Study Evaluating INS018_055 Administered Orally to Subjects with Idiopathic Pulmonary Fibrosis (IPF)

Last updated: September 3, 2024
Sponsor: InSilico Medicine Hong Kong Limited
Overall Status: Completed

Phase

2

Condition

Cystic Fibrosis

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Treatment

Placebo

INS018_055

Clinical Study ID

NCT05938920
INS018-055-003
  • Ages > 40
  • All Genders

Study Summary

The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).

The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients aged ≥40 years based on the date of the written informedconsent form

  2. Diagnosis of IPF as defined by American Thoracic Society/European RespiratorySociety/Japanese Respiratory Society/Latin American Thoracic Association guidelines

  3. In a stable condition and suitable for study participation based on the results ofmedical history, physical examination, vital signs, 12-lead ECG, and laboratoryevaluation

  4. Subjects with background pirfenidone or nintedanib may be enrolled if their regimenof antifibrotic therapy has been stable for > 8 weeks prior to Visit 1

  5. Meeting all of the following criteria during the screening period:

  6. FVC ≥40% predicted of normal

  7. DLCO corrected for Hgb ≥25% and ≤80% predicted of normal.

  8. forced expiratory volume in the first second/FVC (FEV1/FVC) ratio >0.7 based onpre-bronchodilator value

Exclusion

Exclusion Criteria:

  1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screeningperiod, as determined by the investigator

  2. Patients who are unwilling to refrain from smoking within 3 months prior toscreening and until the end of the study

  3. Female patients who are pregnant or nursing

  4. Abnormal ECG findings

Other protocol inclusion and exclusion criteria may apply.

Study Design

Total Participants: 71
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 19, 2023
Estimated Completion Date:
August 08, 2024

Connect with a study center

  • Anhui Chest Hospital

    Hefei, Anhui 230031
    China

    Site Not Available

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University Shougang Hospital

    Beijing, Beijing 100041
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Hainan General Hoapital

    Haikou, Hainan 570311
    China

    Site Not Available

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei 071000
    China

    Site Not Available

  • The second Affiliated Hospital of Harbin Medical University

    Ha'erbin, Heilongjiang 150086
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Wuhan Tongji Medical College Affiliated Union Hospital

    Wuhan, Hubei 430022
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Second Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • The Shengjing Hospital of China medical university

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250013
    China

    Site Not Available

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266011
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 201800
    China

    Site Not Available

  • Zhongshan hospital Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • The West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • The First Affiliated Hospital - Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310006
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang Medicine University

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • Keck School of Medicine of USC LAC + USC Breathmobile

    Los Angeles, California 90033
    United States

    Site Not Available

  • Florida Lung Asthma and Sleep Specialist - Celeration

    Celebration, Florida 34747-1818
    United States

    Site Not Available

  • Southeastern Research Center

    Winston-Salem, North Carolina 27103-4007
    United States

    Site Not Available

  • OU Health Sciences Center - OU Health Physicians-Cardiology,Pulmonary & Vascular Medicine Clinic

    Oklahoma City, Oklahoma 73104-5417
    United States

    Site Not Available

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina 29201-2953
    United States

    Site Not Available

  • Univerity of Texas Southwestern Medical Center - Heart and Lung Clinic

    Dallas, Texas 75235-6243
    United States

    Site Not Available

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas 75069-1898
    United States

    Site Not Available

  • Research Centers of America

    McKinney, Texas 75071
    United States

    Site Not Available

  • University of Utah, University Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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