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Mycobacterium Abscessus InfectionPhase 2REBOUNDNCT07301320

Epetraborole in Patients With Mycobacterium Abscessus Lung Disease

A Phase 2 study testing Epetraborole in people with Mycobacterium Abscessus Infection, run by Kevin Winthrop at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus complex (MABc) Lung Disease (LD) of mild to moderate severity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mycobacterium Abscessus Infection
What is being tested?
Epetraborole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteUnited States
Study dates
30 Mar 2026to May 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients who are 18 years of age or older.
  • Willing and able to provide written informed consent.
  • Patients with MABc lung disease, meeting the following (a) Microbiological, (b) Clinical, (c) Radiographic
  • Microbiological criteria: i. Documentation of at least 1 Pre-Study MABc-positive respiratory specimen (sputum or deep bronchial specimen) collected per standard of care within 6 months prior to signing the consent form.
  • At least 1 Screening MABc-positive expectorated or induced sputum sample. b. Clinical criteria: At least 2 of the following patient-reported clinical symptoms: i. Chest pain ii. Chronic cough iii. Coughing up blood iv. Fatigue v. Fever (documented by thermometer) vi. Mucus (sputum) production vii. Night sweats (drenching perspiration with no other obvious etiology, e.g. perimenopausal) viii. Poor appetite ix. Shortness of breath x. Weight loss (unintentional, more than 5% of usual weight in 6 to 12 months) c. Radiographic criteria: Non-contrast chest CT scan within 4 months prior to signing the ICF (Pre-Study chest CT) or within the Screening Period (Screening chest CT) with abnormalities consistent with MABc-LD based on local interpretation (e.g. Investigator or local radiologist).
  • Patients who, in the opinion of the investigator, will not require initiation of guideline-directed antibiotic therapy for treatment of MABc-LD within the next 6 months, and for whom a delay, in order for the subject to participate in a placebo-controlled clinical trial, is considered both reasonable and clinically acceptable.
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  • Patients who are willing to comply with all the study activities and procedures throughout the duration of the study.
  • Patients must agree to use an effective method of birth control, if applicable, as follows: Females of childbearing potential (FOCPs; defined in Appendix 1, Contraception Requirements) must commit to either sexual abstinence or use of at least 2 medically accepted, effective methods of birth control (defined in Contraception Requirements) from Screening through the EOS Visit
  • Males who are sexually active with a FOCP must agree to use an effective barrier method of contraception (defined in Contraception Requirements) from Screening through the EOS Visit
  • Patients expected to survive with continued antimycobacterial therapy and appropriate supportive care from Screening through the LFU Visit, in the judgment of the Investigator.

Who cannot join

  • Patients with a presence of any suspected or confirmed disease or condition at Screening or the time of randomization that, in the opinion of the Investigator, may confound the assessment of symptom-based clinical response, including, but not limited to, the following:
  • Radiographic presence of cavitary disease (defined as a patient with one or more cavities >2 cm internal diameter)
  • Cystic fibrosis or other inherited disorders of airway ciliary dysfunction (e.g., primary ciliary dyskinesia)
  • Active allergic bronchopulmonary mycosis
  • Anticipated or planned lung surgery for treatment of MABc lung disease
  • Disseminated MABc infection, or other known or suspected non-pulmonary source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, or urinary tract infection) requiring non-study antimicrobial therapy
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  • Concomitant pulmonary infection requiring antimicrobial therapy, including infection caused by fungi, viruses, non-MABc mycobacteria (e.g., Mycobacterium tuberculosis, Mycobacterium avium intracellulare, Mycobacterium avium complex, Mycobacterium kansasii), or other bacteria (e.g., Pseudomonas aeruginosa, Staphylococcus aureus).
  • Note: Patients with MABc lung disease and concomitant non-MABc lung infection requiring antimicrobial therapy must complete the antimicrobial treatment for the non-MABc infection prior to randomization. Patients with respiratory specimen cultures that contain growth of non-MABc organisms that are deemed by the Investigator to be respiratory tract colonizers and who do not require or receive specific antimicrobial therapy may remain eligible. The Investigator should discuss such cases with the Study Investigator prior to randomization and provide rationale for study eligibility in the source document.
  • Patients on brensocatib who have not been on a stable dose for at least 12 weeks.
  • Patients with active pulmonary malignancy (primary or metastatic) or any malignancy that required or would require chemotherapy or radiation therapy within 1 year prior to randomization through the LFU Visit.
  • Patients with creatinine clearance (CrCl) of <30 mL/min, as estimated by the Cockcroft-Gault formula, at Screening: Estimated CrCl (mL/min) = (140 - Age [years]) × Actual Body Weight [kg] × [0.85 if Female]) / (72 × Serum Creatinine [mg/dL]).
  • Patients with any of the following hematological findings:
  • Hemoglobin <11.0 g/dL or <6.83 mmol/L.
  • Donation of blood or plasma within 28 days prior to randomization; or symptomatic loss of blood or hemorrhage within 28 days prior to randomization.
  • Pre-existing (inborn or acquired) disorder of hematopoiesis that could substantially worsen the effect of EBO on hemoglobin levels or potentially prevent hemoglobin recovery post cessation of treatment, for example, thalassemia, sickle cell disease, hemolytic anemia, Inherited bone marrow failure syndromes, myelodysplastic or myeloproliferative disorders, bone marrow transplantation
  • Patients with severe hemoptysis within 28 days prior to randomization, defined as >100 mL (approximately >7 tbsp blood) over any 24-hour period.
  • Patients with severe hepatic impairment, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN) or total bilirubin >2 × ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).
  • Patients who are pregnant or breastfeeding.
  • Patients with a mean QT interval corrected using Fridericia's formula (QTcF) >500 msec based 12-lead ECG at Screening.
  • Patients with an immunodeficiency or an immunocompromised condition and risk for an opportunistic pulmonary infection, including:
  • History of lung transplantation
  • Known history of human immunodeficiency virus (HIV) infection plus either an active acquired immunodeficiency syndrome (AIDS)-defining illness in the past 12 months, or a known cluster of differentiation 4 (CD4) count <200/mm3 within the past 12 months
  • Neutropenia at Screening (absolute neutrophil count <1,000 neutrophils/mm3)
  • Use of immunosuppressive therapy at Screening that in the opinion of the Investigator may place the patient at risk for an opportunistic pulmonary infection, including transplant rejection medication and chronic systemic corticosteroids defined as ≥15 mg/day of prednisone or systemic equivalent for >4 weeks.
  • Patients with an anticipated start of new non-study antimycobacterial therapy to be administered at any time between Screening and EOT.
  • Patients who have participated in a clinical trial of an investigational agent within 30 days (or 5 half-lives, whichever is longer) prior to Screening.
  • Patients with any prior exposure to epetraborole.
  • Patients with any condition that, in the opinion of the Investigator, interferes with the ability to safely complete the study or adhere to study requirements, including the patient's inability or unwillingness to comply with all study assessments and visits.
  • Patients with hypersensitivity to any EBO excipient (e.g., microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc).
  • Patients with a history of eosinophilic interstitial pneumonitis
  • For eligibility purposes, vital signs, clinical laboratory tests, and ECGs may be repeated once if an abnormal result is observed at the initial reading during Screening.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Felicity Coulter, PhD contact

503-494-2565

rebound@ohsu.edu

Brandy Peacock, DAOM, MAcOM contact

(503) 494-8022

rebound@ohsu.edu

United States1 site, 1 recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Alyssa Schroeder, 503-494-2136, rebound@ohsu.edu

    Felicity Coulter, PhD, 503-494-2565, rebound@ohsu.edu

    Recruiting

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Prospective, Investigator-Initiated Trial to Assess the Efficacy, Safety, and Pharmacokinetics of Epetraborole in Patients With Mycobacterium Abscessus Lung Disease: REBOUND Study

This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus complex (MABc) Lung Disease (LD) of mild to moderate severity. For this study, two EBO oral dose regimens will be studied in patients with MABc-LD, each compared to a placebo group (ie, 4 treatment groups): 500 mg daily and 750 mg daily. Detailed inclusion and exclusion criteria attempt to identify only those patients who have acceptable risks based upon the EBO preclinical findings, phase 1, phase 2, and Phase 3 experience; standard-of-care procedures; and the specified procedures of the study. Following receipt of informed consent, and a Screening period, eligible patients will be randomized to one of the 4 treatment groups to receive active or matched placebo EBO tablets for 84 days. Patients will be assessed for clinical and microbiological evidence of efficacy. At selected investigative sites, patients will undergo sparse PK sampling. Safety and tolerability will be determined by standard clinical and laboratory assessment, with oversight by a qualified and appropriately constituted Data Safety Monitoring Board (DSMB). Data collected during the study will be analyzed per a comprehensive Statistical Analysis Plan (SAP). The study will be registered on clinicaltrials.gov. The total duration of patient participation is approximately 6 months.

Read the detailed description

Non-tuberculous mycobacterial lung disease (NTM-LD) is a chronic, debilitating disease that can cause significant morbidity and mortality, and reduces quality of life. The primary intervention to treat NTM-LD is antibiotic treatment to eliminate the causative pathogen and thereby prevent progression of NTM-associated lung destruction and respiratory compromise. Among NTM organisms causing pulmonary infection, Mycobacterium abscessus complex (MABc) LD requires particularly complicated, prolonged and onerous intravenous treatment regimens that are burdensome to patients. New therapeutic options, especially those that can be administered orally, represent a high unmet need.

Epetraborole (EBO), a boron-containing heterocycle also possessing amine and hydroxyl functional groups, blocks bacterial protein synthesis by inhibiting bacterial LeuRS. Epetraborole is active against Mycobacterium abscessus complex (MABc) organisms in vitro, including against isolates resistant to drugs commonly used to treat MABc-Lung Disease (LD) (e.g., clarithromycin and amikacin). To date, no clinical efficacy data are available for use of EBO in humans with MABc-LD. However, available nonclinical and PK data support the potential efficacy of EBO in MABc-LD. A Phase 1 human lung PK study in healthy volunteers showed that the exposure of EBO in alveolar (lung) macrophages, lung cells that are primarily infected with mycobacteria in NTM-LD, was approximately 5-fold higher than in plasma. EBO exposure in pulmonary epithelial lining fluid (ELF) is approximately 53% of that in plasma. Because NTM organisms may also be found in ELF, adequate EBO concentrations in that space are potentially important to achieve therapeutic success. Furthermore, PK/PD modeling data support the potential efficacy of EBO for treatment of MABc-LD. Since the EBO MIC90 for MABc isolates is ~256-fold lower than that observed for MAC isolates from the truncated EBO-301 Phase 2/3 study in treatment-refractory Mycobacterium avium complex lung disease, treatment outcomes in MABc-LD are expected to be favorable. The molecule therefore has the potential to address the unmet need in MABc-LD patients with limited treatment options.

For this study, two oral EBO dose regimens will be studied in patients with MABc-LD compared to placebo: 500 mg daily and 750 mg daily.

Being tested
Epetraborole, Placebo
Keywords
NTM, nontuberculous mycobacteria, Mycobacterium abscessus, M. abscessus, abscessus
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.

  • EpetraboroleDrug

    High-dose intervention (750mg daily)

  • EpetraboroleDrug

    Low-dose intervention (500mg daily)

  • PlaceboDrug

    Placebo intervention (matching the high-dose experimental intervention)

  • PlaceboDrug

    Placebo intervention (matching the low-dose experimental intervention)

Study groups in NCT07301320
Study groupRoleWhat they receive
High Dose EpetraboroleExperimentalThis arm is a daily treatment regimen of a 750mg oral dose of Epetraborole.
Receives: Drug: Epetraborole
Low Dose EpetraboroleExperimentalThis arm is a daily treatment regimen of a 500mg oral dose of Epetraborole.
Receives: Drug: Epetraborole
High Dose PlaceboPlacebo comparatorThis arm is a daily treatment regimen of a placebo, matching the high dose experimental arm.
Receives: Drug: Placebo
Low Dose PlaceboPlacebo comparatorThis arm is a daily treatment regimen of a placebo, matching the low dose experimental arm.
Receives: Drug: Placebo

What is being measured

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

  1. Clinical Response (NTM Symptom Evaluation Instrument) at Day 84

    Improvement in severity of at least 50% of the symptoms present at baseline and no deterioration in severity of symptoms present at baseline

    Measured: Day 1 to Day 84

  2. Sputum culture conversion by Day 84

    Defined as 3 consecutive negative cultures one month apart without intervening or subsequent positives

    Measured: Day 1 to Day 84

  3. Decrease in semi-quantitative sputum culture counts at Day 84

    Defined as improvement in sputum colony count category as defined by Griffith et al, 2015

    Measured: Day 1 to Day 84

  4. Change from baseline in Quality of Life - Bronchiectasis (QOL-B) Respiratory Domain at Day 84

    QOL-B Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life

    Measured: Day 1 to Day 84

  5. Change from baseline in MACrO2 PRO at Day 84

    MACrO2 scores range from 0 to 100, with lower scores indicating better symptom-related quality of life

    Measured: Day 1 to Day 84

  6. Sputum culture conversion by Day 56

    Defined as 2 consecutive negative cultures collected one month apart without intervening or subsequent positives

    Measured: Day 1 to Day 56

Secondary outcomes (9)

  1. Patient Global Impression of Change (PGI-C) at Day 84

    The Patient Global Impression of Change Scale has a minimum value of 1 and a maximum value of 7. For this scale, higher scores indicate a worse outcome.

    Measured: Day 1 to Day 84

  2. Patient Global Impression of Severity (PGI-S) at Day 84

    The Patient Global Impression of Severity Scale measures severity of a patient's overall status over the previous 7 days. The responses on this scale have a minimum value of 'None' and a maximum value of 'Very severe' related to severity. For this scale, higher scores ('Very severe') indicate a worse outcome.

    Measured: Day 1 to Day 84

  3. Physician Visual Analog Scale (VAS) - Global at Day 84

    The Physician Visual Analog Scale - Global has a minimum value of 0 and a maximum value of 10. For this scale, higher scores indicate a worse outcome.

    Measured: Day 1 to Day 84

  4. Physician Visual Analog Scale (VAS) - Respiratory at Day 84

    The Physician Visual Analog Scale - Respiratory has a minimum value of 0 and a maximum value of 10. For this scale, higher scores indicate a worse outcome.

    Measured: Day 1 to Day 84

  5. NTM Symptoms Scale (NTM-SS) Questionnaire at Day 84

    The Non-tuberculous Mycobacteria Symptoms Scale measures symptoms within the previous 7 days including respiratory, fatigue, temperature, appetite/weight, cognition/mood, and sleep. Questions on this scale have a minimum value of 'Never' and a maximum value of 'Always' related to the prevalence of symptoms. For this scale, higher scores ('Always') indicate a worse outcome.

    Measured: Day 1 to Day 84

  6. Time to growth in liquid medium

    Measured at Days 14, 28, 42, 56, and 84

    Measured: Day 1 to Day 84

  7. Time to first negative sputum culture

    Measured: Day 1 to Day 84

  8. Proportion of patients with an on-treatment MABC isolate demonstrating decreasing sensitivity to EBO

    Measured: Day 1 to Day 84

  9. Sputum culture conversion by Day 84

    Defined as 2 consecutive negative cultures one month apart without intervening or subsequent positives

    Measured: Day 1 to Day 84

Timeline

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

  1. First posted24 Dec 2025
  2. Study start30 Mar 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionMay 2028 (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
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07301320
Sponsor's protocol ID
REBOUND Trial
Acronym
REBOUND
Status last verified
May 2026
First submitted
22 Dec 2025
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • National Cancer Institute. (2017). Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. https://doi.org/10.33329/ctcae.v5.0

  • Bowman CJ, Becourt-Lhote N, Boulifard V, Cordts R, Corriol-Rohou S, Enright B, Erkman L, Harris J, Hartmann A, Hilpert J, Kervyn S, Mattson B, Morford L, Muller M, Powell M, Sobol Z, Srinivasan R, Stark C, Thompson KE, Turner KJ, Barrow P. Science-Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels. Clin Pharmacol Ther. 2023 Feb;113(2):226-245. doi: 10.1002/cpt.2602. Epub 2022 May 5.

    PubMed 35388453

  • Kaneko T, Otoshi R, Sekine A, Baba T, Yamada C, Haga S, Tagami Y, Sawazumi T, Takemura T, Komatsu S, Hagiwara E, Ogura T. Drug-related pneumonitis caused by amikacin liposome inhalation suspension: One pathologically proven case and single-center experience. Respir Investig. 2024 Jul;62(4):513-516. doi: 10.1016/j.resinv.2024.04.003. Epub 2024 Apr 13.

    PubMed 38615375

  • Rimal B, Lippincott CK, Panthi CM, Xie Y, Keepers TR, Alley M, Lamichhane G. Efficacy of epetraborole against Mycobacteroides abscessus in a mouse model of lung infection. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0064824. doi: 10.1128/aac.00648-24. Epub 2024 Jul 17.

    PubMed 39016592

  • Li L, Henkle E, Youngquist BM, Seo S, Hamed K, Melnick D, Lyon CJ, Jiang L, Zelazny AM, Hu TY, Winthrop KL, Ning B. Serum Cell-Free DNA-based Detection of Mycobacterium avium Complex Infection. Am J Respir Crit Care Med. 2024 May 15;209(10):1246-1254. doi: 10.1164/rccm.202303-0401OC.

    PubMed 38190702

  • Griffith DE, Adjemian J, Brown-Elliott BA, Philley JV, Prevots DR, Gaston C, Olivier KN, Wallace RJ Jr. Semiquantitative Culture Analysis during Therapy for Mycobacterium avium Complex Lung Disease. Am J Respir Crit Care Med. 2015 Sep 15;192(6):754-60. doi: 10.1164/rccm.201503-0444OC.

    PubMed 26068042

  • Eckburg PB, Clarke D, Long J, et al. 2022. Tolerability and pharmacokinetics of oral epetraborole at the predicted therapeutic dosage for Mycobacterium avium complex (MAC) lung disease: a phase 1b dose-ranging and food effect study. In ID week. Washington DC

  • Griffith DE, Daley CL. Treatment of Mycobacterium abscessus Pulmonary Disease. Chest. 2022 Jan;161(1):64-75. doi: 10.1016/j.chest.2021.07.035. Epub 2021 Jul 24.

    PubMed 34314673

  • Daley CL, Iaccarino JM, Lange C, Cambau E, Wallace RJ Jr, Andrejak C, Bottger EC, Brozek J, Griffith DE, Guglielmetti L, Huitt GA, Knight SL, Leitman P, Marras TK, Olivier KN, Santin M, Stout JE, Tortoli E, van Ingen J, Wagner D, Winthrop KL. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline. Clin Infect Dis. 2020 Aug 14;71(4):e1-e36. doi: 10.1093/cid/ciaa241.

    PubMed 32628747

  • Strnad L, Winthrop KL. Treatment of Mycobacterium abscessus Complex. Semin Respir Crit Care Med. 2018 Jun;39(3):362-376. doi: 10.1055/s-0038-1651494. Epub 2018 Aug 2.

    PubMed 30071551

  • Diel R, Ringshausen F, Richter E, Welker L, Schmitz J, Nienhaus A. Microbiological and Clinical Outcomes of Treating Non-Mycobacterium Avium Complex Nontuberculous Mycobacterial Pulmonary Disease: A Systematic Review and Meta-Analysis. Chest. 2017 Jul;152(1):120-142. doi: 10.1016/j.chest.2017.04.166. Epub 2017 Apr 28.

    PubMed 28461147

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epetraborole in people with Mycobacterium Abscessus Infection, run by Kevin Winthrop at 1 site in United States.

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 10 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Contact Felicity Coulter, PhD (503-494-2565, rebound@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response (NTM Symptom Evaluation Instrument) at Day 84 (time frame: Day 1 to Day 84). The study lists 6 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 NCT07301320, which also lists 11 linked publications.

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 6 May 2026.

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