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NCT04035668 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT04035668 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 73 participants.
The verdict
NCT04035668, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study Summary
This was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome. LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor.
Interventions
- DRUG Placebo
- DRUG Remibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2019-07-12 |
| Est. Completion | 2021-11-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04035668
The ClinicalTrials.gov registry entry for NCT04035668 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04035668 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04035668 about?
NCT04035668 is a clinical study titled "A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome". This was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome. LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor.
What is the current status of trial NCT04035668?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2019-07-12. Estimated completion is 2021-11-23.
What interventions are being tested in trial NCT04035668?
The interventions under investigation include: Placebo (DRUG), Remibrutinib (DRUG).
Who is sponsoring clinical trial NCT04035668?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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