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Nontuberculous Mycobacterium InfectionPhase 2NCT06004037

Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex

A Phase 2 study testing Delpazolid in people with Nontuberculous Mycobacterium Infection and Mycobacterium Abscessus Infection, run by LigaChem Biosciences, Inc. at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Delpazolid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
5 sitesSouth Korea
Study dates
16 Jan 2024to 29 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Pre-screening: Adults aged 19 years or above
  • Pre-screening: Patients diagnosed with MABC (including subspecies abscessus, bolletii, and massiliense) pulmonary disease in radiologic and microbiologic evaluations
  • LCB01-0371 MIC ≤ 8 μg/mL for MABC
  • Patients who continue to show positivity for MABC even after treatments based on the guidelines of ATS/ERS/ESCMID/IDSA for at least 6 months prior to screening, and who meet all of the following criteria:
  • Patients who have been confirmed positive at least once in the last sputum or bronchoscopy sample culture performed prior to screening
  • Patients who have not achieved culture conversion (at least 3 consecutive negative mycobacteria cultures in the sputum or bronchoscopy sample collected at an interval of at least 4 weeks) within 6 months prior to screening
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  • Patients who can voluntarily expectorate sputum at screening
  • Patients with a life expectancy of 12 weeks or more
  • Patients with adequate organ function who meet the following criteria:
  • Hemoglobin > 9.0 g/dL (without transfusion within 2 weeks prior to measurement)
  • Absolute neutrophil count ≥ 1,500/µL (without administration of G-CSF within 2 weeks prior to measurement)
  • Platelet ≥ 100,000/µL
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 × ULN
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance >30 mL/min (calculated with the Cockcroft-Gault formula)
  • Patients who voluntarily provided a written consent to participate in the clinical study

Who cannot join

  • Patients who cannot swallow the study drug tablet due to dysphagia, nasogastric tube insertion, etc.
  • Patients diagnosed with cystic fibrosis
  • Patients who have received a lung transplant
  • Patients with disseminated or extrapulmonary nontuberculous mycobacteria
  • Patients with known active pulmonary tuberculosis
  • Patients with NTM infections other than MABC
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  • Patients with an active pulmonary malignancy within 1 year prior to screening or Patients with other malignancies that require chemotherapy or radiotherapy
  • Patients who has received linezolid for MABC treatment within 3 months prior to screening
  • Patients with known HIV positivity or a suspected infection thereof or Patients with a known active hepatitis B or C infection
  • Patients who currently have a clinically significant cardiovascular disease
  • Patients with severe cardiac failure (New York Heart Association [NYHA] class III/IV) that occurred within 24 weeks prior to screening
  • Patients with pulmonary embolism or deep venous thrombosis that occurred within 24 weeks prior to screening
  • Patients whose multidrug therapy for treatment of MABC was changed within 4 weeks prior to screening (Discontinuation, dose adjustment, change of administration route, etc., are allowed.)
  • Patients for whom the administration of contraindicated concomitant drugs that correspond to the following cannot be discontinued during the clinical study or for whom their administration is necessary
  • Administration of a new antibacterial agent for the prioritized treatment of NTM, especially MABC, other than background therapy
  • Monoamine oxidase inhibitors
  • Serotonin reuptake inhibitor or serotonin 5-HT1 receptor agonists
  • Meperidine or buspirone
  • Drugs that lower epilepsy threshold; tramadol, etc.
  • Tricyclic Antidepressant
  • Other investigational products: If there is a history of administration within 30 days prior to screening, it falls under the exclusion criteria.
  • Pregnant or breastfeeding women and women of childbearing potential who do not agree to practice appropriate contraceptive methods*:

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Asan Medical Center

    Seoul

  • Bundang Seoul National University Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Bundang Hospital

    Seoul

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 2a, Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of LCB01-0371 (Delpazolid) as Add-on Therapy in Patients With Refractory Mycobacterium Abscessus Complex Pulmonary Disease

The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease

Read the detailed description

Delpazolid, which demonstrates effects similar to other oxazolidinone-class drugs and has confirmed good safety, aims to evaluate its efficacy in MABC-PD patients who are unresponsive to guideline-based treatments

Being tested
Delpazolid
Keywords
NTM, MABC, MABC-PD, rapid growers
Medical subject headings
Mycobacterium Infections, Nontuberculous

What participants receive

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

  • DelpazolidDrug

    Also called LCB01-0371

    Three tablets (400 mg/tablet) of delpazolid will be orally administered once daily for 12 weeks.

    After 3 months (12 weeks) of administration, if the investigator determines that there are clinical benefits, an additional extended treatment of up to 9 months (40 weeks) may be given, amounting to 1 year of treatment in total.

Study groups in NCT06004037
Study groupRoleWhat they receive
delpazolidExperimentalIn addition to background therapy for MABC, patients will be given orally three tablets (400 mg/tablet) of LCB01-0371 for 12 weeks.
Receives: Drug: Delpazolid

What is being measured

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

  1. semi-quantitative scale (SQS) change versus baseline

    The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.

    Measured: 12 weeks

Secondary outcomes (10)

  1. Change from baseline in SQS

    The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.

    Measured: 4 weeks and 8 weeks

  2. Sputum culture conversion rate

    neg culture x3( sputum conversion)

    Measured: 12 weeks

  3. Time to culture conversion

    from the date of assignment to the first negative result.

    Measured: 12 weeks

  4. Time to positivity in the liquid culture automated system (MGIT)

    time to detection of positive in MGIT system

    Measured: 12 weeks

  5. Negative sputum culture rate at each time point after baseline

    negative culture results in MGIT and solid media

    Measured: 12 weeks

  6. Change from baseline in the inflammatory marker

    erythrocyte sedimentation rate [ESR]) at each time point

    Measured: 12 weeks

  7. Change from baseline in the CT score

    The CT scan score will be transformed onto a scale of 0-42, with lower scores representing improved lung presentations.

    Descriptive statistics for each point in time are presented, and intra-group comparison of CT score changes at 12 weeks compared to baseline

    Measured: 12 weeks

  8. Quality of Life Questionnaire-Bronchiectasis

    The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.

    Measured: 12 weeks

  9. Six-minute walk test

    Six-minute walk test

    Measured: 12 weeks

  10. Extended administration

    1. SQS at each time point compared to baseline in subjects receiving extended administration
    • The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load 2) Inflammatory markers at each time point compared to baseline in subjects receiving extended administration
    • erythrocyte sedimentation rate 3) CT scores at each time point compared to baseline in subjects receiving extended administration
    • The CT scan score will be transformed onto a scale of 0-42, with lower scores representing improved lung presentations.
    1. QOL-B change at each time point compared to baseline in subjects receiving extended administration
    • The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
    1. sputum culture negative conversion at each time point compared to baseline in subjects receiving extended administration
    • negative culture results in MGIT and solid media

    Measured: After 12 weeks

Timeline

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

  1. First posted22 Aug 2023
  2. Study start16 Jan 2024
  3. Primary completion15 Sep 2025
  4. Study completion29 Jun 2026

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004037
Sponsor's protocol ID
LCB01-0371-2004
Status last verified
Jul 2026
First submitted
16 Aug 2023
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Delpazolid in people with Nontuberculous Mycobacterium Infection and Mycobacterium Abscessus Infection, run by LigaChem Biosciences, Inc. at 5 sites in South Korea.

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 16 inclusion and 22 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: finished, as of the sponsor's last update on 10 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 5 sites in 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

semi-quantitative scale (SQS) change versus baseline (time frame: 12 weeks). 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 NCT06004037.

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 10 Jul 2026.

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