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NCT04541589 · ClinicalTrials.gov registry record · Phase 2
Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
NCT04541589: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04541589 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 206 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04541589, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
Study Summary
This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201 (NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab at two dose level.
Primary Outcome
An AE was defined as any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant. TEAE included all AEs up to the last dose date plus 14 weeks or the end of the entire study (including the safety follow-up period), whichever occurred earlier. A patient with multiple severity ratings for an AE was only counted under the maximum rating. Additionally, a patient with multiple occurrences of an event was c
Interventions
- OTHER Placebo
- DRUG Iscalimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2024-08-19 |
| Phase | Phase 2 |
What the finished NCT04541589 record still lists
NCT04541589 is an interventional study that assigns participants to a tested intervention. The registered 206 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 (55% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04541589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04541589 about?
NCT04541589 is a clinical study titled "Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome". This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201 (NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab...
What is the current status of trial NCT04541589?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2021-01-05. Estimated completion is 2024-08-19.
What interventions are being tested in trial NCT04541589?
The interventions under investigation include: Placebo (OTHER), Iscalimab (DRUG).
Who is sponsoring clinical trial NCT04541589?
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 NCT04541589's enrollment target sits among peer trials
206 298th of 2000 higher than 1,703 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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