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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02792231




Registration number
NCT02792231
Ethics application status
Date submitted
2/06/2016
Date registered
7/06/2016

Titles & IDs
Public title
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
Scientific title
A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.
Secondary ID [1] 0 0
2015-005419-33
Secondary ID [2] 0 0
COMB157G2302
Universal Trial Number (UTN)
Trial acronym
ASCLEPIOS II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Scelrosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ofatumumab subcutaneous injection
Treatment: Drugs - Teriflunomide-matching placebo capsules
Treatment: Drugs - Teriflunomide capsule
Treatment: Drugs - Matching placebo of ofatumumab subcutaneous injections

Experimental: OMG 20 mg - Ofatumumab 20 mg pre-filled syringes for subcutaneous injectionon on days 1

,7 ,14, week 4 and every 4 weeks thereafter and a teriflunomide-matching placebo, taken orally once daily

Active comparator: TER 14 mg - Teriflunomide 14 mg oral capsule taken once daily and matching placebo for subcutaneous injections to ofatumumab on days 1, 7, 14, week 4 and every 4 weeks thereafter


Treatment: Drugs: Ofatumumab subcutaneous injection
Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter

Treatment: Drugs: Teriflunomide-matching placebo capsules
Placebo capsule, matching in appearance to teriflunomide, taken orally once daily

Treatment: Drugs: Teriflunomide capsule
Teriflunomide 14 mg oral capsule taken once daily

Treatment: Drugs: Matching placebo of ofatumumab subcutaneous injections
Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Relapse Rate (ARR)
Timepoint [1] 0 0
Baseline up to 2.5 years
Secondary outcome [1] 0 0
3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data
Timepoint [1] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [2] 0 0
3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302
Timepoint [2] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [3] 0 0
6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data
Timepoint [3] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [4] 0 0
6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2302
Timepoint [4] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [5] 0 0
6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data
Timepoint [5] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [6] 0 0
6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2302
Timepoint [6] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [7] 0 0
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan
Timepoint [7] 0 0
Baseline, yearly up to 2.5 years
Secondary outcome [8] 0 0
Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate)
Timepoint [8] 0 0
Baseline, yearly up to 2.5 years
Secondary outcome [9] 0 0
Neurofilament Light Chain (NfL) Concentration in Serum
Timepoint [9] 0 0
Month 3, 12 and 24
Secondary outcome [10] 0 0
Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline
Timepoint [10] 0 0
Baseline, Months 12 and 24
Secondary outcome [11] 0 0
Participants With Confirmed Relapse
Timepoint [11] 0 0
Baseline up to 2.5 years
Secondary outcome [12] 0 0
Annualized Relapse Rate (ARR) >8 Weeks After Onset of Treatment
Timepoint [12] 0 0
Baseline up to 2.5 years
Secondary outcome [13] 0 0
3-month Confirmed Disability Worsening (3mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data
Timepoint [13] 0 0
Baseline up to 2.5 years
Secondary outcome [14] 0 0
6-month Confirmed Disability Worsening (6mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data
Timepoint [14] 0 0
Baseline up to 2.5 years
Secondary outcome [15] 0 0
6-month Confirmed Cognitive Decline on Symbol Digit Modalities Test (SDMT) - Pooled Data
Timepoint [15] 0 0
Baseline, every 6 months up to 2.5 years
Secondary outcome [16] 0 0
6-month Confirmed Disability Worsening (6mCDW) or 6-month Confirmed Cognitive Decline (6mCCD) - Pooled Data
Timepoint [16] 0 0
Baseline up to 2.5 years
Secondary outcome [17] 0 0
Change in Cognitive Performance Measured by the Symbol Digit Modalities Test (SDMT) - Pooled Data
Timepoint [17] 0 0
Baseline up to 2.5 years
Secondary outcome [18] 0 0
6-month Confirmed Worsening of at Least 20% in the Timed 25-Foot Walk (T25FW) - Pooled Data
Timepoint [18] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [19] 0 0
6-month Confirmed Worsening of at Least 20% in the 9-Hole Peg Test (9HPT) - Pooled Data
Timepoint [19] 0 0
Baseline, every 6 months up to 2.5 years
Secondary outcome [20] 0 0
6-month Confirmed Disability Improvement (6mCDI) Sustained Until End of Study (EOS) as Measured by EDSS - Pooled Data
Timepoint [20] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [21] 0 0
Number of New or Enlarging T2 Lesions on MRI Per Year From Month 12 Until End of Study (EOS)
Timepoint [21] 0 0
Month 12 up to 2.5 years
Secondary outcome [22] 0 0
Percent Change in T2 Lesion Volume Relative to Baseline
Timepoint [22] 0 0
Baseline, Month 12, Month 24
Secondary outcome [23] 0 0
No Evidence of Disease Activity (NEDA-4)
Timepoint [23] 0 0
Baseline, Month 12, Month 24
Secondary outcome [24] 0 0
Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score Change From Baseline
Timepoint [24] 0 0
Baseline, every 6 months up to 2.5 years
Secondary outcome [25] 0 0
Multiple Sclerosis Impact Scale (MSIS-29) Psychological Impact Score Change From Baseline
Timepoint [25] 0 0
Baseline, every 6 months up to 2.5 years
Secondary outcome [26] 0 0
Annualized Relapse Rates (ARR) by NfL High-low Subgroups - Pooled Data
Timepoint [26] 0 0
Baseline up to 2.5 years
Secondary outcome [27] 0 0
Number of New or Enlarging T2 Lesions Per Year by NfL High-low Subgroups - Pooled Data
Timepoint [27] 0 0
Baseline, yearly up to 2.5 years
Secondary outcome [28] 0 0
Brain Volume Loss by NfL High-low Subgroups - Pooled Data
Timepoint [28] 0 0
Baseline, Months 12 and 24
Secondary outcome [29] 0 0
Pharmacokinetic (PK) Concentrations of Ofatumumab
Timepoint [29] 0 0
Baseline, Weeks 4, 12, 24, 48, 96

Eligibility
Key inclusion criteria
* Male or female patients aged 18 to 55 years at Screening
* Diagnosis of multiple sclerosis (MS)
* Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with disease activity
* Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior to randomization
* Disability status at Screening with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5
* Neurologically stable within 1 month prior to randomization
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with primary progressive MS or SPMS without disease activity
* Disease duration of more than 10 years in patients with an EDSS score of 2 or less
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/10/2020
Sample size
Target
Accrual to date
Final
955
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
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Pennsylvania
Country [18] 0 0
United States of America
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South Carolina
Country [19] 0 0
United States of America
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Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
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Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Argentina
State/province [26] 0 0
Tucuman
Country [27] 0 0
Austria
State/province [27] 0 0
Vienna
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Belgium
State/province [29] 0 0
Antwerpen
Country [30] 0 0
Belgium
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Aalst
Country [31] 0 0
Belgium
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Bruxelles
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Belgium
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Gent
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Bulgaria
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Sofia
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Canada
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Ontario
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Canada
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Quebec
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Croatia
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Osijek
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Zagreb
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Czech Republic
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Tampere
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Cedex1
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France
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Essen
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Hamburg
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Germany
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Hannover
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Heidelberg
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Homburg
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Koln
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Leipzig
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Germany
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Minden
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Germany
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Siegen
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Germany
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Ulm
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Germany
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Unterhaching
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India
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Mumbai
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PD
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Lisboa
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Loures
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Portugal
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Santa Maria da Feira
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Moscow
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Nizhny Novgorod
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Novosibirsk
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Saint Petersburg
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Russian Federation
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St. Petersburg
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Slovakia
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Bratislava
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Slovakia
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Martin
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Slovakia
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Ruzomberok
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South Africa
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Pretoria
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South Africa
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Rosebank
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Spain
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Andalucia
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Spain
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Madrid
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Vizcaya
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Spain
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San Sebastian
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Switzerland
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Lugano
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Taiwan
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Tainan
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Turkey
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Haseki / Istanbul
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Izmir
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Mersin
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Trabzon
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United Kingdom
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Beds
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United Kingdom
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South Yorkshire
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02792231