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NCT03926611 · ClinicalTrials.gov registry record · Phase 2
This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 311
- Enrollment target
NCT03926611: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03926611 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 311 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (134% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03926611, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 311 participants
- Enrollment target
Study Summary
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
Primary Outcome
UAS7 score change (LS mean Change) from baseline at Week 4 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS) The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7
Interventions
- DRUG LOU064 Arm 1
- DRUG LOU064 Arm 2
- DRUG LOU064 Arm 3
- DRUG LOU064 Arm 4
- DRUG LOU064 Arm 5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2021-04-15 |
| Phase | Phase 2 |
What the finished NCT03926611 record still lists
NCT03926611 is an interventional study that assigns participants to a tested intervention. The registered 311 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (134% higher).
The record links to 0 conditions, and to 5 interventions - of which LOU064 Arm 1 is the first listed.
NCT03926611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03926611 about?
NCT03926611 is a clinical study titled "This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines". 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
What is the current status of trial NCT03926611?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 311 participants. The study started on 2019-06-06. Estimated completion is 2021-04-15.
What interventions are being tested in trial NCT03926611?
The interventions under investigation include: LOU064 Arm 1 (DRUG), LOU064 Arm 2 (DRUG), LOU064 Arm 3 (DRUG), LOU064 Arm 4 (DRUG), LOU064 Arm 5 (DRUG).
Who is sponsoring clinical trial NCT03926611?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03926611's enrollment target sits among peer trials
311 162nd of 2000 higher than 1,839 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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