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SNCTP000000973 | NCT01665144

Wirksamkeit und Sicherheit von Siponimod (BAF312) bei Patienten mit sekundär progredienter Multipler Sklerose

Data source: BASEC (Imported from 04.12.2020), WHO (Imported from 29.11.2020)
Changed: 01.11.2020
Disease category: Nervous System diseases, Musculoskeletal deseases (non cancer)

Brief description of trial (Data source: BASEC)

In dieser Studie wird die Wirksamkeit und Sicherheit von Siponimod (BAF312) für die Behandlung, der von Neurodegeneration geprägter sekundär progredienter Form der Multiplen Sklerose untersucht. BAF312 gehört zu der Wirkstoffklasse der Sphingosin-1 Phosphate-Rezeptor (S1PR) -Modulatoren deren erster Vertreter, Gilenya (Fingolimod), seit 2011 in der Schweiz zur Behandlung der schubförmig remittierenden MS zugelassen ist.
Bei der Behandlung der SPMS besteht weiterhin ein medizinisches Bedürfnis nach Therapien welche die Progression der Erkrankung hinauszögern. Die zurzeit bereits für die Behandlung der sekundär progredienten multiplen Sklerose (SPMS) verfügbaren Interferon-Therapien haben hauptsächlich eine Wirksamkeit auf die Reduktion der Schubrate. Jedoch beeinflussen sie nur teilweise das Fortschreiten der Behinderung. Zudem bringt einer Therapie mit Mitoxantron hohe Risiken bezüglich Kardiotoxizität und Leukämie mit sich.
Aus diesem Grund wird diese Studie mit einem Placebo Vergleichspräparat durchgeführt. Placebo-kontrollierte MS Studien werden als ethisch vertretbar erachtet, wenn sie in Indikationen durchgeführt werden, in denen nur begrenzt wirksame Therapien vorhanden sind.

Health conditions investigated (Data source: BASEC)

Patienten mit sekundäre progrendierende Form Multiple Sclerose

Health conditions (Data source: WHO)

Secondary Progressive Multiple Sclerosis

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

All patients will start the treatment with a 6-day dose titration pack of Siponimod (BAF312) (0.25 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.25 mg, 2 mg) continuing to a 2 mg BAF312/placebo dose.

Interventions (Data source: WHO)

Drug: BAF312;Drug: Placebo

Criteria for participation in trial (Data source: BASEC)

Written informed consent; Male or female patients aged 18 to 60 years; Prior history of relapsing-remitting MS; SPMS defined by a progressive increase in disability; Disability status at Screening with an EDSS score of 3.0 to 6.5; Documented EDSS progression

Exclusion criteria (Data source: BASEC)

Active chronic inflammatory disease; history of malignancy; macular edema; varicella-zoster; unable to undergo MRI scan; treated with BAF312 previously

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Prior history of relapsing remitting MS

- SPMS defined as progressive increase of disability over at least 6 months

- EDSS score of 3.0 to 6.5

- No relapse of corticosteroid treatment within 3 months

Exclusion Criteria:

- Women of child bearing potential must use reliable forms of contraception.

- Diagnosis of Macular edema during screening period

- Any medically unstable condition determined by investigator.

- Unable to undergo MRI scans

- Hypersensitivity to any study drugs or drugs of similar class Other protocol defined
inclusion/exclusion may apply.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT01665144

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT01665144

Further information on trial

Date trial registered

03.08.2012

Incorporation of the first participant

20.12.2012

Recruitment status

Active, not recruiting

Academic title (Data source: WHO)

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Percentage of Participants With 3-month Confirmed Disibility Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

Secundary end point (Data source: WHO)

Efficacy of BAF312 Relative to Placebo in Reducing the Increase in T2 Lesion Volume;The Delay in Time to Confirmed Disability Progression as Measured by EDSS.;Efficacy of BAF Relative to Placebo in Annualized Relapses Rate and Time to the First Relapse;Overall Response Rate on the MSWS-12.;Effect on Inflammatory Disease Activity and Burden of Disease as Measured by MRI;Effect on 3-month Confirmed Disability Progression as Defined by EDSS in Predefined Sub-groups;Efficacy of BAF312 Relative to Placebo in Confirmed Worsening of 25 Foot Walk Test

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

https://clinicaltrials.gov/ct2/show/results/NCT01665144

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Basel, Lausanne, Lugano, St. Gallen, Zurich

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Czechia, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Weidenfeller Alla
0041 41 7637316
alla.weidenfeller@novartis.com

Contact for general information (Data source: WHO)

Novartis Pharmaceuticals
Novartis Pharmaceuticals

Contact for scientific information (Data source: WHO)

Novartis Pharmaceuticals
Novartis Pharmaceuticals

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Novartis Pharmaceuticals

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Further trial identification numbers

Secondary ID (Data source: WHO)

CBAF312A2304