AsthmaPhase 1NCT03851250
A Study of MRx-4DP0004 in Asthma
A Phase 1 study testing MRx-4DP0004 in people with Asthma, run by 4D pharma plc at 4 sites in 2 countries.
Trial summary
This is a multicentre, phase I/II, double-blind, placebo-controlled study of MRx-4DP0004 in participants taking long-term medication for asthma. Participants will take two capsules of MRx-4DP0004 twice daily in addition to their existing asthma medication for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- MRx-4DP0004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 4 Jul 2019to 26 Apr 2023
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented history and diagnosis of asthma at least 6 months prior to Visit 1.
- Stable current asthma treatment as per GINA steps 2-4 (ICS with or without LABA) for at least 2 months prior to Visit 1.
- ACQ-6 score >1.5 and <=4
- FEV1 >50% of predicted normal
- Following protocol specified contraception requirements.
Who cannot join
- Non-compliant with prescribed asthma maintenance treatment.
- At significant risk of exposure to a change in environmental sensitising substances during the study.
- Co-morbidities not optimally controlled for the last 3 months or any co-morbidity that may put the subject at risk or influence the outcome of the study.
- Hepatitis B or C or HIV.
- GI fistula, feeding tubes or inflammatory bowel disease.
- GI disease resulting in inability for oral intake, malabsorption syndrome, surgical procedures affecting absorption, uncontrolled inflammatory bowel disease.
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- History of life-threatening asthma.
- Systemic corticosteroids within 6 weeks of first dose.
- Allergy to all of ampicillin, clindamycin and imipenem.
- Probiotic supplements.
- Immunosuppression or immunosuppressant medication.
- Use of ICS and LABA as Maintenance and Reliever Therapy.
- Smokers or nicotine users within 3 months of screening.
- Former smokers >15 pack years.
- Systemic antibiotics within 6 weeks of first dose.
- Clinically significant haematology and serum biochemistry.
- Sensitivity to any constituent of IMP.
- Diastolic blood pressure <45 or >90, systolic blood pressure <95 or >155mmHg, Pulse rate <40 or >100 bpm.
- Clinically significant ECGs or structural cardiac abnormalities.
- Any other condition that may interfere with primary objective.
- Receipt of a positive COVID-19 test result within 4 weeks of first dose of IMP
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom3 sites
Bradford Teaching Hospital
Bradford, West Yorkshire
4D Site Leicester
Leicester
4D Site Manchester
Manchester
United States1 site
OHSU Allergy and Clinical Immunology Clinic
Portland, Oregon, 97239
About this study
Official title: A First in Human, Double-blind, Placebo-controlled, Multicentre Phase I/II Study to Evaluate the Safety, Tolerability and Immune Modulatory Effects of MRx-4DP0004 in Participants Taking Long-term Control Medication for Their Asthma
This is a multicentre, phase I/II, double-blind, placebo-controlled study of MRx-4DP0004 in participants taking long-term medication for asthma. Participants will take two capsules of MRx-4DP0004 twice daily in addition to their existing asthma medication for 12 weeks. Safety and tolerability and immune modulatory effects of MRx-4DP0004 will be assessed throughout the study.
- Conditions
- Asthma
- Being tested
- MRx-4DP0004, Placebo
- Keywords
- MRx-4DP0004, Asthma, Live Biotherapeutic Product
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRx-4DP0004Drug
Participants randomised to receive MRx-4DP0004 will take it in addition to their regular asthma medication.
PlaceboDrug
Participants randomised to receive placebo will take it in addition to their regular asthma medication.
| Study group | Role | What they receive |
|---|---|---|
| MRx-4DP0004 | Experimental | MRx-4DP0004 is a Live Biotherapeutic Product containing 10^9 to 10^10 Colony Forming Units.
Participants randomised to this arm will take 2 capsules twice daily at approximately 12 hour intervals for 12 weeks. Receives: Drug: MRx-4DP0004 |
| Placebo | Placebo comparator | Participants randomised to this arm will take 2 capsules of placebo twice daily at approximately 12 hour intervals for 12 weeks.
All participants will receive placebo in a single blind manner for two weeks in addition to the 12 weeks of double blind treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each treatment arm experiencing adverse events
Adverse events will be considered alongside other primary outcome measures for assessment of safety and tolerability.
Measured: Baseline to Day 127
Number of clinically relevant adverse changes in clinical laboratory tests in each treatment arm
Clinically relevant adverse changes clinical laboratory tests will be considered alongside other primary outcome measures for assessment of safety and tolerability. Clinical laboratory tests will include clinical chemistry, haematology and urinalysis.
Measured: Baseline to Day 127
Number of clinically relevant adverse changes in vital signs in each treatment arm
Clinically relevant adverse changes in vital signs will be considered alongside other primary outcome measures for assessment of safety and tolerability. Vital signs assessments will include measurement of systolic blood pressure, diastolic blood pressure, oral body temperature and pulse rate.
Measured: Baseline to Day 127
Number of clinically relevant adverse changes in 12-lead ECGs in each treatment arm
The number of participants experiencing clinically relevant adverse changes in Clinically relevant adverse changes in vital signs will be considered alongside other primary outcome measures for assessment of safety and tolerability. ECG assessments will include measurement of PR, QRS, QT and QTcF.
Measured: Baseline to Day 127
Secondary outcomes (11)
Difference in the mean change in the Asthma Control Questionnaire (ACQ-6) between treatment arms
The ACQ-6 consists of 6 questions relating to control of asthma symptoms answered on a 7 point scale. The overall score is the mean of the 6 questions and is rated from 0 (totally controlled) to 6 (severely uncontrolled).
Measured: Baseline to Day 99
Difference in the number of subjects achieving good asthma control (as defined by an ACQ-6 score <1.0) between treatment arms.
The ACQ-6 consists of 6 questions relating to control of asthma symptoms answered on a 7 point scale. The overall score is the mean of the 6 questions and is rated from 0 (totally controlled) to 6 (severely uncontrolled).
Measured: Baseline to Day 99
Difference in the number of asthma exacerbations between treatment arms
To determine if MRx-4DP0004 can reduce the number of asthma exacerbations, the number of participants experiencing an exacerbation will be assessed.
Measured: Baseline to Day 99
Difference in the number of hospitalisations due to asthma exacerbation between treatment arms
To determine if MRx-4DP0004 can reduce the number of hospitalisations due to exacerbation of asthma symptoms, the number of participants who are hospitalised due to an exacerbation will be assessed.
Measured: Baseline to Day 99
Difference in the change from baseline in Forced Expiratory Volume in 1 second (FEV1) between treatment arms
To assess the response to MRx-4DP0004 in respect of changes to FEV1, the change from baseline in FEV1 will be assessed.
Measured: Baseline to Day 99
Difference in the change from baseline in Peak Expiratory Flow (PEF) between treatment arms
To assess the response to MRx-4DP0004 in respect of changes to PEF, the change from baseline in PEF will be assessed.
Measured: Baseline to Day 99
Difference in the change from baseline in Forced Vital Capacity (FVC) between treatment arms
To assess the response to MRx-4DP0004 in respect of changes to FVC, the change from baseline in FVC will be assessed.
Measured: Baseline to Day 99
Difference in the change from baseline in blood eosinophils between treatment arms
To assess the effect of MRx-4DP0004 on levels of eosinophils in blood, the change from baseline in percentage and absolute eosinophil counts will be assessed.
Measured: Baseline to Day 99
Difference in the change from baseline in blood neutrophils between treatment arms
To assess the effect of MRx-4DP0004 on levels of neutrophils in blood, the change from baseline in percentage and absolute neutrophil counts will be assessed.
Measured: Baseline to Day 99
Difference in the change from baseline in use of short-acting beta agonists (SABAs) between treatment arms
To assess the effect of MRx-4DP0004 on the use of SABAs, the change from baseline in SABA use will be assessed.
Measured: 7 period prior to baseline to 7 day period prior to Day 99
Difference in the mean change from baseline in the Asthma Quality of Life Questionnaire (standardised version) (AQLQ(S)) between treatment arms
The AQLQ(S) consists of 32 questions relating to quality of life in relation to asthma answered on a 7 point scale. The overall score is the mean of the 32 questions and is rated from 7 (not impaired at all) to 1 (severely impaired).
Measured: Baseline to Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start4 Jul 2019
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Why it stopped: Sponsor insolvency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4D pharma plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Brightling, Professor, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851250
- Sponsor's protocol ID
- MRx-4DP0004-I-001
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2019
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human, Double-blind, Placebo-controlled, Multicentre Phase I/II Study to Evaluate the Safety, Tolerability and Immune Modulatory Effects of MRx-4DP0004 in Participants Taking Long-term Control Medication for Their Asthma
- ClinicalTrials.gov ID
- NCT03851250
- Acronym / sponsor ID
- MRx-4DP0004-I-001
- Conditions
- Asthma
- Keywords
- MRx-4DP0004, Asthma, Live Biotherapeutic Product
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor insolvency
- Enrolment
- 34 participants (actual)
- Lead sponsor
- 4D pharma plcIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 22 Feb 2019 (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.
This is a multicentre, phase I/II, double-blind, placebo-controlled study of MRx-4DP0004 in participants taking long-term medication for asthma. Participants will take two capsules of MRx-4DP0004 twice daily in addition to their existing asthma medication for 12 weeks. Safety and tolerability and immune modulatory effects of MRx-4DP0004 will be assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRx-4DP0004 | Experimental | Drug: MRx-4DP0004MRx-4DP0004 is a Live Biotherapeutic Product containing 10^9 to 10^10 Colony Forming Units. Participants randomised to this arm will take 2 capsules twice daily at approximately 12 hour intervals for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomised to this arm will take 2 capsules of placebo twice daily at approximately 12 hour intervals for 12 weeks. All participants will receive placebo in a single blind manner for two weeks in addition to the 12 weeks of double blind treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented history and diagnosis of asthma at least 6 months prior to Visit 1.
- Stable current asthma treatment as per GINA steps 2-4 (ICS with or without LABA) for at least 2 months prior to Visit 1.
- ACQ-6 score >1.5 and <=4
- FEV1 >50% of predicted normal
- Following protocol specified contraception requirements.
Key exclusion criteria (21 listed)
- Non-compliant with prescribed asthma maintenance treatment.
- At significant risk of exposure to a change in environmental sensitising substances during the study.
- Co-morbidities not optimally controlled for the last 3 months or any co-morbidity that may put the subject at risk or influence the outcome of the study.
- Hepatitis B or C or HIV.
- GI fistula, feeding tubes or inflammatory bowel disease.
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 |
|---|---|---|
| MRx-4DP0004Participants randomised to receive MRx-4DP0004 will take it in addition to their regular asthma medication. | Drug | MRx-4DP0004 |
| PlaceboParticipants randomised to receive placebo will take it in addition to their regular asthma medication. | Drug | Placebo |
Primary outcome
Number of participants in each treatment arm experiencing adverse events
Time frame: Baseline to Day 127
Adverse events will be considered alongside other primary outcome measures for assessment of safety and tolerability.
Number of clinically relevant adverse changes in clinical laboratory tests in each treatment arm
Time frame: Baseline to Day 127
Clinically relevant adverse changes clinical laboratory tests will be considered alongside other primary outcome measures for assessment of safety and tolerability. Clinical laboratory tests will include clinical chemistry, haematology and urinalysis.
Number of clinically relevant adverse changes in vital signs in each treatment arm
Time frame: Baseline to Day 127
Clinically relevant adverse changes in vital signs will be considered alongside other primary outcome measures for assessment of safety and tolerability. Vital signs assessments will include measurement of systolic blood pressure, diastolic blood pressure, oral body temperature and pulse rate.
Number of clinically relevant adverse changes in 12-lead ECGs in each treatment arm
Time frame: Baseline to Day 127
The number of participants experiencing clinically relevant adverse changes in Clinically relevant adverse changes in vital signs will be considered alongside other primary outcome measures for assessment of safety and tolerability. ECG assessments will include measurement of PR, QRS, QT and QTcF.
11 secondary outcomes
Difference in the mean change in the Asthma Control Questionnaire (ACQ-6) between treatment arms
Time frame: Baseline to Day 99
Difference in the number of subjects achieving good asthma control (as defined by an ACQ-6 score <1.0) between treatment arms.
Time frame: Baseline to Day 99
Difference in the number of asthma exacerbations between treatment arms
Time frame: Baseline to Day 99
Difference in the number of hospitalisations due to asthma exacerbation between treatment arms
Time frame: Baseline to Day 99
Difference in the change from baseline in Forced Expiratory Volume in 1 second (FEV1) between treatment arms
Time frame: Baseline to Day 99
Difference in the change from baseline in Peak Expiratory Flow (PEF) between treatment arms
Time frame: Baseline to Day 99
Difference in the change from baseline in Forced Vital Capacity (FVC) between treatment arms
Time frame: Baseline to Day 99
Difference in the change from baseline in blood eosinophils between treatment arms
Time frame: Baseline to Day 99
Difference in the change from baseline in blood neutrophils between treatment arms
Time frame: Baseline to Day 99
Difference in the change from baseline in use of short-acting beta agonists (SABAs) between treatment arms
Time frame: 7 period prior to baseline to 7 day period prior to Day 99
Difference in the mean change from baseline in the Asthma Quality of Life Questionnaire (standardised version) (AQLQ(S)) between treatment arms
Time frame: Baseline to Day 99
Results and safety
The study was stopped early (reason given: Sponsor insolvency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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.
Christopher Brightling, Professor principal investigator
University of Leicester
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRx-4DP0004 in people with Asthma, run by 4D pharma plc at 4 sites in 2 countries.
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 5 inclusion and 21 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Sponsor insolvency). 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?
Number of participants in each treatment arm experiencing adverse events (time frame: Baseline to Day 127). The study lists 4 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 17 Apr 2024.