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NCT03905525 · ClinicalTrials.gov registry record · Phase 2
Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 273
- Enrollment target
NCT03905525: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03905525 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 273 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03905525, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 273 participants
- Enrollment target
Study Summary
This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
Primary Outcome
ESSDAI is a validated disease outcome measure for SjS that contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The domains (weights) are as follows: constitutional (3), lymphadenopathy (4), glandular (2), articular (2), cutaneous (3), pulmonary (5), renal (5), muscular (6), perip
Interventions
- OTHER Placebo
- DRUG CFZ533
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2023-06-06 |
| Phase | Phase 2 |
What the finished NCT03905525 record still lists
NCT03905525 is an interventional study that assigns participants to a tested intervention. The registered 273 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 (105% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03905525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03905525 about?
NCT03905525 is a clinical study titled "Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome". This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
What is the current status of trial NCT03905525?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 273 participants. The study started on 2019-10-01. Estimated completion is 2023-06-06.
What interventions are being tested in trial NCT03905525?
The interventions under investigation include: Placebo (OTHER), CFZ533 (DRUG).
Who is sponsoring clinical trial NCT03905525?
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 NCT03905525's enrollment target sits among peer trials
273 204th of 2000 higher than 1,797 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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