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NCT04109313 · ClinicalTrials.gov registry record · Phase 2
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
A Phase 2 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 229
- Enrollment target
- 20
- Study locations
NCT04109313 is a Phase 2 study of Chronic Spontaneous Urticaria that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 229 participants, below the 1,414-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT04109313, a Phase 2 study of Chronic Spontaneous Urticaria, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 229 participants
- Enrollment target
- 20
- Study locations
Study Summary
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)
Conditions Studied
Interventions
- DRUG LOU064
Study Locations (20)
California
- Novartis Investigative Site - Mission Viejo
- Novartis Investigative Site - San Diego
- Novartis Investigative Site - Walnut Creek
Ontario
- Novartis Investigative Site - London
- Novartis Investigative Site - Niagara Falls
- Novartis Investigative Site - Ottawa
Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - La Plata
Other
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Liège
Arizona
- Novartis Investigative Site - Litchfield Park
Arkansas
- Novartis Investigative Site - Little Rock
Florida
- Novartis Investigative Site - Pembroke Pines
Kentucky
- Novartis Investigative Site - Owensboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2019-10-24 |
| Est. Completion | 2022-09-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04109313
The ClinicalTrials.gov registry entry for NCT04109313 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,414-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (84% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 1 intervention - of which LOU064 is the first listed.
NCT04109313 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Ontario, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT04109313 about?
NCT04109313 is a clinical study titled "An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU". 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)
What is the current status of trial NCT04109313?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2019-10-24. Estimated completion is 2022-09-09.
What conditions does trial NCT04109313 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT04109313?
The interventions under investigation include: LOU064 (DRUG).
Who is sponsoring clinical trial NCT04109313?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04109313 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.