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

Sjogren's Syndrome Clinical Trial

— TWINSS Extn  

Official title:

A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04541589
• Other study ID #: CCFZ533B2201E1
• Secondary ID: 2020-001942-20
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 5, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This Extension study is a 48-week treatment study, with a safety follow-up period of 12 weeks. This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who must have participated in the TWINSS core study, CCFZ533B2201 (NCT03905525) and must have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60.

Study treatment will be administered as bi-weekly subcutaneous injections (Q2W s.c.) via prefilled syringes (PFS).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 206
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Participants must have participated in the TWINSS core study, CCFZ533B2201 (NCT03905525), and must have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60

2. Signed informed consent must be obtained prior to participation in the Extension study (i.e. before commencement of the Week 60 assessments of the core study)

3. In the judgement of the Investigator, participants must be expected to clinically benefit from continued iscalimab therapy

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study.

1. Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness, specifically:

• Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSDAI domains

• Active rheumatoid arthritis (RA) that impedes 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 is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's Syndrome organ domain assessments

2. Use of other investigational drugs other than iscalimab during the core study

3. 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

4. Pregnant or nursing (lactating) women, where pregnancy is 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

5. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 14 weeks after stopping of investigational drug.

6. 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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• CFZ533 (iscalimab)
Biological

Other:
• CFZ533 Placebo
Matching placebo

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Australia	Novartis Investigative Site	Nedlands	Western Australia
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Wien
Brazil	Novartis Investigative Site	Juiz de Fora	MG
Brazil	Novartis Investigative Site	São Paulo	SP
Brazil	Novartis Investigative Site	Vitoria	ES
Canada	Novartis Investigative Site	Rimouski	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Trois Rivieres	Quebec
Chile	Novartis Investigative Site	Santiago	RM
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Valdivia	Los Rios
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Medellin	Antioquia
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Le Kremlin Bicetre
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Strasbourg
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Wuerzburg
Greece	Novartis Investigative Site	Athens
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szekesfehervar	Fejer
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Kfar Saba
Israel	Novartis Investigative Site	Ramat Gan
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Pisa	PI
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Sasebo-city	Nagasaki
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Rotterdam
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Ponte de Lima
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Cluj Napoca
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Tomsk
Sweden	Novartis Investigative Site	Stockholm	SE
Turkey	Novartis Investigative Site	Ankara
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Doncaster
United Kingdom	Novartis Investigative Site	Manchester
United States	The John Hopkins Jerome L Greene	Baltimore	Maryland
United States	Ochsner Health System Research Department	Baton Rouge	Louisiana
United States	Tufts School of Dental Medicine	Boston	Massachusetts
United States	North GA Rheumatology Group, PC CAIN457FUS01	Duluth	Georgia
United States	Uni Wisconsin School Med Pub Health .	Madison	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Chile,  Colombia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Portugal,  Romania,  Russian Federation,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-emergent adverse events (TEAEs)	Number and percentage of participants having any AE	60 weeks
Secondary	Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods	To assess the pharmacokinetics (PK trough levels)	60 weeks
Secondary	Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study	To assess immunogenicity of iscalimab	60 weeks

External Links

•   Core study