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NCT02573467 · ClinicalTrials.gov registry record · Phase 3
An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
A Phase 3 study of Sporadic Inclusion Body Myositis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
- 20
- Study locations
NCT02573467 is a Phase 3 study of Sporadic Inclusion Body Myositis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 211 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT02573467, a Phase 3 study of Sporadic Inclusion Body Myositis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
- 20
- Study locations
Study Summary
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and c
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bimagrumab
Study Locations (20)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Ghent
- Novartis Investigative Site - Copenhagen
- Novartis Investigative Site - Paris
California
- Novartis Investigative Site - Orange
- Novartis Investigative Site - Sacramento
Massachusetts
- Novartis Investigative Site - Boston
- Novartis Investigative Site - Boston
Texas
- Novartis Investigative Site - Dallas
- Novartis Investigative Site - Houston
Arizona
- Novartis Investigative Site - Phoenix
Florida
- Novartis Investigative Site - Miami
Kansas
- Novartis Investigative Site - Kansas City
Maryland
- Novartis Investigative Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2015-11-02 |
| Est. Completion | 2017-02-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02573467
The ClinicalTrials.gov registry entry for NCT02573467 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sporadic Inclusion Body Myositis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02573467 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02573467 about?
NCT02573467 is a clinical study titled "An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203". This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patie...
What is the current status of trial NCT02573467?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2015-11-02. Estimated completion is 2017-02-13.
What conditions does trial NCT02573467 study?
This clinical trial studies the following conditions: Sporadic Inclusion Body Myositis.
What interventions are being tested in trial NCT02573467?
The interventions under investigation include: Placebo (DRUG), Bimagrumab (DRUG).
Who is sponsoring clinical trial NCT02573467?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02573467 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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