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

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Novartis

Status and phase

Completed
Phase 3
Phase 2

Conditions

Sporadic Inclusion Body Myositis

Treatments

Drug: BYM338/bimagrumab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01925209
CBYM338B2203

Details and patient eligibility

About

This study evaluated 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).

Enrollment

251 patients

Sex

All

Ages

36 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key 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.);

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

251 participants in 4 patient groups, including a placebo group

BYM338/bimagrumab 10 mg/kg
Experimental group
Description:
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
Treatment:
Drug: BYM338/bimagrumab
BYM338/bimagrumab 3 mg/kg
Experimental group
Description:
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
Treatment:
Drug: BYM338/bimagrumab
BYM338/bimagrumab 1 mg/kg
Experimental group
Description:
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
Treatment:
Drug: BYM338/bimagrumab
Placebo
Placebo Comparator group
Description:
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

38

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Data sourced from clinicaltrials.gov

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