Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01874340
• Other study ID #: CAIN457B2203
• Secondary ID: 2012-004019-29
• Status: Terminated
• Phase: Phase 2
• First received: May 28, 2013
• Last updated: May 14, 2015
• Start date: June 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: ANSM: National Agency for the Safety of MedicineJapan: Pharmaceuticals and Medical Devices AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySwitzerland: SwissmedicTurkey: Turkish Republic Ministry of Health, Turkish Pharmaceuticals and Medical Devices AgencyGermany: Paul-Ehrlich-InstitutItaly: The Italian Medicines AgencyPortugal: Instituto Nacional de Farmacia e do Medicamento (INFARMED)Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria

• Disease duration of 10 years or less

• At least one relapse in the last year

• EDSS score 0 to 5.0 at entry

Exclusion Criteria:

• Active chronic disease of the immune system other than multiple sclerosis

• History of malignancy within the past 5 years

• Active systemic bacterial, viral or fungal infections

• Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)

• Any medically unstable condition

• Unable to undergo MRI scans or repeated blood tests

• Pregnant or nursing females

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

• Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Placebo
Placebo will be administered at predefined visits over the 6-month treatment phase.
• AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Brugge
Czech Republic	Novartis Investigative Site	JIhlava
France	Novartis Investigative Site	St Herblain
Italy	Novartis Investigative Site	Roma	RM
Japan	Novartis Investigative Site	Osaka-city	Osaka
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Poznan
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Sweden	Novartis Investigative Site	Stockholm
Turkey	Novartis Investigative Site	Atakum / Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Italy,  Japan,  Poland,  Russian Federation,  Spain,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions	Due to early termination this trial was not powered for efficacy no statistical analysis was performed	Months 3, 4, 5, 6	No
Secondary	Annualized Relapse Rate	Due to early termination this trial was not powered for efficacy no statistical analysis was performed	6 Months	No
Secondary	Combined Unique Active Lesions (CUAL)	Due to early termination this trial was not powered for efficacy no statistical analysis was performed	Months 3, 4, 5, 6	No
Secondary	Change in Total Volume of T2-weighted Lesions	Due to early termination this trial was not powered for efficacy no statistical analysis was performed	Baseline, Month 6	No
Secondary	Number of Particpants With Adverse Events as a Measure of Safety and Tolerability	Number of particpants with Adverse events as a measure of safety and tolerability	6 months	Yes