TWINSS Extn: Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed 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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Arm 1 Arm 1 - Iscalimab Dose 1 |
Drug: CFZ533 (iscalimab)
Biological
Other Names:
|
Active Comparator: Arm 2 Arm 2 - Iscalimab Dose 2 and Placebo |
Drug: CFZ533 (iscalimab)
Biological
Other Names:
Other: CFZ533 Placebo
Matching placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-emergent AEs (TEAEs) [60 weeks]
Number and percentage of participants having any AE
- Change in laboratory evaluations for hematology from baseline to each study visit [60 weeks]
Number and percentage of participants with notable abnormalities
- Change in laboratory evaluations for serum chemistry from baseline to each study visit [60 weeks]
Number and percentage of participants with notable abnormalities
- Change in vital sign measurements from baseline for each post-baseline visit [60 weeks]
Number and percentage of participants with notable abnormalities
Secondary Outcome Measures
- Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods [60 weeks]
To assess the pharmacokinetics (PK trough levels)
- Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study [60 weeks]
To assess immunogenicity of iscalimab
Eligibility Criteria
Criteria
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
-
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
-
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)
-
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.
- 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
-
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 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
-
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.
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Investigative Site | Baltimore | Maryland | United States | 21224 |
2 | Novartis Investigative Site | Ciudad Autonoma de Bs As | Buenos Aires | Argentina | C1055AAF |
3 | Novartis Investigative Site | Graz | Austria | 8036 | |
4 | Novartis Investigative Site | Wien | Austria | 1090 | |
5 | Novartis Investigative Site | Vitoria | ES | Brazil | 29055 450 |
6 | Novartis Investigative Site | São Paulo | SP | Brazil | 01244-030 |
7 | Novartis Investigative Site | Toronto | Ontario | Canada | M5T 2S8 |
8 | Novartis Investigative Site | Rimouski | Quebec | Canada | G5L 5T1 |
9 | Novartis Investigative Site | Trois Rivieres | Quebec | Canada | G8Z 1Y2 |
10 | Novartis Investigative Site | Valdivia | Los Rios | Chile | 5110683 |
11 | Novartis Investigative Site | Santiago | RM | Chile | 7500588 |
12 | Novartis Investigative Site | Santiago | Chile | 7500710 | |
13 | Novartis Investigative Site | Santiago | Chile | ||
14 | Novartis Investigative Site | Medellin | Antioquia | Colombia | 050001 |
15 | Novartis Investigative Site | Barranquilla | Atlantico | Colombia | 080002 |
16 | Novartis Investigative Site | Brest | France | 29200 | |
17 | Novartis Investigative Site | Le Kremlin Bicetre | France | 94275 | |
18 | Novartis Investigative Site | Strasbourg | France | 67000 | |
19 | Novartis Investigative Site | Bonn | Germany | 53105 | |
20 | Novartis Investigative Site | Dresden | Germany | 01307 | |
21 | Novartis Investigative Site | Freiburg | Germany | 79106 | |
22 | Novartis Investigative Site | Wuerzburg | Germany | 97080 | |
23 | Novartis Investigative Site | Athens | Greece | 115 27 | |
24 | Novartis Investigative Site | Szekesfehervar | Fejer | Hungary | 8000 |
25 | Novartis Investigative Site | Szeged | Hungary | 6720 | |
26 | Novartis Investigative Site | Kfar Saba | Israel | 44281 | |
27 | Novartis Investigative Site | Ramat Gan | Israel | 52621 | |
28 | Novartis Investigative Site | Milano | MI | Italy | 20132 |
29 | Novartis Investigative Site | Nagoya | Aichi | Japan | 457 8510 |
30 | Novartis Investigative Site | Sasebo-city | Nagasaki | Japan | 857-1165 |
31 | Novartis Investigative Site | Kurashiki | Okayama | Japan | 710-8522 |
32 | Novartis Investigative Site | Chuo ku | Tokyo | Japan | 104-8560 |
33 | Novartis Investigative Site | Seoul | Seocho Gu | Korea, Republic of | 06591 |
34 | Novartis Investigative Site | Rotterdam | Netherlands | 3015 CE | |
35 | Novartis Investigative Site | Lisboa | Portugal | 1050-034 | |
36 | Novartis Investigative Site | Lisboa | Portugal | 1649-035 | |
37 | Novartis Investigative Site | Ponte de Lima | Portugal | 4990 041 | |
38 | Novartis Investigative Site | Brasov | Romania | 500283 | |
39 | Novartis Investigative Site | Ekaterinburg | Russian Federation | 620028 | |
40 | Novartis Investigative Site | Kazan | Russian Federation | 420097 | |
41 | Novartis Investigative Site | Moscow | Russian Federation | 115522 | |
42 | Novartis Investigative Site | St Petersburg | Russian Federation | 195257 | |
43 | Novartis Investigative Site | Tomsk | Russian Federation | 634009 | |
44 | Novartis Investigative Site | Ankara | Turkey | 06560 | |
45 | Novartis Investigative Site | Doncaster | United Kingdom | DN2 5LT |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CCFZ533B2201E1