Clinical Trials List
Protocol NumberCVAY736A2301E1
2024-01-15 - 2031-06-30
Phase III
Not yet recruiting3
Recruiting1
ICD-10M35.00
Sicca syndrome, unspecified
ICD-10M35.01
Sicca syndrome with keratoconjunctivitis
ICD-10M35.09
Sicca syndrome with other organ involvement
ICD-9710.2
Sicca syndrome
A randomized, double-blind 2-arm NEPTUNUS extension study to assess the long-term safety and efficacy of ianalumab in patients with Sjögren’s syndrome
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Taiwan
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/06
Investigators and Locations
Co-Principal Investigator
- 黃建中 無
- Po-Hao Huang 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 蘇昱日 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yi-Hsing Chen
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Hughes syndrome
Objectives
The primary objective of this 3-year extension trial is to continue evaluating the safety and tolerability of ianalumab 300 mg treatment monthly or every 3 months. Another objective is to investigate the long-term efficacy of both ianalumab 300 mg dosing regimens.
Test Drug
VAY736/ianalumabVAY736/ianalumab
Active Ingredient
VAY736
VAY736
VAY736
Dosage Form
230
230
230
Dosage
300
300 mg/2 mL
300 mg/2 mL
Endpoints
Target Assessment Metrics
Primary Objective
To assess the long-term safety and tolerability of ianalumab in participants with Schullen syndrome
● Incidence of treatment-emergent adverse events (TEAEs)/severe adverse events (SAEs)
Primary Objective
To assess the long-term safety and tolerability of ianalumab in participants with Schullen syndrome
● Incidence of treatment-emergent adverse events (TEAEs)/severe adverse events (SAEs)
Inclution Criteria
Key Inclusion Criteria
1. Participants must have signed a participant consent form prior to participating in the extension trial.
2. Participants must have previously participated in one of the two NEPTUNUS core trials (CVAY736A2301 or CVAY736A2302) and completed 48 weeks of treatment in the core trial without interruption.
3. The trial administrator must determine that continued ianalumab treatment is expected to provide clinical benefit to the participant.
1. Participants must have signed a participant consent form prior to participating in the extension trial.
2. Participants must have previously participated in one of the two NEPTUNUS core trials (CVAY736A2301 or CVAY736A2302) and completed 48 weeks of treatment in the core trial without interruption.
3. The trial administrator must determine that continued ianalumab treatment is expected to provide clinical benefit to the participant.
Exclusion Criteria
Important Exclusion Criteria
1. Treatments excluded in the NEPTUNUS-1 and NEPTUNUS-2 trial protocols (see Section 5.2, Exclusion Criteria for the NEPTUNUS Trial Protocol, for details).
2. Scheduled to receive a live vaccine during the trial period.
3. Pregnant or breastfeeding women; pregnancy is defined as the state from conception until the end of pregnancy, with a positive laboratory test for human chorionic gonadotropin (hCG) confirming pregnancy.
4. Women of childbearing potential (WOCBP), defined as all women who are physiologically capable of becoming pregnant; participation is only permitted if highly effective contraception is used during the trial treatment and for 6 months after discontinuation of the investigational drug. Highly effective contraception includes:
• Complete abstinence, if consistent with the participant's preferred daily lifestyle. Methods of contraception such as the rhythm method (e.g., calendar method, ovulation tracking method, basal body temperature method, post-ovulation method) and withdrawal methods are not accepted.
• Women must have undergone bilateral tubal ligation, female sterilization (with surgical removal of both oophores, regardless of hysterectomy), or total hysterectomy at least 6 weeks prior to starting the trial. Women who have only had their ovaries removed must have their hormone levels monitored to confirm their fertility status.
• Male sterilization (at least 6 months prior to screening). For female participants in this trial, the male with vasectomy must be their sole sexual partner.
• Use of oral hormonal contraceptives (estrogen and progesterone), injectable or implantable devices, or intrauterine devices (IUDs), intrauterine systems (IUS), or other equivalent hormonal contraceptive methods (failure rate <1%), such as hormonal vaginal rings or contraceptive patches.
If a woman is using oral contraceptives, the same contraceptive must have been maintained at a stable dose for at least 3 months prior to the start of the trial.
Contraceptive measures should be taken according to the local approved prescribing information for the medications used.
Postmenopausal women are defined as those who have spontaneously stopped menstruating for 12 months and whose clinical characteristics are consistent (e.g., appropriate age, history of vasomotor symptoms). Women who have experienced menopause or have undergone bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks prior to menopause are considered infertile. Women who have only undergone oophorectomy must have their hormone levels monitored to confirm their fertility status before being considered infertile.
If local regulations differ from the above contraceptive methods, please follow the local regulations and state them in the participant consent form (ICF).
5. United States (and other countries, where local regulations apply to male contraception): Sexually active men may participate in the trial unless they agree to use barrier contraception during sexual intercourse with fertile women during the trial treatment period. Reports indicate that the failure rate of condom-only use exceeds 1% per year; therefore, it is recommended that female partners of male trial participants use a second method of contraception. Although ianalumab does not cause birth defects or genotoxicity and is not transmitted through semen, men are still required to use contraception according to FDA regulations.
For sexually active men worldwide, contraception should be used according to the local prescribing information for the medication.
1. Treatments excluded in the NEPTUNUS-1 and NEPTUNUS-2 trial protocols (see Section 5.2, Exclusion Criteria for the NEPTUNUS Trial Protocol, for details).
2. Scheduled to receive a live vaccine during the trial period.
3. Pregnant or breastfeeding women; pregnancy is defined as the state from conception until the end of pregnancy, with a positive laboratory test for human chorionic gonadotropin (hCG) confirming pregnancy.
4. Women of childbearing potential (WOCBP), defined as all women who are physiologically capable of becoming pregnant; participation is only permitted if highly effective contraception is used during the trial treatment and for 6 months after discontinuation of the investigational drug. Highly effective contraception includes:
• Complete abstinence, if consistent with the participant's preferred daily lifestyle. Methods of contraception such as the rhythm method (e.g., calendar method, ovulation tracking method, basal body temperature method, post-ovulation method) and withdrawal methods are not accepted.
• Women must have undergone bilateral tubal ligation, female sterilization (with surgical removal of both oophores, regardless of hysterectomy), or total hysterectomy at least 6 weeks prior to starting the trial. Women who have only had their ovaries removed must have their hormone levels monitored to confirm their fertility status.
• Male sterilization (at least 6 months prior to screening). For female participants in this trial, the male with vasectomy must be their sole sexual partner.
• Use of oral hormonal contraceptives (estrogen and progesterone), injectable or implantable devices, or intrauterine devices (IUDs), intrauterine systems (IUS), or other equivalent hormonal contraceptive methods (failure rate <1%), such as hormonal vaginal rings or contraceptive patches.
If a woman is using oral contraceptives, the same contraceptive must have been maintained at a stable dose for at least 3 months prior to the start of the trial.
Contraceptive measures should be taken according to the local approved prescribing information for the medications used.
Postmenopausal women are defined as those who have spontaneously stopped menstruating for 12 months and whose clinical characteristics are consistent (e.g., appropriate age, history of vasomotor symptoms). Women who have experienced menopause or have undergone bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks prior to menopause are considered infertile. Women who have only undergone oophorectomy must have their hormone levels monitored to confirm their fertility status before being considered infertile.
If local regulations differ from the above contraceptive methods, please follow the local regulations and state them in the participant consent form (ICF).
5. United States (and other countries, where local regulations apply to male contraception): Sexually active men may participate in the trial unless they agree to use barrier contraception during sexual intercourse with fertile women during the trial treatment period. Reports indicate that the failure rate of condom-only use exceeds 1% per year; therefore, it is recommended that female partners of male trial participants use a second method of contraception. Although ianalumab does not cause birth defects or genotoxicity and is not transmitted through semen, men are still required to use contraception according to FDA regulations.
For sexually active men worldwide, contraception should be used according to the local prescribing information for the medication.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
600 participants
