An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
Public ClinicalTrials.gov record NCT04109313. 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
An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)
Study identification
- NCT ID
- NCT04109313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 229 participants
Conditions and interventions
Conditions
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
- Oct 24, 2019 (Actual)
- Primary completion
- Sep 9, 2022 (Actual)
- Completion
- Sep 9, 2022 (Actual)
- Last update posted
- Jun 20, 2024
2019 – 2022
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| 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 | 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 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04109313, 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 Jun 20, 2024 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04109313 live on ClinicalTrials.gov.