Clinical trial NCT01874340: Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Relapsing Multiple Sclerosis
AIN457
Secukinumab
Magnetic Resonance Imaging
Relapsing Remitting Multiple Sclerosis
Autoimmune Diseases
Nervous System Diseases
Immune System Diseases
Demyelinating Diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions
timeFrame: Months 3, 4, 5, 6
Secondary outcomes:
measure: Annualized Relapse Rate
timeFrame: 6 Months
measure: Combined Unique Active Lesions (CUAL)
timeFrame: Months 3, 4, 5, 6
measure: Change in Total Volume of T2-weighted Lesions
timeFrame: Baseline, Month 6
measure: Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: JIhlava
country: Czech Republic
facility: Novartis Investigative Site
city: St Herblain
country: France
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Atakum / Samsun
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: