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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04541589




Registration number
NCT04541589
Ethics application status
Date submitted
14/08/2020
Date registered
9/09/2020

Titles & IDs
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
Secondary ID [1] 0 0
2020-001942-20
Secondary ID [2] 0 0
CCFZ533B2201E1
Universal Trial Number (UTN)
Trial acronym
TWINSS Extn
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjogren's Syndrome 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CFZ533 (iscalimab)
Other interventions - CFZ533 Placebo

Active comparator: Arm 1 - Arm 1 - Iscalimab Dose 1

Active comparator: Arm 2 - Arm 2 - Iscalimab Dose 2 and Placebo


Treatment: Drugs: CFZ533 (iscalimab)
Biological

Other interventions: CFZ533 Placebo
Matching placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
60 weeks
Secondary outcome [1] 0 0
Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods
Timepoint [1] 0 0
60 weeks
Secondary outcome [2] 0 0
Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study
Timepoint [2] 0 0
60 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/08/2024
Actual
Sample size
Target
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Caba
Country [10] 0 0
Austria
State/province [10] 0 0
Graz
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Brazil
State/province [12] 0 0
ES
Country [13] 0 0
Brazil
State/province [13] 0 0
MG
Country [14] 0 0
Brazil
State/province [14] 0 0
SP
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Los Rios
Country [18] 0 0
Chile
State/province [18] 0 0
RM
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
Colombia
State/province [20] 0 0
Antioquia
Country [21] 0 0
Colombia
State/province [21] 0 0
Atlantico
Country [22] 0 0
France
State/province [22] 0 0
Brest
Country [23] 0 0
France
State/province [23] 0 0
Le Kremlin Bicetre
Country [24] 0 0
France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Strasbourg
Country [26] 0 0
Germany
State/province [26] 0 0
Bonn
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Freiburg
Country [29] 0 0
Germany
State/province [29] 0 0
Wuerzburg
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Hungary
State/province [31] 0 0
Fejer
Country [32] 0 0
Hungary
State/province [32] 0 0
Szeged
Country [33] 0 0
Israel
State/province [33] 0 0
Haifa
Country [34] 0 0
Israel
State/province [34] 0 0
Kfar Saba
Country [35] 0 0
Israel
State/province [35] 0 0
Ramat Gan
Country [36] 0 0
Italy
State/province [36] 0 0
MI
Country [37] 0 0
Italy
State/province [37] 0 0
PI
Country [38] 0 0
Japan
State/province [38] 0 0
Aichi
Country [39] 0 0
Japan
State/province [39] 0 0
Nagasaki
Country [40] 0 0
Japan
State/province [40] 0 0
Okayama
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seocho Gu
Country [43] 0 0
Netherlands
State/province [43] 0 0
Zuid Holland
Country [44] 0 0
Netherlands
State/province [44] 0 0
Groningen
Country [45] 0 0
Portugal
State/province [45] 0 0
Lisboa
Country [46] 0 0
Portugal
State/province [46] 0 0
Ponte de Lima
Country [47] 0 0
Romania
State/province [47] 0 0
Brasov
Country [48] 0 0
Romania
State/province [48] 0 0
Cluj Napoca
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Ekaterinburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Kazan
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Moscow
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St Petersburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Tomsk
Country [54] 0 0
Sweden
State/province [54] 0 0
SE
Country [55] 0 0
Turkey
State/province [55] 0 0
Ankara
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Birmingham
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Doncaster
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04541589