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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 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 206 participants.

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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.

Interventions

  • OTHER Placebo
  • DRUG Iscalimab

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2021-01-05
Est. Completion 2024-08-19
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT04541589

The ClinicalTrials.gov registry entry for NCT04541589 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 206 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.

NCT04541589 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.