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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03580369 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,072 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hi
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 |
What the finished NCT03580369 record still lists
NCT03580369 is an interventional study that assigns participants to a tested intervention. Its 1,072 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03580369 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03580369's enrollment target sits among peer trials
1,072 272nd of 2000 higher than 1,729 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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