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

Overview

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)

Full Title of Study: “A Ph. 2, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, & Tolerability of Oral Omadacycline in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2023

Detailed Description

The total duration of subject participation in the study is approximately 5 months which includes a total duration of study treatment for approximately 3 months (84 days). Eligible participants will be randomized 1.5:1 to receive 3 months of treatment with either omadacycline or placebo (monotherapy). The study will use a double-dummy design in order to maintain the study blinding.

Interventions

  • Drug: Omadacycline Oral Tablet
    • omadacycline 300 mg orally, once daily (150 mg tablets x 2)
  • Drug: Placebo
    • placebo tablets resembling omadacycline orally, once daily (x 2 tablets)

Arms, Groups and Cohorts

  • Experimental: Omadacycline 300 mg PO
    • omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h
  • Placebo Comparator: Placebo PO
    • Placebo tablets resembling omadacycline (x 2) administered once daily, q24h

Clinical Trial Outcome Measures

Primary Measures

  • Clinical Response on NTM Symptom Assessment Scale at Day 84
    • Time Frame: Day 1 to Day 84/EOT
    • Improvement in severity of at least 50% of symptoms present at baseline
  • Reported adverse events (AEs)
    • Time Frame: Day 1 to Day 84/EOT
    • To assess reported adverse events
  • Changes from baseline in laboratory tests
    • Time Frame: Day 1 to Day 84/EOT
    • To assess the incidents of abnormal hematology, biochemistry, coagulation and urinalysis assessments following 84 days of IP administration
  • Clinically significant (CS), outside normal range laboratory tests
    • Time Frame: Day 1 to Day 84/EOT
    • To assess the incidents of CS abnormal hematology, biochemistry, coagulation and urinalysis assessments following 84 days of IP administration
  • Changes from baseline in vital signs
    • Time Frame: Day 1 to Day 84/EOT
    • To assess the incidents of abnormal heart rate and blood pressure assessments following 84 days of IP administration
  • Clinically significant (CS) vital signs
    • Time Frame: Day 1 to Day 84/EOT
    • To assess the incidents of CS heart rate and blood pressure following 84 days of IP administration
  • Changes from baseline in electrocardiogram (ECG)
    • Time Frame: Day 1 to Day 84/EOT
    • To assess the incidents of abnormal heart rate, cardiac rhythm, PR interval, RR interval, QRS interval, QT interval and QTc interval assessments following 84 days of IP administration
  • Clinically significant (CS) electrocardiogram (ECG) findings
    • Time Frame: Day 1 to Day 84/EOT
    • To assess the incidents of CS and QTc interval assessments following 84 days of IP administration

Secondary Measures

  • Change from baseline in the total score of the Quality of Life – Bronchiectasis (QOL-B) questionnaire
    • Time Frame: Day 1 to Day 84/EOT
  • Change from baseline in global score and individual domain scores of the St. George Respiratory Questionnaire (SGRQ)
    • Time Frame: Day 1 to Day 84/EOT
  • Change from baseline in Patient-Reported Outcomes Measurement Information System Short Form v1.0 – Fatigue 7a Daily (PROMIS-7a)
    • Time Frame: Day 1 to Day 84/EOT
  • Change from baseline in Patient Clinical Impression of Severity (PGI-S)
    • Time Frame: Day 1 to Day 84/EOT
  • Change from baseline in Patient Clinical Impression of Change (PGI-C)
    • Time Frame: Day 1 to Day 84/EOT
  • Change from baseline in Clinical Global Impression – Severity of Illness (CGI-S)
    • Time Frame: Day 1 to Day 84/EOT
  • Change from baseline in Clinical Global Impression – Improvement (CGI-I)
    • Time Frame: Day 1 to Day 84/EOT
  • Patients reporting no new symptoms with a severity worse than mild on the NTM Symptom Assessment Questionnaire
    • Time Frame: Day 1 to Day 84/EOT
  • Decrease in quantitative sputum culture at Day 84
    • Time Frame: Day 1 to Day 84/EOT
  • Time to growth in liquid medium only
    • Time Frame: Day 1 to Day 84/EOT
  • Time to first negative sputum culture
    • Time Frame: Day 1 to Day 84/EOT

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Paratek Pharmaceuticals Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gail Berman, MD, Study Chair, Paratek Pharmaceuticals Inc
  • Overall Contact(s)
    • Alissa Sirbu, 617.459.5307, alissa.sirbu@paratekpharma.com

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