Trials / Terminated
TerminatedNCT01920477
Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris
OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is expressed only in B lymphocytes. The purpose of this study was to evaluate the efficacy, tolerability, and safety of ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every 4 weeks, (with an additional 20 mg loading dose \[i.e. 40 mg total\] at both Week 0 and Week 4) in subjects with PV. It was anticipated that with sustained B-cell depletion in the presence of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein) autoantibodies in PV, that clinical remission of the disease would result.
Detailed description
Novartis terminated the development of the PV program and this study was terminated for non-safety reasons
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ofatumumab | Ofatumumab (human monoclonal antibody) was provided in prefilled glass syringes initial syringes contained 0.6ml (60mg) of concentration 100 mg/m: drug product subsequently modified to 0.4 mL (20mg) concentration (50mg/ML) drug product |
| BIOLOGICAL | Placebo | Placebo to match the active doses will consist of prefilled glass syringes filled with normal saline. |
Timeline
- Start date
- 2013-08-13
- Primary completion
- 2016-04-13
- Completion
- 2018-01-11
- First posted
- 2013-08-12
- Last updated
- 2019-06-06
- Results posted
- 2019-06-06
Locations
16 sites across 8 countries: United States, Australia, Greece, Israel, Italy, Japan, Poland, Romania
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01920477. Inclusion in this directory is not an endorsement.