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.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines
Study identification
- NCT ID
- NCT03926611
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- 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 6, 2019 (Actual)
- Primary completion
- Jan 14, 2021 (Actual)
- Completion
- Apr 15, 2021 (Actual)
- Last update posted
- Apr 29, 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 29, 2022 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03926611 live on ClinicalTrials.gov.