Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

A Multicenter, Open-label, Single-arm, Multiple-dose Study to Characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous Ianalumab in Chinese Adult Participants With Autoimmune Diseases

The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD). Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 (NCT05349214) and lupus nephritis (LN) CVAY736K12301 (NCT05126277) on an optional basis. This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies .

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erythematosus; Sjogren Disease
• Intervention / Treatment: Drug: ianalumab

Detailed Description

The study consists of the following periods:

• Screening Period: up to 4 weeks
• Treatment Period (Week 0 - Week 12) : 12 weeks

• Extended Treatment Period (after the completion of Week 12 - Week 52 (End of Treatment (EoT)) : 40 weeks

  ~ After completion of the 12-week treatment, participants will have the option to enter the Extended Treatment Period. If a participant does not enter the Extended Treatment Period, the EoT visit will be performed at the next planned visit following the completion of Week 12, followed by the Post-treatment Follow-up Period.

• Post-treatment Follow-up Period: at least 20 weeks and up to 2 years from the last dose of study treatment.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Male and female patients 18 years to 70 years of age (inclusive)
• Body weight at least 35 kg and not more than 120 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2 at screening
• Diagnosed with SjD and/or SLE as determined by the investigator
• Have active disease (SjD and/or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
• Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment

Key Exclusion Criteria:

• Use of prohibited therapies
• Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection
• Receipt of live/attenuated vaccine within a 4-week period before first dosing
• Uncontrolled co-existing serious disease
• Pregnant or nursing (lactating) women
• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ianalumab 300 mg; Participants will receive Ianalumab 300 mg subcutaneous (s.c.) monthly	Drug: ianalumab; ianalumab will be provided in a pre-filled Syringe (PFS) of 150 mg/1 mL for s.c. administration. Two injections of 1mL each will be administered monthly.; Other Names: VAY736

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of ianalumab after the 3rd dose	Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ianalumab. AUCtau of ianalumab will be summarized with descriptive statistics.	Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr)
Observed maximum blood concentration (Cmax)of ianalumab after the 3rd dose	Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ianalumab. Cmax of ianalumab will be summarized with descriptive statistics.	Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr)
Time of maximum observed drug concentration occurrence (Tmax) of ianalumab after the 3rd dose	Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ianalumab. Tmax of ianalumab will be summarized with descriptive statistics.	Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ctrough of ianalumab at the end of dosing interval	Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ianalumab. Ctrough of ianalumab will be summarized with descriptive statistics.	Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.	From date of enrollment till 30 days after end of Treatment, assessed up to approximately 44 months
Anti-ianalumab antibodies (ADA)	Immunogenicity (IG) blood samples will be collected for anti-drug antibodies characterization. ADA of ianalumab will be summarized with descriptive statistics.	Day 1 (Baseline), Week 8 to 11 Day 57 (Pre-dose), Week 12 Day 85, Week 24 Day 169, Week 36 Day 253, Week 52 Day 365, Week 68 Day 477 and Week 156 Day 1093
Presence of anti-drug antibodies (ADA)	Immunogenicity (IG) blood samples will be collected to assess the presence ADA of ianalumab.	Day 1 (Baseline), Week 8 to 11 Day 57 (Pre-dose), Week 12 Day 85, Week 24 Day 169, Week 36 Day 253, Week 52 Day 365, Week 68 Day 477 and Week 156 Day 1093

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2024
• Primary Completion (Estimated): December 17, 2025
• Study Completion (Estimated): June 24, 2028

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: VAY736; B cell depletion; ianalumab; Systemic lupus erythematosus (SLE); Pharmacokinetic (PK); Sjogren Disease (SjD)
• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lupus Erythematosus, Systemic; Autoimmune Diseases; Sjogren's Syndrome
• Other Study ID Numbers: CVAY736A2104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No