A Phase 3 Study of Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis
2026년 7월 17일 업데이트: Shanghai Ark Biopharmaceutical Co., Ltd.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This is a phase 3 clinical study conducted in China.
The primary objective is to compare the efficacy and safety of AK3280 400 mg versus placebo and active control (pirfenidone) in IPF patients.
연구 개요
상세 설명
This is a multicenter, randomized, double-blind, placebo-controlled and open-label active-controlled phase 3 clinical study conducted in China. This study plans to enroll 263 IPF participants. After completing screening assessments and meeting all enrollment criteria, IPF participants will be randomized in a 4:2:1 ratio to: AK3280 400 mg BID group (double-blind); Placebo BID group (double-blind); Pirfenidone 600 mg TID group (open-label).
The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and record any adverse medical events.
Participants are in the study for up to one and a half years. Subjects who complete the Week 52 visit of randomized controlled treatment study may be offered the opportunity to enter an open-label extension (OLE) study.
연구 유형
중재적
등록 (추정된)
263
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jayson Zhou
- 전화번호: +8618796252099
- 이메일: jayson.zhou@arkbiosciences.com
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100029
- China-Japan Friendship Hospital
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연락하다:
- Huaping Dai
- 전화번호: +861084205566
- 이메일: daihuaping@ccmu.edu.cn
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수석 연구원:
- Huaping Dai
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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
Inclusion Criteria:
- Age ≥ 40 years at enrolment
- Diagnosis of IPF per ATS/ERS/JRS/ALAT 2022 guidelines
- HRCT central review completed during screening or within 12 months prior to screening. If participant did not undergo lung surgical biopsy, HRCT imaging must be consistent with usual interstitial pneumonia (UIP) pattern for definitive IPF diagnosis.
- No prior anti-fibrotic treatment, or discontinued anti-fibrotic therapy for ≥4 weeks or 5 half-lives (whichever is longer) prior to randomization
- Screening assessments meeting all of the following: 1) Standardized %pFVC ≥ 50% and ≤ 90%；2) Hemoglobin-corrected %pDLco ≥ 30% and ≤ 90%；3) Resting SpO2 ≥ 88%
Exclusion Criteria:
- History of hypersensitivity to pirfenidone or AK3280
- Known intolerance to pirfenidone single dose of 200 mg (total daily dose 600 mg)
- Hospitalization due to acute IPF exacerbation within 8 weeks prior to screening or during screening
- Within 4 weeks prior to screening or during screening, local or systemic infection requiring: 1) Hospitalization ≥ 24 hours; or 2) Use of systemic antibiotics (IV, IM, oral, or inhaled)
- History of active tuberculosis within 12 months prior to screening
- History of other clinically significant lung diseases besides IPF (e.g., asthma, COPD, interstitial pneumonia of known cause, acute severe pulmonary infection, etc.), or planned lung transplantation within 6 months after signing informed consent
- Post-bronchodilator FEV1/FVC < 0.7 or positive bronchodilator response (defined as ≥ 12% relative increase in FEV1 and ≥ 200 mL absolute increase in FEV1 after bronchodilator use) during screening
- History of heart disease meeting NYHA Class III-IV
- History of liver cirrhosis, severe hepatic impairment, or end-stage liver disease
- Screening liver function abnormalities meeting any of the following:1) AST ≥ 2× ULN; 2) ALT ≥ 2× ULN; 3) ALP ≥ 2× ULN; 4) Total bilirubin ≥ 1.5× ULN
- Screening cystatin C-estimated eGFR < 60 mL/min/1.73m²
- Screening coagulation test meeting any of the following: 1) INR > 2; 2) Both PT and APTT prolonged > 1.5× ULN
- History of any clinically diagnosed autoimmune disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- Uncontrolled diabetes during screening (HbA1c > 10%)
- History of malignancy or possible malignancy upon evaluation (except treated localized basal cell carcinoma of the skin or cervical carcinoma in situ without recurrence)
- History of immunodeficiency, including but not limited to HIV infection
- History of any disease other than IPF with life expectancy < 18 months; or requiring long-term medical care, or limited self-care ability; or conditions that the investigator believes may affect participant's ability to complete this clinical study, complete study-related assessments, or affect safety or efficacy assessments
- Use of prohibited medications with potential effects on efficacy endpoints within 4 weeks or 5 half-lives (whichever is longer) prior to randomization
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 |
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실험적: AK3280 400 mg BID
During the randomized controlled treatment study, participants will receive AK3280 400 mg twice daily in a masked manner.
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Participants will receive AK3280 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.
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위약 비교기: Placebo
During the randomized controlled treatment study, participants will receive placebo matching 400 mg twice daily in a masked manner.
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Participants will receive placebo matching 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.
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활성 비교기: Pirfenidone 600 mg TID
During the randomized controlled treatment study, participants will receive pirfenidone titrated gradually to 600 mg three times daily in an open-label manner.
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Participants will receive pirfenidone three times daily, within 30 minutes after meals.
Initial dosing should be titrated gradually under doctor guidance: start with 200 mg each time, increase by 200 mg each time to maintain final dose of 600 mg each time within 2 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Absolute change from baseline in FVC at Week 52
기간: Baseline to Week 52
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The FVC indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
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Baseline to Week 52
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Absolute change from baseline in FVC at Week 12, 24, and 42
기간: Baseline to Week 12, 24, and 42
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The FVC indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
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Baseline to Week 12, 24, and 42
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Proportion of participants with relative decline from baseline in FVC ≥10%, ≥15%, and ≥20% at Week 12, 24, 42, and 52
기간: At Week 12, 24, 42, and 52
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Relative decline from baseline in FVC ≥10%, ≥15%, and ≥20% indicates varying degrees of disease progression.
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At Week 12, 24, 42, and 52
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Absolute change from baseline in standardized %pFVC at Week12, 24, 42, and 52
기간: Baseline to Week 12, 24, 42, and 52
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Standardized %pFVC is calculated as the ratio of measured FVC to predicted FVC.
The predicted FVC is derived using a standardized formula.
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Baseline to Week 12, 24, 42, and 52
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Proportion of participants with absolute decline from baseline in standardized %pFVC ≥10% at Week 12, 24, 42, and 52
기간: At Week 12, 24, 42, and 52
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Absolute decline from baseline in standardized %pFVC ≥10% indicates rapid disease progression.
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At Week 12, 24, 42, and 52
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Absolute change from baseline in hemoglobin-corrected %pDLco at Week 12, 24, 42, and 52
기간: At Week 12, 24, 42, and 52
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The hemoglobin-corrected %pDLco measures the ability of oxygen moves from alveoli to blood.
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At Week 12, 24, 42, and 52
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Change from baseline in L-PF score at Week 12, 24, 42, and 52
기간: At Week 12, 24, 42, and 52
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The L-PF is a self-administered, quality of life questionnaire validated for patients with progressive fibrosing interstitial lung disease (ILD), including IPF.
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At Week 12, 24, 42, and 52
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Change from baseline in 6MWT distance at Week 12, 24, 42, and 52
기간: At Week 12, 24, 42, and 52
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At Week 12, 24, 42, and 52
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Time to first acute exacerbation of IPF within 52 weeks
기간: Baseline to Week 52
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An exacerbation of IPF is defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality in HRCT.
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Baseline to Week 52
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Progression-free survival (PFS), defined as the time from randomization to disease progression or death, whichever occurs first.
기간: Baseline to Week 52
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IPF disease progression is defined as the occurrence of any of the following events:
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Baseline to Week 52
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Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) within 52 weeks
기간: Baseline to Week 52
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TEAEs and SAEs will be assessed via patient-reported symptoms, vital signs, physical examination, 12-lead ECG, HRCT, and laboratory assessments.
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Baseline to Week 52
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Zhen Fu, Medical Director
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 (추정된)
2026년 8월 31일
기본 완료 (추정된)
2028년 9월 30일
연구 완료 (추정된)
2029년 3월 31일
연구 등록 날짜
최초 제출
2026년 7월 17일
QC 기준을 충족하는 최초 제출
2026년 7월 17일
처음 게시됨 (실제)
2026년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 17일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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