Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-2)

August 20, 2026 updated by: Protara Therapeutics

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer

TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).

The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).

This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.

Participants will be enrolled into one of 2 cohorts:

Cohort A:

  • Participants with CIS (± Ta/T1) who are BCG naive, or
  • Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis

Cohort B:

  • Participants who are BCG unresponsive

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.
131

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

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 Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires (HIBA)
        • Contact:
          • Use Central Contact
      • Buenos Aires, Argentina, C1280
        • Recruiting
        • Hospital Británico de Buenos Aires
        • Contact:
          • Use Central Contact
      • CABA, Argentina, C1419
        • Recruiting
        • Centro Argentino de Urologia
        • Contact:
          • Use Central Contact
      • CABA, Argentina, C1419
        • Recruiting
        • Hospital Sírio Libanês
        • Contact:
          • Use Central Contact
      • Córdoba, Argentina, X5000KPH
        • Recruiting
        • Centro Urologico Profesor Bengio SA
        • Contact:
          • Use Central Contact
      • Córdoba, Argentina, X5088
        • Recruiting
        • CEMAIC
        • Contact:
          • Use Central Contact
      • Munro, Argentina, 1605
        • Recruiting
        • Clinica Privada Independencia
        • Contact:
          • Use Central Contact
  • Brazil
    • Minas Gerais
      • Nova Lima, Minas Gerais, Brazil, 34006-059
        • Recruiting
        • Kyushu University Hospital
        • Contact:
          • Use Central Contact
      • Nova Lima, Minas Gerais, Brazil, 34006-059
        • Recruiting
        • Office of Lucas Nougeria MA
        • Contact:
          • Use Central Contact
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-070
        • Recruiting
        • Santa Casa de Misericordia de Porto Alegre
        • Contact:
          • Use Central Contact
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Recruiting
        • Nucleo de Pesquisa Clinica do Rio Grande so Sul
        • Contact:
          • Use Central Contact
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Recruiting
        • Centro de Urologia Avancada
        • Contact:
          • Use Central Contact
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-970
        • Recruiting
        • Hospital de Clinicas da UNICAMP
        • Contact:
          • Use Central Contact
      • Jardim Paulista, São Paulo, Brazil, 01401-002
        • Recruiting
        • Instituto Dor de Pesquisa e Ensino
        • Contact:
          • Use Central Contact
      • Santo André, São Paulo, Brazil, 09060-650
        • Recruiting
        • Faculdade de Medicina ABC-CEPHO
        • Contact:
          • Use Central Contact
  • Canada
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada, V2T 1X8
        • Terminated
        • Exdeo Clinical Research Inc
    • Ontario
      • Brampton, Ontario, Canada, L6T 4S5
        • Withdrawn
        • Jonathan Giddes Medicine Professional Corporation
      • Toronto, Ontario, Canada, M4N 3M5
        • Withdrawn
        • Sunnybrook Research Institute
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • UHN Princess Margaret Cancer Centre Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • Recruiting
        • The Research Institute of the McGill University Health Centre
        • Contact:
          • Use Central Contact
  • Japan
    • Aichi-ken
      • Komaki-shi, Aichi-ken, Japan, 485-0044
        • Recruiting
        • Komaki City Hospital
        • Contact:
          • Use Central Contact
      • Nagoya, Aichi-ken, Japan, 435-8511
        • Recruiting
        • Japanese Red Cross Aichi Medical Center Nayoya Daiichi
        • Contact:
          • Use Central Contact
    • Chiba
      • Funabashi-shi, Chiba, Japan, 273-8588
        • Recruiting
        • Funabashi Municipal Medical Center
        • Contact:
          • Use Central Contact
      • Sakura-shi, Chiba, Japan, 285-8741
        • Recruiting
        • Fuji City General Hospital
        • Contact:
          • Use Central Contact
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
          • Use Central Contact
    • Hyōgo
      • Amagasaki-shi, Hyōgo, Japan, 660-8550
        • Recruiting
        • Hyogo Prefectural Amagasaki General Medical Center
        • Contact:
          • Use Central Contact
    • Ibaraki
      • Hitachi-shi, Ibaraki, Japan, 317-0077
        • Recruiting
        • Hitachi General Hospital
        • Contact:
          • Use Central Contact
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 221-0855
        • Recruiting
        • Yokohama Municipal Citizen's Hospital
        • Contact:
          • Use Central Contact
    • Niigata
      • Niigata, Niigata, Japan, 961-8566
        • Recruiting
        • Niigata Cancer Center Hospital
        • Contact:
          • Use Central Contact
    • Osaka
      • Osaka, Osaka, Japan, 543-855
        • Recruiting
        • Japanese Red Cross Osaka Hospital
        • Contact:
          • Use Central Contact
    • Shizuoka
      • Fuji-shi, Shizuoka, Japan, 417-8567
        • Recruiting
        • Toho University Medical Center Sakura Hospital
        • Contact:
          • Use Central Contact
    • Toyama
      • Toyama, Toyama, Japan, 930-0152
        • Recruiting
        • Toyama University Hospital
        • Contact:
          • Use Central Contact
  • Taiwan
    • Kanagawa
      • Kaohsiung City, Kanagawa, Taiwan, 807561
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
          • Use Central Contact
  • Ukraine
      • Kapitanivka, Ukraine, 08111
        • Recruiting
        • Arensia Kapitanivka - PPDS
        • Contact:
          • Use Central Contact
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Recruiting
        • Urology Centers of Alabama
        • Contact:
          • Use Central Contact
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Use Central Contact
      • Queen Creek, Arizona, United States, 85140
        • Recruiting
        • East Valley Urology Center of Arizona
        • Contact:
          • Use Central Contact
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Arkansas Urology
        • Contact:
          • Use Central Contact
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Michael Oefelein Clinical Trials
        • Contact:
          • Use Central Contact
      • Los Angeles, California, United States, 90017
        • Terminated
        • Urology Group of Southern California
      • Orange, California, United States, 92697
        • Recruiting
        • University Of California Irvine Medical Center
        • Contact:
          • Use Central Contact
      • San Diego, California, United States, 92123
        • Withdrawn
        • Genesis Research
      • Torrance, California, United States, 90505
        • Recruiting
        • Genesis Research LLC
        • Contact:
          • Use Central Contact
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Colorado University - Anshutz
        • Contact:
          • Use Central Contact
      • Denver, Colorado, United States, 80211
        • Recruiting
        • AdventHealth Medical Group Urology of Denver
        • Contact:
          • Use Central Contact
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Advanced Urology
        • Contact:
          • Use Central Contact
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Urology Associates of Denver
        • Contact:
          • Use Central Contact
    • Florida
      • Gainesville, Florida, United States, 32611
        • Withdrawn
        • University of Florida Health Jacksonville
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Use Central Contact
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • Recruiting
        • Comprehensive Urologic Care
        • Contact:
          • Use Central Contact
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Southern Urology
        • Contact:
          • Use Central Contact
      • Shreveport, Louisiana, United States, 71105
        • Withdrawn
        • Ochsner Health LSU - Regional Urology
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
          • Use Central Contact
      • Plymouth, Massachusetts, United States, 02360
        • Recruiting
        • Greater Boston Urology, LLC
        • Contact:
          • Use Central Contact
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • Recruiting
        • Minnesota Urology, Woodbury
        • Contact:
          • Use Central Contact
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Use Central Contact
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Specialty Clinic Research of St. Louis
        • Contact:
          • Use Central Contact
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
          • Use Central Contact
    • New York
      • Garden City, New York, United States, 11530
        • Terminated
        • AccuMed Research Associates
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
        • Contact:
          • Use Central Contact
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester, Department of Urology
        • Contact:
          • Use Central Contact
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Associated Medical Professionals of NY, PLLC
        • Contact:
          • Use Central Contact
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
          • Use Central Contact
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Main Campus, Cleveland
        • Contact:
          • Use Central Contact
      • Toledo, Ohio, United States, 43606
        • Withdrawn
        • University of Toledo
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
          • Use Central Contact
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
        • Contact:
          • Use Central Contact
    • Tennessee
      • Memphis, Tennessee, United States, 38128
        • Recruiting
        • Conrad Person Clinic
        • Contact:
          • Use Central Contact
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates PC
        • Contact:
          • Use Central Contact
    • Texas
      • Amarillo, Texas, United States, 79106
        • Withdrawn
        • Amarillo Urology Research
      • Arlington, Texas, United States, 76017
        • Recruiting
        • Urology Partners of North Texas
        • Contact:
          • Use Central Contact
      • Austin, Texas, United States, 78745
        • Recruiting
        • Urology Austin, LLC
        • Contact:
          • Use Central Contact
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
          • Use Central Contact
      • Houston, Texas, United States, 77027
        • Recruiting
        • Houston Metro Urology
        • Contact:
          • Use Central Contact
      • Houston, Texas, United States, 77074
        • Withdrawn
        • Clinical Trial Network
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio
        • Contact:
          • Use Central Contact
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • Virginia Urology
        • Contact:
          • Use Central Contact
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Spokane Urology
        • Contact:
          • Use Central 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female participants 18 years of age or older at the time of signing informed consent
  • Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
  • Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
  • Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive.

Exclusion Criteria:

  • Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
  • Central confirmed variant histology
  • Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
  • Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
  • Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history

For more information on eligibility criteria, please contact the Sponsor

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: N/A
  • Interventional Model: Single Group 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: TARA-002
TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain.
Biological: TARA-002
All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, 18 and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60.

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
Time Frame
Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002
Time Frame: Month 3 to Month 60
Month 3 to Month 60

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 A: Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) according to central pathology after treatment with TARA-002
Time Frame: Month 3 to Month 60
Month 3 to Month 60
Cohort A and B: Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002
Time Frame: Month 3 to Month 60
Month 3 to Month 60
Cohort A and B: Progression free survival after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Disease-specific progression free survival after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Overall survival after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Disease specific survival after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Time to cystectomy after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Time to progression after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Time to disease worsening after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002
Time Frame: Day 1 to Month 60
AE = adverse event; TEAE = treatment emergent adverse event; SAE = serious adverse event; TESAE = treatment emergent serious adverse event
Day 1 to Month 60
Cohort A and B: Change from baseline in urine pharmacodynamic biomarker levels (including IL-6, IL-8, IFN-γ, and TNF-α) after treatment with TARA-002
Time Frame: Day 1 to Day 72
Day 1 to Day 72
Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24
Time Frame: Day 1 to Month 24
EORTC = European Organization for Research and Treatment of Cancer; QLQ-NMIBC24 = Questionnaire for Patients with NMIBC
Day 1 to Month 24
Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30
Time Frame: Day 1 to Month 24
EORTC = European Organization for Research and Treatment of Cancer; QLQ-C30 = Questionnaire for Patients with Cancer
Day 1 to Month 24
Cohort A and B: Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Time Frame: Month 3 to Month 60
Month 3 to Month 60
Cohort A and B: High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Time Frame: Month 3 to Month 60
Month 3 to Month 60
Cohort A and B: Complete Response rate (all recurrent bladder cancer, including low grade Ta) at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Time Frame: Month 3 to Month 60
Month 3 to Month 60

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.
Protara Therapeutics

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: Chief Scientific Operations Officer, Protara Therapeutics

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.
September 15, 2023

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.
October 1, 2031

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 1, 2032

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).
June 29, 2023

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.
July 14, 2023

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.
July 18, 2023

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.
August 24, 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.
August 20, 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.
January 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.
  • TARA-002-101-Ph2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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