이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis (INFLO-2)

2026년 9월 9일 업데이트: Mannkind Corporation

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial of the Efficacy and Safety of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Followed by an Open-Label Extension

This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg BID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

153

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

  • 이름: Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD
  • 전화번호: 203-796-3407
  • 이메일: wfares@mannkindcorp.com

연구 장소

  • 캐나다
    • Ontario
      • Windsor, Ontario, 캐나다, N8X1T3
        • 모병
        • Trial Management Group Inc
        • 연락하다:

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:

  • 40-80 years old when signing consent and entering screening.
  • Diagnosed with IPF based on current ATS/ERS/JRS/ALAT guidelines.
  • Either new to treatment or on a stable dose of pirfenidone and/or nerandomilast for at least 3 months before screening.
  • Weighs more than 40 kg (88 lb) at screening.
  • Women who can become pregnant:
  • Must have a negative pregnancy test at screening.
  • Must use an approved birth control method from screening until at least 1 month after the last study dose.
  • Men who can father a child and are sexually active with women who can become pregnant:
  • Must use an approved birth control method during treatment and for at least 3 months after the last study dose.
  • Must not donate sperm during treatment and for at least 3 months after the last study dose.
  • Willing to follow all study rules and restrictions.
  • Willing and able to attend study visits and complete study procedures.
  • Able to perform spirometry (lung function testing) as required by the study.

Exclusion Criteria:

  • Has a lung disease caused by something other than IPF.
  • Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).
  • Has another condition that significantly affects breathing.
  • Has serious heart or blood vessel disease.
  • Has a recent or current infection.
  • Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.
  • Has a history of asthma (except childhood asthma that has resolved).
  • Has another medical condition or abnormal test result that may affect study participation or safety.
  • Cannot perform high-quality spirometry testing.
  • Has obstructive lung disease.
  • Has abnormal liver function tests.
  • Has moderate to severe liver disease.
  • Has severe kidney disease.
  • Has recently used high-dose steroids or other immune-suppressing medications.
  • Has active cancer or recent cancer treatment.
  • Is on, or expected to be added to, a transplant list.
  • Had major surgery recently or has planned procedures that could interfere with the study.
  • Has had a severe reaction to nintedanib or cannot take nintedanib safely.
  • Has recently used certain medications that may interact with the study drug.
  • Is currently using, or plans to use, prohibited medications during the study.
  • Has recently participated in another clinical trial.
  • Has current alcohol or drug abuse issues.
  • Donated a significant amount of blood recently.
  • Received a live vaccine recently.
  • Currently smokes, recently smoked, or quit smoking less than 1 year ago.
  • Requires more than 6 L/min of oxygen while at rest.

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: Nintedanib DPI 2X day 1st dose
Inhalable
의약품: Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
위약 비교기: Placebo 2X day 1st dose
Inhalable
의약품: Placebo
Placebo oral inhalation powder
실험적: Nintedanib DPI 2X day 2nd dose
2nd dose
의약품: Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
위약 비교기: Placebo 2X day 2nd dose
2nd dose
의약품: Placebo
Placebo oral inhalation powder

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety and Efficacy
기간: From enrollment to the end of randomized treatment at 12 weeks
Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)
From enrollment to the end of randomized treatment at 12 weeks
Events of clinical bronchospasm
기간: From enrollment to the end of open-label treatment at 36 weeks
Events of clinical bronchospasm (e.g., treatment-emergent adverse event [TEAE] of wheezing or chest tightness immediately after inhalation)
From enrollment to the end of open-label treatment at 36 weeks
FEV1 change
기간: From enrollment to the end of open-label treatment at 36 weeks
Change in forced expiratory volume in 1 second (FEV1) (mL)
From enrollment to the end of open-label treatment at 36 weeks
Spirometry Change
기간: enrollment to end of open label at 36 weeks
Change in FEV1/forced vital capacity (FVC) ratio
enrollment to end of open label at 36 weeks
Study Drug Discontinuation
기간: From enrollment to the end of open-label treatment at 36 weeks
Rate of study drug discontinuations
From enrollment to the end of open-label treatment at 36 weeks
Study Drug Dose Reductions
기간: From enrollment to the end of open-label treatment at 36 weeks
Rate of study drug dose reductions
From enrollment to the end of open-label treatment at 36 weeks
Adverse Events
기간: From enrollment to the end of open-label treatment at 36 weeks
Rate of TEAEs
From enrollment to the end of open-label treatment at 36 weeks
Related Adverse Events
기간: From enrollment to the end of open-label treatment at 36 weeks
Rate of treatment-related adverse events (TRAEs)
From enrollment to the end of open-label treatment at 36 weeks
Serious Adverse Events
기간: From enrollment to the end of open-label treatment at 36 weeks
Rate of serious adverse events (SAEs)
From enrollment to the end of open-label treatment at 36 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Efficacy of Nintedanib DPI
기간: From enrollment to the end of randomized treatment at 12 weeks
To assess a potential efficacy signal of different doses of Nintedanib DPI over 12 weeks in patients with IPF.
From enrollment to the end of randomized treatment at 12 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Mannkind Corporation

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 5월 15일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2028년 6월 1일

연구 등록 날짜

최초 제출

2026년 6월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 25일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MKC-NI-003

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

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