Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

NCT ID: NCT06411639

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2028-06-24

Brief Summary

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 .

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.

Conditions

Sjogren Disease; Systemic Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ianalumab 300 mg

Participants will receive Ianalumab 300 mg subcutaneous (s.c.) monthly

Group Type: EXPERIMENTAL

ianalumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

VAY736

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

CVAY736A2104

Identifier Type: -

Identifier Source: org_study_id