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A Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo for Adults Participants With ATTR-CM (ATTRiumph)

2026년 7월 13일 업데이트: AstraZeneca

A Phase IIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo in Adult Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

The purpose of this randomised, double-blind, placebo-controlled, multicenter study is to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

This is a Phase IIb, multicenter, double-blind study in 326 participants, who will be randomized to receive either eplontersen and ALXN2220 or eplontersen and placebo once every four weeks. Participants will also receive daily supplemental doses of the recommended daily allowance of vitamin A.

연구 유형

중재적

등록 (추정된)

326

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 독일
      • Berlin, 독일, 10117
        • Research Site
      • Cologne, 독일, 50937
        • Research Site
      • Essen, 독일, 45147
        • Research Site
      • Hamburg, 독일, 22767
        • Research Site
      • Heidelberg, 독일, 69120
        • Research Site
      • Homburg, 독일, 66421
        • Research Site
      • München, 독일, 81377
        • Research Site
      • Münster, 독일, 48149
        • Research Site
  • 미국
    • California
      • La Jolla, California, 미국, 92037
        • Research Site
      • San Francisco, California, 미국, 94115
        • Research Site
      • Stanford, California, 미국, 94305
        • Research Site
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20010
        • Research Site
    • Florida
      • Jacksonville, Florida, 미국, 32224
        • Research Site
      • Miami, Florida, 미국, 33176
        • Research Site
      • Weston, Florida, 미국, 33331
        • Research Site
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Research Site
    • Missouri
      • Kansas City, Missouri, 미국, 64111
        • Research Site
      • St Louis, Missouri, 미국, 63110
        • Research Site
    • New York
      • New York, New York, 미국, 10032
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599
        • Research Site
      • Durham, North Carolina, 미국, 27710
        • Research Site
    • Ohio
      • Cleveland, Ohio, 미국, 44195
        • Research Site
    • Oregon
      • Portland, Oregon, 미국, 97239
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, 미국, 17822
        • Research Site
      • Philadelphia, Pennsylvania, 미국, 19104
        • Research Site
    • Tennessee
      • Germantown, Tennessee, 미국, 38138
        • Research Site
    • Texas
      • Dallas, Texas, 미국, 75390
        • Research Site
      • Houston, Texas, 미국, 77030
        • Research Site
    • Utah
      • Salt Lake City, Utah, 미국, 84132
        • Research Site
    • Virginia
      • Falls Church, Virginia, 미국, 22042
        • Research Site
  • 스웨덴
      • Gothenburg, 스웨덴, 413 45
        • Research Site
      • Lund, 스웨덴, 22242
        • Research Site
      • Stockholm, 스웨덴, 171 64
        • Research Site
      • Uppsala, 스웨덴, 751 85
        • Research Site
  • 스페인
      • Barcelona, 스페인, 08035
        • Research Site
      • Jaén, 스페인, 23007
        • Research Site
      • L'Hospitalet de Llobregat, 스페인, 08907
        • Research Site
      • Majadahonda, 스페인, 28222
        • Research Site
      • Málaga, 스페인, 29010
        • Research Site
      • Pamplona, 스페인, 31008
        • Research Site
      • Salamanca, 스페인, 37007
        • Research Site
      • Valencia, 스페인, 46010
        • Research Site
  • 영국
      • London, 영국, NW3 2QG
        • Research Site
      • London, 영국, NW10 2PB
        • Research Site
  • 이탈리아
      • Bologna, 이탈리아, 40138
        • Research Site
      • Florence, 이탈리아, 50134
        • Research Site
      • Milan, 이탈리아, 20138
        • Research Site
      • Padova, 이탈리아, 35128
        • Research Site
      • Pavia, 이탈리아, 27100
        • Research Site
      • Pisa, 이탈리아, 56124
        • Research Site
      • Torino, 이탈리아, 10154
        • Research Site
      • Torrette - Ancona, 이탈리아, 60126
        • Research Site
      • Trieste, 이탈리아, IT-34149
        • Research Site
  • 일본
      • Bunkyō City, 일본, 113-8431
        • Research Site
      • Kurume-shi, 일본, 830-0011
        • Research Site
      • Sapporo, 일본, 060-8543
        • Research Site
      • Shinjuku-ku, 일본, 160-8582
        • Research Site
      • Suita, 일본, 565-8565
        • Research Site
  • 중국
      • Beijing, 중국, 100730
        • Research Site
      • Beijing, 중국, 100034
        • Research Site
      • Changsha, 중국, 410012
        • Research Site
      • Chongqing, 중국, 400042
        • Research Site
      • Guangzhou, 중국, 510080
        • Research Site
      • Hangzhou, 중국, 310009
        • Research Site
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4Z6
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V6Z 1Y6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, B3H 3A7
        • Research Site
    • Ontario
      • London, Ontario, 캐나다, N6A 5A5
        • Research Site
      • Toronto, Ontario, 캐나다, M5G 2C4
        • Research Site
    • Quebec
      • Montreal, Quebec, 캐나다, H1T 1C8
        • Research Site
  • 프랑스
      • Créteil, 프랑스, 94010
        • Research Site
      • Marseille, 프랑스, 13005
        • Research Site
      • Rennes, 프랑스, 35033
        • Research Site
      • Toulouse, 프랑스, 31059
        • 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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Capable of giving informed consent.

Inclusion Criteria:

  • Participant must be ≥ 18 years to ≤ 85 years at the time of signing the informed consent.

  • Participants who have a diagnosis of ATTR-CM with either wild-type or variant TTR genotype based on 1 of the following:

    1. Endomyocardial biopsy with confirmatory TTR amyloid typing OR
    2. Grade 2 or 3 cardiac uptake on 99mTc scintigraphy in the absence of monoclonal gammopathy OR
    3. Grade 2 or 3 cardiac uptake on 99mTc scintigraphy AND confirmatory TTR amyloid typing in the presence of monoclonal gammopathy.
  • NYHA Class I to III at Screening and life expectancy of ≥ 1 year as per the Investigator's judgement.
  • End-diastolic IVST ≥ 12 mm on echocardiography.
  • NT-proBNP ≥ 600pg/mL for participants without ongoing atrial fibrillation/flutter at Screening or NT-proBNP ≥ 1200pg/mL for participants with ongoing atrial fibrillation/flutter at Screening.

  • Able to complete symptom-limited maximal CPET at Screening based on the following test criteria:

    1. Able to exercise to near exhaustion during CPET as exhibited by RER ≥ 1.0 during symptom-limited CPET conducted during screening.
    2. If participant does not achieve RER ≥1.0, the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before randomization) after the initial test.
  • Treated according to locally recognised guidelines on standard-of-care treatment for patients with HF. Therapy should have been individually optimised and stable for ≥ 4 weeks (except diuretics) and include, unless contraindicated or not tolerated, treatment of high BP (targeting SBP < 130 mmHg as suggested in 2022 American College of Cardiology/American Heart Association/Heart Failure Society of America HF guidelines), and ischaemic heart disease.
  • Willingness to adhere to daily self-administered vitamin A supplementation (3000 IU).

Exclusion Criteria:

  • Known leptomeningeal amyloidosis.
  • Known light chain (AL) or secondary (amyloid A) amyloidosis, or any other form of systemic amyloidosis.
  • Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy primarily due to hypertension, valvular heart disease, or ischaemic heart disease per Investigator's assessment.
  • Acute coronary syndrome, unstable angina, stroke, transient ischaemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 12 weeks of Screening.
  • Uncontrolled hypertension (average resting SBP > 160 mmHg or DBP > 100 mmHg at Screening).
  • Average resting SBP < 90 mmHg or symptomatic orthostatic hypotension, despite appropriate treatment, at Screening per Investigator's assessment.
  • Uncontrolled ventricular clinically significant cardiac arrhythmia, per Investigator's assessment.
  • Left ventricular ejection fraction < 30% on echocardiography measured locally at Screening.
  • Severe pulmonary impairment (SpO₂ < 92%) defined as resting SpO₂ below 92% on room air, measured by pulse oximetry, indicative of severe lung disease. Participants requiring supplemental oxygen to maintain SpO₂ ≥ 92%.
  • Participants with renal failure requiring dialysis.
  • History of solid organ transplantation or ventricular assist device or listing for heart transplantation at Screening. Note: prior history of planned corneal transplant is not an exclusion criterion.
  • Suspected or known intolerance/allergy to proteins or any components of the study intervention.

  • Any of the following results conducted at screening:

    i) Haemoglobin <8g/dL for women or <9g/dL for men. ii) Platelet count <125 X10*9/L or other disorder associated with clinically significant thrombocytopenia.

iii) ALT >2.0 X ULN iv) TBL >2.5 X ULN (participants with known Gilbert's syndrome can be included with TBL >2.5 X ULN as long as direct bilirubin is ≤ 1.5 X ULN) v) Serum retinol level < LLN vi) By CKD-EPI formula, eGFR <20 mL/min/1.73 m2 measured by the central laboratory at Screening.

  • Current unstable liver or biliary disease per Investigator's assessment.
  • Multiple myeloma, lymphoma, leukemia, or any malignancy or clonal stem cell disorder within the past 5 years (except basal cell or squamous epithelial carcinomas of the skin, melanoma in situ or cervical carcinoma in situ that have been curatively resected, Stage I cancer in remission, or adequately treated prostate cancer stage I, IIA, or IIB with Gleason score ≤ 3+4 and prostate-specific antigen < 20 ng/mL).
  • Any prior treatment with an ATTR amyloid depleter or a TTR gene silencing agent approved or in clinical development.
  • Participated in a structured exercise training programme within the 1 month prior to Screening or planned to start during the trial.
  • Participation in another investigational clinical study or intake of another investigational drug within 30 calendar days or 5 half-lives of the IMP, whichever is longer before signing the ICF.
  • Judgement by the Investigator that the participant should not participate in the study if the participant has a known medical or psychological condition or other risk factor that might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
  • Previous enrolment or randomisation in the present study.

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
실험적: Eplontersen and ALXN2220
Subcutaneous eplontersen and intravenous ALXN2220 every 4 weeks
의약품: Eplontersen
Eplontersen delivered subcutaneously, once every 4 weeks
생물학적: ALXN2220
ALXN2220 delivered intravenously, once every 4 weeks
위약 비교기: Eplontersen and placebo
Subcutaneous eplontersen and intravenous placebo every 4 weeks
의약품: Eplontersen
Eplontersen delivered subcutaneously, once every 4 weeks
다른: Placebo
Placebo delivered intravenously, once every 4 weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cardiopulmonary exercise test peak VO2
기간: 52 week
Change from baseline in Cardiopulmonary exercise test peak VO2 at week 52
52 week

2차 결과 측정

결과 측정
측정값 설명
기간
NT-proBNP
기간: 52 week
Change from baseline in NT-proBNP at week 52
52 week
Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score
기간: 52 week

Change from baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score at week 52.

The minimum score is 0 and maximum score is 100. Higher scores indicate better health status.
52 week
Extracellular volume
기간: 52 week
Change from baseline in Extracellular volume (subgroup) at week 52
52 week

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)

2026년 6월 11일

기본 완료 (추정된)

2029년 2월 6일

연구 완료 (추정된)

2029년 2월 6일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 19일

처음 게시됨 (실제)

2026년 5월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D8456C00001

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. All request 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 Pharma 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 de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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