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Estudo de fase IIa avaliando AZD7798 na doença de Crohn (AMALTHEA)

9 de novembro de 2026 atualizado por: AstraZeneca

Um estudo duplo-cego de fase IIa controlado por placebo para avaliar a eficácia e segurança de AZD7798 em pacientes com doença de Crohn moderada 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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

120

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 14163
        • Research Site
      • Potsdam, Alemanha, 14467
        • Research Site
      • Ulm, Alemanha, 89081
        • Research Site
  • 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
  • Austrália
      • Adelaide, Austrália, 5000
        • Research Site
      • Box Hill, Austrália, 3128
        • Research Site
      • Fitzroy, Austrália, 3065
        • Research Site
      • Melbourne, Austrália, 3004
        • Research Site
      • Wollongong, Austrália, 2500
        • 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
  • Bulgária
      • Gorna Oryahovitsa, Bulgária, 5100
        • Research Site
      • Sofia, Bulgária, 1784
        • Research Site
      • Sofia, Bulgária, 1680
        • Research Site
  • Bélgica
      • Leuven, Bélgica, 3000
        • Research Site
  • Canadá
    • Alberta
      • Lethbridge, Alberta, Canadá, 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
  • China
      • Beijing, China, CN-100730
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Guangzhou, China, 510080
        • Research Site
      • Guangzhou, China, 510655
        • Research Site
      • Hangzhou, China, 310016
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanjing, China, 210029
        • Research Site
      • Wuhan, China, 430030
        • Research Site
  • Eslováquia
      • Košice, Eslováquia, 04013
        • Research Site
      • Nitra, Eslováquia, 94901
        • Research Site
      • Prešov, Eslováquia, 08001
        • Research Site
      • Trnava, Eslováquia, 91702
        • Research Site
  • Espanha
      • Barcelona, Espanha, 08022
        • Research Site
      • Seville, Espanha, 41013
        • Research Site
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85054
        • Research Site
    • California
      • Escondido, California, Estados Unidos, 92025
        • Research Site
      • La Jolla, California, Estados Unidos, 92037
        • Research Site
    • Florida
      • Orlando, Florida, Estados Unidos, 32825
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, Estados Unidos, 83404
        • Research Site
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Research Site
    • Michigan
      • Clinton Township, Michigan, Estados Unidos, 48038
        • Research Site
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63156
        • Research Site
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28803
        • Research Site
      • Charlotte, North Carolina, Estados Unidos, 28204
        • Research Site
    • Pennsylvania
      • Uniontown, Pennsylvania, Estados Unidos, 15401
        • Research Site
    • Texas
      • Garland, Texas, Estados Unidos, 75044
        • Research Site
      • San Antonio, Texas, Estados Unidos, 78229
        • Research Site
  • França
      • Montpellier, França, 34090
        • Research Site
      • Pierre-Bénite, França, 69495
        • Research Site
  • Holanda
      • Amsterdam, Holanda, 1081 HZ
        • Research Site
  • Hungria
      • Békéscsaba, Hungria, 5600
        • Research Site
      • Gyöngyös, Hungria, 3200
        • Research Site
  • Itália
      • Milan, Itália, 20132
        • Research Site
      • Milan, Itália, 20157
        • Research Site
      • Roma, Itália, 00152
        • Research Site
      • Rome, Itália, 00168
        • Research Site
  • Japão
      • Hiroshima, Japão, 734-8551
        • Research Site
      • Kashiwa-shi, Japão, 277-0871
        • Research Site
      • Kure-shi, Japão, 737-8505
        • Research Site
      • Minatoku, Japão, 108-8642
        • Research Site
      • Nagasaki, Japão, 852-8501
        • Research Site
      • Nagoya, Japão, 466-8560
        • Research Site
      • Sakura-shi, Japão, 285-8741
        • Research Site
      • Sapporo, Japão, 060-8543
        • Research Site
      • Sendai, Japão, 980-8574
        • Research Site
  • Malásia
      • Johor Bahru, Malásia, 80100
        • Research Site
      • Kota Bharu, Malásia, 15586
        • Research Site
      • Kota Kinabalu, Malásia, 88200
        • Research Site
      • Kuala Lumpur, Malásia, 59100
        • Research Site
      • Kuching, Malásia, 93586
        • Research Site
  • Polônia
      • Bydgoszcz, Polônia, 85-229
        • Research Site
      • Chojnice, Polônia, 89-600
        • Research Site
      • Krakow, Polônia, 30-363
        • Research Site
      • Lublin, Polônia, 20-582
        • Research Site
      • Poznan, Polônia, 60-529
        • Research Site
      • Poznan, Polônia, 61-731
        • Research Site
      • Sopot, Polônia, 81-756
        • Research Site
      • Warsaw, Polônia, 00-189
        • Research Site
      • Warsaw, Polônia, 04-501
        • Research Site
      • Wroclaw, Polônia, 53-149
        • Research Site
  • Romênia
      • Bucharest, Romênia, 020125
        • Research Site
      • Cluj-Napoca, Romênia, 400380
        • Research Site
      • Timișoara, Romênia, 300002
        • Research Site
  • Suécia
      • Linköping, Suécia, 58185
        • Research Site
      • Stockholm, Suécia, 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
  • Turquia (Türkiye)
      • Ankara, Turquia (Türkiye), 6500
        • Research Site
      • Ankara, Turquia (Türkiye), 06800
        • Research Site
      • Antalya, Turquia (Türkiye), 07100
        • Research Site
      • Izmir, Turquia (Türkiye), 35100
        • Research Site
      • Malatya, Turquia (Türkiye), 44280
        • Research Site
      • İzmit, Turquia (Türkiye), 41000
        • Research Site
  • Ucrânia
      • Chernivtsі, Ucrânia, 58022
        • Research Site
      • Kiev, Ucrânia, 02000
        • Research Site
      • Kyiv, Ucrânia, 03680
        • Research Site
      • Kyiv, Ucrânia, 04210
        • Research Site
      • Ternopil, Ucrânia, 46000
        • Research Site
      • Vinnytsia, Ucrânia, 21009
        • Research Site
      • Vinnytsia, Ucrânia, 21001
        • Research Site
  • Vietnã
      • Hanoi, Vietnã, 100000
        • Research Site
      • Ho Chi Minh City, Vietnã, 700000
        • Research Site
      • Hà Nội, Vietnã, 100000
        • Research Site
      • Hồ Chí Minh, Vietnã, 700000
        • Research Site
  • África do Sul
      • Assagay, África do Sul, 3610
        • Research Site
      • Plumstead, África do Sul, 7800
        • Research Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo

Placebo
Outro: Placebo

Placebo
Experimental: AZD7798

AZD7798
Medicamento: AZD7798

AZD7798

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
CDAI remission
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Endoscopic response
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Week 12

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

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de agosto de 2024

Conclusão Primária (Real)

30 de abril de 2026

Conclusão do estudo (Estimado)

14 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de maio de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2024

Primeira postagem (Real)

10 de junho de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D9690C00005

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de 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.

Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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