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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: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01920477 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintenance of a dose \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks and maintenance of the status until Week 60.
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 |
Why NCT01920477 stopped before completion
NCT01920477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01920477 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01920477's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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