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

NCT04486716 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: COMB157GUS07111,116
• Study Type: interventional
• Target: 111
• Locations: 2 countries
• Sites: 20

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

Conditions

Relapsing Multiple Sclerosis

Keywords

Ofatumumab; Relapsing multiple sclerosis; MS; RMS; CIS; RRMS; SPM; ocrelizumab; MRI; CD19 B; adult,; OMB157; open-label; rituximab

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With no Change or a Reduction From Baseline in the Number of Gadolinium Enhancing (GdE) Lesions at Month 12 Using Non-responder Imputation

  Magnetic Resonance Imaging (MRI) was used to measure presence of new or reduction in number of gadolinium enhancing T1 lesions. Each MRI scan was previewed by a local neuroradiologist. The quality of each scan performed was assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol. A nonresponder imputation (NRI) for missing data approach was applied. NRI assumes that a participant was a treatment failure, i.e. non-responder, if they did not have a valid Month 12 MRI assessment, or if they discontinued the study prematurely and did not have a valid Month 12 MRI assessment.

  Baseline (assessed at screening visit), Month 12

• Percentage of Participants With no Change or a Reduction From Baseline in the Number of Gadolinium Enhancing (GdE) Lesions at Month 12 Based on Observed Data

  Magnetic Resonance Imaging (MRI) was used to measure presence of new or reduction in number of gadolinium enhancing T1 lesions. Each MRI scan was previewed by a local neuroradiologist. The quality of each scan performed was assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol. A sensitivity analysis of the primary endpoint was performed based on an observed data approach.

  Baseline (assessed at screening visit), Month 12

Secondary Outcomes (6)

• Number of Participants Who Continued Study Treatment From Baseline to Months 6 and 12

  Baseline, Month 6, Month 12

• Change From Baseline in CD19+ B Cell Counts Obtained by FACS

  Baseline, Month 6, Month 12

• Change From Baseline in CD20+ CD3+ T Cell Counts Obtained by FACS

  Baseline, Month 6, Month 12

• Number of Participants With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline (all prior history), Post-baseline (up to Month 12)

• Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Scores at Baseline, Month 6 and Month 12

  Baseline, Month 6, Month 12

Study Arms (1)

Ofatumumab

EXPERIMENTAL

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

Drug: Ofatumumab

Interventions

Ofatumumab DRUG

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

Also known as: OMB157

Ofatumumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed.
• Male or female participants aged 18 to 60 years (inclusive) at screening.
• 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).
• Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive).
• 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):
• \. 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):
• At least 2 fully infused courses of rituximab 500 mg - 1000 mg iv every 6 months (+/- one month).
• 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)
• Last fully infused rituximab dose must have occurred within 4-9 months prior to baseline.
• \. 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.
• \. Must be able to use a smart device or have a caregiver that can assist.

You may not qualify if:

• 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
• Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverse events:
• Severe infusion-related reactions (Grade 3 or above)
• 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.
• Decreased IgG requiring treatment with Intravenous immunoglobulin
• Participants with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014).
• Participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2015).
• Pregnant or nursing (lactating) women
• 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.
• 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).
• Participants with active systemic bacterial, viral or fungal infections, or known to have acquired immunodeficiency syndrome (AIDS).
• Participants with neurological symptoms consistent with PML or with confirmed PML.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Alabama Neurology Associates PC

Birmingham, Alabama, 35209, United States

Location

Ctr for Neurology and Spine

Phoenix, Arizona, 85018, United States

Location

Neuro Center

Pomona, California, 91767, United States

Location

UC Health Neuroscience Ctr

Aurora, Colorado, 80045, United States

Location

Infinity Clinical Research LLC

Hollywood, Florida, 33024, United States

Location

AMO Corporation

Tallahassee, Florida, 32312, United States

Location

University Of South Florida

Tampa, Florida, 33612, United States

Location

International Neurorehab Institute

Lutherville, Maryland, 21093, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Cente

Boston, Massachusetts, 02215, United States

Location

Neurology Center of New England PC

Foxborough, Massachusetts, 02035, United States

Location

Dragonfly Research LLC

Wellesley, Massachusetts, 02481, United States

Location

Cleveland Clinic Foundation

Las Vegas, Nevada, 89106, United States

Location

Ms Ctr Of Northeastern Ny

Latham, New York, 12110, United States

Location

Columbus Neuroscience

Westerville, Ohio, 43082, United States

Location

Sibyl Wray MD Neurology PC

Knoxville, Tennessee, 37922, United States

Location

Parkland Health and Hospital Systems

Dallas, Texas, 75325, United States

Location

Central TX Neuro Consultants P A

Round Rock, Texas, 78681, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

Caribbean Center for Clinical Research, Inc

Guaynabo, 00968, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 41196386 DERIVED

Related Links

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

MeSH Terms

Interventions

ofatumumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 27, 2020
• Study Start: October 19, 2020
• Primary Completion: November 20, 2023
• Study Completion: October 21, 2024
• Last Updated: January 13, 2026
• Results First Posted: November 1, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PR (1); US (19)