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Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Study Purpose
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the
safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
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.
Interventional
Eligible Ages
40 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- 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.
If the patients were on pirfenidone or nintedanib
previously and have been off for at least 3 months prior to screening, they will be
considered as not on any treatment for IPF.
- 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.
Exclusion Criteria:
- 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.
- Use of any investigational drugs for IPF within 4 weeks prior to screening
Trial Details
Trial ID:
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.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Daewoong Pharmaceutical Co. LTD.
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Song
Principal Investigator Affiliation
AIDS Malignancy Consortium
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Korea, Republic of, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Additional Details
This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the
safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Arms & Interventions
Arms
Experimental: DWN12088 Xmg Tablet (BID)
PRS inhibitor
Placebo Comparator: Placebo 0mg Tablet (BID)
Placebo
Interventions
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.