Pulmonary Mycobacterium Avium Complex InfectionPhase 3CleaR-MACNCT04616924
RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease
A Phase 3 study testing RHB-204 in people with Pulmonary Mycobacterium Avium Complex Infection and Bronchiectasis, run by RedHill Biopharma Limited at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Mycobacterium Avium Complex Infection, Bronchiectasis, Lung Diseases
- What is being tested?
- RHB-204
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 Dec 2020to 28 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Medical Facility
Atlanta, Georgia, 30342
Medical Facility
Boston, Massachusetts, 02215
Medical Facility
Charleston, South Carolina, 29425
Medical Facility
Clearwater, Florida, 33765
Medical Facility
Farmington, Connecticut, 06030-1225
Medical Facility
Gainesville, Florida, 32610
Medical Facility
Glendale, California, 91205
Medical Facility
Kansas City, Kansas, 66160
Medical Facility
Margate, Florida, 33063
Medical Facility
New Orleans, Louisiana, 70112
Medical Facility
New York, New York, 10029
Medical Facility
Newark, New Jersey, 07103
Medical Facility 1
Orlando, Florida, 32803
Medical Facility 2
Orlando, Florida, 32803
Medical Facility
Palm Springs, California, 92262
Medical Facility
Portland, Oregon, 97239
Medical Facility
Rochester, Minnesota, 55902
Medical Facility
Sebring, Florida, 33870
Medical Facility
St Louis, Missouri, 63110
Medical Facility
Tyler, Texas, 75708
Medical Facility
Valdosta, Georgia, 31605
Medical Facility
Vero Beach, Florida, 32960
Medical Facility
Washington D.C., District of Columbia, 20007
Medical Facility
Wauwatosa, Wisconsin, 53226
Medical Facility
Winston-Salem, North Carolina, 27103
About this study
Official title: Study of RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease in Adults With Nodular Bronchiectasis (CleaR-MAC Trial)
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.
Read the detailed description
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.
In order to comply with current treatment duration guidelines (Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment - FDA Draft Guidance September 2021) in this protocol subjects will receive active treatment for 12 months after sputum culture conversion. As such, each subject's first negative culture that defines conversion will determine the total duration of their active study drug treatment. The longest duration of active study drug treatment will be 16 months. At the end of study treatment, all subjects will enter a 3-month post-treatment follow-up period (see study design section below for additional details).
To maintain the blind and integrity of the data, an independent team (Sputum Culture Monitors) will inform sites on each subject's treatment duration based on sputum culture conversion. Sputum Culture Monitors will also have access to randomized treatment allocation. All other study related personnel will remain blinded to sputum culture results and treatment allocation (Sponsor, CRO, medical monitors, safety, ECG and sputum laboratories, site personnel as well as participating subjects).
During Part 1, subjects who have completed at least the first 3 months of treatment with study drug, and at the Investigator's discretion, require rescue therapy (alternative anti-NTM treatment) will discontinue study drug (performing an EOT visit) and remain in the study to complete all scheduled study visits and assessments/procedures to Month 6 (performing an EOS visit).
Subjects who complete treatment based on the timeline provided by the Sputum Culture Monitors (EOT visit) and have an ongoing negative sputum culture will be reconsented to enter a follow-up Extension Study, to evaluate sputum culture results at two (2) further time points: 6 months and 12 months following end of treatment (EOT) for each subject in protocol RHB-204-01.
- Being tested
- RHB-204, Placebo
- Keywords
- MAC, Bronchiectasis, NTM
- Medical subject headings
- Bronchiectasis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHB-204Drug
Also called Clarithromycin 158.3mg, Rifabutin 40mg and Clofazimine 13.3mg
RHB-204
PlaceboDrug
Matching placebo to RHB-204
| Study group | Role | What they receive |
|---|---|---|
| RHB-204 | Experimental | Each capsule contains clarithromycin 158.3mg; rifabutin 40mg; clofazimine 13.3mg. Receives: Drug: RHB-204 |
| Placebo | Placebo comparator | Matching placebo will contain riboflavin, a type of B vitamin, which may discolor urine in a similar fashion as RHB-204. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire - Bronchiectasis (QoL B) Respiratory Symptoms domain score from baseline to Month 6 for RHB-204 compared to placebo
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
Measured: 6 months
Sputum culture conversion (SCC)
The proportion of subjects who achieve SCC by Month 6, defined by 3 consecutive monthly negative sputum cultures, without reversion, at Months 4, 5 \& 6 for THB-204 compared to placebo.
Measured: 6 months
Secondary outcomes (11)
Part 1 Secondary efficacy objective - Reduction of fatigue
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 score from baseline to Month 6 for RHB-204 compared to placebo.
Measured: 6 months
Part 1 Secondary efficacy objective - Time to culture conversion
The time to SCC (month of first negative sputum culture) for RHB-204 compared to placebo.
Measured: 6 months
Part 1 Secondary efficacy objective - Improvement in Physical Functioning
The mean change in the Short Form 36 Physical Functioning domain score from baseline to Month 6 for RHB-204 compared to placebo.
Measured: 6 months
Part 2 Secondary efficacy objective - Durable Sputum culture conversion at end of study
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).
Measured: 19 months
Part 2 Secondary efficacy objective - Durable Sputum culture conversion at end of treatment
Measure the proportion of subjects with SCC by Month 6 who sustain negative sputum cultures at Month 16 for RHB-204 compared to placebo.
Measured: 16 months
QoL B Respiratory Symptoms domain score mean change from baseline to Month 16
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
Measured: 16 months
Part 2 Secondary efficacy objective - Improvement in Quality of Life - Fatigue 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
Measured: 16 months
Part 2 Secondary efficacy objective - Improvement in Quality of Life - Fatigue 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
Measured: 19 months
Part 2 Secondary efficacy objective - Quality of Life Physical Functioning Symptoms 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
Measured: 16 months
Part 2 Secondary efficacy objective - Quality of Life Physical Functioning Symptoms 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
Measured: 19 Months
QoL-B Respiratory Symptoms domain scores at Month 19
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
Measured: 19 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Dec 2020
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Why it stopped: extremely slow enrollment into study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Mycobacterium Avium Complex InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin L. Winthrop, MD, MPH, Study director, Oregon Health and Science UniversityJune L Almenoff, MD, PhD, Study chair, RedHill Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616924
- Sponsor's protocol ID
- RHB-204-01
- Acronym
- CleaR-MAC
- Status last verified
- Jun 2023
- First submitted
- 19 Oct 2020
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease in Adults With Nodular Bronchiectasis (CleaR-MAC Trial)
- ClinicalTrials.gov ID
- NCT04616924
- Acronym / sponsor ID
- CleaR-MAC / RHB-204-01
- Keywords
- MAC, Bronchiectasis, NTM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: extremely slow enrollment into study
- Enrolment
- 12 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In order to comply with current treatment duration guidelines (Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment - FDA Draft Guidance September 2021) in this protocol subjects will receive active treatment for 12 months after sputum culture conversion. As such, each subject's first negative culture that defines conversion will determine the total duration of their active study drug treatment. The longest duration of active study drug treatment will be 16 months. At the end of study treatment, all subjects will enter a 3-month post-treatment follow-up period (see study design section below for additional details).
To maintain the blind and integrity of the data, an independent team (Sputum Culture Monitors) will inform sites on each subject's treatment duration based on sputum culture conversion. Sputum Culture Monitors will also have access to randomized treatment allocation. All other study related personnel will remain blinded to sputum culture results and treatment allocation (Sponsor, CRO, medical monitors, safety, ECG and sputum laboratories, site personnel as well as participating subjects).
During Part 1, subjects who have completed at least the first 3 months of treatment with study drug, and at the Investigator's discretion, require rescue therapy (alternative anti-NTM treatment) will discontinue study drug (performing an EOT visit) and remain in the study to complete all scheduled study visits and assessments/procedures to Month 6 (performing an EOS visit).
Subjects who complete treatment based on the timeline provided by the Sputum Culture Monitors (EOT visit) and have an ongoing negative sputum culture will be reconsented to enter a follow-up Extension Study, to evaluate sputum culture results at two (2) further time points: 6 months and 12 months following end of treatment (EOT) for each subject in protocol RHB-204-01.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHB-204 | Experimental | Drug: RHB-204Each capsule contains clarithromycin 158.3mg; rifabutin 40mg; clofazimine 13.3mg. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo will contain riboflavin, a type of B vitamin, which may discolor urine in a similar fashion as RHB-204. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHB-204Also: Clarithromycin 158.3mg, Rifabutin 40mg and Clofazimine 13.3mgRHB-204 | Drug | RHB-204 |
| PlaceboMatching placebo to RHB-204 | Drug | Placebo |
Primary outcome
Quality of Life Questionnaire - Bronchiectasis (QoL B) Respiratory Symptoms domain score from baseline to Month 6 for RHB-204 compared to placebo
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, defined by 3 consecutive monthly negative sputum cultures, without reversion, at Months 4, 5 \& 6 for THB-204 compared to placebo.
11 secondary outcomes
Part 1 Secondary efficacy objective - Reduction of fatigue
Time frame: 6 months
Part 1 Secondary efficacy objective - Time to culture conversion
Time frame: 6 months
Part 1 Secondary efficacy objective - Improvement in Physical Functioning
Time frame: 6 months
Part 2 Secondary efficacy objective - Durable Sputum culture conversion at end of study
Time frame: 19 months
Part 2 Secondary efficacy objective - Durable Sputum culture conversion at end of treatment
Time frame: 16 months
QoL B Respiratory Symptoms domain score mean change from baseline to Month 16
Time frame: 16 months
Part 2 Secondary efficacy objective - Improvement in Quality of Life - Fatigue 16 months
Time frame: 16 months
Part 2 Secondary efficacy objective - Improvement in Quality of Life - Fatigue 19 Months
Time frame: 19 months
Part 2 Secondary efficacy objective - Quality of Life Physical Functioning Symptoms 16 Months
Time frame: 16 months
Part 2 Secondary efficacy objective - Quality of Life Physical Functioning Symptoms 19 Months
Time frame: 19 Months
QoL-B Respiratory Symptoms domain scores at Month 19
Time frame: 19 Months
Results and safety
The study was stopped early (reason given: extremely slow enrollment into study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin L. Winthrop, MD, MPH study director
Oregon Health and Science University
June L Almenoff, MD, PhD study chair
RedHill Biopharma, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RHB-204 in people with Pulmonary Mycobacterium Avium Complex Infection and Bronchiectasis, run by RedHill Biopharma Limited at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: extremely slow enrollment into study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire - Bronchiectasis (QoL B) Respiratory Symptoms domain score from baseline to Month 6 for RHB-204 compared to placebo (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.