Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Fas IIa-studie som utvärderar AZD7798 vid Crohns sjukdom (AMALTHEA)

9 november 2026 uppdaterad av: AstraZeneca

En dubbelblind, placebokontrollerad fas IIa-studie för att utvärdera effektiviteten och säkerheten av AZD7798 hos patienter med måttlig till svår Crohns sjukdom

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

120

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Chile
      • Santiago, Chile, 8330034
        • Research Site
      • Santiago, Chile, 7500010
        • Research Site
      • Santiago, Chile, 7691236
        • Research Site
      • Viña del Mar, Chile, 2540488
        • Research Site
  • Frankrike
      • Montpellier, Frankrike, 34090
        • Research Site
      • Pierre-Bénite, Frankrike, 69495
        • Research Site
  • Förenta staterna
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85054
        • Research Site
    • California
      • Escondido, California, Förenta staterna, 92025
        • Research Site
      • La Jolla, California, Förenta staterna, 92037
        • Research Site
    • Florida
      • Orlando, Florida, Förenta staterna, 32825
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, Förenta staterna, 83404
        • Research Site
    • Kansas
      • Kansas City, Kansas, Förenta staterna, 66160
        • Research Site
    • Michigan
      • Clinton Township, Michigan, Förenta staterna, 48038
        • Research Site
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63156
        • Research Site
    • North Carolina
      • Asheville, North Carolina, Förenta staterna, 28803
        • Research Site
      • Charlotte, North Carolina, Förenta staterna, 28204
        • Research Site
    • Pennsylvania
      • Uniontown, Pennsylvania, Förenta staterna, 15401
        • Research Site
    • Texas
      • Garland, Texas, Förenta staterna, 75044
        • Research Site
      • San Antonio, Texas, Förenta staterna, 78229
        • 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
  • Kanada
    • Alberta
      • Lethbridge, Alberta, Kanada, T1J4G9
        • 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
  • Nederländerna
      • Amsterdam, Nederländerna, 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
  • Rumänien
      • Bucharest, Rumänien, 020125
        • Research Site
      • Cluj-Napoca, Rumänien, 400380
        • Research Site
      • Timișoara, Rumänien, 300002
        • Research Site
  • Slovakien
      • Košice, Slovakien, 04013
        • Research Site
      • Nitra, Slovakien, 94901
        • Research Site
      • Prešov, Slovakien, 08001
        • Research Site
      • Trnava, Slovakien, 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
  • Turkiet (Türkiye)
      • Ankara, Turkiet (Türkiye), 6500
        • Research Site
      • Ankara, Turkiet (Türkiye), 06800
        • Research Site
      • Antalya, Turkiet (Türkiye), 07100
        • Research Site
      • Izmir, Turkiet (Türkiye), 35100
        • Research Site
      • Malatya, Turkiet (Türkiye), 44280
        • Research Site
      • İzmit, Turkiet (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
  • Ungern
      • Békéscsaba, Ungern, 5600
        • Research Site
      • Gyöngyös, Ungern, 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo

Placebo
Övrig: Placebo

Placebo
Experimentell: AZD7798

AZD7798
Läkemedel: AZD7798

AZD7798

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CDAI remission
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Endoscopic response
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Week 12

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

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 augusti 2024

Primärt slutförande (Faktisk)

30 april 2026

Avslutad studie (Beräknad)

14 maj 2027

Studieregistreringsdatum

Först inskickad

8 maj 2024

Först inskickad som uppfyllde QC-kriterierna

4 juni 2024

Första postat (Faktisk)

10 juni 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D9690C00005

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera