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.
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)
Number of Treatment-emergent AEs (TEAEs)/SAEs — Week 52 to Week 464 Assessment of safety and tolerability of ianalumab (VAY736) in patients with active Sjogrens syndrome
Trial sites (198)
Facility
City
Region
Status
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.
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.
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