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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05985915




Registration number
NCT05985915
Ethics application status
Date submitted
3/08/2023
Date registered
14/08/2023
Date last updated
28/06/2024

Titles & IDs
Public title
A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
Scientific title
A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
Secondary ID [1] 0 0
2022-502966-26
Secondary ID [2] 0 0
CVAY736A2301E1
Universal Trial Number (UTN)
Trial acronym
NEPTUNUS-Ext
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjogrens Syndrome 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ianalumab (VAY736)
Other interventions - Placebo

Experimental: Ianalumab Monthly - ianalumab 300 mg s.c. monthly

Experimental: Ianalumab 3 Monthly - ianalumab 300 mg s.c. every three months


Treatment: Drugs: Ianalumab (VAY736)
VAY736 300 mg /2 mL, PFS, Solution for injection for subcutaneous use

Other interventions: Placebo
Placebo 0 mg/2 mL, PFS, Solution for injection for subcutaneous Use
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Treatment-emergent AEs (TEAEs)/SAEs
Timepoint [1] 0 0
Week 52 to Week 304
Secondary outcome [1] 0 0
ESSDAI change from baseline
Timepoint [1] 0 0
Over time up to Week 204
Secondary outcome [2] 0 0
Proportion of participants achieving ESSPRI = 3 AND = 1.5 points reduction from baseline
Timepoint [2] 0 0
Over time up to Week 204
Secondary outcome [3] 0 0
Proportion of participants achieving meaningful improvement in the SSSD score
Timepoint [3] 0 0
Over time up to Week 204
Secondary outcome [4] 0 0
Pre-dose Ianalumab serum concentrations
Timepoint [4] 0 0
pre-dose (i.e., Ctrough) at Week 52 and Week 64
Secondary outcome [5] 0 0
On-treatment Ianalumab serum concentrations
Timepoint [5] 0 0
During treatment (e.g., Ctrough) i.e. from Week 52 to Week 204 and follow-up i.e. 304, after last dose.
Secondary outcome [6] 0 0
B-cell count measurement
Timepoint [6] 0 0
Week 52 to Week 304

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/07/2030
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS
Recruitment hospital [1] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [3] 0 0
Novartis Investigative Site - Hobart
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
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United States of America
State/province [4] 0 0
Illinois
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
San Miguel De Tucuman
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
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Belgium
State/province [16] 0 0
Leuven
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Brazil
State/province [17] 0 0
BA
Country [18] 0 0
Brazil
State/province [18] 0 0
MG
Country [19] 0 0
Brazil
State/province [19] 0 0
SP
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Burgas
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Colombia
State/province [22] 0 0
Bogota
Country [23] 0 0
Czechia
State/province [23] 0 0
Brno
Country [24] 0 0
Czechia
State/province [24] 0 0
Uherske Hradiste
Country [25] 0 0
France
State/province [25] 0 0
Angers Cedex 9
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France
State/province [26] 0 0
Brest
Country [27] 0 0
France
State/province [27] 0 0
Le Kremlin Bicetre
Country [28] 0 0
France
State/province [28] 0 0
Paris cedex 10
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France
State/province [29] 0 0
Saint Etienne
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Freiburg
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Germany
State/province [34] 0 0
Hannover
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Germany
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Herne
Country [36] 0 0
Germany
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Koeln
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Germany
State/province [37] 0 0
Ludwigshafen
Country [38] 0 0
Germany
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Wuerzburg
Country [39] 0 0
Guatemala
State/province [39] 0 0
Guatemala City
Country [40] 0 0
Guatemala
State/province [40] 0 0
Guatemala
Country [41] 0 0
Hungary
State/province [41] 0 0
Fejer
Country [42] 0 0
Hungary
State/province [42] 0 0
Debrecen
Country [43] 0 0
Hungary
State/province [43] 0 0
Gyula
Country [44] 0 0
Hungary
State/province [44] 0 0
Szeged
Country [45] 0 0
Israel
State/province [45] 0 0
Kfar Saba
Country [46] 0 0
Israel
State/province [46] 0 0
Ramat Gan
Country [47] 0 0
Italy
State/province [47] 0 0
MI
Country [48] 0 0
Italy
State/province [48] 0 0
SA
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Japan
State/province [49] 0 0
Aichi
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Kanagawa
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Japan
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Nagasaki
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Japan
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Okayama
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Japan
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Tokyo
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Lithuania
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Vilnius
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Poland
State/province [57] 0 0
Dolnoslaskie
Country [58] 0 0
Poland
State/province [58] 0 0
Malopolskie
Country [59] 0 0
Poland
State/province [59] 0 0
Wielkopolskie
Country [60] 0 0
Poland
State/province [60] 0 0
Bydgoszcz
Country [61] 0 0
Poland
State/province [61] 0 0
Krakow
Country [62] 0 0
Poland
State/province [62] 0 0
Warszawa
Country [63] 0 0
Poland
State/province [63] 0 0
Wroclaw
Country [64] 0 0
Portugal
State/province [64] 0 0
Guarda
Country [65] 0 0
Portugal
State/province [65] 0 0
Lisboa
Country [66] 0 0
Romania
State/province [66] 0 0
Cluj-Napoca
Country [67] 0 0
Slovakia
State/province [67] 0 0
Bratislava
Country [68] 0 0
Slovakia
State/province [68] 0 0
Kosice
Country [69] 0 0
Slovakia
State/province [69] 0 0
Zvolen
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Cantabria
Country [72] 0 0
Spain
State/province [72] 0 0
Catalunya
Country [73] 0 0
Spain
State/province [73] 0 0
Galicia
Country [74] 0 0
Spain
State/province [74] 0 0
Pais Vasco
Country [75] 0 0
Spain
State/province [75] 0 0
Pontevedra
Country [76] 0 0
Spain
State/province [76] 0 0
Madrid
Country [77] 0 0
Sweden
State/province [77] 0 0
SE
Country [78] 0 0
Taiwan
State/province [78] 0 0
Kaohsiung
Country [79] 0 0
Taiwan
State/province [79] 0 0
Taichung
Country [80] 0 0
Turkey
State/province [80] 0 0
Ankara
Country [81] 0 0
Turkey
State/province [81] 0 0
Kocaeli
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Leeds
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Liverpool
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Newcastle Upon Tyme

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05985915
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05985915