Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
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|ClinicalTrials.gov Identifier: NCT03656562|
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus (SLE)||Drug: VAY736 Drug: VAY736 Placebo Drug: CFZ533 Drug: CFZ533 Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The investigational drug or placebo will be administered on top of SLE background therapy. Patients will be randomized at baseline into one of two treatment cohorts (VAY736 or CFZ533) and to either active or placebo double blind treatment within that cohort. From Week 29 onwards all patients will receive open label active treatment until week 53 in the respective cohort.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Patients, investigator staff, persons performing the assessments, and the clinical trial team (CTT) will remain blind to the identity of the treatment within each cohort from the time of randomization until end of the Week 29 visit|
|Official Title:||A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||April 15, 2021|
|Estimated Study Completion Date :||August 2, 2023|
Experimental: Cohort 1 VAY736
multiple doses of VAY736, s.c.
Powder for solution for injection
Placebo Comparator: Cohort 1 VAY736 Placebo
multiple doses of matching placebo s.c. until week 29. Multiple doses of VAY736, s.c from week 29 until week 53.
Drug: VAY736 Placebo
Solution for injection
Experimental: Cohort 2 CFZ533
multiple doses of CFZ533, i.v.
Concentrate for solution for infusion
Placebo Comparator: Cohort 2 CFZ533 Placebo
multiple doses of matching placebo i.v. until week 29. Multiple doses of CFZ533, i.v. from week 29 until week 53.
Drug: CFZ533 Placebo
Solution for infusion
- SRI-4 response status [ Time Frame: 29 Weeks ]
SRI-4 response status at Week 29 (reduced steroid dose maintained between Weeks 17 and 29).
Clinical efficacy will be measured using the SLE Responder Index (SRI-4), a composite endpoint that incorporates SLEDAI-2K, BILAG 2004, and a visual analog scale (VAS) of physician-rated disease activity to determine patient improvement.
- PhGA VAS - overall disease activity [ Time Frame: from Baseline to Week 29 ]Changes between baseline and Week 29 in the Physicians' Global Assessment (PhGA) visual analog scale (VAS) assessing patient's overall disease activity
- PGA VAS - global disease activity [ Time Frame: from baseline to Week 29 ]Changes between baseline and Week 29 in the Patient's Global Assessment (PGA) visual analog scale (VAS) assessing patient's global disease activity
- Flare rate and time to first flare [ Time Frame: 18 months ]Flare rate and time to first flare, with flare defined as one new 'A' score or two or more 'B' score using BILAG -2004
- Time to first flare [ Time Frame: 18 months ]Time to first flare, with flare defined as one new 'A' score or two or more 'B' score using BILAG -2004
- PK Cohort 1 - Cmax,ss [ Time Frame: 18+ months ]PK Cohort 1 (VAY736): free VAY736 serum concentration (Cmax at steady state)
- PK Cohort 1 - Ctrough,ss [ Time Frame: 18+ months ]PK Cohort 1 (VAY736): free VAY736 serum concentration (Ctrough at steady state)
- PK Cohort 2 - Cmax,ss [ Time Frame: 18 months ]PK Cohort 2 (CFZ533): free CFZ533 concentration in plasma (Cmax at steady state).
- PK Cohort 2 - Ctrough,ss [ Time Frame: 18 months ]PK Cohort 2 (CFZ533): free CFZ533 concentration in plasma (Ctrough at steady state).
- PD Cohort 2 (CFZ533): total soluble CD40 [ Time Frame: 18 months ]PD Cohort 2 (CFZ533): total soluble CD40 in plasma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656562
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals||+81337978748|
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