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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sjogren's Syndrome

In brief

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.

Key facts

Study ID

NCT04541589

Run by

Novartis Pharmaceuticals

People needed

206

Starts

2021-01-05

Expected to finish

2024-08-19

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants had to have participated in the TWINSS core study, CCFZ533B2201 (NCT03905525), and had to have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60.
• Signed informed consent had to be obtained prior to participation in the Extension study (i.e., before commencement of the Week 60 assessments of the core study).
• In the judgment of the Investigator, participants had to be expected to clinically benefit from continued iscalimab therapy.

You may not qualify if…

• Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constituted the principle illness, specifically:
• Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impeded on the ability to score ESSDAI domains
• Active rheumatoid arthritis (RA) that impeded on the ability to score the ESSDAI articular domain
• Systemic sclerosis
• Any other concurrent connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease) that was active and required immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's Syndrome organ domain assessments
• Use of other investigational drugs other than iscalimab during the core study
• Active uncontrolled viral, bacterial or other infections requiring systemic treatment at the time of enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
• Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test
• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception during dosing and for 14 weeks after stopping the investigational drug.
• Missing ESSDAI (Cohort 1 and Cohort 2) or ESSPRI (Cohort 2) scores in the core study at Weeks 0 and 4 or Weeks 40 and 48.

Where it is running

• Ochsner Health System — Baton Rouge, Louisiana, United States
• The John Hopkins Jerome L Greene Sjogren — Baltimore, Maryland, United States
• Tufts School of Dental Medicine — Boston, Massachusetts, United States
• Winthrop University Hospital — Mineola, New York, United States
• Perelman School of Medicine — Philadelphia, Pennsylvania, United States
• Uni Wisconsin School Med Pub Health — Madison, Wisconsin, United States
• Novartis Investigative Site — Ciudad Autonoma de Bs As, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — Nedlands, Western Australia, Australia
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Vitória, Espírito Santo, Brazil
• Novartis Investigative Site — Juiz de Fora, Minas Gerais, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Rimouski, Quebec, Canada
• Novartis Investigative Site — Trois-Rivières, Quebec, Canada
• Novartis Investigative Site — Valdivia, Los Ríos Region, Chile
• Novartis Investigative Site — Santiago, RM, Chile
• Novartis Investigative Site — Santiago, Chile
• Novartis Investigative Site — Santiago, Chile
• Novartis Investigative Site — Medellín, Antioquia, Colombia
• Novartis Investigative Site — Barranquilla, Atlántico, Colombia
• Novartis Investigative Site — Brest, France
• North GA Rheumatology Group PC — Suwanee, Georgia, United States

Full record on ClinicalTrials.gov

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