Phase
Condition
Cystic Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Treatment
Placebo
INS018_055
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients aged ≥40 years based on the date of the written informedconsent form
Diagnosis of IPF as defined by American Thoracic Society/European RespiratorySociety/Japanese Respiratory Society/Latin American Thoracic Association guidelines
In a stable condition and suitable for study participation based on the results ofmedical history, physical examination, vital signs, 12-lead ECG, and laboratoryevaluation
Subjects with background pirfenidone or nintedanib may be enrolled if their regimenof antifibrotic therapy has been stable for > 8 weeks prior to Visit 1
Meeting all of the following criteria during the screening period:
FVC ≥40% predicted of normal
DLCO corrected for Hgb ≥25% and ≤80% predicted of normal.
forced expiratory volume in the first second/FVC (FEV1/FVC) ratio >0.7 based onpre-bronchodilator value
Exclusion
Exclusion Criteria:
Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screeningperiod, as determined by the investigator
Patients who are unwilling to refrain from smoking within 3 months prior toscreening and until the end of the study
Female patients who are pregnant or nursing
Abnormal ECG findings
Other protocol inclusion and exclusion criteria may apply.
Study Design
Connect with a study center
Anhui Chest Hospital
Hefei, Anhui 230031
ChinaSite Not Available
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230601
ChinaSite Not Available
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing 100730
ChinaSite Not Available
Peking University Shougang Hospital
Beijing, Beijing 100041
ChinaSite Not Available
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong 510515
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available
Hainan General Hoapital
Haikou, Hainan 570311
ChinaSite Not Available
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei 071000
ChinaSite Not Available
The second Affiliated Hospital of Harbin Medical University
Ha'erbin, Heilongjiang 150086
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaSite Not Available
Wuhan Tongji Medical College Affiliated Union Hospital
Wuhan, Hubei 430022
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha, Hunan 410008
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
ChinaSite Not Available
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi 330006
ChinaSite Not Available
Second Hospital of Jilin University
Changchun, Jilin 130000
ChinaSite Not Available
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning 110001
ChinaSite Not Available
The Shengjing Hospital of China medical university
Shenyang, Liaoning 110004
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan, Shandong 250013
ChinaSite Not Available
Affiliated Hospital of Qingdao University
Qingdao, Shandong 266011
ChinaSite Not Available
Shanghai Chest Hospital
Shanghai, Shanghai 200030
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai, Shanghai 201800
ChinaSite Not Available
Zhongshan hospital Fudan University
Shanghai, Shanghai 200032
ChinaSite Not Available
Shanxi Bethune Hospital
Taiyuan, Shanxi 030032
ChinaSite Not Available
The West China Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
General Hospital of Tianjin Medical University
Tianjin, Tianjin 300052
ChinaSite Not Available
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang 310006
ChinaSite Not Available
The Second Affiliated Hospital of Zhejiang Medicine University
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
Keck School of Medicine of USC LAC + USC Breathmobile
Los Angeles, California 90033
United StatesSite Not Available
Florida Lung Asthma and Sleep Specialist - Celeration
Celebration, Florida 34747-1818
United StatesSite Not Available
Southeastern Research Center
Winston-Salem, North Carolina 27103-4007
United StatesSite Not Available
OU Health Sciences Center - OU Health Physicians-Cardiology,Pulmonary & Vascular Medicine Clinic
Oklahoma City, Oklahoma 73104-5417
United StatesSite Not Available
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201-2953
United StatesSite Not Available
Univerity of Texas Southwestern Medical Center - Heart and Lung Clinic
Dallas, Texas 75235-6243
United StatesSite Not Available
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069-1898
United StatesSite Not Available
Research Centers of America
McKinney, Texas 75071
United StatesSite Not Available
University of Utah, University Hospital
Salt Lake City, Utah 84132
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.