Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

NCT ID: NCT06293365

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-02
• Study Completion Date: 2029-01-04

Brief Summary

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).

A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

Detailed Description

The study consists of the following periods:

Screening period (up to 4 weeks):

Following the signing of the informed consent, participants will be assessed for eligibility during this period of up to 4 weeks.

Treatment Period 1 + Treatment Period 2, (Week 0 to Week 24):

After completion of the screening period, eligible participants will be randomized at the Baseline visit (Week 0) to one of the 2 treatment sequences (treatment switch at Week 12) in a ratio of 1:1 described below:

• Cohort 1:

• Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 2
• Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2
• Cohort 2:

• Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 2
• Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2 In addition, within each sequence, participants will be further randomized to one of the predetermined injection sites with equal allocation, resulting in a total randomization combination of four (2 sequences x 2 injection sites) for Cohort 1 and six (2 sequences x 3 injection sites) for Cohort 2, respectively.

Extended Treatment period (Week 24 to Week 72): After completion of Week 24 assessment, all participants (who did not discontinue during treatment period) will have the option to enter the extended treatment period to receive ianalumab 300 mg s.c. (Cohort 1: 2 mL AI; Cohort 2: 2 x 1 mL PFS) monthly up to Week 68. The end of treatment (EOT) visit will be performed 4 weeks after the last study treatment administration, i.e., at Week 72.

Mandatory Post-Treatment safety follow-up period (from Week 72 to Week 88): Participants who completed the last study treatment or prematurely discontinued from study treatment will enter the post-treatment safety follow-up period.

Conditional Post-Treatment safety follow-up period (from Week 88 to Week 176) Post-treatment follow-up will be performed until B-cell recovery or up to 2 years. B-cell recovery is defined when CD19+ B-cell counts return to >= 50 cells/μL or >= 80% of baseline value, whichever occurs earlier.

Conditions

Sjögrens Disease; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cohort 1: Sequence 1 + Thigh

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh

(1 x 2 mL) AI in ETP in Thigh/ Abdomen

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2ml AI

Intervention Type: BIOLOGICAL

Solution for injection.

Cohort 1: Sequence 1 + Abdomen

Patients randomized to receive injection

1. X 2 mL) AI in TP1 in Abdomen

2. x 1 mL) PFS in TP2 in Abdomen

(1 x 2 mL) AI in ETP in Thigh/ Abdomen

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2ml AI

Intervention Type: BIOLOGICAL

Solution for injection.

Cohort 1: Sequence 2 + Thigh

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh

(1 x 2 mL) AI in ETP in Thigh/ Abdomen

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2ml AI

Intervention Type: BIOLOGICAL

Solution for injection.

Cohort 1: Sequence 2 + Abdomen

Patients randomized to receive injection

1. X 2 mL) AI in TP1 in Abdomen

2. x 1 mL) PFS in TP2 in Abdomen

(1 x 2 mL) AI in ETP in Thigh/ Abdomen

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2ml AI

Intervention Type: BIOLOGICAL

Solution for injection.

Cohort 2: Sequence 1 + Thigh

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh

1. X 2 mL) PFS in TP2 in Thigh

2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2 ml PFS

Intervention Type: BIOLOGICAL

Solution for injection

Cohort 2: Sequence 1 + Abdomen

Patients randomized to receive injection

1. X 2 mL) PFS in TP1 in Abdomen

2. x 1 mL) PFS in TP2 in Abdomen

(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2 ml PFS

Intervention Type: BIOLOGICAL

Solution for injection

Cohort 2: Sequence 1 + Upper Arm

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Upper Arm

1. X 2 mL) PFS in TP2 in Upper Arm

2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2 ml PFS

Intervention Type: BIOLOGICAL

Solution for injection

Cohort 2: Sequence 2 + Thigh

Patients randomized to receive injection

1. X 2 mL) PFS in TP1 in Thigh

2. x 1 mL) PFS in TP2 in Thigh

(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2 ml PFS

Intervention Type: BIOLOGICAL

Solution for injection

Cohort 2: Sequence 2 + Abdomen

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Abdomen

1. X 2 mL) PFS in TP2 in Abdomen

2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2 ml PFS

Intervention Type: BIOLOGICAL

Solution for injection

Cohort 2: Sequence 2 + Upper Arm

Patients randomized to receive injection

1. X 2 mL) PFS in TP1 in Upper Arm

2. x 1 mL) PFS in TP2 in Upper Arm

(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group Type: EXPERIMENTAL

VAY736 1ml PFS

Intervention Type: BIOLOGICAL

Solution for injection.

VAY736 2 ml PFS

Intervention Type: BIOLOGICAL

Solution for injection

Interventions

VAY736 1ml PFS

Solution for injection.

Intervention Type: BIOLOGICAL

VAY736 2 ml PFS

Solution for injection

Intervention Type: BIOLOGICAL

VAY736 2ml AI

Solution for injection.

Intervention Type: BIOLOGICAL

Other Intervention Names

Ianalumab; Ianalumab; Ianalumab

Eligibility Criteria

Inclusion Criteria

• Signed informed consent must be obtained before any assessment is performed.
• Male and female patients aged 18 years to 70 years (inclusive).
• Body weight at least 35 kg and not more than 150 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 RA, SjD and/or SLE as determined by the investigator.
• Have active disease (RA, SjD 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.
• Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study.

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.
• Plans for administration of live vaccines during the study period.
• 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.
• US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment.

• 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

Locations

Pinnacle Research Group Llc

Anniston, Alabama, United States

Providence Medical Foundation

Fullerton, California, United States

Advanced Medical Research

La Palma, California, United States

Conquest Research

Winter Park, Florida, United States

Parris and Associates Rheumatology

Lawrenceville, Georgia, United States

Indiana Univ School of Dentistry

Indianapolis, Indiana, United States

Ochsner Health System

Baton Rouge, Louisiana, United States

Ahmed Arif Medical Research Center

Grand Blanc, Michigan, United States

Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio, United States

RAO Research LLC

Oklahoma City, Oklahoma, United States

Altoona Center for Clin Res

Duncansville, Pennsylvania, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

Shelby Research LLC

Memphis, Tennessee, United States

Novel Research LLC

Bellaire, Texas, United States

Southwest Rheum Rsrch LLC

Mesquite, Texas, United States

Uni of Texas Health Science Center

San Antonio, Texas, United States

Advanced Rheumatology of Houston

Spring, Texas, United States

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Rimouski, Quebec, Canada

Novartis Investigative Site

Trois-Rivières, Quebec, Canada

Novartis Investigative Site

Brno, , Czechia

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Uherské Hradiště, , Czechia

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Salerno, SA, Italy

Novartis Investigative Site

Krakow, , Poland

Novartis Investigative Site

Lublin, , Poland

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

A Coruña, , Spain

Novartis Investigative Site

Madrid, , Spain

Countries

United States; Argentina; Canada; Czechia; Hungary; Italy; Poland; Spain

Other Identifiers

2023-508996-35-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CVAY736A2202

Identifier Type: -

Identifier Source: org_study_id