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

A Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS)

ClinicalTrials.gov Identifier: NCT04486716

Novartis Reference Number: COMB157GUS07

Last Update: Mar 23, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Relapsing Multiple Sclerosis
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Oct 19, 2020
Completion date 
Jan 01, 2024
Gender 
All
Age(s)
18 Years - 60 Years (Adult)

Interventions

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

Eligibility Criteria

Inclusion Criteria:

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

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):

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):

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.

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:

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

Study Locations

United States
Novartis Investigative Site
Recruiting
Birmingham, 35209
Alabama
United States
Novartis Investigative Site
Recruiting
Encinitas, 92024
California
United States
Novartis Investigative Site
Recruiting
Aurora, 80045
Colorado
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Tallahassee, 32308
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33612
Florida
United States
Novartis Investigative Site
Recruiting
Lutherville, 21093
Maryland
United States
Novartis Investigative Site
Recruiting
Wellesley, 02481
Massachusetts
United States
Novartis Investigative Site
Recruiting
Golden Valley, 55422
Minnesota
United States
Novartis Investigative Site
Recruiting
Las Vegas, 89106
Nevada
United States
Novartis Investigative Site
Recruiting
Latham, 12110
New York
United States
Novartis Investigative Site
Recruiting
Westerville, 43082
Ohio
United States
Novartis Investigative Site
Recruiting
Knoxville, 37922
Tennessee
United States
Novartis Investigative Site
Recruiting
Round Rock, 78681
Texas
United States
Novartis Investigative Site
Recruiting
Seattle, 98122
Washington
United States
Puerto Rico
Novartis Investigative Site
Recruiting
Guaynabo, 00968
-
Puerto Rico

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]