RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A 2-part multi-center, Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of RHB-204 in adult subjects with underlying nodular bronchiectasis and documented MAC lung infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RedHill Biopharma Limited
• Treatments: Clarithromycin; Clofazimine; Rifabutin

Criteria

Key Inclusion Criteria

• Males and females aged ≥18 years to ≤85 years of age, inclusively

• Have a MAC lung infection documented by one MAC positive culture within 18 months prior to screening and a MAC positive culture at screening (cultures need to be at least 1 month apart). Prior sputum for culture may be obtained from sputum or bronchial washings however, sputum collected during screening must be either spontaneously expectorated by the patient or after sputum induction.

• Have MAC lung infection with evidence of underlying nodular infiltrates and/or bronchiectasis on a chest computed tomography (Chest CT) within 6 months of screening.

• Have symptoms of MAC lung infection that include one of the following: respiratory symptoms such as chronic cough, excessive mucous production, fatigue, dyspnea, hemoptysis or systemic symptoms such as fever, night sweats or loss of appetite.

• Be treatment naïve, or if previously treated for MAC, have not received treatment within the 6 months prior to screening

• Subject's weight is above 41 Kilograms or 90 pounds.

Key Exclusion Criteria

• Cavitary lung disease as observed on a chest CT scan (cavitary lesions exceeding 2 cm in diameter).

• Currently taking or treated in the 6 months prior to screening with any of the following: bedaquiline, clofazimine or any component of American Thoracic Society(ATS)/Infectious Diseases Society of America (IDSA) multi-drug recommended therapy (macrolides, ethambutol, rifabutins/rifampins) for MAC or other multi-drug regime for NTM lung disease

• Clarithromycin minimum inhibitory concentration (MIC) ≥32μg/mL on MAC isolates in screening sputum

• Known hypersensitivity or suspected history of hypersensitivity reactions to clarithromycin, rifabutin, or clofazimine or other drugs in each class

• Subjects requiring chronic supplemental oxygen use (including intermittent or continuous use)

• Planned lung resection surgery for MAC lung disease

• Subjects with Cystic Fibrosis, prior solid organ or hematologic transplant

• Current usage of inhaled products containing amikacin, tobramycin or gentamicin

• History of ventricular arrhythmias or family history of Long QT syndrome, including torsades de pointes

• Corrected QT (QTc) interval on electrocardiogram (ECG) >460 ms for females or >450 ms for males, calculated using Fridericia's formula (QTcF)