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

June 4, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

    • 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 x 1 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1646
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1055AAF
        • Novartis Investigative Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, 1878
        • Novartis Investigative Site
    • Tucumán Province
      • San Miguel Tucuman, Tucumán Province, Argentina, T4000DPK
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Novartis Investigative Site
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Novartis Investigative Site
      • Trois-Rivières, Quebec, Canada, G9A 3Y2
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 638 00
        • Novartis Investigative Site
      • Prague, Czechia, 128 00
        • Novartis Investigative Site
      • Uherské Hradiště, Czechia, 686 01
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1134
        • Novartis Investigative Site
      • Budapest, Hungary, 1027
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Novartis Investigative Site
  • Italy
    • SA
      • Salerno, SA, Italy, 84131
        • Novartis Investigative Site
  • Poland
      • Krakow, Poland, 30-002
        • Novartis Investigative Site
      • Lublin, Poland, 20-607
        • Novartis Investigative Site
  • Spain
      • A Coruña, Spain, 15006
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
        • Novartis Investigative Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group LLC
    • California
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation
      • La Palma, California, United States, 90623
        • Advanced Medical Research
    • Florida
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Georgia
      • Lawrenceville, Georgia, United States, 30044
        • Parris and Associates Rheumatology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ School of Dentistry
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Health System
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Ahmed Arif Medical Research Center
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Med Rsrch and Consult LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • RAO Research LLC
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clin Res
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute
      • Memphis, Tennessee, United States, 38119
        • Shelby Research LLC
    • Texas
      • Bellaire, Texas, United States, 77401
        • Novel Research LLC
      • Mesquite, Texas, United States, 75150
        • Southwest Rheum Rsrch LLC
      • San Antonio, Texas, United States, 78229
        • Uni of Texas Health Science Center
      • Spring, Texas, United States, 77382
        • Advanced Rheumatology of Houston

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2ml AI
Solution for injection.
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2ml AI
Solution for injection.
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2ml AI
Solution for injection.
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2ml AI
Solution for injection.
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2 ml PFS
Solution for injection
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2 ml PFS
Solution for injection
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2 ml PFS
Solution for injection
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2 ml PFS
Solution for injection
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2 ml PFS
Solution for injection
Other Names:
  • Ianalumab
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
Biological: VAY736 1ml PFS
Solution for injection.
Other Names:
  • Ianalumab
Biological: VAY736 2 ml PFS
Solution for injection
Other Names:
  • Ianalumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
Time Frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
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
Time Frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
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
Time Frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
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
Time Frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
Time Frame: After the 3rd and 6th dose
To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL AI and 2 x 1 mL PFS
After the 3rd and 6th dose
Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab
Time Frame: At the end of dosing interval
To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL AI and 2 x 1 mL PFS
At the end of dosing interval
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
To evaluate the safety and tolerability of ianalumab administered 300 mg s.c. monthly.
From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Anti-ianalumab antibodies (ADA)
Time Frame: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
To assess the immunogenicity of ianalumab administered 300 mg s.c. monthly
From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Incidence of ADA positive participants
Time Frame: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
To assess the immunogenicity of ianalumab administered 300 mg s.c. monthly
From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Cohort 2: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
Time Frame: After the 3rd and 6th dose
To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL PFS and 2 x 1 mL PFS
After the 3rd and 6th dose
Cohort 2: Concentration at the end of a dosing interval (Ctrough) for ianalumab
Time Frame: At the end of dosing interval
To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL PFS and 2 x 1 mL PFS
At the end of dosing interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVAY736A2202
  • 2023-508996-35-00 (Registry Identifier: EU CT NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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