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Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) (POINT)

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ClinicalTrials.gov Identifier: NCT02907177
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date  ICMJE August 25, 2016
First Posted Date  ICMJE September 20, 2016
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE March 30, 2017
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
Annualized relapse rate (ARR) [ Time Frame: From randomization up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
Number of confirmed relapses per subject-year
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02907177 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • Time to 12-week confirmed disability accumulation (CDA) [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Time to 12-week confirmed disability accumulation (CDA)
  • Time to first confirmed relapse [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Time to first confirmed relapse
  • Mean number of combined unique active lesions (CUALs) per post-baseline scan [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Mean number of combined unique active lesions (CUALs) per post-baseline scan
  • Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS
  • Longitudinal percent change from baseline over time in brain volume [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Longitudinal percent change from baseline over time in brain volume
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
  • Time to 12-week confirmed disability accumulation (CDA) [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
  • Time to first confirmed relapse [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
  • Mean number of combined unique active lesions (CUALs) per post-baseline scan [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
  • Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
  • Longitudinal percent change from baseline over time in brain volume [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
Current Other Pre-specified Outcome Measures
 (submitted: March 30, 2017)
Treatment-emergent adverse events (AEs) and serious AEs [ Time Frame: From time of first study drug intake up to 30 days after study treatment discontinuation ]
Treatment-emergent adverse events (AEs) and serious AEs
Original Other Pre-specified Outcome Measures
 (submitted: September 15, 2016)
Treatment-emergent adverse events (AEs) and serious AEs [ Time Frame: From time of first study drug intake up to 30 days after study treatment discontinuation ]
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Official Title  ICMJE Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Brief Summary This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: Ponesimod
    One tablet of ponesimod 20 mg administered orally once daily in the morning from Day 15 to EOT. To reduce the first-dose effect of ponesimod, an uptitration scheme will be implemented from Day 1 to Day 14 (with dose strength increasing from 2 mg to 20 mg).
  • Other: Placebo
    One tablet of matching placebo administered orally once daily in the morning
Study Arms  ICMJE
  • Experimental: Ponesimod
    Ponesimod
    Intervention: Drug: Ponesimod
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2016)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent prior to initiation of any study-mandated procedure.
  • Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception
  • Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).
  • Ongoing treatment with DMF for at least 6 months prior to screening
  • Active disease after at least 3 months of DMF treatment
  • Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).

Exclusion Criteria:

  • Lactating or pregnant women and women intending to become pregnant during the study.
  • Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).
  • Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Mexico,   Poland,   Portugal,   Russian Federation,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Croatia,   Czech Republic,   Norway
 
Administrative Information
NCT Number  ICMJE NCT02907177
Other Study ID Numbers  ICMJE AC-058B302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Actelion
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP