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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: Completed Phase 2 study of Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
An AE refers to any undesirable medical occurrence, such as an unintended sign (including abnormal laboratory findings), symptom, or disease, experienced by a participant. Serious AEs (SAEs) is defined as any AE that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or any other medically significant condition. Treatment-emergent AE
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 |
What the finished NCT04109313 record still lists
NCT04109313 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 1,414-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (84% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Chronic Spontaneous Urticaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04109313's enrollment target sits among peer trials
229 11th of 18 higher than 8 of 18 other Chronic Spontaneous Urticaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Spontaneous Urticaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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