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Fase IIa-undersøgelse, der evaluerer AZD7798 ved Crohns sygdom (AMALTHEA)

9. november 2026 opdateret af: AstraZeneca

Et dobbeltblindt, placebokontrolleret fase IIa-studie for at evaluere effektiviteten og sikkerheden af ​​AZD7798 hos patienter med moderat til svær Crohns sygdom

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
      • Adelaide, Australien, 5000
        • Research Site
      • Box Hill, Australien, 3128
        • Research Site
      • Fitzroy, Australien, 3065
        • Research Site
      • Melbourne, Australien, 3004
        • Research Site
      • Wollongong, Australien, 2500
        • Research Site
  • Belgien
      • Leuven, Belgien, 3000
        • Research Site
  • Brasilien
      • Campinas, Brasilien, 13092133
        • Research Site
      • Jaú, Brasilien, 17201-130
        • Research Site
      • Porto Alegre, Brasilien, 90035-903
        • Research Site
      • Santo André, Brasilien, 09080-110
        • Research Site
      • São José do Rio Preto, Brasilien, 15090-000
        • Research Site
      • São Paulo, Brasilien, 04077020
        • Research Site
  • Bulgarien
      • Gorna Oryahovitsa, Bulgarien, 5100
        • Research Site
      • Sofia, Bulgarien, 1784
        • Research Site
      • Sofia, Bulgarien, 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
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85054
        • Research Site
    • California
      • Escondido, California, Forenede Stater, 92025
        • Research Site
      • La Jolla, California, Forenede Stater, 92037
        • Research Site
    • Florida
      • Orlando, Florida, Forenede Stater, 32825
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Research Site
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Research Site
    • Michigan
      • Clinton Township, Michigan, Forenede Stater, 48038
        • Research Site
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63156
        • Research Site
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28803
        • Research Site
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Research Site
    • Pennsylvania
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • Research Site
    • Texas
      • Garland, Texas, Forenede Stater, 75044
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Research Site
  • Frankrig
      • Montpellier, Frankrig, 34090
        • Research Site
      • Pierre-Bénite, Frankrig, 69495
        • Research Site
  • Holland
      • Amsterdam, Holland, 1081 HZ
        • Research Site
  • Italien
      • Milan, Italien, 20132
        • Research Site
      • Milan, Italien, 20157
        • Research Site
      • Roma, Italien, 00152
        • Research Site
      • Rome, Italien, 00168
        • Research Site
  • Japan
      • Hiroshima, Japan, 734-8551
        • Research Site
      • Kashiwa-shi, Japan, 277-0871
        • Research Site
      • Kure-shi, Japan, 737-8505
        • Research Site
      • Minatoku, Japan, 108-8642
        • Research Site
      • Nagasaki, Japan, 852-8501
        • Research Site
      • Nagoya, Japan, 466-8560
        • Research Site
      • Sakura-shi, Japan, 285-8741
        • Research Site
      • Sapporo, Japan, 060-8543
        • Research Site
      • Sendai, Japan, 980-8574
        • Research Site
  • Kina
      • Beijing, Kina, CN-100730
        • Research Site
      • Chengdu, Kina, 610041
        • Research Site
      • Guangzhou, Kina, 510080
        • Research Site
      • Guangzhou, Kina, 510655
        • Research Site
      • Hangzhou, Kina, 310016
        • Research Site
      • Nanchang, Kina, 330006
        • Research Site
      • Nanjing, Kina, 210029
        • Research Site
      • Wuhan, Kina, 430030
        • 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
  • Polen
      • Bydgoszcz, Polen, 85-229
        • Research Site
      • Chojnice, Polen, 89-600
        • Research Site
      • Krakow, Polen, 30-363
        • Research Site
      • Lublin, Polen, 20-582
        • Research Site
      • Poznan, Polen, 60-529
        • Research Site
      • Poznan, Polen, 61-731
        • Research Site
      • Sopot, Polen, 81-756
        • Research Site
      • Warsaw, Polen, 00-189
        • Research Site
      • Warsaw, Polen, 04-501
        • Research Site
      • Wroclaw, Polen, 53-149
        • Research Site
  • Rumænien
      • Bucharest, Rumænien, 020125
        • Research Site
      • Cluj-Napoca, Rumænien, 400380
        • Research Site
      • Timișoara, Rumænien, 300002
        • Research Site
  • Slovakiet
      • Košice, Slovakiet, 04013
        • Research Site
      • Nitra, Slovakiet, 94901
        • Research Site
      • Prešov, Slovakiet, 08001
        • Research Site
      • Trnava, Slovakiet, 91702
        • Research Site
  • Spanien
      • Barcelona, Spanien, 08022
        • Research Site
      • Seville, Spanien, 41013
        • Research Site
  • Sverige
      • Linköping, Sverige, 58185
        • Research Site
      • Stockholm, Sverige, 11630
        • Research Site
  • Sydafrika
      • Assagay, Sydafrika, 3610
        • Research Site
      • Plumstead, Sydafrika, 7800
        • 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
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 6500
        • Research Site
      • Ankara, Tyrkiet (Türkiye), 06800
        • Research Site
      • Antalya, Tyrkiet (Türkiye), 07100
        • Research Site
      • Izmir, Tyrkiet (Türkiye), 35100
        • Research Site
      • Malatya, Tyrkiet (Türkiye), 44280
        • Research Site
      • İzmit, Tyrkiet (Türkiye), 41000
        • Research Site
  • Tyskland
      • Berlin, Tyskland, 14163
        • Research Site
      • Potsdam, Tyskland, 14467
        • Research Site
      • Ulm, Tyskland, 89081
        • Research Site
  • Ukraine
      • Chernivtsі, Ukraine, 58022
        • Research Site
      • Kiev, Ukraine, 02000
        • Research Site
      • Kyiv, Ukraine, 03680
        • Research Site
      • Kyiv, Ukraine, 04210
        • Research Site
      • Ternopil, Ukraine, 46000
        • Research Site
      • Vinnytsia, Ukraine, 21009
        • Research Site
      • Vinnytsia, Ukraine, 21001
        • Research Site
  • Ungarn
      • Békéscsaba, Ungarn, 5600
        • Research Site
      • Gyöngyös, Ungarn, 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo

Placebo
Andet: Placebo

Placebo
Eksperimentel: AZD7798

AZD7798
Medicin: AZD7798

AZD7798

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CDAI remission
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endoscopic response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 12

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

Serum AZD7798 concentration (PK)
Up to 85 days
Incidence of anti-drug antibody response
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. august 2024

Primær færdiggørelse (Faktiske)

30. april 2026

Studieafslutning (Anslået)

14. maj 2027

Datoer for studieregistrering

Først indsendt

8. maj 2024

Først indsendt, der opfyldte QC-kriterier

4. juni 2024

Først opslået (Faktiske)

10. juni 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D9690C00005

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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