TerminatedPhase 2/3

Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease

Stopped: EBO-301 truncated Phase 3 study (n=97) misses primary endpoint; results unable to confirm clinical efficacy observed in Phase 2 study.

United States177 participantsStarted 2022-05-20

Plain-language summary

This is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. This study will enroll adult patients with treatment-refractory MAC lung disease who meet all eligibility criteria (including clinical, radiographic, and microbiological criteria).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients who are 18 years of age or older.
✓. Willing and able to provide written informed consent.
✓. Patients with a diagnosis of treatment-refractory MAC lung disease consisting of all of the following (a) Microbiological, (b) Clinical, and (c) Radiographic criteria:
✓. Microbiological criteria:
✓. Clinical criteria: At least 2 of the following patient-reported clinical symptoms:
✓. Radiographic criteria: Non contrast Chest CT scan within 6 months prior to signing the ICF with abnormalities consistent with MAC lung disease.
✓. OBR criteria: An OBR is a combination regimen that consists of ≥2 antimycobacterial agents. The patient-specific OBR must be administered for a minimum duration of 6 consecutive months that is either ongoing at the time of Screening or was stopped or paused no more than 12 months before screening. The OBR regimen administered during Screening must be continued after randomization.
✓. Patients who are willing to comply with all the study activities and procedures throughout the duration of the study and comply with all planned study visits and study procedures from Screening through the LFU Visit.

Exclusion criteria

What they're measuring

Phase 2: Assessment of novel Patient Reported Outcome instrument psychometric properties

Timeframe: Screening (Day -14 to Day -7) to Month 6 + 1 week

Phase 2: Percentage of Participants Achieving Clinical Response

Timeframe: Baseline to Month 6

Phase 2: Adverse Event Profile of 500 mg Once Daily Dose of Epetraborole

Timeframe: Baseline to Month 16

Phase 3: Percentage of Participants Achieving Clinical Response

Timeframe: Baseline to Month 6

Trial details

NCT IDNCT05327803

SponsorAN2 Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-18

View on ClinicalTrials.gov More MAC Lung Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients who are 18 years of age or older.
✓. Willing and able to provide written informed consent.
✓. Patients with a diagnosis of treatment-refractory MAC lung disease consisting of all of the following (a) Microbiological, (b) Clinical, and (c) Radiographic criteria:
✓. Microbiological criteria:
✓. Clinical criteria: At least 2 of the following patient-reported clinical symptoms:
✓. Radiographic criteria: Non contrast Chest CT scan within 6 months prior to signing the ICF with abnormalities consistent with MAC lung disease.
✓. OBR criteria: An OBR is a combination regimen that consists of ≥2 antimycobacterial agents. The patient-specific OBR must be administered for a minimum duration of 6 consecutive months that is either ongoing at the time of Screening or was stopped or paused no more than 12 months before screening. The OBR regimen administered during Screening must be continued after randomization.
✓. Patients who are willing to comply with all the study activities and procedures throughout the duration of the study and comply with all planned study visits and study procedures from Screening through the LFU Visit.

Exclusion criteria

What they're measuring

Phase 2: Assessment of novel Patient Reported Outcome instrument psychometric properties

Timeframe: Screening (Day -14 to Day -7) to Month 6 + 1 week

Phase 2: Percentage of Participants Achieving Clinical Response

Timeframe: Baseline to Month 6

Phase 2: Adverse Event Profile of 500 mg Once Daily Dose of Epetraborole

Timeframe: Baseline to Month 16

Phase 3: Percentage of Participants Achieving Clinical Response

Timeframe: Baseline to Month 6