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Clinical Trials in the UK / NCT05985915
Active, not recruiting Phase 3

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.

NCT05985915 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2023-10-27
Last updated
2026-08-19

Condition(s) studied

Sjogrens Syndrome

Investigational drug(s) / intervention(s)

Ianalumab (VAY736)Placebo

Ianalumab (VAY736): Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use

Placebo: Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use

Study 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 \[NCT05349214\]).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent prior to participation in the extension study. 2. 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. 3. In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy. Exclusion Criteria: 1. Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols (see NEPTUNUS studies protocols exclusion criteria in Section 5.2 for details). 2. Plans for administration of live vaccines during the study period. 3. 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. 4. 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). 5. 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.

Primary outcome measure(s)

Trial sites (198)

FacilityCityRegionStatus
Providence Medical Foundation Fullerton California
Advanced Medical Research La Palma California
Medvin Clinical Research Van Nuys California
Bay Area Arthritis And Osteoporosis Brandon Florida
GNP Research Cooper City Florida
Sarasota Arthritis Res Ctr Sarasota Florida
West Broward Rheumatology Associates Inc Tamarac Florida
Augusta University Georgia Augusta Georgia
North GA Rheumatology Group PC Suwanee Georgia
Clin Invest Specialists Inc Orland Park Illinois
University of Kansas Hospital Kansas City Kansas
Ochsner Health System Baton Rouge Louisiana
The John Hopkins Jerome L Greene Sjogren Baltimore Maryland
Tufts School of Dental Medicine Boston Massachusetts
Arthritis Osteoporosis Assoc of NM Las Cruces New Mexico
NYU Langone Hospital - Long Island Mineola New York
St Lawrence Health System Potsdam New York
Arthritis and Osteoporosis Charlotte North Carolina
On Site Clinical Solutions Llc Charlotte North Carolina
Carolina Arthritis Associates Wilmington North Carolina
STAT Research Inc Dayton Ohio
RAO Research LLC Oklahoma City Oklahoma
Altoona Center for Clin Res Duncansville Pennsylvania
West Tennessee Research Institute Jackson Tennessee
Shelby Research LLC Memphis Tennessee
Precision Comprehensive Research Colleyville Texas
Baylor College Of Medicine Houston Texas
Prolato Clinical Research Center Houston Texas
Houston Rheumatology and Arthrit Katy Texas
First Outpatient Research Unit San Antonio Texas
Advanced Rheumatology of Houston The Woodlands Texas
Arthritis Northwest PLLC Spokane Washington
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Quilmes Buenos Aires
Novartis Investigative Site San Miguel Tucuman Tucumán Province
Novartis Investigative Site Buenos Aires Argentina
Novartis Investigative Site Buenos Aires Argentina
Novartis Investigative Site CABA Argentina
Novartis Investigative Site Maroochydore Queensland
Novartis Investigative Site Woodville South South Australia

+ 158 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05985915 on ClinicalTrials.gov ↗ ← All trials in the UK