This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
Public ClinicalTrials.gov record NCT03926611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines
Study identification
- NCT ID
- NCT03926611
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 311 participants
Conditions and interventions
Conditions
Interventions
- LOU064 Arm 1 Drug
- LOU064 Arm 2 Drug
- LOU064 Arm 3 Drug
- LOU064 Arm 4 Drug
- LOU064 Arm 5 Drug
- LOU064 Arm 6 Drug
- Placebo arm Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 5, 2019
- Primary completion
- Jan 13, 2021
- Completion
- Apr 14, 2021
- Last update posted
- Apr 28, 2022
2019 – 2021
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Litchfield Park | Arizona | 85340 | — |
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | — |
| Novartis Investigative Site | Mission Viejo | California | 92691 | — |
| Novartis Investigative Site | San Diego | California | 92123 | — |
| Novartis Investigative Site | Walnut Creek | California | 94598 | — |
| Novartis Investigative Site | Westminster | California | 92683 | — |
| Novartis Investigative Site | Pembroke Pines | Florida | 33028 | — |
| Novartis Investigative Site | Owensboro | Kentucky | 42301 | — |
| Novartis Investigative Site | Ypsilanti | Michigan | 48197 | — |
| Novartis Investigative Site | St Louis | Missouri | 63141 | — |
| Novartis Investigative Site | Grove City | Ohio | 43123 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03926611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2022 · Synced Jul 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03926611 live on ClinicalTrials.gov.