Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

NCT06411639 | Withdrawn Phase 1

• 1 other identifier: CVAY736A2104
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Sjogren Disease; Systemic Lupus Erythematosus

Keywords

Pharmacokinetic (PK); Systemic lupus erythematosus (SLE); Sjogren Disease (SjD); VAY736; ianalumab; B cell depletion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Ctrough of ianalumab at the end of dosing interval

  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)

  From date of enrollment till 30 days after end of Treatment, assessed up to approximately 44 months

• Anti-ianalumab antibodies (ADA)

  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)

  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

Study Arms (1)

Ianalumab 300 mg

EXPERIMENTAL

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

Drug: ianalumab

Interventions

ianalumab 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.

Also known as: VAY736

Ianalumab 300 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: November 25, 2024
• Primary Completion: December 17, 2025
• Study Completion (Estimated): June 24, 2028
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share