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
Status: Recruiting
Location: See all (34) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Pinnacle Research Group Llc
RECRUITING
Anniston
California
Providence Medical Foundation
ACTIVE_NOT_RECRUITING
Fullerton
Advanced Medical Research
ACTIVE_NOT_RECRUITING
La Palma
Florida
Conquest Research
RECRUITING
Winter Park
Georgia
Parris and Associates Rheumatology
COMPLETED
Lawrenceville
Indiana
Indiana Univ School of Dentistry
RECRUITING
Indianapolis
Louisiana
Ochsner Health System
RECRUITING
Baton Rouge
Michigan
Ahmed Arif Medical Research Center
RECRUITING
Grand Blanc
Ohio
Paramount Med Rsrch and Consult LLC
RECRUITING
Middleburg Heights
Oklahoma
RAO Research LLS
RECRUITING
Oklahoma City
Pennsylvania
Altoona Center for Clin Res
RECRUITING
Duncansville
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Shelby Research LLC
ACTIVE_NOT_RECRUITING
Memphis
Texas
Novel Research LLC
RECRUITING
Bellaire
Southwest Rheum Rsrch LLC
ACTIVE_NOT_RECRUITING
Mesquite
Uni of Texas Health Science Center
RECRUITING
San Antonio
Advanced Rheumatology of Houston
ACTIVE_NOT_RECRUITING
Spring
Other Locations
Argentina
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Ciudad Autonoma De Bs As
Novartis Investigative Site
RECRUITING
Quilmes
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
San Miguel De Tucumán
Canada
Novartis Investigative Site
RECRUITING
Hamilton
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Rimouski
Novartis Investigative Site
RECRUITING
Toronto
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Trois-rivières
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Debrecen
Italy
Novartis Investigative Site
RECRUITING
Salerno
Poland
Novartis Investigative Site
RECRUITING
Krakow
Novartis Investigative Site
RECRUITING
Lublin
Spain
Novartis Investigative Site
RECRUITING
A Coruña
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Santiago De Compostela
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date:2024-07-02
Estimated Completion Date:2029-03-16
Participants
Target number of participants:140
Treatments
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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