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NCT03580369 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,072
- Enrollment target
NCT03580369 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,072 participants.
The verdict
NCT03580369, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,072 participants
- Enrollment target
Study Summary
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
Interventions
- OTHER Placebo
- BIOLOGICAL Omalizumab
- BIOLOGICAL Ligelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,072 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2022-06-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03580369
The ClinicalTrials.gov registry entry for NCT03580369 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,072 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 3 interventions - of which Placebo is the first listed.
NCT03580369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03580369 about?
NCT03580369 is a clinical study titled "A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines". The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population c...
What is the current status of trial NCT03580369?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,072 participants. The study started on 2018-10-17. Estimated completion is 2022-06-14.
What interventions are being tested in trial NCT03580369?
The interventions under investigation include: Placebo (OTHER), Omalizumab (BIOLOGICAL), Ligelizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03580369?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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