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A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
NCT03580356 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03580356
The ClinicalTrials.gov registry entry for NCT03580356 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,078 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03580356 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Maryland, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03580356?
The interventions under investigation include: Placebo (OTHER), Omalizumab (BIOLOGICAL), Ligelizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03580356?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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