Trial record 17 of 76 for:    "idiopathic inflammatory myopathy"

Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients (RESILIENT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01925209
First received: August 15, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

To evaluate the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM)


Condition Intervention Phase
Sporadic Inclusion Body Myositis
Drug: BYM338/bimagrumab
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate Efficacy, Safety, Tolerability of i.v. BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility in Sporadic Inclusion Body Myositis Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from Baseline in 6 Minute Walking Distance Test (6MWD) meters to Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Change from baseline to Week 52 in the distance a patient can walk in a set timeframe. 6 Minute Walking Distance Test measures the distance (in meters) that a patient can walk in a 6 minute timeframe.


Secondary Outcome Measures:
  • Change from Baseline in lean body mass (LBM) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Change from baseline to Week 52 in the total and appendicular lean body mass

  • Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Change from baseline to Week 52 in quadriceps QMT.

  • Change from Baseline in Patient-Reported Physical Function at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Change from baseline to Week 52 in a patient reported outcome instrument.

  • Rate of Fall Events [ Time Frame: Baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108 ] [ Designated as safety issue: Yes ]
    Number of falls

  • Change from Baseline in Short Physical Performance Battery score at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Change from baseline to Week 52 in physical performance as measured by the Short Physical Performance Battery (SPPB).

  • Safety and Tolerability of different i.v. BYM338 doses [ Time Frame: Baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108 ] [ Designated as safety issue: Yes ]
    Safety and tolerability

  • Change from Baseline in 6MWD meters to Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Dose-response relationship


Estimated Enrollment: 240
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BYM338/bimagrumab High Dose
60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated with the BYM338 High Dose administered via intravenous infusion from Day 1 to Week 52, and up to Week 104.
Drug: BYM338/bimagrumab
BYM338 will be administered via intravenous infusion to randomized patients beginning on Day 1 through Week 52, and up to Week 104.
Experimental: BYM338/bimagrumab Mid Dose
60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated with the BYM338 Mid Dose administered via intravenous infusion from Day 1 to Week 52, and up to Week 104.
Drug: BYM338/bimagrumab
BYM338 will be administered via intravenous infusion to randomized patients beginning on Day 1 through Week 52, and up to Week 104.
Experimental: BYM338/bimagrumab Low Dose
60 patients who meet all inclusion criteria and none of the exclusion criteria will be treated with the BYM338 Low Dose administered via intravenous infusion from Day 1 to Week 52, and up to Week 104.
Drug: BYM338/bimagrumab
BYM338 will be administered via intravenous infusion to randomized patients beginning on Day 1 through Week 52, and up to Week 104.
Placebo Comparator: Placebo
60 patients who meet all inclusion criteria and none of the exclusion criteria will be receive matching placebo administered via intravenous infusion from Day 1 to Week 52, and up to Week 104.
Drug: Placebo
Matching placebo will be administered via intravenous infusion to 60 randomized patients beginning on Day 1 through Week 52, and up to Week 104.

  Eligibility

Ages Eligible for Study:   36 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with sporadic inclusion body myositis;
  • Must be able to walk (assistive aids allowed, including intermittent use of wheelchair);

Exclusion Criteria:

  • Must not have other conditions that significantly limit ability to move around;
  • Must not be using corticosteroids. Must not have used systemic corticosteroid (at daily dose >=10mg prednisone) for the past 3 months;
  • Must meet cardiovascular requirements;
  • Must not be pregnant or nursing;
  • Must not have a chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc); Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925209

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 43 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01925209     History of Changes
Other Study ID Numbers: CBYM338B2203
Study First Received: August 15, 2013
Last Updated: June 5, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Novartis:
sporadic inclusion body myositis,
myositis,
muscle wasting,
controlled clinical trial,
randomized,
body mass,
muscle function,
strength,
performance,
physical function

Additional relevant MeSH terms:
Myositis
Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2014