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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: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04035668 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ESSDAI is a validated disease outcome measure for Sjögren's Syndrome. The instrument contains 12 organ-specific domains contributing to disease activity: constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological and biological. For each domain, features of disease activity were scored according to their severity. These scores were summed across the 12 domains in a weighted manner to provide the t
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 |
Why NCT04035668 stopped before completion
NCT04035668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04035668 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04035668's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 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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