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®)

• Register: EUCTR
• Last refreshed on: 16 November 2020
• Main ID: EUCTR2012-000541-12-DE
• Date of registration: 06/07/2016
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd.
• Public title: 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®)
• Scientific title: 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®) - POINT
• Date of first enrolment: 15/11/2016
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000541-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: add-on If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Poland, Portugal, Spain, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen Cilag International NV

Key inclusion & exclusion criteria

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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Ponesimod
Product Code: ACT-128800
Pharmaceutical Form: Tablet
INN or Proposed INN: Ponesimod
Current Sponsor code: ACT-128800
Other descriptive name: PONESIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Ponesimod

Primary Outcome(s)

Main Objective: The primary objective of the study is to determine whether add-on therapy with ponesimod reduces relapse frequency as compared to placebo in subjects with active RMS who are treated with DMF (Tecfidera®).

Timepoint(s) of evaluation of this end point: From randomization up to end of study (EOS)

Primary end point(s): Annualized relapse rate (ARR); defined as the number of confirmed relapses per subject-year.

Secondary Objective: - To assess the effect of add-on therapy with ponesimod vs placebo on disability accumulation and on other aspects of MS disease control in subjects with RMS who are treated with DMF (Tecfidera®);
- To assess the safety and tolerability of add-on therapy with ponesimod vs placebo in subjects with RMS who are treated with DMF (Tecfidera®).

Secondary Outcome(s)

Secondary end point(s): 1. Time to 12-week confirmed disability accumulation (CDA)
2. Time to first confirmed relapse; up to EOS.
3. Mean number of combined unique active lesions (CUALs) per subject per post-baseline MRI scan; up to EOS.
4. Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ–RMS from baseline; up to EOS.
5. Longitudinal percent change over time in brain volume from baseline; up to EOS.

Timepoint(s) of evaluation of this end point: 1. From baseline up to EOS
2. From baseline up to EOS
3. From baseline up to EOS
4. From baseline up to EOS
5. From baseline up to EOS

Secondary ID(s)

AC-058B302

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd.

Ethics review

Status: Approved
Approval date: 15/11/2016
Contact: