Study Description
The purpose of this study is to measure the long-term safety and tolerability of
ianalumab in participants with Sjogrens syndrome who have previously completed treatment
from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302).
- The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection.
All participants will receive ianalumab either monthly or every 3 months.
- The treatment duration will be 3 years with an additional up to 2-year safety
follow-up. The total duration of this extension study will be up to 5 years.
- The visit frequency will be monthly during both the treatment period and mandatory
follow-up, and then less frequently during the subsequent conditional follow-up
Treatment of interest: The randomized treatment (ianalumab) will be received monthly or
every 3 months. Participants assigned to treatment every 3 months will receive placebo
every month between the ianalumab doses to maintain blinding.
Number of Participants: Approximately 600 participants from the NEPTUNUS core studies
will be rolled over into the extension study.
Treatment Groups:There will be no screening period in this trial. From Week 48 of the
NEPTUNUS core study, participants will be given the opportunity to consent to this
extension study.
From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible
participants will be assigned to either one of the treatment regimens:
- ianalumab 300 mg monthly or
- ianalumab 300 mg once every 3 months Participants receiving placebo in either of the
NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or
every 3 months starting from Week 60 and participants receiving ianalumab in either
of the NEPTUNUS core studies will continue the same treatment in the extension
study.
Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe.
Participants will be given the opportunity to self-inject at home on some visits after
receiving training. The primary purpose of this 3-year treatment extension study is the continued evaluation
of the safety and tolerability of treatment with ianalumab 300 mg monthly or every 3
months. An additional purpose is to explore the long-term efficacy of both dosing
regimens of ianalumab 300 mg.
The Primary Objective is to assess the long-term safety and tolerability of ianalumab in
participants with Sjogrens syndrome. Secondary objectives are as follows, To evaluate the
long-term efficacy of VAY736 300 mg administered monthly or every 3 months.
To show comparability of ianalumab Ctrough between 2x 1mL PFS (from the NEPTUNUS core
studies: CVAY736A2301 and CVAY736A2302) and 1x 2mL PFS for participants on continuous
monthly treatment.
To further assess the pharmacokinetics of ianalumab. To assess the impact of long-term
treatment on B-cell depletion. Trial Design: This is a multicenter, randomized,
double-blind, phase 3b study to assess the long-term safety and tolerability of four
treatment regimens of ianalumab in participants with Sjogrens syndrome who have taken
part in and completed one of two NEPTUNUS core studies, NEPTUNUS-1 (CVAY736A2301) or
NEPTUNUS-2 (CVAY736A2302). There will be no screening period in this trial. From week 48
of the NEPTUNUS core study, participants will be given the opportunity to consent to this
extension study. Eligible participants will continue their assigned treatment to receive
ianalumab 300 mg either monthly or every 3 months for up to 3 additional years of
treatment beyond the 1-year core study period. After the treatment period, all
participants will enter a follow-up period to be monitored for at least 20 weeks and then
a conditional (if B-cell recovery criteria have not been met) follow-up period. The total
post treatment follow-up period is up to 2 years.
Study Population: Participants with Sjogrens syndrome who have completed treatment in one
of two NEPTUNUS core studies.
Method of blinding: Double-blind Study treatment assignment method: Participants
randomized to ianalumab 300 mg monthly or every 3 months in one of the NEPTUNUS core
studies will continue their assigned treatment. Participants randomized to placebo in the
NEPTUNUS core studies will be randomized in a 1:1 ratio to either ianalumab 300 mg
monthly or every 3 months.
Participants randomized to ianalumab 300 mg every 3 months will receive placebo (a dummy
treatment) once monthly between doses.
Committees: An independent Data Monitoring Committee (DMC) will be utilized for safety
review throughout the study. A steering committee will be formed to ensure overview of
the study conduct.
Interventions
Ianalumab (VAY736)
Placebo
Eligibility Criteria
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 (lactating) 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, unless they are using highly effective methods of
contraception 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.
- Female bilateral tubal ligation, female sterilization (have had surgical
bilateral oophorectomy with or without hysterectomy) or total hysterectomy at
least six weeks before taking study treatment. In case of oophorectomy alone,
only when the reproductive status of the woman has been confirmed by follow up
hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female
participants on the study, the vasectomized male partner should be the sole
partner for that participant.
- Use of oral (estrogen and progesterone), injected, or implanted hormonal
methods of contraception or placement of an intrauterine device (IUD) or
intrauterine system (IUS), or other forms of hormonal contraception that have
comparable efficacy (failure rate < 1%), for example hormone vaginal ring or
transdermal hormone contraception.
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.
Women are considered post-menopausal if they have had 12 months of natural
(spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate
history of vasomotor symptoms). Women are considered of not child-bearing potential
if they are post-menopausal or have had surgical bilateral oophorectomy (with or
without hysterectomy), total hysterectomy or bilateral tubal ligation at least six
weeks ago. In the case of oophorectomy alone, only when the reproductive status of
the woman has been confirmed by follow-up hormone level assessment is she considered
not of child-bearing potential.
If local regulations deviate from the contraception methods listed above to prevent
pregnancy, local regulations apply and will be described in the informed consent
form (ICF).
5. Sexually active males unless they agree to use barrier protection during intercourse
while taking study treatment are excluded. As condom use alone has a reported
failure rate exceeding 1% per year, it is recommended 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.
Novartis Investigative Site
Recruiting
Tucuman,San Miguel De Tucuman,4000,Argentina
Novartis Investigative Site
Recruiting
Buenos Aires,1646,Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As,C1428azf,Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As,Buenos Aires,C1055aaf,Argentina
Novartis Investigative Site
Recruiting
Quilmes,Buenos Aires,1878,Argentina
Novartis Investigative Site
Recruiting
Maroochydore,Queensland,4558,Australia
Novartis Investigative Site
Recruiting
Woodville South,South Australia,5011,Australia
Novartis Investigative Site
Recruiting
Hobart,Tasmania,7000,Australia
Novartis Investigative Site
Recruiting
Graz,8036,Austria
Novartis Investigative Site
Recruiting
Leuven,3000,Belgium
Novartis Investigative Site
Recruiting
Sao Paulo,01409-902,Brazil
Novartis Investigative Site
Recruiting
Salvador,BA,40150 150,Brazil
Novartis Investigative Site
Recruiting
Vitoria,ES,29055 450,Brazil
Novartis Investigative Site
Recruiting
Juiz de Fora,MG,36010 570,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,04266 010,Brazil
Novartis Investigative Site
Recruiting
Burgas,8000,Bulgaria
Novartis Investigative Site
Recruiting
Sofia,1606,Bulgaria
Novartis Investigative Site
Recruiting
Rimouski,Quebec,G5l 5t1,Canada
Novartis Investigative Site
Recruiting
Sherbrooke,Quebec,J1g 2e8,Canada
Novartis Investigative Site
Recruiting
Trois Rivieres,Quebec,G9a 3y2,Canada
Novartis Investigative Site
Recruiting
Valdivia,Los Rios,5110683,Chile
Novartis Investigative Site
Recruiting
Santiago,RM,7500588,Chile
Novartis Investigative Site
Recruiting
Concepcion,6740,Chile
Novartis Investigative Site
Recruiting
Santiago,7500571,Chile
Novartis Investigative Site
Recruiting
Santiago,7500710,Chile
Novartis Investigative Site
Recruiting
Beijing,100029,China
Novartis Investigative Site
Recruiting
Baotou,Inner Mongolia,014010,China
Novartis Investigative Site
Recruiting
Beijing,100050,China
Novartis Investigative Site
Recruiting
Nanjing,Jiangsu,210008,China
Novartis Investigative Site
Recruiting
Beijing,100730,China
Novartis Investigative Site
Recruiting
Chang Chun,Jilin,130021,China
Novartis Investigative Site
Recruiting
Shanxi,710063,China
Novartis Investigative Site
Recruiting
Linyi,Shandong,276000,China
Novartis Investigative Site
Recruiting
Tianjin,300052,China
Novartis Investigative Site
Recruiting
Taiyuan,Shanxi,030000,China
Novartis Investigative Site
Recruiting
Hefei,Anhui,230001,China
Novartis Investigative Site
Recruiting
Xinxiang,453099,China
Novartis Investigative Site
Recruiting
Chengdu,Sichuan,610041,China
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430030,China
Novartis Investigative Site
Recruiting
Medellin,Antioquia,050001,Colombia
Novartis Investigative Site
Recruiting
Barranquilla,Atlantico,080002,Colombia
Novartis Investigative Site
Recruiting
Bucaramanga,Santander,0001,Colombia
Novartis Investigative Site
Recruiting
Bogota,110221,Colombia
Novartis Investigative Site
Recruiting
Brno,63800,Czechia
Novartis Investigative Site
Recruiting
Uherske Hradiste,686 01,Czechia
Novartis Investigative Site
Recruiting
Brest,29200,France
Novartis Investigative Site
Recruiting
Le Kremlin Bicetre,94275,France
Novartis Investigative Site
Recruiting
Lille,59037,France
Novartis Investigative Site
Recruiting
Paris cedex 10,75010,France
Novartis Investigative Site
Recruiting
St Etienne,42055,France
Novartis Investigative Site
Recruiting
Angers Cedex 9,49933,France
Novartis Investigative Site
Recruiting
Dresden,01307,Germany
Novartis Investigative Site
Recruiting
Wuerzburg,97080,Germany
Novartis Investigative Site
Recruiting
Erlangen,91056,Germany
Novartis Investigative Site
Recruiting
Freiburg,79106,Germany
Novartis Investigative Site
Recruiting
Hannover,30625,Germany
Novartis Investigative Site
Recruiting
Herne,44649,Germany
Novartis Investigative Site
Recruiting
Koeln,50937,Germany
Novartis Investigative Site
Recruiting
Berlin,13353,Germany
Novartis Investigative Site
Recruiting
Ludwigshafen,67063,Germany
Novartis Investigative Site
Recruiting
Athens,115 21,Greece
Novartis Investigative Site
Recruiting
Athens,115 27,Greece
Novartis Investigative Site
Recruiting
Quetzaltenango,9001,Guatemala
Novartis Investigative Site
Recruiting
Guatemala,01010,Guatemala
Novartis Investigative Site
Recruiting
Guatemala City,01011,Guatemala
Novartis Investigative Site
Recruiting
Szeged,6720,Hungary
Novartis Investigative Site
Recruiting
Szekesfehervar,Fejer,8000,Hungary
Novartis Investigative Site
Recruiting
Debrecen,4032,Hungary
Novartis Investigative Site
Recruiting
Eger,3300,Hungary
Novartis Investigative Site
Recruiting
Gyula,5700,Hungary
Novartis Investigative Site
Recruiting
Ahmedabad,Gujarat,380013,India
Novartis Investigative Site
Recruiting
Ahmedabad,Gujarat,380015,India
Novartis Investigative Site
Recruiting
New Delhi,110029,India
Novartis Investigative Site
Recruiting
Kfar Saba,44281,Israel
Novartis Investigative Site
Recruiting
Ramat Gan,52621,Israel
Novartis Investigative Site
Recruiting
Salerno,SA,84100,Italy
Novartis Investigative Site
Recruiting
Milano,MI,20100,Italy
Novartis Investigative Site
Recruiting
Sasebo-city,Nagasaki,857-1165,Japan
Novartis Investigative Site
Recruiting
Chuo ku,Tokyo,104 8560,Japan
Novartis Investigative Site
Recruiting
Nagoya,Aichi,455-8530,Japan
Novartis Investigative Site
Recruiting
Itabashi-ku,Tokyo,173-8610,Japan
Novartis Investigative Site
Recruiting
Nagoya,Aichi,457 8510,Japan
Novartis Investigative Site
Recruiting
Meguro-ku,Tokyo,152-8902,Japan
Novartis Investigative Site
Recruiting
Nagoya,Aichi,457-8511,Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku,Tokyo,160 8582,Japan
Novartis Investigative Site
Recruiting
Kitakyushu,Fukuoka,807-8556,Japan
Novartis Investigative Site
Recruiting
Yokohama,Kanagawa,245-8575,Japan
Novartis Investigative Site
Recruiting
Gwangju,61469,Korea, Republic of
Novartis Investigative Site
Recruiting
Vilnius,08406,Lithuania
Novartis Investigative Site
Recruiting
Ciudad de Mexico,Distrito Federal,06700,Mexico
Novartis Investigative Site
Recruiting
Guadalajara,Jalisco,44650,Mexico
Novartis Investigative Site
Recruiting
Culiacan,Sinaloa,Cp 80000,Mexico
Novartis Investigative Site
Recruiting
Merida,Yucatan,97070,Mexico
Novartis Investigative Site
Recruiting
Mexico,07029,Mexico
Novartis Investigative Site
Recruiting
Krakow,Malopolskie,30-727,Poland
Novartis Investigative Site
Recruiting
Poznan,Wielkopolskie,61-397,Poland
Novartis Investigative Site
Recruiting
Krakow,30 002,Poland
Novartis Investigative Site
Recruiting
Warszawa,00-874,Poland
Novartis Investigative Site
Recruiting
Wroclaw,Dolnoslaskie,52-210,Poland
Novartis Investigative Site
Recruiting
Lisboa,1349-019,Portugal
Novartis Investigative Site
Recruiting
Lisboa,1649 035,Portugal
Novartis Investigative Site
Recruiting
Guarda,6300 858,Portugal
Novartis Investigative Site
Recruiting
Lisboa,1050-034,Portugal
Novartis Investigative Site
Recruiting
Brasov,500283,Romania
Novartis Investigative Site
Recruiting
Cluj Napoca,400006,Romania
Novartis Investigative Site
Recruiting
Bratislava,81108,Slovakia
Novartis Investigative Site
Recruiting
Panorama,7500,South Africa
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Santander,Cantabria,39008,Spain
Novartis Investigative Site
Recruiting
Badalona,Catalunya,08916,Spain
Novartis Investigative Site
Recruiting
La Coruna,Galicia,15006,Spain
Novartis Investigative Site
Recruiting
Bilbao,Pais Vasco,48013,Spain
Novartis Investigative Site
Recruiting
Vigo,Pontevedra,36200,Spain
Novartis Investigative Site
Recruiting
Barcelona,08041,Spain
Novartis Investigative Site
Recruiting
Sabadell,Barcelona,08208,Spain
Novartis Investigative Site
Recruiting
Stockholm,SE,113 65,Sweden
Novartis Investigative Site
Recruiting
Kaohsiung,81346,Taiwan
Novartis Investigative Site
Recruiting
Taichung,40447,Taiwan
Novartis Investigative Site
Recruiting
Taichung,407219,Taiwan
Novartis Investigative Site
Recruiting
Ankara,06500,Turkey
Novartis Investigative Site
Recruiting
Kocaeli,41380,Turkey
Novartis Investigative Site
Recruiting
Ankara,06100,Turkey
Novartis Investigative Site
Recruiting
Ankara,06230,Turkey
Novartis Investigative Site
Recruiting
Leeds,Ls1 3ex,United Kingdom
Novartis Investigative Site
Recruiting
Liverpool,L9 7al,United Kingdom
Novartis Investigative Site
Recruiting
Newcastle Upon Tyne,Ne1 4lp,United Kingdom
On Site Clinical Solutions Llc
Recruiting
Charlotte,North Carolina,28202,United States
Rakesh C Patel
Baylor College Of Medicine Department Of Medicine
Recruiting
Houston,Texas,77030,United States
Rashmi Maganti
Araceli Boan
Bay Area Arthritis And Osteoporosis
Recruiting
Brandon,Florida,33511,United States
Vipul Joshi
Tufts School of Dental Medicine
Recruiting
Boston,Massachusetts,02111,United States
Athena Papas
Altoona Center for Clin Res Main Center
Recruiting
Duncansville,Pennsylvania,16635,United States
Mary Beyer
Alan J Kivitz
Advanced Rheumatology of Houston
Recruiting
Spring,Texas,77382,United States
Tamar Brionez
Clin Invest Specialists Inc
Recruiting
Orland Park,Illinois,60467,United States
Cory Conniff
Prolato Clinical Research Center
Recruiting
Houston,Texas,77054,United States
Sreedhar Mandayam
Sarasota Arthritis Research Center
Recruiting
Sarasota,Florida,34239,United States
Kimberly Lyn Shue
Shelby Research LLC
Recruiting
Memphis,Tennessee,38119,United States
Ramesh C Gupta
STAT Research Inc .
Recruiting
Dayton,Ohio,45402,United States
Sanford Wolfe
Arthritis Osteoporosis Assoc of NM
Recruiting
Las Cruces,New Mexico,88011,United States
Arthur Snyder
University of Kansas Hospital Main Centre
Recruiting
Kansas City,Kansas,66160,United States
Ghaith Noaiseh
Arthritis Northwest PLLC
Recruiting
Spokane,Washington,99204,United States
Christopher C Wright
West Broward Rheumatology Associates Inc
Recruiting
Tamarac,Florida,33321,United States
Alan R Alberts
Houston Rheumatology & Arthrit
Recruiting
Katy,Texas,77494,United States
Tara Jabeen Rizvi
Advanced Medical Research
Recruiting
La Palma,California,90623,United States
Gerald Ho
Precision Comprehensive Research
Recruiting
Colleyville,Texas,76034,United States
Dhiman Basu
RAO Research LLS
Recruiting
Oklahoma City,Oklahoma,73116,United States
Latisha Heinlen
St Lawrence Health System
Recruiting
Potsdam,New York,13676,United States
Eyal Kedar
Ochsner Health System
Recruiting
Baton Rouge,Louisiana,70809,United States
Saravanan Thiagarajan
First Outpatient Research Unit
Recruiting
San Antonio,Texas,78229,United States
Agustin Escalante
North GA Rheumatology Group PC CAIN457FUS01
Recruiting
Duluth,Georgia,30096,United States
Theresa Lawrence Ford
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.