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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01423110
• Collaborator: (none)
• Enrollment: 14
• Locations: 3
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sporadic Inclusion Body Myositis	Biological: BYM338; Biological: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BYM338	Biological: BYM338
Placebo Comparator: Placebo	Biological: Placebo

Outcome Measures

Primary Outcome Measures

1. Effect of BYM338 on Thigh Muscle Volume by MRI [8 weeks]

   Change in thigh muscle volume

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Scottsdale	Arizona	United States
2	Novartis Investigative Site	Kansas City	Kansas	United States
3	Novartis Investigative Site	Boston	Massachusetts	United States

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for CBYM338X2205 from the Novartis Clinical Trials website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01423110
• Other Study ID Numbers: CBYM338X2205
• First Posted: Aug 25, 2011
• Last Update Posted: Dec 17, 2020
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis Pharmaceuticals: sporadic Inclusion Body Myositis
• Additional relevant MeSH terms: Myositis; Myositis, Inclusion Body

Study Results

No Results Posted as of Dec 17, 2020