Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

NCT04922554 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PTK0796-NTM-20203
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc)

Conditions

Mycobacterium Infections, Nontuberculous; Mycobacterium Abscessus Infection; Nontuberculous Mycobacterial Lung Disease; Nontuberculous Mycobacterial Pulmonary Infection

Keywords

Nontuberculous Mycobacteria (NTM); Mycobacterium abscessus complex (MABc); NTM pulmonary disease; NTM lung disease

Outcome Measures

Primary Outcomes (10)

• Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84

  A clinical responder is defined as a participant who shows improvement in at least 50% of baseline symptoms on the NTM Symptom Assessment Questionnaire at the Day 84 Visit. This self-administered tool assesses 12 common NTM symptoms, each rated on a 4-point scale (absent, mild, moderate, severe), reflecting the participant's overall impression over the past week. The questionnaire is completed solely by the participant, without any interpretation from clinicians or site staff.

  Day 1 to Day 84

• Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84 With no Deterioration in Severity of Symptoms That Were Present at Baseline.

  A clinical responder is defined as a participant who shows improvement in at least 50% of baseline symptoms with no deterioration of symptoms present at baseline on the NTM Symptom Assessment Questionnaire at the Day 84 Visit. This self-administered tool assesses 12 common NTM symptoms, each rated on a 4-point scale (absent, mild, moderate, severe), reflecting the participant's overall impression over the past week. The questionnaire is completed solely by the participant, without any interpretation from clinicians or site staff.

  Day 1 to Day 84

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  A TEAE is an adverse event that occurred on or after first dose of test article and those existing AEs that worsened on or after first dose of test article. An SAE is an adverse event that results in death, is life-threatening, requires hospitalization or extends an existing one, causes significant or lasting disability/incapacity, or leads to a congenital anomaly or birth defect. Additionally, events that may not meet these criteria but are medically significant can also be classified as SAEs.

  From screening period (up to 8 weeks prior to randomization) through Day 114 (at any study timepoint)

• Change From Baseline in Laboratory Test Parameters - Hepatic and Enzymatic Biomarkers

  To assess the incidents of abnormal hepatic and enzymatic biomarkers following 84 days of IP administration

  Day 1 (Baseline) to Day 84/EOT

• Number of Participants With Potentially Clinically Significant (PCS) Laboratory Parameter

  Laboratory PCS event is defined as at least a 2 grade increase from baseline based on the Division of Microbiology and Infectious Diseases (DMID) v5.0.

  Day 1 through Day 84 (at any study timepoint)

• Change From Baseline in Systolic and Diastolic Blood Pressure

  To assess the incidents of abnormal blood pressure assessments following 84 days of IP administration

  Day 1 (Baseline) to Day 84/EOT

• Change From Baseline in Heart Rate

  To assess the incidents of abnormal heart rate following 84 days of IP administration

  Day 1 (Baseline) to Day 84/EOT

• Number of Participants With PCS Threshold Vital Signs Measurement

  To assess the incidents of PCS heart rate and blood pressure following 84 days of IP administration

  Day 1 through Day 84 (at any study timepoint)

• Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, and QTcF Interval

  To assess the incidents of cardiac rhythm, PR interval, QRS interval, QT interval and QTc interval assessments following 84 days of IP administration

  Day 1 (Baseline) to Day 84/EOT

• Number of Participants With PCS QTcF Value

  To assess the incidents of PCS and QTc interval assessments following 84 days of IP administration

  Day 1 through Day 84/EOT (at any study timepoint)

Secondary Outcomes (18)

• Change From Baseline in the Total Score of the Quality of Life - Bronchiectasis (QOL-B) Questionnaire - Emotional Functioning Domain

  Day 1 (Baseline) to Day 84/EOT

• Change From Baseline in the Total Score of the QOL-B Questionnaire - Health Perceptions Domain

  Day 1 (Baseline) to Day 84/EOT

• Change From Baseline in the Total Score of the QOL-B Questionnaire - Physical Functioning Domain

  Day 1 (Baseline) to Day 84/EOT

• Change From Baseline in the Total Score of the QOL-B Questionnaire - Respiratory Symptoms Domain

  Day 1 (Baseline) to Day 84/EOT

• Change From Baseline in the Total Score of the QOL-B Questionnaire - Role Functioning Domain

  Day 1 (Baseline) to Day 84/EOT

Study Arms (2)

Omadacycline 300 mg PO

EXPERIMENTAL

omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h

Drug: Omadacycline Oral Tablet

Placebo PO

PLACEBO COMPARATOR

Placebo tablets resembling omadacycline (x 2) administered once daily, q24h

Drug: Placebo

Interventions

Omadacycline Oral Tablet DRUG

omadacycline 300 mg orally, once daily (150 mg tablets x 2)

Also known as: Nuzyra

Omadacycline 300 mg PO

Placebo DRUG

placebo tablets resembling omadacycline orally, once daily (x 2 tablets)

Also known as: placebo tablets

Placebo PO

Eligibility Criteria

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

You may qualify if:

• Has a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc
• Has at least 2 of the following NTM-infection symptoms present at Screening and Baseline: chronic cough, coughing up blood (hemoptysis), wheezing, chest pain, frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue, fever, night sweats, poor appetite, and/or weight loss.
• At least 1 positive pulmonary (sputum) culture for MABc in the 6 months prior to Screening and 1 positive culture at Screening
• Radiographic evidence of MABc infection via computed tomography (CT) scan of the chest within 3 months prior to Screening
• In the opinion of the investigator, guideline-directed antibiotic therapy for treatment of MABc will not be required within the next 3 months, and a delay, in order for the subject to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable

You may not qualify if:

• Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC
• Has received systemic or inhaled antibiotic therapy (other than chronic macrolide therapy) within 4 weeks prior to Screening
• Has any of the following medical conditions:
• Active pulmonary malignancy, or any type of malignancy requiring chemotherapy or radiation within 1 year prior to Screening
• Active allergic bronchopulmonary mycosis, or any other condition requiring chronic treatment with systemic corticosteroids within 90 days prior to Screening
• Radiologic evidence of cavitary disease
• Known active pulmonary tuberculosis
• Cystic fibrosis
• History of lung transplantation
• Another advanced lung disease with a known percent predicted forced expiratory volume in 1 second \< 30%.
• Disseminated or extra-pulmonary NTM disease
• Has been previously treated with omadacycline
• Has a history of hypersensitivity or allergic reaction to tetracyclines

Sponsors & Collaborators

• Paratek Pharmaceuticals Inc: lead

Study Sites (17)

Stanford University

Stanford, California, 94305, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20057, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Infectious Disease Consultants of the Treasure Coast

Vero Beach, Florida, 32960, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30342, United States

Location

Louisiana State University Medical Center Health Sciences Center-New Orleans Section of Pulmonary/Critical Care & Allergy/Immunology

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Northwell Health

New Hyde Park, New York, 11042, United States

Location

Einstein/Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Jahanbakhsh S, Howland J, Ndayishimiye Uwineza MO, Thwaites MT, Pillar CM, Serio AW, Anastasiou DM, Hufnagel DA. Evaluation of omadacycline against intracellular Mycobacterium abscessus in an infection model in human macrophages. JAC Antimicrob Resist. 2023 Sep 15;5(5):dlad104. doi: 10.1093/jacamr/dlad104. eCollection 2023 Oct.

  PMID: 37720564 DERIVED

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Interventions

omadacycline

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Paratek Medical Information
• Organization: Paratek Pharmaceuticals Inc

medinfo@paratekpharma.com

1-833-727-2835

Study Officials

• Amy Manley

  Paratek Pharmaceuticals Inc

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 10, 2021
• Study Start: October 15, 2021
• Primary Completion: June 17, 2024
• Study Completion: July 17, 2024
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)