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Fase IIa-studie som evaluerer AZD7798 ved Crohns sykdom (AMALTHEA)

9. november 2026 oppdatert av: AstraZeneca

En dobbeltblind, placebokontrollert fase IIa-studie for å evaluere effektiviteten og sikkerheten til AZD7798 hos pasienter med moderat til alvorlig Crohns sykdom

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • 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
  • Belgia
      • Leuven, Belgia, 3000
        • Research Site
  • Brasil
      • Campinas, Brasil, 13092133
        • Research Site
      • Jaú, Brasil, 17201-130
        • Research Site
      • Porto Alegre, Brasil, 90035-903
        • Research Site
      • Santo André, Brasil, 09080-110
        • Research Site
      • São José do Rio Preto, Brasil, 15090-000
        • Research Site
      • São Paulo, Brasil, 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
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85054
        • Research Site
    • California
      • Escondido, California, Forente stater, 92025
        • Research Site
      • La Jolla, California, Forente stater, 92037
        • Research Site
    • Florida
      • Orlando, Florida, Forente stater, 32825
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, Forente stater, 83404
        • Research Site
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Research Site
    • Michigan
      • Clinton Township, Michigan, Forente stater, 48038
        • Research Site
    • Missouri
      • St Louis, Missouri, Forente stater, 63156
        • Research Site
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28803
        • Research Site
      • Charlotte, North Carolina, Forente stater, 28204
        • Research Site
    • Pennsylvania
      • Uniontown, Pennsylvania, Forente stater, 15401
        • Research Site
    • Texas
      • Garland, Texas, Forente stater, 75044
        • Research Site
      • San Antonio, Texas, Forente stater, 78229
        • Research Site
  • Frankrike
      • Montpellier, Frankrike, 34090
        • Research Site
      • Pierre-Bénite, Frankrike, 69495
        • Research Site
  • Italia
      • Milan, Italia, 20132
        • Research Site
      • Milan, Italia, 20157
        • Research Site
      • Roma, Italia, 00152
        • Research Site
      • Rome, Italia, 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
  • Nederland
      • Amsterdam, Nederland, 1081 HZ
        • 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
  • Romania
      • Bucharest, Romania, 020125
        • Research Site
      • Cluj-Napoca, Romania, 400380
        • Research Site
      • Timișoara, Romania, 300002
        • Research Site
  • Slovakia
      • Košice, Slovakia, 04013
        • Research Site
      • Nitra, Slovakia, 94901
        • Research Site
      • Prešov, Slovakia, 08001
        • Research Site
      • Trnava, Slovakia, 91702
        • Research Site
  • Spania
      • Barcelona, Spania, 08022
        • Research Site
      • Seville, Spania, 41013
        • Research Site
  • Sverige
      • Linköping, Sverige, 58185
        • Research Site
      • Stockholm, Sverige, 11630
        • Research Site
  • Sør-Afrika
      • Assagay, Sør-Afrika, 3610
        • Research Site
      • Plumstead, Sør-Afrika, 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
  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye), 6500
        • Research Site
      • Ankara, Tyrkia (Türkiye), 06800
        • Research Site
      • Antalya, Tyrkia (Türkiye), 07100
        • Research Site
      • Izmir, Tyrkia (Türkiye), 35100
        • Research Site
      • Malatya, Tyrkia (Türkiye), 44280
        • Research Site
      • İzmit, Tyrkia (Türkiye), 41000
        • Research Site
  • Tyskland
      • Berlin, Tyskland, 14163
        • Research Site
      • Potsdam, Tyskland, 14467
        • Research Site
      • Ulm, Tyskland, 89081
        • Research Site
  • Ukraina
      • Chernivtsі, Ukraina, 58022
        • Research Site
      • Kiev, Ukraina, 02000
        • Research Site
      • Kyiv, Ukraina, 03680
        • Research Site
      • Kyiv, Ukraina, 04210
        • Research Site
      • Ternopil, Ukraina, 46000
        • Research Site
      • Vinnytsia, Ukraina, 21009
        • Research Site
      • Vinnytsia, Ukraina, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo

Placebo
Annen: Placebo

Placebo
Eksperimentell: AZD7798

AZD7798
Legemiddel: AZD7798

AZD7798

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. august 2024

Primær fullføring (Faktiske)

30. april 2026

Studiet fullført (Antatt)

14. mai 2027

Datoer for studieregistrering

Først innsendt

8. mai 2024

Først innsendt som oppfylte QC-kriteriene

4. juni 2024

Først lagt ut (Faktiske)

10. juni 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D9690C00005

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere