinical measure documented within the last 6 months

2. Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverse events:

1. Severe infusion-related reactions (Grade 3 or above)

2. Recurrent infections defined as ≥ 2 severe infections or ≥ 3 respiratory infections or the need for ≥ 2 courses of antibiotics since starting aCD20 therapy, if the Investigator believes this is related to therapy.

3. Decreased IgG requiring treatment with Intravenous immunoglobulin

3. Participants with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014).

4. Participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2015).

5. Pregnant or nursing (lactating) women

6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 6 months after stopping study medication.

7. Participants with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency).

8. Participants with active systemic bacterial, viral or fungal infections, or known to have acquired immunodeficiency syndrome (AIDS).

9. Participants with neurological symptoms consistent with PML or with confirmed PML.

10. Participants at risk of developing or having reactivation of syphilis or tuberculosis

11. Participants at risk of developing or having reactivation of hepatitis.

12. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration. a. There is presently no contraindication for the use of an inactivated, viral-vector-or mRNA based Sars-CoV-2 vaccine in patients who are immunocompromised. However, different Sars-CoV-2 vaccines may have various mechanisms of action and different associated potential risks. Please review local prescribing information of any specific Sars-CoV-2 vaccine and comply with local prescribing information requirements for specific contra-indications and special warnings and precautions for use.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alabama Neurology Associates PC

Birmingham, Alabama, United States

Ctr for Neurology and Spine

Phoenix, Arizona, United States

Neuro Center

Pomona, California, United States

UC Health Neuroscience Ctr

Aurora, Colorado, United States

Infinity Clinical Research LLC

Hollywood, Florida, United States

AMO Corporation

Tallahassee, Florida, United States

University Of South Florida

Tampa, Florida, United States

International Neurorehab Institute

Lutherville, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Cente

Boston, Massachusetts, United States

Neurology Center of New England PC

Foxborough, Massachusetts, United States

Dragonfly Research LLC

Wellesley, Massachusetts, United States

Cleveland Clinic Foundation

Las Vegas, Nevada, United States

Ms Ctr Of Northeastern Ny

Latham, New York, United States

Columbus Neuroscience

Westerville, Ohio, United States

Sibyl Wray MD Neurology PC

Knoxville, Tennessee, United States

Parkland Health and Hospital Systems

Dallas, Texas, United States

Central TX Neuro Consultants P A

Round Rock, Texas, United States

Swedish Neuroscience Institute

Seattle, Washington, United States

Caribbean Center for Clinical Research, Inc

Guaynabo, , Puerto Rico

Countries

United States; Puerto Rico

References

Hua LH, Brown B, Camacho E, Chinea AR, Greenberg BM, Henry RG, Houtsma E, Moreo N, Alvarez E. Switch from intravenous anti-CD20 therapy to subcutaneous ofatumumab in patients with relapsing MS: results from the OLIKOS study. J Neurol. 2025 Oct 24;272(11):725. doi: 10.1007/s00415-025-13462-w.

Reference Type: DERIVED

PMID: 41196386 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2802

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

111,116

Identifier Type: OTHER

Identifier Source: secondary_id

COMB157GUS07

Identifier Type: -

Identifier Source: org_study_id