Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Studio di fase IIa sulla valutazione dell'AZD7798 nella malattia di Crohn (AMALTHEA)

9 novembre 2026 aggiornato da: AstraZeneca

Uno studio di fase IIa in doppio cieco, controllato con placebo, per valutare l'efficacia e la sicurezza di AZD7798 in pazienti con malattia di Crohn da moderata a grave

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

120

Fase

  • Fase 2

Contatti e Sedi

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

Luoghi di studio

  • Argentina
      • CABA, Argentina, C1025ABI
        • Research Site
      • CABA, Argentina, 1125
        • Research Site
      • Ciudad Autonoma de Bs As, Argentina, C1013AAB
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1128
        • Research Site
      • San Miguel de Tucumán, Argentina, 4000
        • Research Site
  • Australia
      • Adelaide, Australia, 5000
        • Research Site
      • Box Hill, Australia, 3128
        • Research Site
      • Fitzroy, Australia, 3065
        • Research Site
      • Melbourne, Australia, 3004
        • Research Site
      • Wollongong, Australia, 2500
        • Research Site
  • Belgio
      • Leuven, Belgio, 3000
        • Research Site
  • Brasile
      • Campinas, Brasile, 13092133
        • Research Site
      • Jaú, Brasile, 17201-130
        • Research Site
      • Porto Alegre, Brasile, 90035-903
        • Research Site
      • Santo André, Brasile, 09080-110
        • Research Site
      • São José do Rio Preto, Brasile, 15090-000
        • Research Site
      • São Paulo, Brasile, 04077020
        • Research Site
  • Bulgaria
      • Gorna Oryahovitsa, Bulgaria, 5100
        • Research Site
      • Sofia, Bulgaria, 1784
        • Research Site
      • Sofia, Bulgaria, 1680
        • Research Site
  • Canada
    • Alberta
      • Lethbridge, Alberta, Canada, T1J4G9
        • Research Site
  • Chile
      • Santiago, Chile, 8330034
        • Research Site
      • Santiago, Chile, 7500010
        • Research Site
      • Santiago, Chile, 7691236
        • Research Site
      • Viña del Mar, Chile, 2540488
        • Research Site
  • Cina
      • Beijing, Cina, CN-100730
        • Research Site
      • Chengdu, Cina, 610041
        • Research Site
      • Guangzhou, Cina, 510080
        • Research Site
      • Guangzhou, Cina, 510655
        • Research Site
      • Hangzhou, Cina, 310016
        • Research Site
      • Nanchang, Cina, 330006
        • Research Site
      • Nanjing, Cina, 210029
        • Research Site
      • Wuhan, Cina, 430030
        • Research Site
  • Francia
      • Montpellier, Francia, 34090
        • Research Site
      • Pierre-Bénite, Francia, 69495
        • Research Site
  • Germania
      • Berlin, Germania, 14163
        • Research Site
      • Potsdam, Germania, 14467
        • Research Site
      • Ulm, Germania, 89081
        • Research Site
  • Giappone
      • Hiroshima, Giappone, 734-8551
        • Research Site
      • Kashiwa-shi, Giappone, 277-0871
        • Research Site
      • Kure-shi, Giappone, 737-8505
        • Research Site
      • Minatoku, Giappone, 108-8642
        • Research Site
      • Nagasaki, Giappone, 852-8501
        • Research Site
      • Nagoya, Giappone, 466-8560
        • Research Site
      • Sakura-shi, Giappone, 285-8741
        • Research Site
      • Sapporo, Giappone, 060-8543
        • Research Site
      • Sendai, Giappone, 980-8574
        • Research Site
  • Italia
      • Milan, Italia, 20132
        • Research Site
      • Milan, Italia, 20157
        • Research Site
      • Roma, Italia, 00152
        • Research Site
      • Rome, Italia, 00168
        • Research Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Research Site
      • Kota Bharu, Malaysia, 15586
        • Research Site
      • Kota Kinabalu, Malaysia, 88200
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Kuching, Malaysia, 93586
        • Research Site
  • Olanda
      • Amsterdam, Olanda, 1081 HZ
        • Research Site
  • Polonia
      • Bydgoszcz, Polonia, 85-229
        • Research Site
      • Chojnice, Polonia, 89-600
        • Research Site
      • Krakow, Polonia, 30-363
        • Research Site
      • Lublin, Polonia, 20-582
        • Research Site
      • Poznan, Polonia, 60-529
        • Research Site
      • Poznan, Polonia, 61-731
        • Research Site
      • Sopot, Polonia, 81-756
        • Research Site
      • Warsaw, Polonia, 00-189
        • Research Site
      • Warsaw, Polonia, 04-501
        • Research Site
      • Wroclaw, Polonia, 53-149
        • Research Site
  • Romania
      • Bucharest, Romania, 020125
        • Research Site
      • Cluj-Napoca, Romania, 400380
        • Research Site
      • Timișoara, Romania, 300002
        • Research Site
  • Slovacchia
      • Košice, Slovacchia, 04013
        • Research Site
      • Nitra, Slovacchia, 94901
        • Research Site
      • Prešov, Slovacchia, 08001
        • Research Site
      • Trnava, Slovacchia, 91702
        • Research Site
  • Spagna
      • Barcelona, Spagna, 08022
        • Research Site
      • Seville, Spagna, 41013
        • Research Site
  • Stati Uniti
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85054
        • Research Site
    • California
      • Escondido, California, Stati Uniti, 92025
        • Research Site
      • La Jolla, California, Stati Uniti, 92037
        • Research Site
    • Florida
      • Orlando, Florida, Stati Uniti, 32825
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, Stati Uniti, 83404
        • Research Site
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160
        • Research Site
    • Michigan
      • Clinton Township, Michigan, Stati Uniti, 48038
        • Research Site
    • Missouri
      • St Louis, Missouri, Stati Uniti, 63156
        • Research Site
    • North Carolina
      • Asheville, North Carolina, Stati Uniti, 28803
        • Research Site
      • Charlotte, North Carolina, Stati Uniti, 28204
        • Research Site
    • Pennsylvania
      • Uniontown, Pennsylvania, Stati Uniti, 15401
        • Research Site
    • Texas
      • Garland, Texas, Stati Uniti, 75044
        • Research Site
      • San Antonio, Texas, Stati Uniti, 78229
        • Research Site
  • Sud Africa
      • Assagay, Sud Africa, 3610
        • Research Site
      • Plumstead, Sud Africa, 7800
        • Research Site
  • Svezia
      • Linköping, Svezia, 58185
        • Research Site
      • Stockholm, Svezia, 11630
        • Research Site
  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
  • Turchia (Türkiye)
      • Ankara, Turchia (Türkiye), 6500
        • Research Site
      • Ankara, Turchia (Türkiye), 06800
        • Research Site
      • Antalya, Turchia (Türkiye), 07100
        • Research Site
      • Izmir, Turchia (Türkiye), 35100
        • Research Site
      • Malatya, Turchia (Türkiye), 44280
        • Research Site
      • İzmit, Turchia (Türkiye), 41000
        • Research Site
  • Ucraina
      • Chernivtsі, Ucraina, 58022
        • Research Site
      • Kiev, Ucraina, 02000
        • Research Site
      • Kyiv, Ucraina, 03680
        • Research Site
      • Kyiv, Ucraina, 04210
        • Research Site
      • Ternopil, Ucraina, 46000
        • Research Site
      • Vinnytsia, Ucraina, 21009
        • Research Site
      • Vinnytsia, Ucraina, 21001
        • Research Site
  • Ungheria
      • Békéscsaba, Ungheria, 5600
        • Research Site
      • Gyöngyös, Ungheria, 3200
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Hà Nội, Vietnam, 100000
        • Research Site
      • Hồ Chí Minh, Vietnam, 700000
        • Research 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 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. 18 to 80 years of age.

  2. Diagnosis of Crohn's disease established with verifiable clinical, AND at least one of imaging, endoscopic and/or histopathologic evidence.

  3. Moderate to severe active Crohn's disease.

  4. Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation.

  5. Capable of giving signed informed consent.

  6. A history of at least one of:

    1. Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR
    2. Corticosteroid dependency (defined as inability to taper below budesonide 6 mg/day or prednisolone 10 mg/day equivalent dosing without recurrent active disease) for the treatment of Crohn's disease.

Exclusion Criteria:

  1. Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases.

  2. Symptomatic strictures or bowel stenoses, or strictures preventing passage of endoscope throughout the colon (including at screening endoscopy).

  3. Any complications of Crohn's disease where surgery is anticipated or planned prior to end of study treatment.

  4. Evidence of extensive prior gastrointestinal surgical interventions.

  5. Within 3 months prior to screening endoscopy visit:

    1. History of toxic megacolon
    2. Diagnosis of peritonitis or need for treatment of peritonitis
    3. Bowel perforation or evidence of obstruction.

  6. All intrabdominal abscesses are excluded. Cutaneous and perianal/perirectal abscesses and fistulae are excluded unless adequately drained at least 4 weeks prior to screening endoscopy visit with no anticipation for surgery prior to end of study treatment.

  7. Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study.

  8. Evidence of an increased risk of colorectal cancer.

  9. Symptomatic oral Crohn's disease within one year.

  10. Any of the following treatments within the specified time period prior to screening endoscopy visit

    1. An anti-TNF biologic within 8 weeks prior to screening endoscopy visit
    2. Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit
    3. Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit
    4. Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit
    5. Treatment with apheresis within 4 weeks prior to screening endoscopy visit
    6. Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study
    7. Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit
    8. Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit
    9. Any previous exposure to AZD7798.

  11. Any initiation or changes in dosing of the following medications prior to screening endoscopy visit as outlined: (a) 5-aminosalicylates within 2 weeks (b) Oral corticosteroids within 2 weeks or stable doses of steroids exceeding the following dose equivalents: (i) Systemic steroids > 20 mg/day or prednisolone equivalent (ii) Steroids with limited systemic effects (eg, budesonide and beclomethasone), exceeding maximum budesonide dose equivalent (9 mg/day) (c) Immunomodulators within 4 weeks (d) Antibiotic therapy for the treatment of Crohn's disease (e) Probiotics within 2 weeks.

  12. Chronic use of nonsteroidal anti-inflammatory drugs.

  13. Evidence of recent or currently active infection, including use of IV or oral antibiotics for documented infection within 30 days prior to screening endoscopy visit.

  14. Evidence of chronic HBV or HCV.

  15. History of TB (active or latent) unless an appropriate course of treatment has been completed.

  16. Positive diagnostic TB test at screening.

  17. History of serious opportunistic infection within 12 months prior to screening endoscopy visit.

  18. CMV colitis within previous 12 months prior to screening endoscopy visit.

  19. Positive C. difficile toxin stool test at screening.

  20. Symptomatic herpes zoster infection within 3 months prior to screening endoscopy.

  21. Any identified immunodeficiency.

  22. Abnormal laboratory results at screening suggesting participation may be unsafe, which will prevent the patient from completing the study, or will interfere with the interpretation of the study results.

  23. Reproduction:

    1. Pregnant and breastfeeding patients, or those planning to breastfeed during the study
    2. FOCBP unless completely abstinent or using a highly effective contraception and barrier method of contraception.

  24. Prolonged QTcF interval.

  25. Clinically significant cardiovascular conditions.

  26. Current malignancy or history of malignancy.

  27. Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease or other major disease other than active Crohn's disease.

  28. Current enrolment in another interventional study or treatment with any investigational drug within 4 months prior to screening endoscopy visit.

  29. Unstable lifestyle factors.

  30. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

  31. Investigator concerns regarding patient's willingness and ability to attend all study visits, comply with the study procedures, read in order to complete questionnaires, or to complete the study period

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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo

Placebo
Altro: Placebo

Placebo
Sperimentale: AZD7798

AZD7798
Droga: AZD7798

AZD7798

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
CDAI remission
Lasso di tempo: Week 12

Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight
Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Endoscopic response
Lasso di tempo: Week 12

Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed
Week 12
Endoscopic remission
Lasso di tempo: Week 12

Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed
Week 12
Endoscopic score change from baseline
Lasso di tempo: Week 12

Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed
Week 12
CDAI response
Lasso di tempo: Week 12

Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight
Week 12
CDAI score change from baseline
Lasso di tempo: Week 12

Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight
Week 12
Symptomatic remission
Lasso di tempo: Week 12

Decrease of average daily stool frequency and average daily abdominal pain
Week 12
Serum AZD7798 concentration
Lasso di tempo: Up to 85 days

Serum AZD7798 concentration (PK)
Up to 85 days
Incidence of anti-drug antibody response
Lasso di tempo: Up to 36 weeks

Incidence of anti-drug antibody (ADA) response - number and percentages with a positive ADA result
Up to 36 weeks
Titre of anti-drug antibody response
Lasso di tempo: Up to 36 weeks

Titre of anti-drug antibody (ADA) response - immunogenicity titre will be summarized descriptively as a continuous variable, only for ADA positive tests
Up to 36 weeks

Collaboratori e investigatori

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

Sponsor

AstraZeneca

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)

28 agosto 2024

Completamento primario (Effettivo)

30 aprile 2026

Completamento dello studio (Stimato)

14 maggio 2027

Date di iscrizione allo studio

Primo inviato

8 maggio 2024

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2024

Primo Inserito (Effettivo)

10 giugno 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D9690C00005

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Periodo di condivisione IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criteri di accesso alla condivisione IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

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 .

Sottoscrivi