A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05985915
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Austria, Bulgaria, Canada, Czechia, France, Germany, Guatemala, Hungary, Israel, Italy, Japan, Poland, Portugal, Romania, Slovakia, Spain, Taiwan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sjogrens Syndrome
Additional Details

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.

Arms & Interventions

Arms

Experimental: Ianalumab Monthly

ianalumab 300 mg s.c. monthly

Experimental: Ianalumab 3 Monthly

ianalumab 300 mg s.c. every three months

Interventions

Drug: - Ianalumab (VAY736)

VAY736 300 mg /2 mL, PFS, Solution for injection for subcutaneous use

Other: - Placebo

Placebo 0 mg/2 mL, PFS, Solution for injection for subcutaneous Use

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Advanced Medical Research, La Palma, California

Status

Recruiting

Address

Advanced Medical Research

La Palma, California, 90623

Site Contact

Andy Hodgson

[email protected]

562-867-8195

West Broward Rheumatology Assoc Inc, Tamarac, Florida

Status

Recruiting

Address

West Broward Rheumatology Assoc Inc

Tamarac, Florida, 33321

Duluth, Georgia

Status

Recruiting

Address

North GA Rheumatology Group, PC CAIN457FUS01

Duluth, Georgia, 30096

Site Contact

Jerry Wilkerson

[email protected]

770-822-1090

Clin Invest Specialists Inc, Orland Park, Illinois

Status

Recruiting

Address

Clin Invest Specialists Inc

Orland Park, Illinois, 60467

Site Contact

Megi Stafa

[email protected]

847-599-2492

Ochsner Health System, Baton Rouge, Louisiana

Status

Recruiting

Address

Ochsner Health System

Baton Rouge, Louisiana, 70809

Arthritis Osteoporosis Assoc of NM, Las Cruces, New Mexico

Status

Recruiting

Address

Arthritis Osteoporosis Assoc of NM

Las Cruces, New Mexico, 88011

STAT Research Inc ., Dayton, Ohio

Status

Recruiting

Address

STAT Research Inc .

Dayton, Ohio, 45402

RAO Research LLS, Oklahoma City, Oklahoma

Status

Recruiting

Address

RAO Research LLS

Oklahoma City, Oklahoma, 73116

Site Contact

Emma Hendrix

[email protected]

405-608-8060

Advanced Rheumatology of Houston, Spring, Texas

Status

Recruiting

Address

Advanced Rheumatology of Houston

Spring, Texas, 77382

Site Contact

Kathleen Dang

[email protected]

281-766-7886

International Sites

Novartis Investigative Site, Quilmes, Buenos Aires, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Quilmes, Buenos Aires, 1878

Novartis Investigative Site, Maroochydore, Queensland, Australia

Status

Recruiting

Address

Novartis Investigative Site

Maroochydore, Queensland, 4558

Novartis Investigative Site, Hobart, Tasmania, Australia

Status

Recruiting

Address

Novartis Investigative Site

Hobart, Tasmania, 7000

Novartis Investigative Site, Graz, Austria

Status

Recruiting

Address

Novartis Investigative Site

Graz, , 8036

Novartis Investigative Site, Burgas, Bulgaria

Status

Recruiting

Address

Novartis Investigative Site

Burgas, , 8000

Novartis Investigative Site, Sherbrooke, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Sherbrooke, Quebec, J1G 2E8

Novartis Investigative Site, Brno, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Brno, , 63800

Novartis Investigative Site, Uherske Hradiste, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Uherske Hradiste, , 686 01

Novartis Investigative Site, Angers Cedex 9, France

Status

Recruiting

Address

Novartis Investigative Site

Angers Cedex 9, , 49933

Novartis Investigative Site, Brest, France

Status

Recruiting

Address

Novartis Investigative Site

Brest, , 29200

Novartis Investigative Site, Saint Etienne, France

Status

Recruiting

Address

Novartis Investigative Site

Saint Etienne, , 42100

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 13353

Novartis Investigative Site, Dresden, Germany

Status

Recruiting

Address

Novartis Investigative Site

Dresden, , 01307

Novartis Investigative Site, Erlangen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Erlangen, , 91056

Novartis Investigative Site, Freiburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Freiburg, , 79106

Novartis Investigative Site, Ludwigshafen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Ludwigshafen, , 67063

Novartis Investigative Site, Wuerzburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Wuerzburg, , 97080

Novartis Investigative Site, Guatemala, Guatemala

Status

Recruiting

Address

Novartis Investigative Site

Guatemala, , 01010

Novartis Investigative Site, Szekesfehervar, Fejer, Hungary

Status

Recruiting

Address

Novartis Investigative Site

Szekesfehervar, Fejer, 8000

Novartis Investigative Site, Debrecen, Hungary

Status

Recruiting

Address

Novartis Investigative Site

Debrecen, , 4032

Novartis Investigative Site, Gyula, Hungary

Status

Recruiting

Address

Novartis Investigative Site

Gyula, , 5700

Novartis Investigative Site, Szeged, Hungary

Status

Recruiting

Address

Novartis Investigative Site

Szeged, , 6720

Novartis Investigative Site, Kfar Saba, Israel

Status

Recruiting

Address

Novartis Investigative Site

Kfar Saba, , 4428164

Novartis Investigative Site, Ramat Gan, Israel

Status

Recruiting

Address

Novartis Investigative Site

Ramat Gan, , 52621

Novartis Investigative Site, Milano, MI, Italy

Status

Recruiting

Address

Novartis Investigative Site

Milano, MI, 20100

Novartis Investigative Site, Nagoya, Aichi, Japan

Status

Recruiting

Address

Novartis Investigative Site

Nagoya, Aichi, 457 8510

Novartis Investigative Site, Kitakyushu-city, Fukuoka, Japan

Status

Recruiting

Address

Novartis Investigative Site

Kitakyushu-city, Fukuoka, 807-8556

Novartis Investigative Site, Yokohama, Kanagawa, Japan

Status

Recruiting

Address

Novartis Investigative Site

Yokohama, Kanagawa, 245-8575

Novartis Investigative Site, Kurashiki, Okayama, Japan

Status

Active, not recruiting

Address

Novartis Investigative Site

Kurashiki, Okayama, 710-8522

Novartis Investigative Site, Chuo ku, Tokyo, Japan

Status

Recruiting

Address

Novartis Investigative Site

Chuo ku, Tokyo, 104-8560

Novartis Investigative Site, Meguro-ku, Tokyo, Japan

Status

Recruiting

Address

Novartis Investigative Site

Meguro-ku, Tokyo, 152-8902

Novartis Investigative Site, Shinjuku-ku, Tokyo, Japan

Status

Recruiting

Address

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160 8582

Novartis Investigative Site, Wroclaw, Dolnoslaskie, Poland

Status

Recruiting

Address

Novartis Investigative Site

Wroclaw, Dolnoslaskie, 52 416

Novartis Investigative Site, Wroclaw, Dolnoslaskie, Poland

Status

Recruiting

Address

Novartis Investigative Site

Wroclaw, Dolnoslaskie, 52-210

Novartis Investigative Site, Poznan, Wielkopolskie, Poland

Status

Recruiting

Address

Novartis Investigative Site

Poznan, Wielkopolskie, 61-397

Novartis Investigative Site, Bydgoszcz, Poland

Status

Recruiting

Address

Novartis Investigative Site

Bydgoszcz, , 85 168

Novartis Investigative Site, Krakow, Poland

Status

Recruiting

Address

Novartis Investigative Site

Krakow, , 30 002

Novartis Investigative Site, Warszawa, Poland

Status

Recruiting

Address

Novartis Investigative Site

Warszawa, , 00-874

Novartis Investigative Site, Wrocław, Poland

Status

Recruiting

Address

Novartis Investigative Site

Wrocław, , 50367

Novartis Investigative Site, Lisboa, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Lisboa, , 1050-034

Novartis Investigative Site, Lisboa, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Lisboa, , 1649-035

Novartis Investigative Site, Cluj-Napoca, Romania

Status

Recruiting

Address

Novartis Investigative Site

Cluj-Napoca, , 400006

Novartis Investigative Site, Bratislava, Slovakia

Status

Recruiting

Address

Novartis Investigative Site

Bratislava, , 811 08

Novartis Investigative Site, Kosice, Slovakia

Status

Recruiting

Address

Novartis Investigative Site

Kosice, , 04011

Novartis Investigative Site, Zvolen, Slovakia

Status

Recruiting

Address

Novartis Investigative Site

Zvolen, , 960 01

Novartis Investigative Site, Sabadell, Barcelona, Spain

Status

Recruiting

Address

Novartis Investigative Site

Sabadell, Barcelona, 08208

Novartis Investigative Site, Santander, Cantabria, Spain

Status

Recruiting

Address

Novartis Investigative Site

Santander, Cantabria, 39008

Novartis Investigative Site, La Coruna, Galicia, Spain

Status

Recruiting

Address

Novartis Investigative Site

La Coruna, Galicia, 15006

Novartis Investigative Site, Vigo, Pontevedra, Spain

Status

Recruiting

Address

Novartis Investigative Site

Vigo, Pontevedra, 36200

Novartis Investigative Site, Kaohsiung, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Kaohsiung, , 81346

Novartis Investigative Site, Taichung, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Taichung, , 407

Novartis Investigative Site, Leeds, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Leeds, , LS1 3EX

Novartis Investigative Site, Liverpool, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Liverpool, , L9 7AL