Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||40 Years and Over|
- - Male or female patients aged ≥40 years based on the date of the written informed consent form.
- - Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines.
- - In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation.
- - Patients receiving local standard-of-care for IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least 3 months prior to screening, or neither pirfenidone nor nintedanib.
- - 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 on pre-bronchodilator value.
- - Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
- - Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study.
- - Female patients who are pregnant or nursing.
- - Abnormal ECG findings.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Daewoong Pharmaceutical Co. LTD.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||AIDS Malignancy Consortium|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Korea, Republic of, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Idiopathic Pulmonary Fibrosis|
This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Experimental: DWN12088 Xmg Tablet (BID)
Placebo Comparator: Placebo 0mg Tablet (BID)
Drug: - DWN12088
DWN12088 Xmg Tablet (BID)
Drug: - Placebo
Placebo 0mg Tablet (BID)
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.