Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Novartis

Status and phase: Withdrawn; Phase 1

Conditions: Sjogren Disease; Systemic Lupus Erythematosus

Treatments: Drug: ianalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06411639

CVAY736A2104

Details and patient eligibility

About

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 .

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Ianalumab 300 mg

Experimental group

Description:

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

Treatment:

Drug: ianalumab

Sponsor of this trial

Lead Sponsor

Novartis