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Experimental drug aims to slow lung scarring in IPF

NCT ID NCT05389215

Disease control Sponsor: Daewoong Pharmaceutical Co. LTD. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether an experimental drug called DWN12088 can safely slow the decline in lung function for people with idiopathic pulmonary fibrosis (IPF), a progressive lung-scarring disease. About 102 adults aged 40 and older with stable IPF will be randomly assigned to receive either DWN12088 or a placebo, and neither they nor their doctors will know which they receive. The study measures changes in breathing tests, lung scans, and exercise capacity over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called DWN12088
What this could lead to
If successful, DWN12088 could offer a new treatment option to slow lung function decline in people with idiopathic pulmonary fibrosis.
What could go wrong
This is a mid-stage trial with only 102 participants, so results may not confirm benefit. The drug could also cause side effects not yet seen in earlier studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • Ajou University Hospital

    Hwaseong-si, Gyeonggido, 16499, South Korea

  • Asan Medical Center

    Seoul, Seoul, 05505, South Korea

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Dignity Health Norton Thoracic Institute

    Phoenix, Arizona, 85013, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Inje University Busan Paik Hospital

    Busan, Busan, 47392, South Korea

  • Legacy Research Institute

    Portland, Oregon, 97232, United States

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406, United States

  • Loyola University Medical Center (LUMC)

    Maywood, Illinois, 60153, United States

  • Myongji Hospital

    Goyang-si, Gyeonggi-do, 10475, South Korea

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Pulmonary Associates, PA

    Mesa, Arizona, 85206-1346, United States

  • Pulmonix Research, LLC

    Greensboro, North Carolina, 27403, United States

  • Samsung Medical Center

    Seoul, Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul, 03722, South Korea

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggido, 14584, South Korea

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

    Bucheon-si, Gyeonggi-do, 14647, South Korea

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017, United States

  • The U.S. Department of Veterans Affairs

    Charleston, South Carolina, 29401, United States

  • The University of California San Francisco

    San Francisco, California, 94143, United States

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

    San Antonio, Texas, 78229-3901, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9020, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Ulsan University Hospital

    Ulsan, Ulsan, 44033, South Korea

  • University of Kansas Medical Center Research Institute, Inc

    Kansas City, Kansas, 66160, United States

  • University of Michigan Health System

    Michigan Center, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

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