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

NCT01874340 | Terminated Phase 2 Results DMC

• 2 other identifiers: CAIN457B22032012-004019-29
• Study Type: interventional
• Target: 28
• Locations: 10 countries
• Sites: 13

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Annualized Relapse Rate

  6 Months

• Combined Unique Active Lesions (CUAL)

  Months 3, 4, 5, 6

• Change in Total Volume of T2-weighted Lesions

  Baseline, Month 6

• Number of Particpants With Adverse Events as a Measure of Safety and Tolerability

  6 months

Study Arms (4)

AIN457 low dose

EXPERIMENTAL

AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.

Drug: AIN457

Placebo

PLACEBO COMPARATOR

Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2).

Drug: Placebo

AIN457 middle dose

EXPERIMENTAL

AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis

Drug: AIN457

AIN457 high dose

EXPERIMENTAL

AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.

Drug: AIN457

Interventions

Placebo DRUG

Placebo will be administered at predefined visits over the 6-month treatment phase.

Placebo

AIN457 DRUG

AIN457 will be administered at predefined visits over the 6-month treatment phase.

AIN457 high dose; AIN457 low dose; AIN457 middle dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Bruges, 8000, Belgium

Location

Novartis Investigative Site

Jihlava, 586 33, Czechia

Location

Novartis Investigative Site

Saint-Herblain, 44800, France

Location

Novartis Investigative Site

Roma, RM, 00133, Italy

Location

Novartis Investigative Site

Osaka, Osaka, 556-0016, Japan

Location

Novartis Investigative Site

Lodz, 93-121, Poland

Location

Novartis Investigative Site

Poznan, 60-355, Poland

Location

Novartis Investigative Site

Moscow, 127018, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194044, Russia

Location

Novartis Investigative Site

Bilbao, Basque Country, 48013, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Stockholm, 17176, Sweden

Location

Novartis Investigative Site

Atakum / Samsun, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Autoimmune Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Diseases

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System

Limitations and Caveats

Due to early termination this trial was not powered for efficacy no statistical analysis was performed

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 11, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 1, 2015
• Results First Posted: June 1, 2015

Record last verified: 2015-05

Locations

BE (1); IT (1); PL (2); RU (2); JP (1); TU (1); CZ (1); FR (1); ES (2); SE (1)