Clinical trial NCT03249714: Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
Official title: A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Multiple Sclerosis
Keywords: double-blind
placebo controlled
ofatumumab
relapsing multiple sclerosis
Japanese patients
MS
RMS
adult
OMB157
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study had 2 parts: A controlled Core and an open-label Extension.

* Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group, multicenter study evaluated the efficacy, safety and tolerability and PK of ofatumumab in patients with RMS.
* Extension part: The Core part was followed by an Extension part in which all patients received open-label ofatumumab. In the Extension part, patients were treated for at least 24 weeks and no longer than 48 weeks.

Sixty-four patients were randomized in a 2:1 ratio to ofatumumab or placebo in the Core part; half of the study patients were from Japan and the other half from the other countries.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part
timeFrame: Baseline up to Week 24
measure: Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part
timeFrame: Baseline up to Week 24
measure: Annualized Relapse Rate (ARR) - Core Part
timeFrame: Baseline up to Week 24
measure: Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
timeFrame: Pre-dose at Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24
measure: B-cell Counts - Japan vs Non-Japan - Core Part
timeFrame: Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24
measure: Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part
timeFrame: Week 24 up to Week 48
measure: Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part
timeFrame: Week 24 up to Week 48
measure: Annualized Relapse Rate (ARR) - Extension Part
timeFrame: Week 24 up to Week 48
measure: Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part
timeFrame: Weeks 24, 28, 36, 48
measure: B-cell Counts - Extension Part
timeFrame: Weeks 24, 36 and 48
measure: Participants With Confirmed Relapse - Core and Extension Parts
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
city: Toon-city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kawagoe
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kodaira
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
References: