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

NCT06004037 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: LCB01-0371-2004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Nontuberculous Mycobacterium Infection; Mycobacterium Abscessus Infection

Keywords

NTM; MABC; MABC-PD; rapid growers

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (10)

• Change from baseline in SQS

  4 weeks and 8 weeks

• Sputum culture conversion rate

  12 weeks

• Time to culture conversion

  12 weeks

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

  12 weeks

• Negative sputum culture rate at each time point after baseline

  12 weeks

Study Arms (1)

delpazolid

EXPERIMENTAL

In addition to background therapy for MABC, patients will be given orally three tablets (400 mg/tablet) of LCB01-0371 for 12 weeks.

Drug: Delpazolid

Interventions

Delpazolid DRUG

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.

Also known as: LCB01-0371

delpazolid

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• LigaChem Biosciences, Inc.: lead

Study Sites (5)

Asan Medical Center

Seoul, South Korea

Location

Bundang Seoul National University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Interventions

delpazolid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: January 16, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)