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Studio in aperto che confronta AAA817 rispetto allo standard di cura nel trattamento di adulti mCRPC positivi per PSMA precedentemente trattati che hanno presentato una progressione della malattia durante o dopo la terapia mirata con [177Lu]Lu-PSMA (PSMAcTION)

19 settembre 2026 aggiornato da: Novartis Pharmaceuticals

PSMAcTION: studio di fase II/III, in aperto, internazionale, multicentrico, randomizzato su AAA817 rispetto allo standard di cura nel trattamento di partecipanti adulti affetti da cancro alla prostata metastatico resistente alla castrazione positivo per PSMA progredito durante o dopo [177Lu]Lu-PSMA Terapia mirata

This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy.

Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Study CAAA817A12201 consists of 2 parts: a randomized, open-label, international, multicenter, phase II study (Phase II) to collect more information to support the proposed dose of AAA817 and a randomized, open-label, international, multicenter, 2- arm phase III study (Phase III) aimed to evaluate the efficacy and safety of proposed dose of AAA817 vs. investigator's choice of standard of care (SoC) in the treatment of adult participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had treatments with ARPI and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy. The purpose of the phase II part (Phase II) of this study is to collect additional information to support proposed phase III dose of AAA817.

Tipo di studio

Interventistico

Iscrizione (Stimato)

443

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Novartis Pharmaceuticals
  • Numero di telefono: +41613241111

Luoghi di studio

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Reclutamento
        • Novartis Investigative Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Reclutamento
        • Novartis Investigative Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Reclutamento
        • Novartis Investigative Site
  • Brasile
    • São Paulo
      • São Paulo, São Paulo, Brasile, 01308-050
        • Reclutamento
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brasile, 05652-000
        • Reclutamento
        • Novartis Investigative Site
  • Cina
      • Beijing, Cina, 100036
        • Reclutamento
        • Novartis Investigative Site
      • Beijing, Cina, 100034
        • Reclutamento
        • Novartis Investigative Site
      • Guangzhou, Cina, 510060
        • Reclutamento
        • Novartis Investigative Site
      • Shanghai, Cina, 200025
        • Reclutamento
        • Novartis Investigative Site
      • Shanghai, Cina, 200032
        • Reclutamento
        • Novartis Investigative Site
      • Tianjin, Cina, 300480
        • Reclutamento
        • Novartis Investigative Site
      • Tianjin, Cina, 300300
        • Reclutamento
        • Novartis Investigative Site
    • Fujian
      • Fuzhou, Fujian, Cina, 350025
        • Reclutamento
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Cina, 430022
        • Reclutamento
        • Novartis Investigative Site
      • Wuhan, Hubei, Cina, 430030
        • Reclutamento
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210006
        • Reclutamento
        • Novartis Investigative Site
      • Nanjing, Jiangsu, Cina, 210029
        • Reclutamento
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, Cina, 110011
        • Reclutamento
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, Cina, 710032
        • Reclutamento
        • Novartis Investigative Site
      • Xian, Shanxi, Cina, 710061
        • Reclutamento
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • Reclutamento
        • Novartis Investigative Site
  • Corea del Sud
      • Seoul, Corea del Sud, 03080
        • Reclutamento
        • Novartis Investigative Site
      • Seoul, Corea del Sud, 05505
        • Reclutamento
        • Novartis Investigative Site
      • Seoul, Corea del Sud, 06591
        • Reclutamento
        • Novartis Investigative Site
      • Seoul, Corea del Sud, 03722
        • Reclutamento
        • Novartis Investigative Site
  • Giappone
      • Chiba, Giappone, 2608717
        • Reclutamento
        • Novartis Investigative Site
      • Fukuoka, Giappone, 8128582
        • Reclutamento
        • Novartis Investigative Site
      • Fukuoka, Giappone, 8110213
        • Reclutamento
        • Novartis Investigative Site
      • Fukuoka, Giappone, 8120033
        • Reclutamento
        • Novartis Investigative Site
      • Fukushima, Giappone, 9601295
        • Reclutamento
        • Novartis Investigative Site
      • Ishikawa, Giappone, 9208641
        • Reclutamento
        • Novartis Investigative Site
      • Kyoto, Giappone, 6068507
        • Reclutamento
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Giappone, 2778577
        • Reclutamento
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Giappone, 0608648
        • Reclutamento
        • Novartis Investigative Site
    • Hyōgo
      • Kobe, Hyōgo, Giappone, 6500047
        • Reclutamento
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Giappone, 2360004
        • Reclutamento
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Reclutamento
        • Novartis Investigative Site
  • Israele
      • Beersheba, Israele, 8457108
        • Reclutamento
        • Novartis Investigative Site
      • Haifa, Israele, 3109601
        • Reclutamento
        • Novartis Investigative Site
      • Jerusalem, Israele, 9112001
        • Reclutamento
        • Novartis Investigative Site
      • Petah Tikva, Israele, 4941492
        • Reclutamento
        • Novartis Investigative Site
      • Ramat Gan, Israele, 5265601
        • Reclutamento
        • Novartis Investigative Site
      • Tel Aviv, Israele, 6423906
        • Reclutamento
        • Novartis Investigative Site
  • Malaysia
    • Kuala Lumpur
      • Putrajaya, Kuala Lumpur, Malaysia, 62250
        • Reclutamento
        • Novartis Investigative Site
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 46050
        • Reclutamento
        • Novartis Investigative Site
      • Petaling Jaya, Selangor, Malaysia, 46150
        • Reclutamento
        • Novartis Investigative Site
  • Messico
      • Huxquilucan, Messico, 52763
        • Reclutamento
        • Novartis Investigative Site
    • Mexico City
      • Mexico City, Mexico City, Messico, 14050
        • Reclutamento
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119228
        • Reclutamento
        • Novartis Investigative Site
      • Singapore, Singapore, 168583
        • Reclutamento
        • Novartis Investigative Site
      • Singapore, Singapore, 258499
        • Reclutamento
        • Novartis Investigative Site
  • Stati Uniti
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85258
        • Reclutamento
        • Honor Health Research Institute
        • Investigatore principale:
          • Michael Gordon
        • Contatto:
    • California
      • Los Angeles, California, Stati Uniti, 90073
        • Reclutamento
        • VA Greater LA Healthcare System
        • Contatto:
        • Investigatore principale:
          • Gholam Reza Berenji
      • Palo Alto, California, Stati Uniti, 94304-1207
        • Reclutamento
        • VA Palo Alto Health Care System
        • Investigatore principale:
          • Minal Vasanawala
        • Contatto:
      • Palo Alto, California, Stati Uniti, 94304
        • Reclutamento
        • Stanford University Medical Center
        • Investigatore principale:
          • Hong Song
        • Contatto:
      • Santa Barbara, California, Stati Uniti, 93105
        • Reclutamento
        • Sansum Clinic
        • Investigatore principale:
          • Gregg Newman
        • Contatto:
      • Santa Monica, California, Stati Uniti, 90404
        • Reclutamento
        • Saint Johns Cancer Institute
        • Investigatore principale:
          • Przemyslaw Twardowski
        • Contatto:
    • Colorado
      • Denver, Colorado, Stati Uniti, 80218
        • Reclutamento
        • Rocky Mountain Cancer Centers
        • Investigatore principale:
          • Manojkumar Bupathi
        • Contatto:
    • Connecticut
      • Hartford, Connecticut, Stati Uniti, 06102
    • Florida
      • Miami, Florida, Stati Uniti, 33173
      • Orlando, Florida, Stati Uniti, 32804
        • Reclutamento
        • AdventHealth
        • Investigatore principale:
          • Ravi Shridhar
        • Contatto:
    • Georgia
      • Athens, Georgia, Stati Uniti, 30607
        • Reclutamento
        • University Cancer and Blood Center LLC
        • Contatto:
        • Investigatore principale:
          • Petros Nikolinakos
      • Atlanta, Georgia, Stati Uniti, 30322
        • Reclutamento
        • Emory University
        • Investigatore principale:
          • Shahid Sattar Ahmed
        • Contatto:
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • Reclutamento
        • University of Chicago
        • Investigatore principale:
          • Mohammad Atiq
        • Contatto:
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Reclutamento
        • Indiana University
        • Investigatore principale:
          • Nabil Adra
        • Contatto:
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160
        • Reclutamento
        • University of Kansas Hospital
        • Investigatore principale:
          • Xinglei Shen
        • Contatto:
    • Louisiana
      • Metairie, Louisiana, Stati Uniti, 70006
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Beth Israel Deaconess Medical Center
        • Investigatore principale:
          • David J Einstein
        • Contatto:
      • Boston, Massachusetts, Stati Uniti, 02115
        • Reclutamento
        • Dana Farber Cancer Institute
        • Investigatore principale:
          • Xiao Wei
        • Contatto:
    • Missouri
      • St Louis, Missouri, Stati Uniti, 63110
        • Reclutamento
        • WA Uni School Of Med
        • Investigatore principale:
          • Jeff Michalski
        • Contatto:
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68154
        • Reclutamento
        • Nebraska Cancer Specialists
        • Investigatore principale:
          • Samuel Mehr
        • Contatto:
    • New Jersey
      • Voorhees Township, New Jersey, Stati Uniti, 08043
        • Reclutamento
        • New Jersey Urology LLC
        • Contatto:
        • Investigatore principale:
          • Gordon Brown
    • New York
      • New York, New York, Stati Uniti, 10029
        • Reclutamento
        • Mount Sinai Hosp Med School
        • Investigatore principale:
          • Randy Yeh
        • Contatto:
      • Syracuse, New York, Stati Uniti, 13210
        • Reclutamento
        • Associated Med Professionals of NY
        • Investigatore principale:
          • Steven Finkelstein
        • Contatto:
      • The Bronx, New York, Stati Uniti, 10467
        • Reclutamento
        • Montefiore Medical Center
        • Investigatore principale:
          • Benjamin A Gartrell
        • Contatto:
    • Ohio
      • Gahanna, Ohio, Stati Uniti, 43230
        • Reclutamento
        • Central Ohio Urology Group
        • Investigatore principale:
          • Benjamin Martin
        • Contatto:
    • Oregon
      • Springfield, Oregon, Stati Uniti, 97477
        • Reclutamento
        • Oregon Urology Institute
        • Investigatore principale:
          • Bryan Mehlhaff
        • Contatto:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19111
        • Reclutamento
        • Fox Chase Cancer Center
        • Contatto:
        • Investigatore principale:
          • Matthew Zibelman
    • South Carolina
      • Myrtle Beach, South Carolina, Stati Uniti, 29572
        • Reclutamento
        • Carolina Urologic Research Center
        • Investigatore principale:
          • Neal D Shore
        • Contatto:
    • Texas
      • Dallas, Texas, Stati Uniti, 75251
        • Reclutamento
        • Texas Oncology
        • Contatto:
        • Investigatore principale:
          • Michael P Herman
      • San Antonio, Texas, Stati Uniti, 78229
    • Utah
      • Murray, Utah, Stati Uniti, 84107
        • Reclutamento
        • Utah Intermountain Medical Center
        • Investigatore principale:
          • David Gill
        • Contatto:
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Reclutamento
        • Virginia Cancer Specialists
        • Investigatore principale:
          • Gregory Scott Sibley
        • Contatto:
      • Roanoke, Virginia, Stati Uniti, 24014
        • Reclutamento
        • Onco Hemato Asso of SW Virginia
        • Investigatore principale:
          • David Buck
        • Contatto:
    • Washington
      • Seattle, Washington, Stati Uniti, 98109-1024
        • Reclutamento
        • Fred Hutchinson Cancer Research Center
        • Contatto:
        • Investigatore principale:
          • Ruben Raychaudhuri
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Reclutamento
        • Medical College Of Wisconsin
        • Investigatore principale:
          • Deepak Kilari
        • Contatto:
  • Svizzera
      • Basel, Svizzera, 4031
        • Reclutamento
        • Novartis Investigative Site
      • Bellinzona, Svizzera, 6500
        • Reclutamento
        • Novartis Investigative Site
      • Bern, Svizzera, 3010
        • Reclutamento
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10002
        • Reclutamento
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Reclutamento
        • Novartis Investigative Site
      • Taipei, Taiwan, 103616
        • Reclutamento
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Reclutamento
        • Novartis Investigative Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 100 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria: ∙

  • adults ≥ 18 years of age.
  • ECOG performance status of 0 to 2.
  • histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
  • PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
  • castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
  • Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy.
  • ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
  • eGFR as requested by the sponsor

Exclusion Criteria:

  • Any investigational agents within 28 days prior to the day of randomization.
  • Any 225Ac-based investigational compound used prior to the day of randomization.
  • Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
  • Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
  • Baseline xerostomia ≥ Grade 2 by CTCAE v.5
  • History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
  • History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 2 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).

Other protocol-defined inclusion/exclusion criteria may apply.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Phase II: AAA817 Dose B

AAA817 will be given for a number of cycles; a cycle = 8 weeks
Droga: AAA817

The investigational treatment is AAA817

Altri nomi:
  • [225Ac]Ac-PSMA-617)
Droga: AAA817

Investigational treatment is the Dose B of AAA817

Altri nomi:
  • [225Ac]Ac-PSMA-617
Comparatore attivo: Phase III: Investigator's choice of SoC

Participants will be given Standard of Care (SOC) treatment per Investigator's choice.
Droga: Investigators choice of SoC

The control treatment in Phase III is investigator's choice of SoC
Sperimentale: Phase II: AAA817 Dose A

AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks
Droga: AAA817

The investigational treatment is AAA817

Altri nomi:
  • [225Ac]Ac-PSMA-617)
Droga: AAA817

Investigational treatment is the Dose B of AAA817

Altri nomi:
  • [225Ac]Ac-PSMA-617
Sperimentale: Phase III: Recommended Phase 3 Dose of AAA817

Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks
Droga: AAA817

The investigational treatment is AAA817

Altri nomi:
  • [225Ac]Ac-PSMA-617)
Droga: AAA817

Investigational treatment is the Dose B of AAA817

Altri nomi:
  • [225Ac]Ac-PSMA-617

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biochemical response rate (Phase II)
Lasso di tempo: from date of randomization up to approximately 24 months

Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement
from date of randomization up to approximately 24 months
Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II
Lasso di tempo: from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later

Safety defined as the type, incidence and severity of AEs and SAEs, and deaths
from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later
Tolerability of the proposed dose of AAA817- Phase II
Lasso di tempo: From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817

Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure
From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817
Radiographic progression-free survival (rPFS)- Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis
from date of randomization up to approximately 24 months
Overall survival (OS)- Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants who are alive or who are lost to follow-up at the time of analysis
from date of randomization up to approximately 24 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Radiographic progression-free survival (rPFS)- Phase II
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis
from date of randomization up to approximately 24 months
Progression free survival (PFS)- Phase II
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of Participants meeting Progression Free Survival
from date of randomization up to approximately 24 months
Overall response rate (ORR)- Phase II
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR)
from date of randomization up to approximately 24 months
Disease control rate (DCR)- Phase II
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants with BOR of CR, PR, stable disease (SD) or non-CR/non-PD
from date of randomization up to approximately 24 months
Overall survival (OS)- Phase II
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants who are alive or who are lost to follow-up at the analysis data cut-off
from date of randomization up to approximately 24 months
Progression free survival (PFS) -Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants with PFS -defined as the time from date of randomization to first documented progression
from date of randomization up to approximately 24 months
Overall response rate (ORR)- Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

ORR is defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR)
from date of randomization up to approximately 24 months
Disease control rate (DCR) -Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

DCR is defined as the percentage of participants with BOR of confirmed CR, PR, stable disease (SD) or Non-CR/Non progressive disease (PD)
from date of randomization up to approximately 24 months
Duration of response (DoR)- Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants with confirmed DoR defined as duration of time between the date of first documented response (CR or PR) and progression or death due to any cause, whichever occurs first.
from date of randomization up to approximately 24 months
Time to first radiographic soft tissue progression (TTSTP)- Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants with confirmed first radiographic progression in soft tissue
from date of randomization up to approximately 24 months
First symptomatic skeletal event (TTSSE)_Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants with confirmed skeletal event is defined as new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, or requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurs first
from date of randomization up to approximately 24 months
Prostate specific antigen (PSA) response -Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

PSA50 is defined as the percentage of participants who achieved a confirmed ≥ 50% decrease from baseline
from date of randomization up to approximately 24 months
Patient reported disease related symptoms and health-related quality of life (HRQoL): Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

Percentage of participants who had a Change from baseline on FACT-P Prostate Cancer Subscale (PCS)
from date of randomization up to approximately 24 months
Time to worsening on the Worst Pain: Phase III
Lasso di tempo: from date of randomization up to approximately 24 months

Time to worsening on the Worst Pain defined as the time from randomization to the first occurrence of worsening on the Worst Pain item (brief pain inventory - short form (BPI-SF)) of at least 30% of baseline or minimum of 2 points increase from baseline, or death due to any cause, whichever occurs first. BPI-SF is a self-reported questionnaire to evaluate pain intensity (severity) and impact of pain on the participant's daily functioning (interference).
from date of randomization up to approximately 24 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 febbraio 2025

Completamento primario (Stimato)

27 giugno 2028

Completamento dello studio (Stimato)

19 luglio 2033

Date di iscrizione allo studio

Primo inviato

17 dicembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

16 gennaio 2025

Primo Inserito (Effettivo)

17 gennaio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CAAA817A12201
  • 2024-512342-42-00 (Altro identificatore: EU CTIS)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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