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NCT04210843 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,033
- Enrollment target
NCT04210843: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04210843 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 1,033 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04210843, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,033 participants
- Enrollment target
Study Summary
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
Primary Outcome
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 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A highe
Interventions
- DRUG Ligelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,033 participants |
| Start Date | 2020-04-08 |
| Est. Completion | 2022-09-01 |
| Phase | Phase 3 |
Why NCT04210843 stopped before completion
NCT04210843 is an interventional study that assigns participants to a tested intervention. Its 1,033 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 1 intervention - of which Ligelizumab is the first listed.
NCT04210843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04210843 about?
NCT04210843 is a clinical study titled "Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab". The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite s...
What is the current status of trial NCT04210843?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,033 participants. The study started on 2020-04-08. Estimated completion is 2022-09-01.
What interventions are being tested in trial NCT04210843?
The interventions under investigation include: Ligelizumab (DRUG).
Who is sponsoring clinical trial NCT04210843?
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 NCT04210843's enrollment target sits among peer trials
1,033 288th of 2000 higher than 1,713 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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