ACTIVE_NOT_RECRUITING

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

Conditions

Sjögrens Disease Systemic Lupus Erythematosus Rheumatoid Arthritis Sjögrens Disease (SjD)Systemic lupus erythematosus (SLE)Rheumatoid Arthritis (RA)Pharmacokinetic (PK) comparability 2 mL auto-injector (AI)1 mL pre-filled syringe (PFS)2 mL pre-filled syringe (PFS)VAY736 ianalumab B cell depletion Area under the curve (AUC)Cmax

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL Pre-filled Syringe With 1 mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Quick Facts

Study Start:2024-07-02

Study Completion:2029-01-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06293365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Pinnacle Research Group Llc

Anniston, Alabama, 36207

United States

Providence Medical Foundation

Fullerton, California, 92835

United States

Advanced Medical Research

La Palma, California, 90623

United States

Conquest Research

Winter Park, Florida, 32789

United States

Parris and Associates Rheumatology

Lawrenceville, Georgia, 30044

United States

Indiana Univ School of Dentistry

Indianapolis, Indiana, 46202

United States

Ochsner Health System

Baton Rouge, Louisiana, 70809

United States

Ahmed Arif Medical Research Center

Grand Blanc, Michigan, 48439

United States

Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio, 44130

United States

RAO Research LLC

Oklahoma City, Oklahoma, 73116

United States

Altoona Center for Clin Res

Duncansville, Pennsylvania, 16635

United States

West Tennessee Research Institute

Jackson, Tennessee, 38305

United States

Shelby Research LLC

Memphis, Tennessee, 38119

United States

Novel Research LLC

Bellaire, Texas, 77401

United States

Southwest Rheum Rsrch LLC

Mesquite, Texas, 75150

United States

Uni of Texas Health Science Center

San Antonio, Texas, 78229

United States

Advanced Rheumatology of Houston

Spring, Texas, 77382

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-02

Study Completion Date2029-01-04

Study Record Updates

Study Start Date2024-07-02

Study Completion Date2029-01-04

Terms related to this study

Keywords Provided by Researchers

Sjögrens Disease (SjD)
Systemic lupus erythematosus (SLE)
Rheumatoid Arthritis (RA)
Pharmacokinetic (PK) comparability
2 mL auto-injector (AI)
1 mL pre-filled syringe (PFS)
2 mL pre-filled syringe (PFS)
VAY736
ianalumab
B cell depletion
Area under the curve (AUC)
Cmax

Additional Relevant MeSH Terms

Sjögrens Disease
Systemic Lupus Erythematosus
Rheumatoid Arthritis