Adults 18 to 99, any sex, with Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· 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
Death
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
0
Arm 2 - Iscalimab 300 mg
0
Adverse event (all severities)
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
127
Arm 2 - Iscalimab 300 mg
43
Adverse Event- Mild
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
57
Arm 2 - Iscalimab 300 mg
24
Adverse Event- Moderate
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
62
Arm 2 - Iscalimab 300 mg
17
Adverse Event- Severe
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
8
Arm 2 - Iscalimab 300 mg
2
Serious Adverse Event
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
13
Arm 2 - Iscalimab 300 mg
2
Adverse Event leading to study medication discontinuation
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
8
Arm 2 - Iscalimab 300 mg
2
Free Iscalimab Concentration in PlasmaSecondary· 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).
Day 1
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
3.56
± 372.2
Arm 2 - Iscalimab 300 mg
451.8
± 0.751
Day 113
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
125
± 62.7
Arm 2 - Iscalimab 300 mg
56.9
± 54.0
Day 225
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
126
± 104.7
Arm 2 - Iscalimab 300 mg
50.3
± 57.0
Day 337
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
138
± 69.3
Arm 2 - Iscalimab 300 mg
62.6
± 63.3
Day 421
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
4.47
± 533.7
Arm 2 - Iscalimab 300 mg
350.4
± 0.336
Incidence of Anti-iscalimab Antibodies in PlasmaSecondary· 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).
Group
Value
95% CI
Arm 1: Iscalimab 600 mg
1
Arm 2 - Iscalimab 300 mg
2
Adverse events — posted to ClinicalTrials.gov
Time frame: 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.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm 1: Iscalimab 600 mg
Serious: 13/152 (9%)
Deaths: 0/152
Arm 2 - Iscalimab 300 mg
Serious: 2/54 (4%)
Deaths: 0/54
Serious adverse events (17 terms)
Reaction
System
Arm 1: Iscalimab 600 mg
Arm 2 - Iscalimab 300 mg
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Granulocytopenia
Blood and lymphatic system disorders
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
Glaucoma
Eye disorders
—
—
Anal prolapse
Gastrointestinal disorders
—
—
Cholangitis
Hepatobiliary disorders
—
—
Food allergy
Immune system disorders
—
—
Bartholinitis
Infections and infestations
—
—
COVID-19
Infections and infestations
—
—
COVID-19 pneumonia
Infections and infestations
—
—
Sjogren's syndrome
Musculoskeletal and connective tissue disorders
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07281456 — Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
· Phase 2
· recruiting
NCT07180537 — Creating Health Course Study for People With Rheumatological Conditions
· NA
· recruiting
NCT07236762 — An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
· Phase 1
· recruiting
NCT07041099 — A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
· Phase 1
· recruiting
NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 16 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04541589.