Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01920477 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT01920477 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 35 participants.
The verdict
NCT01920477, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-08-13 |
| Est. Completion | 2018-01-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01920477
The ClinicalTrials.gov registry entry for NCT01920477 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 35 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 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01920477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01920477 about?
NCT01920477 is a clinical study titled "Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris". 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....
What is the current status of trial NCT01920477?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2013-08-13. Estimated completion is 2018-01-11.
What interventions are being tested in trial NCT01920477?
The interventions under investigation include: Placebo (BIOLOGICAL), Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01920477?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.