Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

Phase 2

Completed

• Conditions: Sporadic Inclusion Body Myositis
• Interventions: Biological: BYM338; Biological: Placebo

• Registration Number: NCT01423110
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-25
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2017-02
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-27
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis

Exclusion Criteria

• Unable to walk at least 3 meters without assistance from another person
• Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months
• patients with a history or presence of renal impairment and/or liver disease

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BYM338	BYM338	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Effect of BYM338 on Thigh Muscle Volume by MRI	8 weeks	Change in thigh muscle volume

Secondary Outcome Measures

Name	Time	Method
Effect of BYM338 on muscle function by 'Timed Get Up and Go' test	8 weeks	Change in muscle function measured on scale by test results

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Boston, Massachusetts, United States