Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Sjogren's Syndrome
Treatment
Ianalumab (VAY736)
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 toWeek 48 without treatment discontinuation in core NEPTUNUS studies.
In the judgement of the Investigator, participants must be expected to clinicallybenefit from continued ianalumab therapy.
Exclusion
Exclusion Criteria:
Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols (seeNEPTUNUS studies protocols exclusion criteria in Section 5.2 for details).
Plans for administration of live vaccines during the study period.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive human Chorionic Gonadotropin (hCG) laboratory test.
Women of child-bearing potential (WOCBP), defined as all women physiologicallycapable of becoming pregnant, unless they are using highly effective methods ofcontraception while taking study treatment during dosing and for 6 months afterstopping of investigational drug. Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyleof the participant. Periodic abstinence (e.g., calendar, ovulation,symptothermal, post-ovulation methods) and withdrawal are not acceptablemethods of contraception.
Female bilateral tubal ligation, female sterilization (have had surgicalbilateral oophorectomy with or without hysterectomy) or total hysterectomy atleast six weeks before taking study treatment. In case of oophorectomy alone,only when the reproductive status of the woman has been confirmed by follow uphormone level assessment.
Male sterilization (at least 6 months prior to screening). For femaleparticipants on the study, the vasectomized male partner should be the solepartner for that participant.
Use of oral (estrogen and progesterone), injected, or implanted hormonalmethods of contraception or placement of an intrauterine device (IUD) orintrauterine system (IUS), or other forms of hormonal contraception that havecomparable efficacy (failure rate < 1%), for example hormone vaginal ring ortransdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pillfor a minimum of 3 months before taking study treatment. Contraception should be used in accordance with locally approved prescribinginformation 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-appropriatehistory of vasomotor symptoms). Women are considered of not child-bearing potentialif they are post-menopausal or have had surgical bilateral oophorectomy (with orwithout hysterectomy), total hysterectomy or bilateral tubal ligation at least sixweeks ago. In the case of oophorectomy alone, only when the reproductive status ofthe woman has been confirmed by follow-up hormone level assessment is she considerednot of child-bearing potential. If local regulations deviate from the contraception methods listed above to preventpregnancy, local regulations apply and will be described in the informed consentform (ICF).
- United States (and other countries, if male contraception is locally required):Sexually active males, unless they agree to use barrier protection duringintercourse 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 isrecommended that female partners of male study participants use a second method ofbirth control. Although ianalumab is not teratogenic and/or genotoxic, and nottransferred 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.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires C1055AAF
ArgentinaActive - Recruiting
Novartis Investigative Site
Quilmes, Buenos Aires 1878
ArgentinaActive - Recruiting
Novartis Investigative Site
Tucuman, San Miguel De Tucuman 4000
ArgentinaActive - Recruiting
Novartis Investigative Site
Buenos Aires, 1646
ArgentinaActive - Recruiting
Novartis Investigative Site
Maroochydore, Queensland 4558
AustraliaActive - Recruiting
Novartis Investigative Site
Woodville, South Australia 5011
AustraliaSite Not Available
Novartis Investigative Site
Woodville South, South Australia 5011
AustraliaActive - Recruiting
Novartis Investigative Site
Hobart, Tasmania 7000
AustraliaActive - Recruiting
Novartis Investigative Site
Graz, 8036
AustriaActive - Recruiting
Novartis Investigative Site
Stockerau, 2000
AustriaActive - Recruiting
Novartis Investigative Site
Leuven, 3000
BelgiumActive - Recruiting
Novartis Investigative Site
Salvador, BA 40150 150
BrazilActive - Recruiting
Novartis Investigative Site
Vitoria, ES 29055 450
BrazilActive - Recruiting
Novartis Investigative Site
Juiz de Fora, MG 36010 570
BrazilActive - Recruiting
Novartis Investigative Site
Sao Paulo, 01409-902
BrazilActive - Recruiting
Novartis Investigative Site
Burgas, 8000
BulgariaActive - Recruiting
Novartis Investigative Site
Sofia, 1606
BulgariaActive - Recruiting
Novartis Investigative Site
Sydney, Nova Scotia B1P 1P3
CanadaActive - Recruiting
Novartis Investigative Site
Rimouski, Quebec G5L 5T1
CanadaActive - Recruiting
Novartis Investigative Site
Sherbrooke, Quebec J1G 2E8
CanadaActive - Recruiting
Novartis Investigative Site
Trois Rivieres, Quebec G9A 3Y2
CanadaActive - Recruiting
Novartis Investigative Site
Valdivia, Los Rios 5110683
ChileActive - Recruiting
Novartis Investigative Site
Concepcion, 6740
ChileActive - Recruiting
Novartis Investigative Site
Santiago, 7500710
ChileActive - Recruiting
Novartis Investigative Site
Hefei, Anhui 230001
ChinaActive - Recruiting
Novartis Investigative Site
Guangzhou, Guangdong 510630
ChinaActive - Recruiting
Novartis Investigative Site
Shenzhen, Guangdong 518020
ChinaActive - Recruiting
Novartis Investigative Site
Wuhan, Hubei 430030
ChinaActive - Recruiting
Novartis Investigative Site
Baotou, Inner Mongolia 014010
ChinaActive - Recruiting
Novartis Investigative Site
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
Novartis Investigative Site
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
Novartis Investigative Site
Pingxiang, Jiangxi 337000
ChinaActive - Recruiting
Novartis Investigative Site
Chang Chun, Jilin 130021
ChinaActive - Recruiting
Novartis Investigative Site
Shenyang, Liaoning 110011
ChinaActive - Recruiting
Novartis Investigative Site
Linyi, Shandong 276000
ChinaActive - Recruiting
Novartis Investigative Site
Taiyuan, Shanxi 030000
ChinaActive - Recruiting
Novartis Investigative Site
Chengdu, Sichuan 610041
ChinaActive - Recruiting
Novartis Investigative Site
Yinchuan City, The Ningxia Hui Autonomous Reg 750000
ChinaActive - Recruiting
Novartis Investigative Site
Beijing, 100029
ChinaActive - Recruiting
Novartis Investigative Site
Shanghai, 200011
ChinaActive - Recruiting
Novartis Investigative Site
Shanxi, 710063
ChinaActive - Recruiting
Novartis Investigative Site
Tianjin, 300052
ChinaActive - Recruiting
Novartis Investigative Site
Xinxiang, 453099
ChinaActive - Recruiting
Novartis Investigative Site
Medellin, Antioquia 050001
ColombiaActive - Recruiting
Novartis Investigative Site
Barranquilla, Atlantico 080002
ColombiaActive - Recruiting
Novartis Investigative Site
Bucaramanga, Santander 0001
ColombiaActive - Recruiting
Novartis Investigative Site
Bogota, 110221
ColombiaActive - Recruiting
Novartis Investigative Site
Brno, 63800
CzechiaActive - Recruiting
Novartis Investigative Site
Uherske Hradiste, 686 01
CzechiaActive - Recruiting
Novartis Investigative Site
Angers Cedex 9, 49933
FranceActive - Recruiting
Novartis Investigative Site
Brest, 29200
FranceActive - Recruiting
Novartis Investigative Site
Dijon, 21034
FranceActive - Recruiting
Novartis Investigative Site
Le Kremlin Bicetre, 94275
FranceActive - Recruiting
Novartis Investigative Site
Lille, 59037
FranceActive - Recruiting
Novartis Investigative Site
Paris 13, 75651
FranceActive - Recruiting
Novartis Investigative Site
Paris cedex 10, 75010
FranceActive - Recruiting
Novartis Investigative Site
Saint Etienne, 42100
FranceSite Not Available
Novartis Investigative Site
St Etienne, 42055
FranceActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Dresden, 01307
GermanyActive - Recruiting
Novartis Investigative Site
Erlangen, 91056
GermanyActive - Recruiting
Novartis Investigative Site
Freiburg, 79106
GermanyActive - Recruiting
Novartis Investigative Site
Hannover, 30625
GermanyActive - Recruiting
Novartis Investigative Site
Herne, 44649
GermanyActive - Recruiting
Novartis Investigative Site
Koeln, 50937
GermanyActive - Recruiting
Novartis Investigative Site
Ludwigshafen, 67063
GermanyActive - Recruiting
Novartis Investigative Site
Wuerzburg, 97080
GermanyActive - Recruiting
Novartis Investigative Site
Athens, 115 27
GreeceActive - Recruiting
Novartis Investigative Site
Guatemala, 01010
GuatemalaActive - Recruiting
Novartis Investigative Site
Guatemala City, 01010
GuatemalaActive - Recruiting
Novartis Investigative Site
Quetzaltenango, 9001
GuatemalaActive - Recruiting
Novartis Investigative Site
Szekesfehervar, Fejer 8000
HungaryActive - Recruiting
Novartis Investigative Site
Debrecen, 4032
HungaryActive - Recruiting
Novartis Investigative Site
Eger, 3300
HungaryActive - Recruiting
Novartis Investigative Site
Gyula, 5700
HungaryActive - Recruiting
Novartis Investigative Site
Szeged, 6720
HungaryActive - Recruiting
Novartis Investigative Site
Ahmedabad, Gujarat 380015
IndiaActive - Recruiting
Novartis Investigative Site
New Delhi, 110029
IndiaActive - Recruiting
Novartis Investigative Site
Kfar Saba, 44281
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan, 52621
IsraelActive - Recruiting
Novartis Investigative Site
Ancona, AN 60126
ItalyActive - Recruiting
Novartis Investigative Site
Milano, MI 20100
ItalySite Not Available
Novartis Investigative Site
Salerno, SA 84100
ItalyActive - Recruiting
Novartis Investigative Site
Napoli, 80131
ItalyActive - Recruiting
Novartis Investigative Site
Nagoya, Aichi 457-8511
JapanActive - Recruiting
Novartis Investigative Site
Kitakyushu, Fukuoka 807-8556
JapanActive - Recruiting
Novartis Investigative Site
Kitakyushu-city, Fukuoka 807-8556
JapanSite Not Available
Novartis Investigative Site
Sapporo city, Hokkaido 060 8648
JapanSite Not Available
Novartis Investigative Site
Yokohama, Kanagawa 245-8575
JapanActive - Recruiting
Novartis Investigative Site
Kuwana, Mie 511-0061
JapanActive - Recruiting
Novartis Investigative Site
Sasebo-city, Nagasaki 857-1165
JapanActive - Recruiting
Novartis Investigative Site
Kurashiki, Okayama 710-8522
JapanSite Not Available
Novartis Investigative Site
Bunkyo ku, Tokyo 113-8431
JapanSite Not Available
Novartis Investigative Site
Chuo ku, Tokyo 104 8560
JapanActive - Recruiting
Novartis Investigative Site
Itabashi-ku, Tokyo 173-8610
JapanActive - Recruiting
Novartis Investigative Site
Meguro-ku, Tokyo 152-8902
JapanActive - Recruiting
Novartis Investigative Site
Shinjuku-ku, Tokyo 160 8582
JapanActive - Recruiting
Novartis Investigative Site
Seoul, Seocho Gu 06591
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Gwangju, 61469
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Vilnius, 08406
LithuaniaActive - Recruiting
Novartis Investigative Site
Ciudad de Mexico, Distrito Federal 06700
MexicoActive - Recruiting
Novartis Investigative Site
Guadalajara, Jalisco 44650
MexicoActive - Recruiting
Novartis Investigative Site
Culiacan, Sinaloa CP 80000
MexicoActive - Recruiting
Novartis Investigative Site
Merida, Yucatan 97070
MexicoActive - Recruiting
Novartis Investigative Site
Mexico, 07029
MexicoActive - Recruiting
Novartis Investigative Site
Krakow, Malopolskie 30-727
PolandActive - Recruiting
Novartis Investigative Site
Poznan, Wielkopolskie 61-397
PolandActive - Recruiting
Novartis Investigative Site
Bydgoszcz, 85 168
PolandSite Not Available
Novartis Investigative Site
Warszawa, 00-874
PolandActive - Recruiting
Novartis Investigative Site
Wroclaw, 50367
PolandSite Not Available
Novartis Investigative Site
Wrocław, 50367
PolandSite Not Available
Novartis Investigative Site
Guarda, 6300 858
PortugalActive - Recruiting
Novartis Investigative Site
Lisboa, 1050-034
PortugalActive - Recruiting
Novartis Investigative Site
Brasov, 500283
RomaniaActive - Recruiting
Novartis Investigative Site
Bucuresti, 011172
RomaniaSite Not Available
Novartis Investigative Site
Cluj Napoca, 400006
RomaniaActive - Recruiting
Novartis Investigative Site
Cluj-Napoca, 400006
RomaniaSite Not Available
Novartis Investigative Site
Bratislava, 81108
SlovakiaActive - Recruiting
Novartis Investigative Site
Kosice, 04011
SlovakiaSite Not Available
Novartis Investigative Site
Zvolen, 960 01
SlovakiaSite Not Available
Novartis Investigative Site
Panorama, 7500
South AfricaActive - Recruiting
Novartis Investigative Site
Stellenbosch, 7600
South AfricaActive - Recruiting
Novartis Investigative Site
Cordoba, Andalucia 14004
SpainActive - Recruiting
Novartis Investigative Site
Sabadell, Barcelona 08208
SpainActive - Recruiting
Novartis Investigative Site
Santander, Cantabria 39008
SpainActive - Recruiting
Novartis Investigative Site
Badalona, Catalunya 08916
SpainActive - Recruiting
Novartis Investigative Site
La Coruna, Galicia 15006
SpainActive - Recruiting
Novartis Investigative Site
Bilbao, Pais Vasco 48013
SpainActive - Recruiting
Novartis Investigative Site
Vigo, Pontevedra 36200
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, 08041
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28034
SpainActive - Recruiting
Novartis Investigative Site
Stockholm, SE 113 65
SwedenActive - Recruiting
Novartis Investigative Site
Kaohsiung, 83301
TaiwanActive - Recruiting
Novartis Investigative Site
Taichung, 40447
TaiwanActive - Recruiting
Novartis Investigative Site
Ankara, 06500
TurkeyActive - Recruiting
Novartis Investigative Site
Kocaeli, 41380
TurkeyActive - Recruiting
Novartis Investigative Site
Leeds, LS1 3EX
United KingdomActive - Recruiting
Novartis Investigative Site
Liverpool, L9 7AL
United KingdomActive - Recruiting
Novartis Investigative Site
Newcastle Upon Tyme, NE4 4LP
United KingdomSite Not Available
Novartis Investigative Site
Newcastle Upon Tyne, NE1 4LP
United KingdomActive - Recruiting
Advanced Medical Research
La Palma, California 90623
United StatesActive - Recruiting
Bay Area Arthritis And Osteoporosis
Brandon, Florida 33511
United StatesActive - Recruiting
Sarasota Arthritis Res Ctr
Sarasota, Florida 34239
United StatesActive - Recruiting
Sarasota Arthritis Research Center
Sarasota, Florida 34239
United StatesActive - Recruiting
West Broward Rheumatology Assoc Inc
Tamarac, Florida 33321
United StatesSite Not Available
West Broward Rheumatology Associates Inc
Tamarac, Florida 33321
United StatesActive - Recruiting
North GA Rheumatology Group PC
Duluth, Georgia 30096
United StatesSite Not Available
North GA Rheumatology Group PC CAIN457FUS01
Duluth, Georgia 30096
United StatesActive - Recruiting
North GA Rheumatology Group, PC CAIN457FUS01
Duluth, Georgia 30096
United StatesActive - Recruiting
North GA Rheumatology Group PC
Suwanee, Georgia 30024
United StatesActive - Recruiting
Clin Invest Specialists Inc
Orland Park, Illinois 60467
United StatesActive - Recruiting
University of Kansas Hospital
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Kansas Hospital .
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Kansas Hospital Main Centre
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160-7330
United StatesActive - Recruiting
Ochsner Health System
Baton Rouge, Louisiana 70809
United StatesActive - Recruiting
The John Hopkins Jerome L Greene Sjogren
Baltimore, Maryland 21224
United StatesActive - Recruiting
Tufts School of Dental Medicine
Boston, Massachusetts 02111
United StatesActive - Recruiting
Arthritis Osteoporosis Assoc of NM
Las Cruces, New Mexico 88011
United StatesActive - Recruiting
Winthrop University Hospital
Mineola, New York 11501
United StatesActive - Recruiting
St Lawrence Health System
Potsdam, New York 13676
United StatesActive - Recruiting
Arthritis and Osteoporosis
Charlotte, North Carolina 28207
United StatesActive - Recruiting
On Site Clinical Solutions Llc
Charlotte, North Carolina 28202
United StatesActive - Recruiting
STAT Research Inc
Dayton, Ohio 45402
United StatesActive - Recruiting
STAT Research Inc .
Dayton, Ohio 45402
United StatesActive - Recruiting
RAO Research LLS
Oklahoma City, Oklahoma 73116
United StatesActive - Recruiting
Altoona Center for Clin Res
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Altoona Center for Clin Res Main Center
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesActive - Recruiting
Shelby Research LLC
Memphis, Tennessee 38119
United StatesActive - Recruiting
Precision Comprehensive Research
Colleyville, Texas 76034
United StatesActive - Recruiting
BCM-Institute for Clinical Research
Houston, Texas 77030
United StatesActive - Recruiting
Baylor College Of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
Baylor College Of Medicine Department Of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
Houston Rheumatology & Arthrit
Katy, Texas 77494
United StatesActive - Recruiting
First Outpatient Research Unit
San Antonio, Texas 78229
United StatesActive - Recruiting
Advanced Rheumatology of Houston
Spring, Texas 77382
United StatesActive - Recruiting
Arthritis Northwest PLLC
Spokane, Washington 99204
United StatesActive - Recruiting
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