Trial record 1 of 1 for:
RHB-204 Pulmonary Mycobacterium avium Complex (MAC) Disease in Adults with Nodular Bronchiectasis (CleaR-MAC Trial)
RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease (CleaR-MAC)
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| ClinicalTrials.gov Identifier: NCT04616924 |
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Recruitment Status :
Recruiting
First Posted : November 5, 2020
Last Update Posted : January 25, 2023
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Sponsor:
RedHill Biopharma Limited
Information provided by (Responsible Party):
RedHill Biopharma Limited
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Mycobacterium Avium Complex Infection Bronchiectasis Lung Diseases | Drug: RHB-204 Drug: Placebo | Phase 3 |
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.
The co-primary efficacy endpoints at the end of Part 1 evaluate the proportion of patients with sputum culture conversion after 6 months of treatment defined as three consecutive monthly negative sputum cultures at Months 4, 5, and 6 for RHB-204 compared to placebo and the mean change in the Quality of Life Questionnaire - Bronchiectasis (QoL-B) Respiratory Symptoms domain score from baseline to Month 6 for RHB-204 compared to placebo.
At the Month 6 visit (end of Part 1), after all assessments including questionnaires and sputum samples have been collected, subjects will enter Part 2 of the study and receive open-label RHB-204 for 10 months to Month 16, followed by a post-treatment follow-up visit 3 months later, at Month 19.
Patient reported outcomes and durability of microbiological response will be assessed at Month 6 and Month 19 (3 months post-completion of treatment).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 125 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Study of RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease in Adults With Nodular Bronchiectasis (CleaR-MAC Trial) |
| Actual Study Start Date : | December 1, 2020 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Mycobacterial Infections
| Arm | Intervention/treatment |
|---|---|
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Experimental: RHB-204
Each capsule contains clarithromycin 158.3mg; rifabutin 40mg; clofazimine 13.3mg.
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Drug: RHB-204
RHB-204
Other Name: Clarithromycin 158.3mg, Rifabutin 40mg and Clofazimine 13.3mg |
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Placebo Comparator: Placebo
Matching placebo will contain riboflavin, a type of B vitamin, which may discolor urine in a similar fashion as RHB-204.
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Drug: Placebo
Matching placebo to RHB-204 |
Primary Outcome Measures :
- Quality of Life Questionnaire - Bronchiectasis (QoL B) Respiratory Symptoms domain score [ Time Frame: 6 months ]The mean change in the Quality of Life Questionnaire - Bronchiectasis (QoL B) Respiratory Symptoms domain score from baseline to Month 6 for RHB-204 compared to placebo
- Sputum culture conversion (SCC) [ Time Frame: 6 months ]The proportion of subjects who achieve SCC by Month 6. This will be evaluated at Month 6 whereby SCC is defined by at least 3 prior consecutive negative monthly sputum cultures at Month 6.
Secondary Outcome Measures :
- Part 1 Secondary efficacy objective - Reduction of fatigue [ Time Frame: 6 months ]The mean change in the PROMIS Fatigue SF 8a score from baseline to Month 6 for RHB-204 compared to placebo. The PROMIS Fatigue SF 8a is scored out of 40, whereby a score of 40 is the worst a patient can feel.
- Part 1 Secondary efficacy objective - Time to culture conversion [ Time Frame: 6 months ]The time to SCC (month of first negative sputum culture) for RHB-204 compared to placebo.
- Part 1 Secondary efficacy objective - Improvement in Physical Functioning [ Time Frame: 6 months ]The mean change in the Short Form 36 Physical Functioning domain score from baseline to Month 6 for RHB-204 compared to placebo.
- Part 2 Secondary efficacy objective - Durable Sputum culture conversion at end of study [ Time Frame: 19 months ]The proportion of subjects with SCC by Month 6 who sustain negative sputum cultures at Month 16 and negative sputum culture at Month 19 (3 months off treatment) for RHB-204 compared to placebo (durable responders).
- Part 2 Secondary efficacy objective - Durable Sputum culture conversion at end of treatment [ Time Frame: 16 months ]Measure the proportion of subjects with SCC by Month 6 who sustain negative sputum cultures at Month 16 for RHB-204 compared to placebo.
- QoL B Respiratory Symptoms domain score mean change from baseline to Month 16 [ Time Frame: 16 months ]The mean change in Quality of Life Questionnaire - Bronchiectasis (QoL-B) Respiratory Symptoms domain scores from baseline to Month 16 for ex-RHB-204 compared to ex-placebo
- Part 2 Secondary efficacy objective - Improvement in Quality of Life - Fatigue 16 months [ Time Frame: 16 months ]The mean change in the PROMIS Fatigue SF 8a score from baseline to Month 16 for ex-RHB-204 compared to ex-placebo
- Part 2 Secondary efficacy objective - Improvement in Quality of Life - Fatigue 19 Months [ Time Frame: 19 months ]The mean change in the PROMIS Fatigue SF 8a score from baseline to Month 19 for ex-RHB-204 compared to ex-placebo
- Part 2 Secondary efficacy objective - Quality of Life Physical Functioning Symptoms 16 Months [ Time Frame: 16 months ]The mean change in the Short Form 36 Physical Functioning domain score from baseline to Month 16 for ex-RHB-204 compared to ex-placebo
- Part 2 Secondary efficacy objective - Quality of Life Physical Functioning Symptoms 19 Months [ Time Frame: 19 Months ]The mean change in the Short Form 36 Physical Functioning domain score from baseline to Month 19 for ex-RHB-204 compared to ex-placebo
- QoL-B Respiratory Symptoms domain scores at Month 19 [ Time Frame: 19 Months ]The mean change in Quality of Life Questionnaire - Bronchiectasis (QoL-B) Respiratory Symptoms domain scores from baseline to Month 19 for ex-RHB-204 compared to ex-placebo
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04616924
Contacts
| Contact: Gilead Raday, MSc. | +972 3 541 3131 | gilead@redhillbio.com | |
| Contact: Gina Eagle, MD | 972 (0)3 541 3131 | ginaeagle@getpharmaconsulting.com |
Locations
| United States, California | |
| Medical Facility | Recruiting |
| Glendale, California, United States, 91205 | |
| Medical Facility | Recruiting |
| Palm Springs, California, United States, 92262 | |
| United States, Connecticut | |
| Medical Facility | Not yet recruiting |
| Farmington, Connecticut, United States, 06030-1225 | |
| United States, District of Columbia | |
| Medical Facility | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Medical Facility | Recruiting |
| Clearwater, Florida, United States, 33765 | |
| Medical Facility | Not yet recruiting |
| Gainesville, Florida, United States, 32610 | |
| Medical Facility | Recruiting |
| Margate, Florida, United States, 33063 | |
| Medical Facility 1 | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Medical Facility 2 | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Medical Facility | Recruiting |
| Sebring, Florida, United States, 33870 | |
| Medical Facility | Recruiting |
| Vero Beach, Florida, United States, 32960 | |
| United States, Georgia | |
| Medical Facility | Not yet recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Medical Facility | Recruiting |
| Valdosta, Georgia, United States, 31605 | |
| United States, Kansas | |
| Medical Facility | Not yet recruiting |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| Medical Facility | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Medical Facility | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Medical Facility | Not yet recruiting |
| Rochester, Minnesota, United States, 55902 | |
| United States, Missouri | |
| Medical Facility | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Medical Facility | Not yet recruiting |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Medical Facility | Recruiting |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Medical Facility | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Oregon | |
| Medical Facility | Recruiting |
| Portland, Oregon, United States, 97239 | |
| United States, South Carolina | |
| Medical Facility | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Medical Facility | Recruiting |
| Tyler, Texas, United States, 75708 | |
| United States, Wisconsin | |
| Medical Facility | Not yet recruiting |
| Wauwatosa, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
| Study Director: | Kevin L. Winthrop, MD, MPH | Oregon Health and Science University | |
| Study Chair: | June L Almenoff, MD, PhD | RedHill Biopharma, Inc. |
| Responsible Party: | RedHill Biopharma Limited |
| ClinicalTrials.gov Identifier: | NCT04616924 |
| Other Study ID Numbers: |
RHB-204-01 |
| First Posted: | November 5, 2020 Key Record Dates |
| Last Update Posted: | January 25, 2023 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by RedHill Biopharma Limited:
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MAC Bronchiectasis NTM |
Additional relevant MeSH terms:
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Mycobacterium Infections Mycobacterium avium-intracellulare Infection Lung Diseases Bronchiectasis Respiratory Tract Diseases Bronchial Diseases Mycobacterium Infections, Nontuberculous Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Clarithromycin |
Rifabutin Clofazimine Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Inflammatory Agents Leprostatic Agents |