A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

June 19, 2026 updated by: Novartis Pharmaceuticals

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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 (Estimated)

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.
502

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

  • Austria
      • Linz, Austria, 4021
        • Withdrawn
        • Novartis Investigative Site
      • Vienna, Austria, A 1090
        • Recruiting
        • Novartis Investigative Site
      • Vienna, Austria, 1190
        • Recruiting
        • Novartis Investigative Site
      • Vienna, Austria, 1100
        • Recruiting
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Novartis Investigative Site
  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Novartis Investigative Site
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • Novartis Investigative Site
    • Oost Vlaanderen
      • Aalst, Oost Vlaanderen, Belgium, 9300
        • Recruiting
        • Novartis Investigative Site
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • Recruiting
        • Novartis Investigative Site
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Recruiting
        • Novartis Investigative Site
      • North York, Ontario, Canada, M6B 3H7
        • Recruiting
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Hradec Králové, Czechia, 500 02
        • Recruiting
        • Novartis Investigative Site
      • Jaroměř, Czechia, 551 01
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 128 08
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 150 06
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 14021
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Esbjerg, Denmark, 6700
        • Recruiting
        • Novartis Investigative Site
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Novartis Investigative Site
      • Roskilde, Denmark, 4000
        • Recruiting
        • Novartis Investigative Site
      • Viborg, Denmark, 8800
        • Recruiting
        • Novartis Investigative Site
  • France
      • Paris, France, 75015
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75012
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75013
        • Recruiting
        • Novartis Investigative Site
      • Pessac, France, 33604
        • Recruiting
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Recruiting
        • Novartis Investigative Site
      • Rennes, France, 35033
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Ahaus, Germany, 48683
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Bonn, Germany, 53105
        • Recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 22763
        • Recruiting
        • Novartis Investigative Site
      • Lüneburg, Germany, 21339
        • Withdrawn
        • Novartis Investigative Site
      • Mannheim, Germany, 68165
        • Recruiting
        • Novartis Investigative Site
      • München, Germany, 80636
        • Recruiting
        • Novartis Investigative Site
      • Münster, Germany, 48149
        • Recruiting
        • Novartis Investigative Site
      • Oldenburg, Germany, 26133
        • Recruiting
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60594
        • Recruiting
        • Novartis Investigative Site
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, Germany, 67655
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01099
        • Recruiting
        • Novartis Investigative Site
      • Leipzig, Saxony, Germany, 04289
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Beersheba, Israel, 8457108
        • Recruiting
        • Novartis Investigative Site
      • Haifa, Israel, 3109601
        • Recruiting
        • Novartis Investigative Site
      • Haifa, Israel, 3104802
        • Recruiting
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Novartis Investigative Site
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Novartis Investigative Site
      • Nahariya, Israel, 2210001
        • Recruiting
        • Novartis Investigative Site
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60126
        • Recruiting
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24127
        • Recruiting
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Withdrawn
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Recruiting
        • Novartis Investigative Site
    • CE
      • Caserta, CE, Italy, 81100
        • Recruiting
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44124
        • Recruiting
        • Novartis Investigative Site
    • IS
      • Pozzilli, IS, Italy, 86077
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20162
        • Recruiting
        • Novartis Investigative Site
      • Milan, MI, Italy, 20138
        • Recruiting
        • Novartis Investigative Site
      • Milan, MI, Italy, 20157
        • Recruiting
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italy, 35128
        • Recruiting
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italy, 33170
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Recruiting
        • Novartis Investigative Site
      • Amsterdam, North Holland, Netherlands, 1090 HM
        • Recruiting
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3079 DZ
        • Recruiting
        • Novartis Investigative Site
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Novartis Investigative Site
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Alcabideche, Portugal, 2755-009
        • Recruiting
        • Novartis Investigative Site
      • Braga, Portugal, 4710243
        • Recruiting
        • Novartis Investigative Site
      • Coimbra, Portugal, 3004-561
        • Recruiting
        • Novartis Investigative Site
      • Vila Nova de Gaia, Portugal, 4434 502
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Withdrawn
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46010
        • Recruiting
        • Novartis Investigative Site
    • Extremadura
      • Cáceres, Extremadura, Spain, 10003
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Novartis Investigative Site
      • Geneva, Switzerland, 1211
        • Recruiting
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Novartis Investigative Site
      • Lugano, Switzerland, 6900
        • Recruiting
        • Novartis Investigative Site
      • Zurich, Switzerland, 8091
        • Withdrawn
        • Novartis Investigative Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE3 9QP
        • Recruiting
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L14 3PE
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Novartis Investigative Site
      • Londonderry, United Kingdom, BT47 6SB
        • Recruiting
        • Novartis Investigative Site
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Novartis Investigative Site
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • Novartis Investigative Site
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Novartis Investigative Site
      • Tyne and Wear, United Kingdom, NE29 8NH
        • Recruiting
        • Novartis Investigative Site
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
        • Recruiting
        • Novartis Investigative Site
    • Nothern Ireland
      • Portadown, Nothern Ireland, United Kingdom, BT63 5QQ
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Heart Center Research Llc
        • Principal Investigator:
          • Vernon R Hunter
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • Cardiovascular Res Found
        • Principal Investigator:
          • Ronald P Karlsberg
        • Contact:
      • Covina, California, United States, 91723
        • Recruiting
        • Flourish Clinical Resrch Covin
        • Principal Investigator:
          • Fahed Bitar
        • Contact:
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials
        • Principal Investigator:
          • Mehrdad Ariani
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University Medical Center
        • Principal Investigator:
          • Abha Khandelwal
        • Contact:
      • San Diego, California, United States, 92103-8415
        • Recruiting
        • University of California San Diego
        • Contact:
        • Principal Investigator:
          • Anna Narezkina
      • San Francisco, California, United States, 94143
        • Recruiting
        • UC San Francisco Medical Center
        • Principal Investigator:
          • Eveline Stock
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Withdrawn
        • Excel Medical Clinical Trials LLC
      • Bradenton, Florida, United States, 34209
      • Miami, Florida, United States, 33138
        • Recruiting
        • Flourish Res Acq LLC North Miami
        • Principal Investigator:
          • Rimsky Denis
        • Contact:
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Inpatient Research Clinical LLC
        • Principal Investigator:
          • Alexis Gutierrez
        • Contact:
      • Naples, Florida, United States, 34102
        • Withdrawn
        • Advanced Research for Health Improvement LLC
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Midwest Heart and Vascular Spec
        • Principal Investigator:
          • Vasvi Singh
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Michael Honigberg
        • Contact:
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Benjamin Wessler
        • Contact:
          • Veronique Recile
          • Phone Number: +1 617 636 5897
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Womens Hosp Harvard Med School
        • Principal Investigator:
          • Rhanderson Cardoso
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Khaled Abdul-Nour
        • Contact:
      • Flint, Michigan, United States, 48504
        • Recruiting
        • AA Medical Research Center
        • Principal Investigator:
          • Ahmed A Arif
        • Contact:
      • Royal Oak, Michigan, United States, 48073-4192
        • Recruiting
        • William Beaumont Hospital
        • Principal Investigator:
          • Joel Skaistis
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Daniel Duprez
        • Contact:
      • Minneapolis, Minnesota, United States, 55407
        • Withdrawn
        • Minneapolis Heart Institute
    • New Jersey
      • Summit, New Jersey, United States, 07901
    • New York
      • Albany, New York, United States, 12211
        • Recruiting
        • Capital Cardiology Associates
        • Principal Investigator:
          • Lance Sullenberger
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Med at Mt Sinai
        • Contact:
        • Principal Investigator:
          • Robert Rosenson
      • New York, New York, United States, 10021
        • Active, not recruiting
        • New York Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • Recruiting
        • Strong Memorial Hospital
        • Principal Investigator:
          • Robert Block
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Lindner Ctr At The Christ Hosp
        • Principal Investigator:
          • Sitaramesh Emani
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Withdrawn
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Heart Institute
        • Contact:
        • Principal Investigator:
          • Alexander Postalian
      • Houston, Texas, United States, 77034
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Virginia Heart
        • Principal Investigator:
          • Tariq Haddad
        • Contact:
      • Manassas, Virginia, United States, 20109
        • Recruiting
        • Carient Heart and Vascular
        • Principal Investigator:
          • Vikram Prasanna
        • Contact:

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female ≥50 to <80 years of age at Screening Part II
  • Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
  • Mild or moderate calcific aortic valve stenosis
  • At the randomization visit, participant must be optimally treated for existing CV risk factors

Exclusion Criteria:

  • Severe calcific aortic valve stenosis
  • Uncontrolled hypertension
  • History of malignancy of any organ system
  • History of hemorrhagic stroke or other major bleeding
  • Platelet count ≤ LLN
  • Active liver disease or hepatic dysfunction
  • Significant kidney disease
  • Pregnant or nursing women

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
Drug: Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg
Other Names:
  • TQJ230
Placebo Comparator: Matching placebo
Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
Drug: Matching placebo
Matching placebo
Other Names:
  • Placebo

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
Change in peak aortic jet velocity
Time Frame: 36 months
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
36 months
Change in aortic valve calcium score
Time Frame: 36 months
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography
36 months

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
Change in Lp(a) levels
Time Frame: 12 months
To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12
12 months
Change in fibrocalcific thickening of the aortic valve
Time Frame: 36 months
To assess the effect of pelacarsen (TQJ230) vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in fibrocalcific thickening of the aortic valve by contrast CT
36 months
Time from randomization to first occurrence of composite clinical endpoint event
Time Frame: Up to 36 months

To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either:

  1. Unplanned CAVS related hospital admission
  2. Aortic valve intervention
  3. Death related to calcific aortic valve stenosis
Up to 36 months

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
March 7, 2024

Primary Completion (Estimated)

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.
March 12, 2030

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.
March 12, 2030

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).
December 2, 2022

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.
December 2, 2022

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.
December 12, 2022

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 23, 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 19, 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.
  • CTQJ230A12203

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 the applicable laws and regulations.

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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