Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

NCT03249714 | Completed Phase 2 Results DMC

• 1 other identifier: COMB157G1301
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 14

Brief Summary

The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries

Conditions

Relapsing Multiple Sclerosis

Keywords

double-blind; placebo controlled; ofatumumab; relapsing multiple sclerosis; Japanese patients; MS; RMS; adult; OMB157

Outcome Measures

Primary Outcomes (1)

• Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part

  Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, and subgroup of baseline number of Gd-enhancing T1 lesions (0 or \>=1) as explanatory variables, and logarithm of the patient's number of scans as the offset variable.

  Baseline up to Week 24

Secondary Outcomes (11)

• Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part

  Baseline up to Week 24

• Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part

  Baseline up to Week 24

• Annualized Relapse Rate (ARR) - Core Part

  Baseline up to Week 24

• Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part

  Pre-dose at Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24

• B-cell Counts - Japan vs Non-Japan - Core Part

  Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24

Study Arms (2)

OMB 20 mg

EXPERIMENTAL

Ofatumumab 20 mg subcutaneous injection on Days 1,7, 14 and every 4 weeks for 24 weeks in Core. Core placebo patients received loading dose at Weeks 25 and 26 and then all Extension patients received dose every 4 Weeks up to Week 48.

Drug: Ofatumumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection matching to ofatumumab every 4 weeks for 24 weeks in Core

Drug: Matching placebo of ofatumumab

Interventions

Ofatumumab DRUG

Provided in pre-filled syringes for subcutaneous injection (s.c.) administration containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content)

OMB 20 mg

Matching placebo of ofatumumab DRUG

Matching placebo in pre-filled syringes

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of multiple sclerosis (MS)
• Relapsing MS (RMS)
• At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization
• EDSS score of 0 to 5.5

You may not qualify if:

• Primary progressive MS or SPMS without disease activity
• Patients with an active chronic disease of the immune system other than MS
• Patients at risk of developing or having reactivation of hepatitis
• Patients with active systemic infections or with neurological findings consistent with PML

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (14)

Novartis Investigative Site

Tōon, Ehime, 791-0295, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 063-0005, Japan

Location

Novartis Investigative Site

Morioka, Iwate, 020-8505, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980 8574, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 983 8512, Japan

Location

Novartis Investigative Site

Kawagoe, Saitama, 350 8550, Japan

Location

Novartis Investigative Site

Kodaira, Tokyo, 187-8551, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160 8582, Japan

Location

Novartis Investigative Site

Chiba, 260 8677, Japan

Location

Novartis Investigative Site

Niigata, 951 8520, Japan

Location

Novartis Investigative Site

Osaka, 556-0016, Japan

Location

Novartis Investigative Site

Kazan', 420021, Russia

Location

Novartis Investigative Site

Novosibirsk, 630007, Russia

Location

Related Links

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

MeSH Terms

Interventions

ofatumumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: March 15, 2018
• Primary Completion: December 26, 2019
• Study Completion: July 29, 2020
• Last Updated: April 29, 2022
• Results First Posted: February 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

RU (2); JP (12)