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

Study of Safety and Tolerability of CFZ533 in Patients With Sjogren's Syndrome (TWINSS Extn)

Yamada Hiroyuki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Yamada Hiroyuki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Not Recruiting

Jan. 07, 2021

Interventional

non-randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

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

1.Sjogren'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 Sjogren'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

Both

Sjogren's Syndrome

Arm 1 - Iscalimab Dose 1
Arm 2 - Iscalimab Dose 2 and Placebo

Sjogren's Syndrome, autoimmune, ESSDAI, ESSPRI, anti-CD40, CFZ533, iscalimab, TWINSS Extension

1.Incidence of Treatment-emergent AEs (TEAEs) [ Time Frame: 60 weeks ]
2.Change in laboratory evaluations for hematology from baseline to each study visit [ Time Frame: 60 weeks ]
3.Change in laboratory evaluations for serum chemistry from baseline to each study visit [ Time Frame: 60 weeks ]
4.Change in vital sign measurements from baseline for each post-baseline visit [ Time Frame: 60 weeks ]

+81-956-33-7151

Nov. 10, 2020

No

Australia/Hungary