A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
NEPTUNUS-Ext
2 other identifiers
interventional
612
34 countries
196
Brief Summary
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Longer than P75 for phase_3
196 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
October 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 22, 2033
April 29, 2026
April 1, 2026
9.5 years
August 3, 2023
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Treatment-emergent AEs (TEAEs)/SAEs
Assessment of safety and tolerability of ianalumab (VAY736) in patients with active Sjogrens syndrome
Week 52 to Week 464
Secondary Outcomes (6)
Percentage of participants achieving ≥ 5 points reduction from baseline in ESSDAI
Over time up to Week 360
Percentage of participants achieving ≥2.3 points reduction from baseline in ESSPRI among participants with baseline ESSPRI ≥3 score over time
Over time up to Week 360
Percentage of participants achieving ≥2.0 points reduction from baseline in SSSD among participants with baseline SSSD ≥3
Over time up to Week 360
Pre-dose Ianalumab serum concentrations
pre-dose at Week 48 (from core study) and Week 64
On-treatment Ianalumab serum concentrations
During treatment (from Week 52 to Week 204) and follow-up (From Week 208 to Week 304)
- +1 more secondary outcomes
Study Arms (2)
Ianalumab Monthly
EXPERIMENTALIanalumab 300 mg s.c. monthly during initial double-blind treatment period. Open-label treatment and receive ianalumab 300 mg monthly.
Ianalumab 3 Monthly
EXPERIMENTALIanalumab 300 mg s.c. every three months and placebo once monthly between doses during initial double-blind treatment period. Open-label treatment and receive ianalumab 300 mg monthly.
Interventions
Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use
Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use
Eligibility Criteria
You may qualify if:
- Signed informed consent prior to participation in the extension study.
- Participants must have participated in either one of the two NEPTUNUS core studies, CVAY736A2301 or CVAY736A2302, and must have completed the entire treatment up to Week 48 without treatment discontinuation in core NEPTUNUS studies.
- In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy.
You may not qualify if:
- Plans for administration of live vaccines during the study period.
- Pregnant or nursing (breastfeeding) 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, from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
- WOCBP are excluded unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment during dosing and for 6 months after stopping of investigational drug. Highly effective contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post- ovulation methods) and withdrawal are not acceptable methods of contraception.
- Bilateral tubal occlusion or bilateral tubal ligation (at least six weeks before taking study treatment).
- Sterilization (vasectomy) of male partner (s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical process.
- Use of hormonal contraception methods:
- Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.
- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable.
- Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Contraception should be used in accordance with locally approved prescribing information of concomitant medications administered.
- If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the informed consent form (ICF).
- United States (and other countries, if male contraception is locally required): Sexually active males, unless they agree to use barrier protection during intercourse with a woman of child-bearing potential, while taking study treatment. As condom use alone has a reported failure rate exceeding 1% per year, it is recommended that female partners of male study participants use a second method of birth control. Although ianalumab is not teratogenic and/or genotoxic, and not transferred to semen, male contraception is required, as requested by FDA.
- Globally, for all sexually active males, contraception should be used in accordance with the locally approved prescribing information of concomitant medications administered.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (197)
Providence Medical Foundation
Fullerton, California, 92835, United States
Advanced Medical Research
La Palma, California, 90623, United States
Medvin Clinical Research
Van Nuys, California, 91405, United States
Bay Area Arthritis And Osteoporosis
Brandon, Florida, 33511, United States
GNP Research
Cooper City, Florida, 33024, United States
Sarasota Arthritis Res Ctr
Sarasota, Florida, 34239, United States
West Broward Rheumatology Associates Inc
Tamarac, Florida, 33321, United States
Augusta University Georgia
Augusta, Georgia, 30912, United States
North GA Rheumatology Group PC
Suwanee, Georgia, 30024, United States
Clin Invest Specialists Inc
Orland Park, Illinois, 60467, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Ochsner Health System
Baton Rouge, Louisiana, 70809, United States
The John Hopkins Jerome L Greene Sjogren
Baltimore, Maryland, 21224, United States
Tufts School of Dental Medicine
Boston, Massachusetts, 02111, United States
Arthritis Osteoporosis Assoc of NM
Las Cruces, New Mexico, 88011, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
St Lawrence Health System
Potsdam, New York, 13676, United States
Arthritis and Osteoporosis
Charlotte, North Carolina, 28202, United States
On Site Clinical Solutions Llc
Charlotte, North Carolina, 28202, United States
Carolina Arthritis Associates
Wilmington, North Carolina, 28401, United States
STAT Research Inc
Dayton, Ohio, 45402, United States
RAO Research LLC
Oklahoma City, Oklahoma, 73116, United States
Altoona Center for Clin Res
Duncansville, Pennsylvania, 16635, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Shelby Research LLC
Memphis, Tennessee, 38119, United States
Precision Comprehensive Research
Colleyville, Texas, 76034, United States
Baylor College Of Medicine
Houston, Texas, 77030, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
Houston Rheumatology and Arthrit
Katy, Texas, 77494, United States
First Outpatient Research Unit
San Antonio, Texas, 78229, United States
Advanced Rheumatology of Houston
Spring, Texas, 77382, United States
Arthritis Northwest PLLC
Spokane, Washington, 99204, United States
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2023
First Posted
August 14, 2023
Study Start
October 27, 2023
Primary Completion (Estimated)
April 22, 2033
Study Completion (Estimated)
April 22, 2033
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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