Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02250443
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Sporadic Inclusion Body Myositis (sIBM)

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is an open-label, long-term study for those patients who participated in the prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term dosing. However due to lack of efficacy in patients with sIBM, the study was terminated early.

Key Dates

Start date
Mar 11, 2014
Status verified
Mar 2019
Primary completion
Aug 23, 2016
Completion
Aug 23, 2016

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BYM338
    BYM338 Group

Primary Outcome Measure

Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 29 month ]

Locations (2)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85013-
Novartis Investigative SiteBostonMassachusetts02115-

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Novartis Investigative Site· Phoenix, AZNovartis Investigative Site· Boston, MA

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