Trial · NCT04541589

Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome

NCT04541589, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2025-06-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome. Trials, record NCT04541589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04541589

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
NCT number: NCT04541589
Status: Completed
Phases: Phase 2
Enrollment: 206 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Sjogren's Syndrome
Interventions: Iscalimab, Placebo
First posted: 2020-09-09
Last updated: 2025-10-16
Other registries' IDs: eudract:2020-001942-20
Results first posted: 2025-06-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From start of extension study up to 14 weeks after last study-drug administration or end of study (whichever occurred earlier), assessed up to approximately 60 weeks	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 counted only once. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events, with the following grading system: Mild: usually transient in nature and generally not interfering with normal activities; Moderate: sufficiently discomforting to interfere with normal activities; Severe: prevented normal activities. A serious adverse event (SAE) was defined as any AE that required medical intervention, hospitalization, or results in death, disability, or a birth defect.
Secondary	Free Iscalimab Concentration in Plasma	Predose at Day 1, 113, 225, 337 and 421	Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods. Blood sample was collected at the specified timepoints to assess the concentration of free iscalimab. The baseline assessment of this extension study (Day 1) was identical to the last timepoint (FUP3/Week 60) of the core study (CCFZ533B2201).
Secondary	Incidence of Anti-iscalimab Antibodies in Plasma	60 weeks	Number of participants with anti-iscalimab antibodies (ADA) in plasma at any time during the study. The baseline assessment of this extension study (Day 1) was identical to the last timepoint (FUP3/Week 60) of the core study (CCFZ533B2201).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From start of extension study up to 14 weeks after last study-drug administration or end of study (whichever occurred earlier), assessed up to approximately 60 weeks	The Safety Set (SAF) included all participants who received at least one dose of study treatment. Participants were analyzed according to the actual treatment received.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Free Iscalimab Concentration in Plasma	Predose at Day 1, 113, 225, 337 and 421	The pharmacokinetic set (PKS) included all participants who received at least one dose of iscalimab treatment and had quantifiable PK measurements of iscalimab. Number analysed refers to the number of participants with a quantifiable PK measurement at the specified time point	microgram / mililiter	GEOMETRIC_MEAN
SECONDARY	Incidence of Anti-iscalimab Antibodies in Plasma	60 weeks	The immunogenicity Set (IMS) included all subjects who received at least one dose of iscalimab treatment and had quantifiable immunogenicity measurements of iscalimab.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 1: Iscalimab 600 mg	Death	0	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 2 - Iscalimab 300 mg	Death	0	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 1: Iscalimab 600 mg	Adverse event (all severities)	127	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 2 - Iscalimab 300 mg	Adverse event (all severities)	43	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 1: Iscalimab 600 mg	Adverse Event- Mild	57	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 2 - Iscalimab 300 mg	Adverse Event- Mild	24	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 1: Iscalimab 600 mg	Adverse Event- Moderate	62	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 2 - Iscalimab 300 mg	Adverse Event- Moderate	17	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 1: Iscalimab 600 mg	Adverse Event- Severe	8	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Arm 2 - Iscalimab 300 mg	Adverse Event- Severe	2	Participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Arm 1: Iscalimab 600 mg	152
Treatment Period	STARTED	Arm 2 - Iscalimab 300 mg	54
Treatment Period	COMPLETED	Arm 1: Iscalimab 600 mg	133
Treatment Period	COMPLETED	Arm 2 - Iscalimab 300 mg	47
Treatment Period	NOT COMPLETED	Arm 1: Iscalimab 600 mg	19
Treatment Period	NOT COMPLETED	Arm 2 - Iscalimab 300 mg	7
Safety Follow-up Period	STARTED	Arm 1: Iscalimab 600 mg	152
Safety Follow-up Period	STARTED	Arm 2 - Iscalimab 300 mg	54
Safety Follow-up Period	COMPLETED	Arm 1: Iscalimab 600 mg	143
Safety Follow-up Period	COMPLETED	Arm 2 - Iscalimab 300 mg	49

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events64

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Neutropenia	Blood and lymphatic system disorders	Arm 1: Iscalimab 600 mg	10	152
other	Neutropenia	Blood and lymphatic system disorders	Arm 2 - Iscalimab 300 mg	2	54
other	Diarrhoea	Gastrointestinal disorders	Arm 1: Iscalimab 600 mg	13	152
other	Diarrhoea	Gastrointestinal disorders	Arm 2 - Iscalimab 300 mg	4	54
other	Pyrexia	General disorders	Arm 1: Iscalimab 600 mg	8	152
other	Pyrexia	General disorders	Arm 2 - Iscalimab 300 mg	2	54
other	COVID-19	Infections and infestations	Arm 1: Iscalimab 600 mg	39	152
other	COVID-19	Infections and infestations	Arm 2 - Iscalimab 300 mg	16	54
other	Influenza	Infections and infestations	Arm 1: Iscalimab 600 mg	7	152
other	Influenza	Infections and infestations	Arm 2 - Iscalimab 300 mg	7	54

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1: Iscalimab 600 mg	0	152
Total, all-cause mortality	Arm 2 - Iscalimab 300 mg	0	54
Total, other adverse events	Arm 1: Iscalimab 600 mg	102	152
Total, other adverse events	Arm 2 - Iscalimab 300 mg	38	54
Total, serious adverse events	Arm 1: Iscalimab 600 mg	13	152
Total, serious adverse events	Arm 2 - Iscalimab 300 mg	2	54

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm 1: Iscalimab 600 mg vs Arm 2 - Iscalimab 300 mg: Incidence of Anti-iscalimab Antibodies in Plasma	Trial comparisons
Arm 1: Iscalimab 600 mg vs Arm 2 - Iscalimab 300 mg: deaths from any cause	Trial comparisons
Arm 1: Iscalimab 600 mg vs Arm 2 - Iscalimab 300 mg: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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