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NCT03580356 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
A Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,078
- Enrollment target
- 20
- Study locations
NCT03580356: Completed Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
NCT03580356 is a Phase 3 study of Chronic Spontaneous Urticaria that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,078 participants, below the 1,367-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03580356, a Phase 3 study of Chronic Spontaneous Urticaria, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,078 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,079 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 hiv
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Omalizumab
- BIOLOGICAL Ligelizumab
Study Locations (20)
California
- DeMera Allergy Asthma and Immun Ctr - Fresno
- California Allergy and Asthma Medical Group - Los Angeles
- Jonathan Corren Inc - Los Angeles
- Allergy and Asthma Consultants - Redwood City
- Allergy and Asthma Associates of Santa Clara Vally Center - San Jose
Maryland
- John Hopkins University - Baltimore
- Institute for Asthma and Allergy PC - Chevy Chase
- Chesapeake Clinical Research - White Marsh
Florida
- Sarasota Clinical Research - Sarasota
- Olympian Clinical Research - Tampa
Alabama
- Allervie Clinical Research - Birmingham
Arizona
- Medical Resch of Arizona-Div of Allergy Asthma and Immunology - Scottsdale
Arkansas
- Atria Clinical Research Asthma and Allergy Institute - Little Rock
Idaho
- Idaho Research - Eagle
Illinois
- Midwest Allergy Sinus Asthma SC - Normal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,078 participants |
| Start Date | 2018-10-20 |
| Est. Completion | 2022-06-14 |
| Phase | Phase 3 |
What the finished NCT03580356 record still lists
NCT03580356 is an interventional study that assigns participants to a tested intervention. Its 1,078 participants enrollment target places it among the larger protocols in the corpus, below the 1,367-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03580356 names 20 study sites across 13 states, led by California, Maryland, Florida.
Frequently Asked Questions
What is clinical trial NCT03580356 about?
NCT03580356 is a clinical study titled "A Phase III Study of 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 efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,079 male and fem...
What is the current status of trial NCT03580356?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,078 participants. The study started on 2018-10-20. Estimated completion is 2022-06-14.
What conditions does trial NCT03580356 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT03580356?
The interventions under investigation include: Placebo (OTHER), Omalizumab (BIOLOGICAL), Ligelizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03580356?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03580356 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03580356's enrollment target sits among peer trials
1,078 4th of 18 higher than 15 of 18 other Chronic Spontaneous Urticaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Spontaneous Urticaria 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.
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