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

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.

Conditions

Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Sjögrens Disease
Intervention / Treatment

-

Contacts and Locations

Anniston

Pinnacle Research Group Llc, Anniston, Alabama, United States, 36207

Fullerton

Providence Medical Foundation, Fullerton, California, United States, 92835

La Palma

Advanced Medical Research, La Palma, California, United States, 90623

Winter Park

Conquest Research, Winter Park, Florida, United States, 32789

Lawrenceville

Parris and Associates Rheumatology, Lawrenceville, Georgia, United States, 30044

Indianapolis

Indiana Univ School of Dentistry, Indianapolis, Indiana, United States, 46202

Baton Rouge

Ochsner Health System, Baton Rouge, Louisiana, United States, 70809

Grand Blanc

Ahmed Arif Medical Research Center, Grand Blanc, Michigan, United States, 48439

Middleburg Heights

Paramount Med Rsrch and Consult LLC, Middleburg Heights, Ohio, United States, 44130

Oklahoma City

RAO Research LLS, Oklahoma City, Oklahoma, United States, 73116

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2029-02-13