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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 : Terminated (sponsor decision due to low recruitment)
First Posted : September 20, 2016
Last Update Posted : April 6, 2020
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 April 6, 2020
Actual Study Start Date  ICMJE March 30, 2017
Actual Primary Completion Date March 26, 2020   (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
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 The study will assess the efficacy, safety, and tolerability of add-on therapy with ponesimod 20 mg vs placebo in adult participants with active relapsing multiple sclerosis (RMS) who are treated with dimethyl fumarate (DMF). Approximately 600 participants who have been receiving DMF for at least 6 months will be randomized in a 1:1 ratio to ponesimod 20 mg or placebo. The study consists of the following study periods: Pre-randomization period; Treatment period; Post-treatment observation period. The study includes one ponesimod treatment arm at the maintenance dose of 20 mg o.d. corresponding to the optimal dose when used as monotherapy based on the Phase 2 dose-finding trial and its ongoing extension. The study includes a placebo comparator arm, but all patients will remain on DMF background therapy throughout the study. Moreover, participants who experience a confirmed relapse or an event of 24-week confirmed disability accumulation (DMF) while on study drug will have the option to switch to an alternative treatment. The treatment period has a variable duration from a minimum of 60 weeks (for the last subject randomized) to a maximum of 156 weeks for the first subjects randomized in the trial and includes a gradual up-titration of ponesimod from a 2 mg starting dose to a 20 mg maintenance dose over a period of 14 days. The total duration of the study will be approximately up to 167 weeks.
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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 20, 2019)
136
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2016)
600
Actual Study Completion Date  ICMJE March 26, 2020
Actual Primary Completion Date March 26, 2020   (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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Mexico,   Poland,   Portugal,   Russian Federation,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Croatia,   Czech Republic,   Finland,   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
Study Director: Tatiana Scherz, MD, PhD Actelion
PRS Account Actelion
Verification Date April 2020

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