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 Patients With Autoimmune Disease
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 assess the safety and tolerability of ianalumab following the s.c. administration of both devices in patients with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). A second optional cohort may 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
Study Start (Actual) 2024-07-02
Primary Completion (Estimated) 2025-07-29
Study Completion (Estimated) 2029-02-08
Enrollment (Estimated) 140
Study Type INTERVENTIONAL
Phase PHASE2
Locations:
📍 Winter Park, Florida, United States
📍 Grand Blanc, Michigan, United States
📍 Oklahoma City, Oklahoma, United States
📍 Duncansville, Pennsylvania, United States
📍 Bellaire, Texas, United States
📍 Mesquite, Texas, United States

Eligibility Criteria

Description

    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.
    • Other protocol-defined inclusion/exclusion criteria may apply.
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

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

  • First Submitted2024-02-28
  • First Submitted that Met QC Criteria2024-02-28
  • First Posted2024-03-05

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-07-26
  • Last Update Posted2024-07-29
  • Last Verified2024-07