Asthma (Diagnosis)Phase 1ARTMANCT07600190
Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)
A Phase 1 study testing Anakinra 100 Mg/0.67 Ml Inj Syringe in people with Asthma (Diagnosis) and Persistent Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
In this single center, interventional pilot study, 40 participants at high risk for future exacerbation will be randomized to anakinra (v. placebo control) treatment for home administration as part of an asthma action plan (AAP) and monitored through their first moderate asthma exacerbation, triggering treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma (Diagnosis), Persistent Asthma, Moderate Asthma Exacerbation
- What is being tested?
- Anakinra 100 Mg/0.67 Ml Inj Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Provision of signed and dated informed consent form
- Age ≥18 years
- A history of physician-diagnosed persistent asthma or symptoms consistent with persistent asthma based on national or international guidelines for diagnosis and management of asthma.
- Current use of controller therapy such as inhaled corticosteroid (ICS) or ICS in combination with long-acting beta agonist (LABA)
- Asthma exacerbation requiring systemic corticosteroid therapy in the past 12 months
- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy or who have been amenorrheic for 12 months or more.
- Asthma Impairment and Risk Questionnaire (AIRQ) Score >2
Who cannot join
- Clinical contraindications:
- Physician diagnosis of other chronic pulmonary disease including cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema or congenital disorders of the lungs or airways.
- History of undergoing bronchial thermoplasty.
- Intubation for asthma in the last 12 months
- History of malignancy except non-melanoma skin cancer within the last five years.
- Any chronic medical condition considered by the PI as a contraindication to inclusion in the study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic or recurrent infections or immunodeficiency.
Show all 24Show fewer
- Mental illness or history of substance abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- History of smoking: i. Smoking >1 time per week in the past year; ii. If ≥40 years old: Smoked ≥15 pack years; iii. If <40 years old: Smoked ≥10 pack years; iv. Smoking equivalents of 1 pack cigarettes a day for 1 year: 1 cigar or pipe daily for 1 year; Hookah - 1 session per day for 1 year; E-cigarettes or vapes - 1 cartridge/tank/pod per day for 1 year; and active use of smoking/vaping marijuana, specified as once per week in the last year.
- Allergy/sensitivity to study drugs or their formulations, including latex
- Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
- Current participation in an interventional trial in which study administration was administered within the past 60 days or within 5 half-lives of the drug (whichever is greater)
- Pregnancy, plans to get pregnant or nursing a baby. Female volunteers will be asked to use effective birth control (stable regimen of hormonal contraceptive use for at least 6 months, intrauterine device placement, or tubal ligation for at least 6 months through at least one week after study completion) and will provide a urine sample to test for pregnancy on study days. If the test is positive or the participant has reason to believe she may be pregnant, she will be dismissed from the study. Women who have been amenorrheic for 12 months may participate. Male volunteers will be asked to use condoms for the duration of the study through at least one week after study completion.
- Usage of the following medications:
- Use of daily systemic corticosteroid therapy for asthma control
- Use of any immunomodulatory therapy within the preceding 12 months, including biologics that are approved for asthma.
- Currently receiving allergen immunotherapy
- Use of any immunosuppressant therapy within the preceding 12 months will be reviewed by the study physician.
- Laboratory: Participants who meet the following criteria will be excluded from study:
- Positive QuantiFERON-tuberculosis (TB) gold assay. Cases of indeterminate QuantiFERON-TB test results will require a second specimen to be drawn.
- Baseline absolute neutrophil count (ANC) <1.0 x 109/L for participants of African descent, <1.5 x 109/L for other participants
- Allergy/sensitivity to study drugs or their formulations, including latex.
- History of anaphylaxis requiring epinephrine treatment
- Inability or unwillingness of a participant to give written informed consent.
- Inability or unwillingness to self-administer injectable medication (anakinra or placebo).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Chris Brooks, (919) 843-6598, Chris_Brooks@med.unc.edu
Corinne Taylor, 919-962-9841, corinne.lawler@unc.edu
About this study
Official title: Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA) Pilot Study
In this single center, interventional pilot study, 40 participants at high risk for future exacerbation will be randomized to anakinra (v. placebo control) treatment for home administration as part of an asthma action plan (AAP) and monitored through their first moderate asthma exacerbation, triggering treatment dosing over a 26 week period. Key feasibility questions will be assessed in this pilot study to inform trial design and sample size selection for a future multi-site phase II clinical trial testing anakinra as a rescue treatment for moderate asthma exacerbations.
Read the detailed description
This pilot study will incorporate early intervention with the IL-1 receptor antagonist (IL-1RA), anakinra, as part of a home-based asthma action plan (AAP) at the start of a moderate exacerbation with the goal of preventing severe exacerbations requiring systemic steroids. The investigators will determine the feasibility of recruitment, enrollment, and retention for a trial that requires self administered injections; adherence to critical protocol operational tasks and rates of moderate exacerbations; and preliminary safety and efficacy of anakinra treatment during a moderate asthma exacerbation, with the goal of these findings supporting the development a hybrid decentralized phase II trial.
40 adults (≥18 years and < 65 years) with persistent asthma that experienced an exacerbation within the prior 12 months requiring systemic steroid treatment will be enrolled, with the aim to randomize 20 women and 20 men. Up to 100 subjects will be screened to randomize 40 subjects.
Patients are to receive anakinra or placebo during a moderate asthma exacerbation (defined by pre-specified criteria). Investigators will monitor symptom scores, lung function measurements, rescue medication use, systemic corticosteroid use, and healthcare utilization during exacerbations. Device training, blood collection, and nasal sample collection will also occur.
- Being tested
- Anakinra 100 Mg/0.67 Ml Inj Syringe, Saline Placebo/0.67 Ml Inj Syringe
- Keywords
- Asthma, Asthma Exacerbation, Anakinra, Kineret, Interleukin-1 Receptor Antagonist, IL-1 receptor blockade, Airway Inflammation, Persistent Asthma
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra 100 Mg/0.67 Ml Inj SyringeDrug
Active study treatment
Saline Placebo/0.67 Ml Inj SyringeDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Subjects will be randomized to receive two doses of active study treatment (anakinra) upon meeting orange zone exacerbation criteria. Receives: Drug: Anakinra 100 Mg/0.67 Ml Inj Syringe |
| Placebo | Placebo comparator | Subjects will be randomized to receive two doses of placebo upon meeting orange zone exacerbation criteria. Receives: Drug: Saline Placebo/0.67 Ml Inj Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Anakinra on absolute change in morning PEF from baseline during moderate asthma exacerbation
Area under the curve (AUC) of the absolute change from baseline, over the period of treatment day 1 through 10 days post-treatment day 1, calculated using the trapezoidal method, and comparing Anakinra to placebo treatment.
Measured: Day 1 of treatment through day 10 after treatment
Study Design Feasibility - Percentage of participants who experience one moderate asthma exacerbation
Percent of randomized participants who experience one moderate asthma exacerbation (as defined by the participant's asthma action plan) during the 6-month study period.
Measured: The 6-month period from randomization to the end of study visit
Secondary outcomes (14)
Effect of Anakinra on Asthma Index during moderate asthma exacerbation
Asthma Index is a continuous variable that reflects the magnitude and timing of changes in asthma control. Asthma scores are calculated using objective peak expiratory flow (PEF) and subjective symptom score elements over a 48-hour period. Asthma scores will be calculated over the period of treatment day 1 through 10 days post-treatment day 1 and subtracted from the mean Asthma score from a stable baseline 7-day period to obtain the Asthma Index. The area under the curve (AUC) of the Asthma Index will be calculated over the period of treatment day 1 through 10 days post-treatment day 1. Higher Asthma Index AUC values represent a greater cumulative burden of uncontrolled asthma relative to the individual's stable baseline (i.e., worse asthma control), while lower values represent better-maintained asthma control over the assessment period.
Measured: Day 1 of treatment to day 10 after treatment
Intervention Feasibility - Mean number of participants enrolled per month
Mean number of participants completing the screening visit and signing informed consent per month.
Measured: 18 months
Intervention Feasibility - Mean number of participants randomized per month
Mean number of participants completing the training and randomization visit per month.
Measured: 18 months
Intervention Feasibility - Percentage of participants retained through completion of study
Percentage of total randomized participants who complete visit 9 (end of study visit).
Measured: 24 months
Study Design Feasibility - Percentage of participants completing daily PEF measurements
Percentage of randomized participants who complete at least 75% of expected daily PEF measurements.
Measured: 24 months
Fidelity to Study Intervention - Percentage of prescribed doses of study treatment that are self-administered by the participant
Percentage of prescribed doses of study treatment that are completed through self-administration by the study participant during treatment visit 1 or treatment visit 2.
Measured: 24 months
Percentage of participants requiring rescue systemic corticosteroid treatment
Among participants who experience an exacerbation event, the percentage who require treatment with systemic corticosteroids for ongoing symptoms and/or PEF reduction.
Measured: The 10 day period following the start of treatment for an exacerbation
Percentage of participants with rebound worsening of asthma exacerbation after study treatment
Among participants who experience an exacerbation event, the percentage who experience rebound worsening of the asthma exacerbation will be reported. Rebound worsening of asthma exacerbation is defined as an initial improvement in symptoms, short acting beta-agonist (SABA) use and/or peak expiratory flow (PEF) after study treatment with subsequent deterioration shown by a decline in PEF, increased SABA use, or need for systemic corticosteroids during Visits T4-T7.
Measured: The 10 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an asthma exacerbation that requires emergency care
Among participants who experience an exacerbation event, the percentage who require emergency care, defined as an unscheduled primary care visit, urgent care visit, or emergency department visit, will be reported.
Measured: The 10 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an asthma exacerbation that requires hospitalization.
Among participants who experience an exacerbation event, the percentage who require hospitalization will be reported
Measured: The 10 day period following the start of treatment for an exacerbation
Percentage of participants with post-treatment severe neutropenia.
Among participants who inject study treatment for an exacerbation, the percentage with post-treatment severe neutropenia will be reported. A post treatment complete blood count (CBC) will be performed and severe neutropenia will be defined as an absolute neutrophil count (ANC) < 500 cells/µL.
Measured: 14 days following the start of treatment for an exacerbation
Percentage of participants experiencing serious infection
Among participants who inject study treatment for an exacerbation, the percentage who experience a serious infection (including pneumonia, cellulitis, kidney or neurologic infections, and bacteria or sepsis) will be reported.
Measured: The 14 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an injection site reaction
Among participants who inject study treatment for an exacerbation, the percentage who experience injection site reactions will be reported.
Measured: The 14 day period following the start of treatment for an exacerbation
Percentage of accurately identified participants
Electronic medical record (EMR)-based data pulls will occur at intervals throughout the enrollment period to identify potentially eligible participants through a computable phenotype. The percentage of potentially eligible participants that were accurately identified through this computable phenotype will be reported.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Model description
- Subjects will be allocated to placebo or anakinra treatment using permuted block randomization with a block of size 4 (2 placebo, 2 anakinra)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michelle Hernandez, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600190
- Sponsor's protocol ID
- 25-1995
- Other IDs
- R34HL179910
- Acronym
- ARTMA
- Status last verified
- Jul 2026
- First submitted
- 6 May 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA) Pilot Study
- ClinicalTrials.gov ID
- NCT07600190
- Acronym / sponsor ID
- ARTMA / 25-1995
- Keywords
- Asthma, Asthma Exacerbation, Anakinra, Kineret, Interleukin-1 Receptor Antagonist, IL-1 receptor blockade, Airway Inflammation, Persistent Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 20 May 2026 (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.
In this single center, interventional pilot study, 40 participants at high risk for future exacerbation will be randomized to anakinra (v. placebo control) treatment for home administration as part of an asthma action plan (AAP) and monitored through their first moderate asthma exacerbation, triggering treatment dosing over a 26 week period. Key feasibility questions will be assessed in this pilot study to inform trial design and sample size selection for a future multi-site phase II clinical trial testing anakinra as a rescue treatment for moderate asthma exacerbations.
Detailed description
This pilot study will incorporate early intervention with the IL-1 receptor antagonist (IL-1RA), anakinra, as part of a home-based asthma action plan (AAP) at the start of a moderate exacerbation with the goal of preventing severe exacerbations requiring systemic steroids. The investigators will determine the feasibility of recruitment, enrollment, and retention for a trial that requires self administered injections; adherence to critical protocol operational tasks and rates of moderate exacerbations; and preliminary safety and efficacy of anakinra treatment during a moderate asthma exacerbation, with the goal of these findings supporting the development a hybrid decentralized phase II trial.
40 adults (≥18 years and < 65 years) with persistent asthma that experienced an exacerbation within the prior 12 months requiring systemic steroid treatment will be enrolled, with the aim to randomize 20 women and 20 men. Up to 100 subjects will be screened to randomize 40 subjects.
Patients are to receive anakinra or placebo during a moderate asthma exacerbation (defined by pre-specified criteria). Investigators will monitor symptom scores, lung function measurements, rescue medication use, systemic corticosteroid use, and healthcare utilization during exacerbations. Device training, blood collection, and nasal sample collection will also occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be allocated to placebo or anakinra treatment using permuted block randomization with a block of size 4 (2 placebo, 2 anakinra)
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Drug: Anakinra 100 Mg/0.67 Ml Inj SyringeSubjects will be randomized to receive two doses of active study treatment (anakinra) upon meeting orange zone exacerbation criteria. |
| Placebo | Placebo comparator | Drug: Saline Placebo/0.67 Ml Inj SyringeSubjects will be randomized to receive two doses of placebo upon meeting orange zone exacerbation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Age ≥18 years
- A history of physician-diagnosed persistent asthma or symptoms consistent with persistent asthma based on national or international guidelines for diagnosis and management of asthma.
- Current use of controller therapy such as inhaled corticosteroid (ICS) or ICS in combination with long-acting beta agonist (LABA)
- Asthma exacerbation requiring systemic corticosteroid therapy in the past 12 months
Key exclusion criteria (24 listed)
- Clinical contraindications:
- Pregnancy, plans to get pregnant or nursing a baby. Female volunteers will be asked to use effective birth control (stable regimen of hormonal contraceptive use for at least 6 months, intrauterine device placement, or tubal ligation for at least 6 months through at least one week after study completion) and will provide a urine sample to test for pregnancy on study days. If the test is positive or the participant has reason to believe she may be pregnant, she will be dismissed from the study. Women who have been amenorrheic for 12 months may participate. Male volunteers will be asked to use condoms for the duration of the study through at least one week after study completion.
- Usage of the following medications:
- Laboratory: Participants who meet the following criteria will be excluded from study:
- Allergy/sensitivity to study drugs or their formulations, including latex.
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 |
|---|---|---|
| Anakinra 100 Mg/0.67 Ml Inj SyringeActive study treatment | Drug | Active Treatment |
| Saline Placebo/0.67 Ml Inj SyringePlacebo | Drug | Placebo |
Primary outcome
Effect of Anakinra on absolute change in morning PEF from baseline during moderate asthma exacerbation
Time frame: Day 1 of treatment through day 10 after treatment
Area under the curve (AUC) of the absolute change from baseline, over the period of treatment day 1 through 10 days post-treatment day 1, calculated using the trapezoidal method, and comparing Anakinra to placebo treatment.
Study Design Feasibility - Percentage of participants who experience one moderate asthma exacerbation
Time frame: The 6-month period from randomization to the end of study visit
Percent of randomized participants who experience one moderate asthma exacerbation (as defined by the participant's asthma action plan) during the 6-month study period.
14 secondary outcomes
Effect of Anakinra on Asthma Index during moderate asthma exacerbation
Time frame: Day 1 of treatment to day 10 after treatment
Intervention Feasibility - Mean number of participants enrolled per month
Time frame: 18 months
Intervention Feasibility - Mean number of participants randomized per month
Time frame: 18 months
Intervention Feasibility - Percentage of participants retained through completion of study
Time frame: 24 months
Study Design Feasibility - Percentage of participants completing daily PEF measurements
Time frame: 24 months
Fidelity to Study Intervention - Percentage of prescribed doses of study treatment that are self-administered by the participant
Time frame: 24 months
Percentage of participants requiring rescue systemic corticosteroid treatment
Time frame: The 10 day period following the start of treatment for an exacerbation
Percentage of participants with rebound worsening of asthma exacerbation after study treatment
Time frame: The 10 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an asthma exacerbation that requires emergency care
Time frame: The 10 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an asthma exacerbation that requires hospitalization.
Time frame: The 10 day period following the start of treatment for an exacerbation
Percentage of participants with post-treatment severe neutropenia.
Time frame: 14 days following the start of treatment for an exacerbation
Percentage of participants experiencing serious infection
Time frame: The 14 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an injection site reaction
Time frame: The 14 day period following the start of treatment for an exacerbation
Percentage of accurately identified participants
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Michelle Hernandez, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anakinra 100 Mg/0.67 Ml Inj Syringe in people with Asthma (Diagnosis) and Persistent Asthma, run by University of North Carolina, Chapel Hill at 1 site 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 7 inclusion and 24 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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Brooks (919-843-6598, chris_brooks@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Anakinra on absolute change in morning PEF from baseline during moderate asthma exacerbation (time frame: Day 1 of treatment through day 10 after treatment). 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 15 Jul 2026.