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
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
2 other identifiers
interventional
155
8 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
Typical duration for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedStudy Start
First participant enrolled
July 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2029
ExpectedDecember 4, 2025
November 1, 2025
11 months
February 28, 2024
November 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
Cohort 2: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
Cohort 2: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
Secondary Outcomes (7)
Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
After the 3rd and 6th dose
Cohort 2: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
After the 3rd and 6th dose
Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab
At the end of dosing interval
Cohort 2: Concentration at the end of a dosing interval (Ctrough) for ianalumab
At the end of dosing interval
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
- +2 more secondary outcomes
Study Arms (10)
Cohort 1: Sequence 1 + Thigh
EXPERIMENTALPatients 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
Cohort 1: Sequence 1 + Abdomen
EXPERIMENTALPatients 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
Cohort 1: Sequence 2 + Thigh
EXPERIMENTALPatients 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
Cohort 1: Sequence 2 + Abdomen
EXPERIMENTALPatients 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
Cohort 2: Sequence 1 + Thigh
EXPERIMENTALPatients 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
Cohort 2: Sequence 1 + Abdomen
EXPERIMENTALPatients 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
Cohort 2: Sequence 1 + Upper Arm
EXPERIMENTALPatients 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
Cohort 2: Sequence 2 + Thigh
EXPERIMENTALPatients 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
Cohort 2: Sequence 2 + Abdomen
EXPERIMENTALPatients 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
Cohort 2: Sequence 2 + Upper Arm
EXPERIMENTALPatients 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
Interventions
Solution for injection.
Solution for injection
Solution for injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
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
Novartis Investigative Site
Quilmes, Buenos Aires, 1878, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000DPK, Argentina
Novartis Investigative Site
Buenos Aires, 1646, Argentina
Novartis Investigative Site
Buenos Aires, C1055AAF, Argentina
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5, Canada
Novartis Investigative Site
Toronto, Ontario, M5T 2S8, Canada
Novartis Investigative Site
Rimouski, Quebec, G5L 5T1, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, G9A 3Y2, Canada
Novartis Investigative Site
Brno, 638 00, Czechia
Novartis Investigative Site
Prague, 128 00, Czechia
Novartis Investigative Site
Uherské Hradiště, 686 01, Czechia
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032, Hungary
Novartis Investigative Site
Budapest, 1027, Hungary
Novartis Investigative Site
Budapest, 1036, Hungary
Novartis Investigative Site
Salerno, SA, 84131, Italy
Novartis Investigative Site
Krakow, 30-002, Poland
Novartis Investigative Site
Lublin, 20-607, Poland
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706, Spain
Novartis Investigative Site
A Coruña, 15006, Spain
Novartis Investigative Site
Madrid, 28034, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 5, 2024
Study Start
July 2, 2024
Primary Completion
June 5, 2025
Study Completion (Estimated)
January 4, 2029
Last Updated
December 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com