Last Update: Nov 15, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVAY736A2202
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study 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 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. The study consists of the following periods:

Screening period (up to 4 weeks):

Following the signing of the informed consent, participants will be assessed for eligibility during this period of up to 4 weeks.

Treatment Period 1 + Treatment Period 2, (Week 0 to Week 24):

After completion of the screening period, eligible participants will be randomized at the Baseline visit (Week 0) to one of the 2 treatment sequences (treatment switch at Week 12) in a ratio of 1:1 described below:

* Cohort 1:

* Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 2
* Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2
* Cohort 2 (Optional):

* Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 2
* Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2 In addition, within each sequence, participants will be further randomized to one of the predetermined injection sites with equal allocation, resulting in a total randomization combination of four (2 sequences x 2 injection sites) for Cohort 1 and six (2 sequences x 3 injection sites) for Cohort 2, respectively.

Extended Treatment period (Week 24 to Week 72): After completion of Week 24 assessment, all participants (who did not discontinue during treatment period) will have the option to enter the extended treatment period to receive ianalumab 300 mg s.c. (Cohort 1: 2 mL AI; Cohort 2: 2 mL PFS) monthly up to Week 68. The end of treatment (EOT) visit will be performed 4 weeks after the last study treatment administration, i.e., at Week 72.

Mandatory Post-Treatment safety follow-up period (from Week 72 to Week 88): Participants who completed the last study treatment or prematurely discontinued from study treatment will enter the post-treatment safety follow-up period.

Conditional Post-Treatment safety follow-up period (from Week 88 to Week 176) Post-treatment follow-up will be performed until B-cell recovery or up to 2 years. B-cell recovery is defined when CD19+ B-cell counts return to \>= 50 cells/μL or \>= 80% of baseline value, whichever occurs earlier.

Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis
Phase2
Recruiting
140
Jul 10, 2024
Feb 08, 2029
All
18 Years - 70 Years (Adult, Older Adult)

Interventions

Biological

VAY736 1ml PFS

Solution for injection.
Biological

VAY736 2 ml PFS

Solution for injection
Biological

VAY736 2ml AI

Solution for injection.

Eligibility Criteria

Key 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.

Key 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.

Novartis Investigative Site

Recruiting

Trois Rivieres,Quebec,G9a 3y2,Canada

Novartis Investigative Site

Recruiting

Krakow,30 002,Poland

Novartis Investigative Site

Recruiting

La Coruna,Galicia,15006,Spain

Advanced Medical Research

Recruiting

La Palma,California,90623,United States

Andy Hodgson
Gerald Ho

Altoona Center for Clin Res

Recruiting

Duncansville,Pennsylvania,16635,United States

Harley Snyder
Alan J Kivitz

West Tennessee Research Institute

Recruiting

Jackson,Tennessee,38305,United States

Sherry Wiggins
Jacob A. Aelion

Pinnacle Research Group Llc

Recruiting

Anniston,Alabama,36207,United States

Vishala L Chindalore
Jamie Bush

Ahmed Arif Medical Research Center

Recruiting

Grand Blanc,Michigan,48439,United States

Muhaned Masha
Ali Karrar

Uni of Texas Health Science Center

Recruiting

San Antonio,Texas,78284,United States

Agustin Escalante

Advanced Rheumatology of Houston

Recruiting

Spring,Texas,77382,United States

Sarah Orsak
Tamar Brionez

Shelby Research LLC

Recruiting

Memphis,Tennessee,38119,United States

Enas Albana
Ramesh C Gupta

Indiana Univ School of Dentistry

Recruiting

Indianapolis,Indiana,46202,United States

Domenick Zero
Van Bualteng

Paramount Med Rsrch and Consult LLC

Recruiting

Middleburg Heights,Ohio,44130,United States

Denine Ryan
Isam Diab

Conquest Research

Recruiting

Winter Park,Florida,32789,United States

Anand Patel
James Kelly

Novel Research LLC

Recruiting

Bellaire,Texas,77401,United States

Cecilia Valerio
Wajeeha Yousaf

Ochsner Health System

Recruiting

Baton Rouge,Louisiana,70809,United States

Kaela Battles
Saravanan Thiagarajan

RAO Research LLS

Recruiting

Oklahoma City,Oklahoma,73116,United States

Latisha Heinlen
Rebekah Young

Parris and Associates Rheumatology

Recruiting

Lawrenceville,Georgia,30044,United States

Glenn Parris

Providence Medical Foundation

Recruiting

Fullerton,California,92835,United States

Angela Gonzalez
Shirley Pang

Southwest Rheum Rsrch LLC

Recruiting

Mesquite,Texas,75150,United States

Atul K Singhal
Beatriz Montdragon

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals