Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Last updated: January 23, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Trial Not Available

Phase

1

Condition

Dermatomyositis (Connective Tissue Disease)

Cutaneous Lupus Erythematosus

Sjogren's Syndrome

Treatment

ianalumab

Clinical Study ID

NCT06411639
CVAY736A2104
  • Ages 18-70
  • All Genders

Study 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 .

Eligibility Criteria

Inclusion

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 atscreening

  • 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 ofSoC medications for 4 weeks prior to first dosing of study treatment

Exclusion

Key Exclusion Criteria:

  • Use of prohibited therapies

  • Active viral, bacterial or other infections requiring systemic treatment at the timeof 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 physiologicallycapable of becoming pregnant, refusing or unable to use highly effective methods ofcontraception while on study treatment and for 6 months after stopping of study drug

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Treatment Group(s): 1
Primary Treatment: ianalumab
Phase: 1
Study Start date:
November 25, 2024
Estimated Completion Date:
June 24, 2028

Study 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.