Phase 2
N=66
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
Mycobacterium Infections, Nontuberculous · Mycobacterium Abscessus Infection · Nontuberculous Mycobacterial Lung Disease · Nontuberculous Mycobacterial Pulmonary Infection
Bottom Line
View on ClinicalTrials.gov: NCT04922554 ↗Enrolled (actual)
66
Serious AEs
3.0%
Results posted
Jul 2025
Primary outcome: Primary: Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84 — 34.1; 20.0 Percentage of participants — p=0.2182
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omadacycline Oral Tablet (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paratek Pharmaceuticals Inc
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84 |
34.1; 20.0 | 0.2182 |
| PRIMARY 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. |
34.1; 12.0 | 0.0460 sig |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
35; 21; 0; 2 | — |
| PRIMARY Change From Baseline in Laboratory Test Parameters - Hepatic and Enzymatic Biomarkers |
-3.3; -3.0; 10.4; -1.4; 3.9; -3.0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant (PCS) Laboratory Parameter |
0; 0; 2; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic Blood Pressure |
4.3; 2.4; -0.5; 0.7 | — |
| PRIMARY Change From Baseline in Heart Rate |
1.1; 0.2 | — |
| PRIMARY Number of Participants With PCS Threshold Vital Signs Measurement |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, and QTcF Interval |
9.7; 5.8; -0.5; -2.3; -11.7; -2.0 | — |
| PRIMARY Number of Participants With PCS QTcF Value |
3; 5; 1; 2; 1; 0 | — |
| SECONDARY Change From Baseline in the Total Score of the Quality of Life - Bronchiectasis (QOL-B) Questionnaire - Emotional Functioning Domain |
3.5; 2.7 | 0.8240 |
| SECONDARY Change From Baseline in the Total Score of the QOL-B Questionnaire - Health Perceptions Domain |
4.2; -0.9 | 0.2149 |
| SECONDARY Change From Baseline in the Total Score of the QOL-B Questionnaire - Physical Functioning Domain |
5.6; -2.7 | 0.1230 |
| SECONDARY Change From Baseline in the Total Score of the QOL-B Questionnaire - Respiratory Symptoms Domain |
7.5; 2.0 | 0.1168 |
| SECONDARY Change From Baseline in the Total Score of the QOL-B Questionnaire - Role Functioning Domain |
7.4; 0.9 | 0.0743 |
| SECONDARY Change From Baseline in the Total Score of the QOL-B Questionnaire - Social Functioning Domain |
9.6; 2.6 | 0.0899 |
| SECONDARY Change From Baseline in the Total Score of the QOL-B Questionnaire - Treatment Burden Domain |
2.8; 2.3 | 0.9019 |
| SECONDARY Change From Baseline in the Total Score of the QOL-B Questionnaire - Vitality Domain |
9.3; -4.3 | 0.0015 sig |
| SECONDARY Change From Baseline in Global Score and Individual Domain Scores of the SGRQ - Total Score |
-2.7; -3.6; -3.7; -3.5; -5.6; -0.6 | 0.8269 |
| SECONDARY Change From Baseline in Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Fatigue 7a Daily (PROMIS-7a) Score |
-4.3; 1.3 | 0.0010 sig |
| SECONDARY Number of Participants With Improvement in Patient Clinical Impression of Change (PGI-C) |
31; 9 | 0.0020 sig |
| SECONDARY Number of Participants Reporting "Not Present or Mild Severity" in Patient Clinical Impression of Severity (PGI-S) |
26; 12 | 0.3051 |
| SECONDARY Number of Participants With Clinical Global Impression - Severity of Illness (CGI-S) |
14; 4; 9; 8; 11; 9 | 0.3552 |
| SECONDARY Number of Participants With Clinical Global Impression - Improvement (CGI-I) |
29; 11 | 0.0753 |
| SECONDARY Number of Participants With New Symptoms With a Severity Worse Than Mild on the NTM Symptom Assessment Questionnaire at Any Time Post-baseline |
4; 6 | — |
| SECONDARY Number of Participants With Decreased Semi-Quantitative Score of Mycobacterial Sputum Culture From Day 1 to Day 84 |
26; 11 | 0.0168 sig |
| SECONDARY Time to Growth in Liquid Medium Only |
34; NA | 0.0233 sig |
| SECONDARY Time to First Negative Sputum Culture |
30; NA | 0.0349 sig |
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)
Eligibility Criteria
Key Inclusion Criteria
- 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
- Additional inclusion criteria as per protocol
Key Exclusion Criteria
- 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
- Additional exclusion criteria as per protocol
Data sourced from ClinicalTrials.gov (NCT04922554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.