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Trial details
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjögren's Syndrome
Current status:
Approved
|
Date registered:
15/12/2023
Trial version(s)
History: 26/05/2022
History: 26/05/2022
History: 26/05/2022
History: 26/05/2022
Current: 26/05/2022
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2022065051
Protocol number
CVAY736A2302
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjögren's Syndrome
Acronym
Scientific title
A Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome
Acronym
NEPTUNUS-2
Brief summary of the study: English
A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren's syndrome
Brief summary of the study: Arabic
دراسة عشوائيّة التوزيع، مزدوجة التعمية، مرتكزة على المقارنة بدواء وهمي، من 3 مجموعات، متعددة المراكز في المرحلة 3 لتقييم فعاليّة وسلامة دواء إيانالوماب لدى المرضى المصابين بمتلازمة شوغرن النشطة
Health conditions/problem studied: Specify
Sjogren Syndrome
Interventions: Specify
- Biological: VAY736 ianalumab s.c. - Other: Placebo placebo s.c.
Key inclusion and exclusion criteria: Inclusion criteria
- Signed informed consent must be obtained prior to participation in the study - Women and men ≥ 18 years of age - Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria - Time since diagnosis of Sjögren's of ≤ 7.5 years at screening Positive anti-Ro/SSA antibody at screening Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review - Enrollment of anti-Ro/SSA-negative patients will be limited up to ≤10% of the study population - Screening ESSDAI score of ≥ 5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic. - Stimulated whole salivary flow (sSF) rate of ≥ 0.05 mL/min at screening - Ability to communicate well with the Investigator, understand and agree to comply with the requirements of the study - Patients taking hydroxychloroquine (≤ 400 mg/day), methotrexate (≤ 25 mg/week) or azathioprine (≤ 150 mg/day) alone or in combination, are allowed to continue their medication, and must have been on a stable dose for at least 30 days prior to randomization. - Patients taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day predniso(lo)ne or equivalent for at least 30 days before randomization. - Patients taking disease-modifying antirheumatic drugs (DMARDs) other than specifically allowed in inclusion criterion #9 or the following Traditional Chinese Medicines: Total glucoside of peony (TGP) or Tripterium glycosides (TG) - must discontinue these medications at least 30 days prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
- Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness - Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer3. Prior treatment with ianalumab - Prior use of a B-cell depleting therapy other than ianalumab within 36 weeks prior to randomization or as long as B-cell count is <50 cells/μL - Prior treatment with any of the following within 6 months prior to randomization: iscalimab, belimumab , abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins plasmapheresis; i.v. or oral cyclophosphamide and mycophenolate mofetil, i.v. or oral cyclosporine A; any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors) unless explicitly allowed by protocol - Use of corticosteroids (predniso(lo)ne or equivalent corticosteroid) at dose >10 mg/day - Any one of the following laboratory values at screening: Hemoglobin levels < 8.0 g/dL White blood cells (WBC) count < 2.0 x 10E3/µL Platelet count < 80 x 10E3/µL Absolute neutrophil count (ANC) < 0.8 x 10E3/µL - Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms - History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/ L-histidine, polysorbate 20) - History of major organ, hematopoietic stem cell or bone marrow transplant - Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect, and which have not been on a stable dose for at least 30 days prior to Screening, or any anticipated change in the treatment regimen during the course of the study. - Use of topical ocular prescription medications (excluding artificial tears, gels, lubricants) that have not been on a stable dose for at least 90 days prior to randomization, or any anticipated change in the treatment regimen during the course of the study - Receipt of live/attenuated vaccine within a 4-week period prior to randomization - History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result - History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer or Sjögren's related lymphoma), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. - History of sarcoidosis - Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes mellitus), psychiatric or additional physical condition that the Investigator feels may jeopardize the patient in case of participation in this study - Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the subject. - Evidence of active tuberculosis (TB) infection (after anti-TB treatment, patients with history of or latent TB may become eligible according to national guidelines) - Pregnant or nursing (lactating) women, - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational medication. - Patients with a known history of non-compliance to medication, or who were unable or unwilling to complete PRO questionnaires, or who are unable or unwilling to use the device for collection of PROs.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Ianalumab
Type of IMP
Immunological
Pharmaceutical class
human IgG1 monoclonal antibody
Therapeutic indication
Active Sjogren's Syndrome
Therapeutic benefit
Treatment
Biospecimen retention
Samples with DNA**
Biospecimen description
Samples will be shipped to Q2 solutions central lab
Target sample size
5
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
22/02/2023
Date of study closure: Type
Anticipated
Date of study closure: Date
08/03/2028
Recruitment status
Recruiting
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
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
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT05349214?term=CVAY736A2302&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinicaltrials.gov
NCT05349214
Sources of Monetary or Material Support
Name
Novartis Pharmaceuticals
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Nelly
Ziade
Beirut
Lebanon
+96170973214
nellziade@yahoo.fr
Hotel dieu de France Hospital
Scientific
Hind
Khairallah
Beirut
Lebanon
+9611512002 ext. 271
Hind.Khairallah@ fattal.com.lb
Khalil Fattal et
Public
Imad
Uthman
Beirut
Lebanon
+9613379098
iuthman@aub.edu.lb
American University of Beirut Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel dieu de France Hospital
Nelly Ziade
Rheumatology
Approved
American University of Beirut Medical Center
Imad Uthman
Rheumatology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
03/05/2022
Nancy Alam
nancy.alam@usj.edu.lb
+9611421000 ext. 2335
American University of Beirut Medical Center
23/11/2022
Rami Mahfouz
rm11@aub.edu.lb
+9611350 000 ext:5445
Countries of Recruitment
Name
Lebanon
Canada
Hungary
Health Conditions or Problems Studied
Condition
Code
Keyword
Active Sjögren’s syndrome
Other systemic involvement of connective tissue (M35)
Sjögren’s syndrome
Interventions
Intervention
Description
Keyword
Consenting, IMP administration, Laboratory testing
Consenting, IMP administration, Laboratory testing
Consenting, IMP administration, Laboratory testing
Primary Outcomes
Name
Time points
Measure
Efficacy
48 weeks
Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo
Key Secondary Outcomes
Name
Time points
Measure
Efficacy
48 weeks
Proportion of patients achieving ≥3 points reduction from baseline in ESSDAI score at Week 48
Efficacy
48 weeks
Proportion of patients achieving ESSDAI<5 at Week 48
Efficacy
24 weeks
Proportion of patients achieving ESSDAI<5 at Week 48
Efficacy
48 weeks
Change from baseline in stimulated whole salivary flow rate at Week 48
Efficacy
48 weeks
Change from baseline in Physician's Global Assessment (PhGA) of disease activity at Week 48
Efficacy
48 weeks
Change from baseline in Patient's Global Assessment (PaGA) of disease activity at Week 48
Efficacy
48 weeks
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Efficacy
48 weeks
Proportion of patients achieving meaningful improvement in the Sjogren's Syndrome Symptom Diary (SSSD) score at Week 48
Efficacy
48 weeks
Proportion of patients achieving ≥ 1 point or 15% reduction from baseline in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) at Week 48
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Annual Review 2023
24/10/2023
VAY736 IB Edition 15
24/10/2023
PA01 IRB Approval - HDF
24/10/2023
VAY736 SUSARs 01Apr2023-30Sep2023
24/10/2023
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