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

Phase 2

Active, not recruiting

• Conditions: Sjogren's Syndrome
• Interventions: Drug: CFZ533 (iscalimab); Other: CFZ533 Placebo

• Registration Number: NCT04541589
• Lead Sponsor: Novartis Pharmaceuticals

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.

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 Timeline

• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2021-01-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-08-22
• Study Completion: 2024-08-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 206

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	CFZ533 (iscalimab)	Arm 1 - Iscalimab Dose 1
Arm 2	CFZ533 (iscalimab)	Arm 2 - Iscalimab Dose 2 and Placebo
Arm 2	CFZ533 Placebo	Arm 2 - Iscalimab Dose 2 and Placebo

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent adverse events (TEAEs)	60 weeks	Number and percentage of participants having any AE

Secondary Outcome Measures

Name	Time	Method
Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study	60 weeks	To assess immunogenicity of iscalimab
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)

Trial Locations

Locations (8)

Tufts School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States

The John Hopkins Jerome L Greene Sjogren; 🇺🇸 Baltimore, Maryland, United States

Ochsner Health System Research Department; 🇺🇸 Baton Rouge, Louisiana, United States

North GA Rheumatology Group PC CAIN457FUS01; 🇺🇸 Duluth, Georgia, United States

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

Perelman School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Novartis Investigative Site; 🇬🇧 Manchester, United Kingdom

Uni Wisconsin School Med Pub Health .; 🇺🇸 Madison, Wisconsin, United States