Natalizumab Subcutaneous Immunogenicity and Safety Study

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT02142192
• Date of registration: 16/05/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Natalizumab Subcutaneous Immunogenicity and Safety Study SIMPLIFY
• Scientific title: A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
• Date of first enrolment: December 2014
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02142192
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Denmark, Germany, Italy

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Must have documented diagnosis of RMS at screening.

- Must fall within the therapeutic indications stated in the locally approved label for
natalizumab.

- Must have an EDSS score from 0 to 6.5, inclusive.

Key Exclusion Criteria:

- Any prior use of natalizumab.

- Positive for anti-natalizumab antibodies at screening.

- Treatment with immunomodulatory injections (including IFN-ß and glatiramer acetate)
within 2 weeks prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Drug: natalizumab

Primary Outcome(s)

Proportion of participants with persistent anti-natalizumab antibodies [Time Frame: 48 weeks]

Secondary Outcome(s)

Proportion of Participants that experience Adverse Events and Serious Adverse Events [Time Frame: up to 56 weeks]

Proportion of participants with post-injection adverse events (AEs) [Time Frame: 48 weeks]

Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI. [Time Frame: 48 weeks]

Proportion of participants with transient anti-natalizumab antibodies [Time Frame: 48 weeks]

Proportion of participants with clinical relapse [Time Frame: 48 weeks]

Secondary ID(s)

101MS207

2014-000917-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors