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크론병에서 AZD7798을 평가하는 제2a상 연구 (AMALTHEA)

2026년 11월 9일 업데이트: AstraZeneca

중등도 및 중증 크론병 환자에서 AZD7798의 효능과 안전성을 평가하기 위한 이중 맹검, 위약 대조 제 IIa 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

120

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 남아프리카
      • Assagay, 남아프리카, 3610
        • Research Site
      • Plumstead, 남아프리카, 7800
        • Research Site
  • 네덜란드
      • Amsterdam, 네덜란드, 1081 HZ
        • Research Site
  • 대만
      • New Taipei City, 대만, 24352
        • Research Site
      • Taichung, 대만, 40447
        • Research Site
      • Taipei, 대만, 10002
        • Research Site
      • Taoyuan, 대만, 333
        • Research Site
  • 독일
      • Berlin, 독일, 14163
        • Research Site
      • Potsdam, 독일, 14467
        • Research Site
      • Ulm, 독일, 89081
        • Research Site
  • 루마니아
      • Bucharest, 루마니아, 020125
        • Research Site
      • Cluj-Napoca, 루마니아, 400380
        • Research Site
      • Timișoara, 루마니아, 300002
        • Research Site
  • 말레이시아
      • Johor Bahru, 말레이시아, 80100
        • Research Site
      • Kota Bharu, 말레이시아, 15586
        • Research Site
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      • Kuala Lumpur, 말레이시아, 59100
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  • 미국
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    • Pennsylvania
      • Uniontown, Pennsylvania, 미국, 15401
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    • Texas
      • Garland, Texas, 미국, 75044
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      • San Antonio, Texas, 미국, 78229
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  • 베트남
      • Hanoi, 베트남, 100000
        • Research Site
      • Ho Chi Minh City, 베트남, 700000
        • Research Site
      • Hà Nội, 베트남, 100000
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      • Leuven, 벨기에, 3000
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  • 아르헨티나
      • CABA, 아르헨티나, C1025ABI
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      • Ciudad de Buenos Aires, 아르헨티나, 1128
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      • San Miguel de Tucumán, 아르헨티나, 4000
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  • 우크라이나
      • Chernivtsі, 우크라이나, 58022
        • Research Site
      • Kiev, 우크라이나, 02000
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      • Kyiv, 우크라이나, 03680
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      • Kyiv, 우크라이나, 04210
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      • Ternopil, 우크라이나, 46000
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      • Vinnytsia, 우크라이나, 21009
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      • Vinnytsia, 우크라이나, 21001
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  • 이탈리아
      • Milan, 이탈리아, 20132
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  • 일본
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      • Minatoku, 일본, 108-8642
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      • Nagasaki, 일본, 852-8501
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      • Nagoya, 일본, 466-8560
        • Research Site
      • Sakura-shi, 일본, 285-8741
        • Research Site
      • Sapporo, 일본, 060-8543
        • Research Site
      • Sendai, 일본, 980-8574
        • Research Site
  • 중국
      • Beijing, 중국, CN-100730
        • Research Site
      • Chengdu, 중국, 610041
        • Research Site
      • Guangzhou, 중국, 510080
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      • Guangzhou, 중국, 510655
        • Research Site
      • Hangzhou, 중국, 310016
        • Research Site
      • Nanchang, 중국, 330006
        • Research Site
      • Nanjing, 중국, 210029
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      • Wuhan, 중국, 430030
        • Research Site
  • 칠레
      • Santiago, 칠레, 8330034
        • Research Site
      • Santiago, 칠레, 7500010
        • Research Site
      • Santiago, 칠레, 7691236
        • Research Site
      • Viña del Mar, 칠레, 2540488
        • Research Site
  • 캐나다
    • Alberta
      • Lethbridge, Alberta, 캐나다, T1J4G9
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  • 터키 (Türkiye)
      • Ankara, 터키 (Türkiye), 6500
        • Research Site
      • Ankara, 터키 (Türkiye), 06800
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      • Antalya, 터키 (Türkiye), 07100
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      • Izmir, 터키 (Türkiye), 35100
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      • Malatya, 터키 (Türkiye), 44280
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      • İzmit, 터키 (Türkiye), 41000
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  • 폴란드
      • Bydgoszcz, 폴란드, 85-229
        • Research Site
      • Chojnice, 폴란드, 89-600
        • Research Site
      • Krakow, 폴란드, 30-363
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      • Lublin, 폴란드, 20-582
        • Research Site
      • Poznan, 폴란드, 60-529
        • Research Site
      • Poznan, 폴란드, 61-731
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      • Sopot, 폴란드, 81-756
        • Research Site
      • Warsaw, 폴란드, 00-189
        • Research Site
      • Warsaw, 폴란드, 04-501
        • Research Site
      • Wroclaw, 폴란드, 53-149
        • Research Site
  • 프랑스
      • Montpellier, 프랑스, 34090
        • Research Site
      • Pierre-Bénite, 프랑스, 69495
        • Research Site
  • 헝가리
      • Békéscsaba, 헝가리, 5600
        • Research Site
      • Gyöngyös, 헝가리, 3200
        • Research Site
  • 호주
      • Adelaide, 호주, 5000
        • Research Site
      • Box Hill, 호주, 3128
        • Research Site
      • Fitzroy, 호주, 3065
        • Research Site
      • Melbourne, 호주, 3004
        • Research Site
      • Wollongong, 호주, 2500
        • Research Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo

Placebo
다른: Placebo

Placebo
실험적: AZD7798

AZD7798
의약품: AZD7798

AZD7798

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
CDAI remission
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Endoscopic response
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Week 12

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

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 8월 28일

기본 완료 (실제)

2026년 4월 30일

연구 완료 (추정된)

2027년 5월 14일

연구 등록 날짜

최초 제출

2024년 5월 8일

QC 기준을 충족하는 최초 제출

2024년 6월 4일

처음 게시됨 (실제)

2024년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 9일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D9690C00005

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다