Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome

• Register: EUCTR
• Last refreshed on: 12 April 2021
• Main ID: EUCTR2020-001942-20-HU
• Date of registration: 17/09/2020
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome
• Scientific 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
• Date of first enrolment: 16/11/2020
• Target sample size: 160
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001942-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: Parallel group: Cross over: no; Other: yes; Other trial design description: Double-blind until final database lock (DBL) of Core study (CCFZ533B2201), open after DBL; 2 arms; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

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, 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 136
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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

Other protocol-defined inclusion/exclusion criteria may apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Sjögren syndrome
MedDRA version: 21.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: iscalimab
Product Code: CFZ533
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ISCALIMAB
Current Sponsor code: CFZ533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: To assess the pharmacokinetics (PK trough levels) and dose-exposure relationship of iscalimab;
To assess immunogenicity of iscalimab

Timepoint(s) of evaluation of this end point: repeatedly until study completion (60 weeks)

Primary end point(s): Incidence of Treatment-emergent adverse events (TEAEs)/ serious adverse events (SAEs)
Routine hematology and clinical chemistry laboratory test results at analysis visits up to end of study
Vital signs at analysis visits up to end of study

Main Objective: To evaluate the safety and tolerability of iscalimab in patients with Sjogren's, who participated in the TWINSS core study, CCFZ533B2201

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: repeatedly until study completion (60 weeks)

Secondary end point(s): 1. Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods
2. Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study

Secondary ID(s)

CCFZ533B2201E1

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 19/10/2020
Contact: