ABPAPhase 2NCT05667662
Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA
A Phase 2 study testing Itraconazole Powder in people with ABPA, run by Pulmatrix Inc. at 18 sites in 4 countries.
Trial summary
The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are: 1. Is PUR1900 safe and well tolerated in adults with asthma and ABPA? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ABPA
- What is being tested?
- Itraconazole Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 1 Feb 2023to 27 Feb 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a male or female, ≥18 years old at the time of signing the informed consent.
- BMI of ≥18.0 and <40.0 kg/m2 at screening.
- Has a diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update
- Has a confirmed diagnosis of ABPA, based on the modified International Society for human and Animal Mycology (ISHAM) ABPA working group 2013 and 2021 criteria including a history of or documentation at screening of serum IgE ≥ 500 IU/mL and A. fumigatus-specific IgE>0.35KUA/L, or above normal IgE antibody to A. fumigatus, or a positive immediate skin test and at least 2 of the 3 following supportive criteria: eosinophil count >500 cells/µL; A. fumigatus-specific IgG >27 mgA/L or presence of precipitating (or above normal immunoglobulin G [IgG]) antibody to A. fumigatus; consistent radiographic opacities or bronchiectasis on chest CT.
- Is currently considered to be in one of the following stages of ABPA: Stage 2 (Response), Stage 4 (Remission), Stage 5a (Treatment-dependent ABPA), or Stage 5b (Glucocorticoid-dependent asthma).
- At least 1 exacerbation requiring a systemic glucocorticosteroid(s) in the 12 months prior to Screening. For patients on a biologic agent, at least one exacerbation requiring a systemic glucocorticosteroid(s) must have occurred at least 3 months after the initiation of the biologic agent.
Show all 12Show fewer
- Has a serum IgE ≥500 IU/mL at screening.
- Has a documented stable asthma medication regimen during the 28 days prior to the first dose of study drug ; applicable asthma medications can include but are not limited to the following: inhaled short-acting beta agonist (SABA), inhaled long-acting beta agonist (LABA), and leukotriene receptor antagonist (LTRA) use and inhaled and/or oral glucocorticosteroids. SABA use during this period should be mostly within a stable range (e.g., 2 puffs 2 to 4 times a day) and should not exceed 8 puffs a day on 2 out of 3 consecutive days.
- Can perform a valid, reproducible spirometry test with demonstration of a prebronchodilator FEV1 ≥50% of predicted normal for age, sex, race, and height at a screening visit.
- Can demonstrate the correct inhalation technique and achieve a minimum inspiratory flow rate of 45 L/min for the use of the delivery device at screening and before dosing on Day 1.
- Is willing and able to comply with all study procedures and assessments, including scheduled visits, drug dosing plan, study procedures, laboratory tests, and study restrictions.
- Subjects who are sexually active, male subjects able to father a child, and female subjects of childbearing potential must agree to follow contraception requirements.
Who cannot join
- Currently requiring medications that are sensitive substrates for CYP3A4-mediated metabolism or medications that are contraindicated with oral itraconazole.
- Has evidence of ventricular dysfunction, such as congestive cardiac failure (New York Heart Association functional class III or IV), or a history of congestive cardiac failure. N-terminal pro B-type natriuretic peptide (NT pro BNP) will be checked at screening only. A subject with a confirmed value of >400 pg/mL will not be eligible to participate.
- Has used any systemic azole antifungal agent in the 6 weeks before first dose of study drug.
- Has discontinued previously administered biologic agent(s) in the 3 months prior to screening.
- Has a history of life-threatening asthma within the last 24 months, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures.
- Has a current diagnosis of any chronic airway disease other than asthma, ABPA, or bronchiectasis believed to be related to ABPA, such as chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, or Churg-Strauss syndrome. A subject whose predominating clinical disease burden is related to bronchiectasis (e.g., a subject with 2 or more infective exacerbations of bronchiectasis in the past 12 months or a subject with chronic colonization with Pseudomonas aeruginosa) will be excluded. Refer to Appendix 4 for definition of bronchiectasis exacerbations.
Show all 27Show fewer
- Had an occurrence of clinically significant bacterial, viral, or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals, or antifungals within the 28 days before screening. Topical treatments, other than antifungals, are allowed.
- Had an occurrence of asthma or ABPA exacerbations within the 28 days before screening.
- Has the presence of hoarseness or oropharyngeal candidiasis at screening.
- Had a major trauma or surgery within the last 28-days before screening.
- Has a history of any clinically significant cardiovascular, renal, hepatic, or gastrointestinal disease or neurological or psychiatric disorder endocrine, immunological, or autoimmune disease or other medical condition that would affect the subject's safety or confound the assessment of study endpoints as judged by the Investigator.
- Has a history of any clinically significant drug or alcohol abuse in the past 6 months before screening, as judged by the Investigator.
- Has current inhaled tobacco/nicotine or inhaled marijuana use or history of smoking or vaping including tobacco or marijuana within the last 6 months before screening.
- Has a history of any clinically significant drug or alcohol abuse in the past 6 months before screening, as judged by the Investigator.
- Has current tobacco or inhaled marijuana use or history of smoking or vaping including tobacco or marijuana within the last 6 months before screening.
- Has a history of allergic or hypersensitivity reaction or serious adverse reaction after dosing of itraconazole or other antifungal azoles.
- Has a history of serious adverse reaction or known serious hypersensitivity to any of the formulation excipients.
- Has a positive urine test result for drugs of abuse or cotinine at screening (unless, in the opinion of the Investigator, this can be explained by the subject's current medications). Note that results that are positive for a drug of abuse or cotinine may be acceptable for drugs that have been obtained by legal means or non-inhaled tobacco/nicotine product use.
- At screening, has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN), white blood cell (WBC) count > 20,000 X 109/L, absolute neutrophil count <1000 cells/L, platelet counts <100,000 to or >500,000 X 109/L, or hemoglobin <10 g/dL
- Is a female of childbearing potential who is pregnant or lactating or who plans to become pregnant during the study. All female subjects must have a negative pregnancy test at screening and pre dose on Day 1. A woman is of childbearing potential unless she is either permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, bilateral tubal occlusion/ligation, endometrial ablation) or postmenopausal (had no menses for 12 months without an alternative medical cause).
- Has a 12-lead ECG demonstrating a mean QT interval corrected by the Fridericia formula (QTcF) >450 msec for a male subject or >470 msec for a female subject at screening. A repeat triplicate ECG is allowed if a mean QTcF >450 msec for males and >470 msec for females is recorded at Visit 1.
- Has a planned or elective surgery, hospitalizations, or participation in other interventional studies any time during the study that may interfere with study logistics or safety.
- Has donated or had a loss of greater than 400 mL of blood within the 3 months before screening.
- Has other social, psychiatric, surgical, or medical conditions or screening laboratory abnormalities that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the subject inappropriate for entry into the study.
- Received any investigational medical product in a clinical research study within the previous 3 months before first dose of study drug.
- Is a study site employee, an immediate family member of a study site employee, or a Sponsor employee.
- Has previously received PUR1900.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States8 sites
University of Alabama Medical Center at Birmingham
Birmingham, Alabama, 35233
Baylor University Medical Center
Dallas, Texas, 75246
UTMB Health
Galveston, Texas, 77555
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Jonathan Corren, MD
Santa Monica, California, 90025
Medical Research of Arizona
Scottsdale, Arizona, 85251
Southern Illinois University Center for Clinical Research
Springfield, Illinois, 62702
Bensch Clinical Research
Stockton, California, 95207
United Kingdom4 sites
University Hospitals Birmingham - Heartlands Hospital
Birmingham, West Midlands, B9 5SS
CPS Research Limited
Glasgow, G20 7BE
Royal Brompton Hospital
London, SW3 6HP
University Hospital of South Manchester - Wythenshawe Hospital,
Manchester, M23 9LT
Australia3 sites
Royal Perth Hospital
Perth, Western Australia, 6000
Mater Hospital Brisbane, Respiratory Research Group
South Brisbane, Queensland, QLD 4101
Westmead Hospital
Westmead, New South Wales, NSW 2145
France3 sites
CHU de Marseille Hôpital Nord
Marseille, 13015
CHU Pontchaillou
Rennes, Cedex 9, 35033
Nouvel Hôpital Civil
Strasbourg, Strasbourg Cedex, 67091
About this study
Official title: Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients With ABPA
The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are:
- Is PUR1900 safe and well tolerated in adults with asthma and ABPA?
- Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA?
- Is there fungal resistance to A. fumigatus?
Read more
This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period.
Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.
- Conditions
- ABPA
- Being tested
- Itraconazole Powder, Placebo
- Keywords
- Asthma, Allergic Bronchopulmonary Aspergillosis
- Medical subject headings
- Asthma, Aspergillosis, Allergic Bronchopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole PowderDrug
Also called PUR1900
Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients)
PlaceboDrug
Capsules with 11.8 mg total powder (excipients only)
| Study group | Role | What they receive |
|---|---|---|
| PUR1900 40 mg | Experimental | 4 PUR1900 (10 mg itraconazole) Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day. Receives: Drug: Itraconazole Powder |
| PUR1900 20 mg | Experimental | 2 PUR1900 (10 mg itraconazole) Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients) and 2 Placebo Capsules with with 11.8 mg total powder (excipients only) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day. Receives: Drug: Itraconazole Powder |
| Placebo | Placebo comparator | 4 Placebo Capsules with with 11.8 mg total powder (excipients only) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Review of TEAEs from time of consent to study completion.
Measured: 168 days
Safety spirometry assessments
FEV1 (the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration), FVC (liters), and PEFR (L/min) measurements compared to baseline.
Measured: 168 days
Vital sign measurements
Vital signs measurements collected before exposure, during and after treatment and compared to baseline. Vital sign measurements will include respiratory rate (bpm), blood pressure (mmHg), heart rate (bpm), oxygen saturation (by pulse oximetry), and oral or tympanic temperature (°C).
Measured: 168 days
Physical examinations
At screening, a complete physical examination will be performed which includes measurement of height (cm), weight (kg) and evaluation of appearance; skin; head and neck; eyes, ears, nose, and throat; chest and lungs; heart; abdomen; neurological system; and extremities.
Measured: 168 Days
Clinical safety laboratory test results
Hematology, serum chemistry, or urinalysis test results (normal, abnormal, clinical significance) compared to baseline.
Measured: 168 days
Cardiac safety monitoring
Electrocardiogram (ECG) recordings collected before exposure, during and after treatment. Electrocardiogram measurements will include heart rate and PR, RR, QRS, and QT intervals, as well as the QTcF and compared to baseline.
Measured: 168 days
Secondary outcomes (4)
Magnitude of effect of daily administration of PUR1900 - Spirometry
Changes in measured Forced Expiratory Volume (FEV1) over time compared to baseline
Measured: 168 days
Magnitude of effect of daily administration of PUR1900 - Patient Reported Outcomes (ACQ)
Responses to the Asthma Control Questionnaire (ACQ) sored from 0-6 with 0 being totally controlled and 6 being extremely poorly controlled compared to baseline.
Measured: 168 days
Magnitude of effect of daily administration of PUR1900 - Patient Reported Outcomes (AQLQ(s) 12+)
Responses to the Asthma Quality of Life Questionnaire with scores ranging 1-7 and higher scores indicating better quality of life compared to baseline.
Measured: 168 days
Frequency of asthma exacerbations versus baseline
Occurrence of asthma exacerbations before, during, and after treatment with PUR1900
Measured: 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Feb 2023
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ABPAStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Cabell, MD, Study director, Pulmatrix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667662
- Sponsor's protocol ID
- 601-0018
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients With ABPA
- ClinicalTrials.gov ID
- NCT05667662
- Acronym / sponsor ID
- 601-0018
- Conditions
- ABPA
- Keywords
- Asthma, Allergic Bronchopulmonary Aspergillosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 28 Dec 2022 (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.
The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are:
- Is PUR1900 safe and well tolerated in adults with asthma and ABPA?
- Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA?
- Is there fungal resistance to A. fumigatus?
This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period.
Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PUR1900 40 mg | Experimental | Drug: Itraconazole Powder4 PUR1900 (10 mg itraconazole) Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day. |
| PUR1900 20 mg | Experimental | Drug: Itraconazole Powder2 PUR1900 (10 mg itraconazole) Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients) and 2 Placebo Capsules with with 11.8 mg total powder (excipients only) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day. |
| Placebo | Placebo comparator | Drug: Placebo4 Placebo Capsules with with 11.8 mg total powder (excipients only) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Is a male or female, ≥18 years old at the time of signing the informed consent.
- BMI of ≥18.0 and <40.0 kg/m2 at screening.
- Has a diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update
- Has a confirmed diagnosis of ABPA, based on the modified International Society for human and Animal Mycology (ISHAM) ABPA working group 2013 and 2021 criteria including a history of or documentation at screening of serum IgE ≥ 500 IU/mL and A. fumigatus-specific IgE>0.35KUA/L, or above normal IgE antibody to A. fumigatus, or a positive immediate skin test and at least 2 of the 3 following supportive criteria: eosinophil count >500 cells/µL; A. fumigatus-specific IgG >27 mgA/L or presence of precipitating (or above normal immunoglobulin G [IgG]) antibody to A. fumigatus; consistent radiographic opacities or bronchiectasis on chest CT.
- Is currently considered to be in one of the following stages of ABPA: Stage 2 (Response), Stage 4 (Remission), Stage 5a (Treatment-dependent ABPA), or Stage 5b (Glucocorticoid-dependent asthma).
Key exclusion criteria (27 listed)
- Currently requiring medications that are sensitive substrates for CYP3A4-mediated metabolism or medications that are contraindicated with oral itraconazole.
- Has evidence of ventricular dysfunction, such as congestive cardiac failure (New York Heart Association functional class III or IV), or a history of congestive cardiac failure. N-terminal pro B-type natriuretic peptide (NT pro BNP) will be checked at screening only. A subject with a confirmed value of >400 pg/mL will not be eligible to participate.
- Has used any systemic azole antifungal agent in the 6 weeks before first dose of study drug.
- Has discontinued previously administered biologic agent(s) in the 3 months prior to screening.
- Has a history of life-threatening asthma within the last 24 months, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures.
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 |
|---|---|---|
| Itraconazole PowderAlso: PUR1900Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients) | Drug | PUR1900 20 mg, PUR1900 40 mg |
| PlaceboCapsules with 11.8 mg total powder (excipients only) | Drug | Placebo |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: 168 days
Review of TEAEs from time of consent to study completion.
Safety spirometry assessments
Time frame: 168 days
FEV1 (the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration), FVC (liters), and PEFR (L/min) measurements compared to baseline.
Vital sign measurements
Time frame: 168 days
Vital signs measurements collected before exposure, during and after treatment and compared to baseline. Vital sign measurements will include respiratory rate (bpm), blood pressure (mmHg), heart rate (bpm), oxygen saturation (by pulse oximetry), and oral or tympanic temperature (°C).
Physical examinations
Time frame: 168 Days
At screening, a complete physical examination will be performed which includes measurement of height (cm), weight (kg) and evaluation of appearance; skin; head and neck; eyes, ears, nose, and throat; chest and lungs; heart; abdomen; neurological system; and extremities.
Clinical safety laboratory test results
Time frame: 168 days
Hematology, serum chemistry, or urinalysis test results (normal, abnormal, clinical significance) compared to baseline.
Cardiac safety monitoring
Time frame: 168 days
Electrocardiogram (ECG) recordings collected before exposure, during and after treatment. Electrocardiogram measurements will include heart rate and PR, RR, QRS, and QT intervals, as well as the QTcF and compared to baseline.
4 secondary outcomes
Magnitude of effect of daily administration of PUR1900 - Spirometry
Time frame: 168 days
Magnitude of effect of daily administration of PUR1900 - Patient Reported Outcomes (ACQ)
Time frame: 168 days
Magnitude of effect of daily administration of PUR1900 - Patient Reported Outcomes (AQLQ(s) 12+)
Time frame: 168 days
Frequency of asthma exacerbations versus baseline
Time frame: 168 days
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
Chris Cabell, MD study director
Pulmatrix Inc.
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itraconazole Powder in people with ABPA, run by Pulmatrix Inc. at 18 sites in 4 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 12 inclusion and 27 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 2 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 18 sites in United States, United Kingdom, Australia, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Low enrollment). 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?
Incidence of Treatment Emergent Adverse Events (TEAEs) (time frame: 168 days). The study lists 6 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 2 Apr 2024.