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Idiopathic Pulmonary FibrosisPhase 2NCT05389215

Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF

A Phase 2 study testing DWN12088 in people with Idiopathic Pulmonary Fibrosis, run by Daewoong Pharmaceutical Co. LTD. at 30 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
DWN12088
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
30 sitesin 2 countries
Study dates
29 Jul 2022to 30 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States20 sites

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The U.S. Department of Veterans Affairs

    Charleston, South Carolina, 29401

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9020

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Pulmonix Research, LLC

    Greensboro, North Carolina, 27403

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Kansas Medical Center Research Institute, Inc

    Kansas City, Kansas, 66160

  • Loyola University Medical Center (LUMC)

    Maywood, Illinois, 60153

  • Pulmonary Associates, PA

    Mesa, Arizona, 85206-1346

  • University of Michigan Health System

    Michigan Center, Michigan, 48109

  • Dignity Health Norton Thoracic Institute

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Legacy Research Institute

    Portland, Oregon, 97232

  • The University of Texas Health San Antonio Medical Arts & Research Center

    San Antonio, Texas, 78229-3901

  • The University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

South Korea10 sites

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-do, 14647

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggido, 14584

  • Inje University Busan Paik Hospital

    Busan, Busan, 47392

  • Myongji Hospital

    Goyang-si, Gyeonggi-do, 10475

  • Ajou University Hospital

    Hwaseong-si, Gyeonggido, 16499

  • Seoul National University Hospital

    Seoul, Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul, 03722

  • Asan Medical Center

    Seoul, Seoul, 05505

  • Samsung Medical Center

    Seoul, Seoul, 06351

  • Ulsan University Hospital

    Ulsan, Ulsan, 44033

Other trials in South Korea

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis

This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.

Read the detailed description

This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.

Being tested
DWN12088, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DWN12088Drug

    Also called DWN12088 Xmg Tablet (BID)

    DWN12088 Xmg Tablet (BID)

  • PlaceboDrug

    Also called Placebo 0mg Tablet (BID)

    Placebo 0mg Tablet (BID)

Study groups in NCT05389215
Study groupRoleWhat they receive
DWN12088 Xmg Tablet (BID)ExperimentalPRS inhibitor
Receives: Drug: DWN12088
Placebo 0mg Tablet (BID)Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of decline of FVC

    To investigate the efficacy of DWN12088 on pulmonary function

    Measured: From Day 1 through Week 24

  2. Incidents of treatment-emergent adverse events

    To evaluate the safety and tolerability of DWN12088 compared with placebo

    Measured: From Day 1 through Week 24

Secondary outcomes (4)

  1. Time to progression of IPF

    To evaluate the efficacy of DWN12088 on time to progression of IPF

    Measured: From Day 1 through Week 24

  2. Quantitative high-resolution computed tomography

    To evaluate the efficacy of DWN12088 as measured by quantitative high-resolution computed tomography

    Measured: From Day 1 through Week 24

  3. Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance

    To evaluate the efficacy of DWN12088 on functional exercise capacity, assessed by 6MWT distance

    Measured: From Day 1 through Week 24

  4. Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb

    To evaluate the efficacy of DWN12088 on pulmonary diffusion function

    Measured: From Day 1 through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start29 Jul 2022
  3. Primary completion13 Oct 2026 (estimated)
  4. Study completion30 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05389215
Sponsor's protocol ID
DW_DWN12088201
Status last verified
Jul 2026
First submitted
17 Apr 2022
Last updated
16 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DWN12088 in people with Idiopathic Pulmonary Fibrosis, run by Daewoong Pharmaceutical Co. LTD. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of decline of FVC (time frame: From Day 1 through Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05389215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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