Allergic to House Dust MitesPhase 1NCT04184895
A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites
A Phase 1 study testing ASP2390 in people with Allergic to House Dust Mites, run by Astellas Pharma Global Development, Inc. at 2 sites in Germany.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of multiple ascending intradermal doses of ASP2390 in adult male and female participants allergic to house dust mites (HDM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic to House Dust Mites
- What is being tested?
- ASP2390
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesGermany
- Study dates
- 9 Sep 2020to 31 Dec 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a history of house dust mite (HDM) induced allergic rhinitis with or without conjunctivitis of 1 year or longer in duration at screening 1.
- Subject has positive skin prick test (SPT) to D. pteronyssinus.
- Subject has a serum specific immunoglobulin E (IgE) level to D. pteronyssinus at screening 1 or within the past 12 months (if performed and documented at the clinical unit).
- Subject shows a positive symptomatic reaction to an HDM based on total nasal symptom score (TNSS) during the challenge test at screening 2.
- Subject has a forced expiratory volume in 1 second (FEV1) of 80% of predicted value or greater at screening 1.
- Subject has a body mass index (BMI) range of 18.5 to 35.0 kg/m2, inclusive and weighs at least 50 kg at screening 1.
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- A female subject is eligible to participate if the female subject is not pregnant and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP), OR
- WOCBP who agrees to follow the contraceptive guidance starting at screening 1 and throughout the initial safety follow-up period.
- Female subject must agree not to breastfeed starting at screening 1 and throughout the initial safety follow-up period.
- Female subject must not donate ova starting at screening 1 and throughout the initial safety follow-up period.
- A male subject with female partner(s) of childbearing potential must agree to use contraception until after completion of the initial safety follow-up period.
- A male subject must not donate sperm until after completion of the initial safety follow-up period.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner(s) is(are) breastfeeding until after completion of the initial safety follow-up period.
- Subject agrees not to participate in another interventional study while receiving study drug in present study and until after completion of the initial safety follow-up period.
Who cannot join
- Subject with concomitant allergies to seasonal aeroallergens which are anticipated to be or become active through the completion of the week 18 daily symptom diary.
- Subject with a concomitant allergy to an animal dander who has exposure on a regular basis to the respective animal dander.
- Subject has received immunosuppressive treatment within 3 months prior to screening 1.
- Subject has received previous immunotherapy treatment with any HDM allergen within 3 years prior to screening 1.
- Subject is receiving ongoing treatment with any specific immunotherapy for other allergies or plans to receive during the course of the primary study period.
- Subject who has used systemic (or inhaled) steroid, mast cell stabilizing drug, T-helper cell type 2 (Th2) cytokine inhibitor, thromboxane A2 synthesis inhibitor, thromboxane A2 receptor antagonist, β-blocker, α-adrenergic blockers, ergot alkaloids, angiotensin-converting enzyme inhibitors and/or angiotensin-receptor blockers within 2 months prior to first study drug administration.
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- Subject who has used biologics that are immune modulators within 3 months prior to first study drug administration.
- Subject who has received or is planning to receive vaccination of a live vaccine within 28 days prior to the first administration of the study drug and/or subject who has received or is planning to receive vaccination of an inactive vaccine/toxoid within 7 days prior to the first administration of the study drug during the primary study period.
- Subject with mild to severe asthma receiving therapy.
- Subject has a nasal condition that could confound the efficacy or safety assessments.
- Subject who has history of allergic reactions such as anaphylactic shock, exanthema generalized, angioedema or hypotension caused by HDM and/or any medical products (including vaccine) in the past.
- Subject who has immune disorders and/or diseases requiring immunosuppressive drugs.
- Subject who was diagnosed with immunodeficiency in the past.
- Subject who is unable to discontinue antihistamines.
- Subject has received investigational study drug within 28 days or 5 half-lives, whichever is longer, prior to screening 1.
- Subject has a known or suspected intolerance to lactose and/or milk products.
- Subject has used any prescribed or nonprescribed drugs in the 2 weeks prior to first study drug administration, except for occasional use of paracetamol, topical dermatological products, hormonal contraceptives or hormone replacement therapy (HRT), beta-2-agonist for treatment of asthma or rescue medications for rhinitis and for conjunctivitis, or the coronavirus disease 2019 (COVID-19) vaccine within 7 days prior to the first study drug administration.
- Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening 1.
- Subject has a history of drinking more than 21 units of alcohol per week (> 14 units of alcohol for female subjects) within 3 months prior to screening 1 or the subject tests positive for alcohol or drugs of abuse
- Subject has had significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to screening 1.
- Other exclusion criteria apply.
- Subject has a positive result for SARS-CoV-2 PCR test prior to the chamber challenge at screening 2 (repeat virus testing performed 4 to 7 days apart with the second PCR test to be performed a maximum of 2 days prior to the chamber challenge at screening 2) or prior to randomization on day 1.
- Subject has clinical signs and symptoms consistent with COVID-19 infection, e.g., fever, dry cough, dyspnea, sore throat, fatigue, muscle or body aches and gastrointestinal symptoms or confirmed infection by appropriate SARS-CoV-2 PCR test within the 4 weeks prior to screening 1.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1 Multiple Ascending Intradermal Dose Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites
The purpose of this study is to evaluate the safety and tolerability of multiple ascending intradermal doses of ASP2390 in adult male and female participants allergic to house dust mites (HDM).
This study will also evaluate the effect of multiple ascending intradermal doses of ASP2390 on HDM-specific immunoglobulin G subclass 4 (IgG4) levels in adult male and female participants allergic to HDM.
Read the detailed description
Screening will occur up to 6 weeks prior to enrollment. Eligible participants will return to the clinical unit on day -1 (if required by the clinical unit to facilitate the severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] real-time reverse transcription polymerase chain reaction [PCR] procedure) or on day 1.
After the first dose on day 1, all participants will remain in the clinical unit for observation for approximately 24 hours postdose. After the 24 hours, participants will be discharged from the clinical unit provided no reactions have occurred that require additional observation.
For all subsequent doses, participants will remain under direct observation for a minimum of 1 hour postdose. Participants will be discharged from the clinical unit provided no reactions have occurred that require additional observation.
- Conditions
- Allergic to House Dust Mites
- Being tested
- ASP2390, Placebo
- Keywords
- Tolerability, HDM, ASP2390, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2390Biological
Intradermal
PlaceboBiological
Intradermal; normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| ASP2390 Low Dose (Cohort 1) | Experimental | Participants will receive a low dose of ASP2390 once weekly for a total of 12 doses. After all participants in cohort 1 complete 4 doses of treatment, the overall safety and tolerability of the dose will be evaluated by the Dose Escalation Committee (DEC). Receives: Biological: ASP2390 |
| Placebo Low Dose (Cohort 1) | Placebo comparator | Participants will receive a low dose of matching Placebo once weekly for a total of 12 doses. Receives: Biological: Placebo |
| ASP2390 High Dose (Cohort 2) | Experimental | Participants will receive a high dose of ASP2390 once weekly for a total of 12 doses. The dose for cohort 2 may be adapted after the DEC evaluates emergent safety and tolerability data. Receives: Biological: ASP2390 |
| Placebo High Dose (Cohort 2) | Placebo comparator | Participants will receive a high dose of matching Placebo once weekly for a total of 12 doses. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
AEs will be coded using medical dictionary for regulatory activities(MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product whether or not considered related to the medicinal product. Confirmed and suspected SARS-CoV-2 infection and COVID-19 will be recorded as an AE. An AE is considered serious if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.
Measured: Up to week 63
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to week 63
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to week 63
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Routine 12-lead ECGs will be taken after the participant has been resting in the supine position for at least 5 minutes. Routine 12-lead ECGs will be taken in triplicate.
Measured: Up to week 63
Number of participants with subcutaneous immunotherapy systemic reaction events
Subcutaneous immunotherapy systemic reaction events will be graded using the World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System.
Each grade is based on organ system involved and severity. Organ systems are defined as cutaneous, conjunctival, upper respiratory, lower respiratory, gastrointestinal, cardiovascular and other. A reaction from a single organ system such as cutaneous, conjunctival or upper respiratory, but not asthma, gastrointestinal, or cardiovascular is classified as a grade 1. Symptom(s)/sign(s) from more than 1 organ system or asthma, gastrointestinal, or cardiovascular are classified as grades 2 or 3. Respiratory failure or hypotension with or without loss of consciousness define grade 4 and death grade 5. The grade is determined by the physician's clinical judgement.
Measured: Up to week 11
Number of participants with specific local reactogenicity events
Participants will be asked to record local reactogenicity (pain, tenderness, erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (potentially life-threatening).
Measured: Up to week 12
Number of participants with specific systemic reactogenicity events
Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (potentially life-threatening).
Measured: Up to week 12
Secondary outcomes (2)
Change from baseline in immunological response to ASP2390 as assessed by HDM allergen-specific IgG4 levels
The house dust mite (HDM) allergen-specific IgG4 immunological response for all participants will be presented for each treatment by visit using descriptive statistics.
Measured: Baseline and up to week 24
Number of participants with Adverse Events
AEs will be coded using medical dictionary for regulatory activities(MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product whether or not considered related to the medicinal product. Confirmed and suspected SARS-CoV-2 infection and COVID-19 will be recorded as an AE. An AE is considered serious if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start9 Sep 2020
- Primary completion22 Dec 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic to House Dust MitesStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184895
- Sponsor's protocol ID
- 2390-CL-0001
- Other IDs
- 2018-004678-83, 2022-500660-35-00, 2018
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2019
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Ascending Intradermal Dose Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites
- ClinicalTrials.gov ID
- NCT04184895
- Acronym / sponsor ID
- 2390-CL-0001
- Conditions
- Allergic to House Dust Mites
- Keywords
- Tolerability, HDM, ASP2390, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Dec 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.
The purpose of this study is to evaluate the safety and tolerability of multiple ascending intradermal doses of ASP2390 in adult male and female participants allergic to house dust mites (HDM).
This study will also evaluate the effect of multiple ascending intradermal doses of ASP2390 on HDM-specific immunoglobulin G subclass 4 (IgG4) levels in adult male and female participants allergic to HDM.
Detailed description
Screening will occur up to 6 weeks prior to enrollment. Eligible participants will return to the clinical unit on day -1 (if required by the clinical unit to facilitate the severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] real-time reverse transcription polymerase chain reaction [PCR] procedure) or on day 1.
After the first dose on day 1, all participants will remain in the clinical unit for observation for approximately 24 hours postdose. After the 24 hours, participants will be discharged from the clinical unit provided no reactions have occurred that require additional observation.
For all subsequent doses, participants will remain under direct observation for a minimum of 1 hour postdose. Participants will be discharged from the clinical unit provided no reactions have occurred that require additional observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP2390 Low Dose (Cohort 1) | Experimental | Biological: ASP2390Participants will receive a low dose of ASP2390 once weekly for a total of 12 doses. After all participants in cohort 1 complete 4 doses of treatment, the overall safety and tolerability of the dose will be evaluated by the Dose Escalation Committee (DEC). |
| Placebo Low Dose (Cohort 1) | Placebo comparator | Biological: PlaceboParticipants will receive a low dose of matching Placebo once weekly for a total of 12 doses. |
| ASP2390 High Dose (Cohort 2) | Experimental | Biological: ASP2390Participants will receive a high dose of ASP2390 once weekly for a total of 12 doses. The dose for cohort 2 may be adapted after the DEC evaluates emergent safety and tolerability data. |
| Placebo High Dose (Cohort 2) | Placebo comparator | Biological: PlaceboParticipants will receive a high dose of matching Placebo once weekly for a total of 12 doses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject has a history of house dust mite (HDM) induced allergic rhinitis with or without conjunctivitis of 1 year or longer in duration at screening 1.
- Subject has positive skin prick test (SPT) to D. pteronyssinus.
- Subject has a serum specific immunoglobulin E (IgE) level to D. pteronyssinus at screening 1 or within the past 12 months (if performed and documented at the clinical unit).
- Subject shows a positive symptomatic reaction to an HDM based on total nasal symptom score (TNSS) during the challenge test at screening 2.
- Subject has a forced expiratory volume in 1 second (FEV1) of 80% of predicted value or greater at screening 1.
Key exclusion criteria (23 listed)
- Subject with concomitant allergies to seasonal aeroallergens which are anticipated to be or become active through the completion of the week 18 daily symptom diary.
- Subject with a concomitant allergy to an animal dander who has exposure on a regular basis to the respective animal dander.
- Subject has received immunosuppressive treatment within 3 months prior to screening 1.
- Subject has received previous immunotherapy treatment with any HDM allergen within 3 years prior to screening 1.
- Subject is receiving ongoing treatment with any specific immunotherapy for other allergies or plans to receive during the course of the primary study period.
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 |
|---|---|---|
| ASP2390Intradermal | Biological | ASP2390 High Dose (Cohort 2), ASP2390 Low Dose (Cohort 1) |
| PlaceboIntradermal; normal saline solution | Biological | Placebo High Dose (Cohort 2), Placebo Low Dose (Cohort 1) |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to week 63
AEs will be coded using medical dictionary for regulatory activities(MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product whether or not considered related to the medicinal product. Confirmed and suspected SARS-CoV-2 infection and COVID-19 will be recorded as an AE. An AE is considered serious if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to week 63
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and/or AEs
Time frame: Up to week 63
Number of participants with potentially clinically significant vital sign values.
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to week 63
Routine 12-lead ECGs will be taken after the participant has been resting in the supine position for at least 5 minutes. Routine 12-lead ECGs will be taken in triplicate.
Number of participants with subcutaneous immunotherapy systemic reaction events
Time frame: Up to week 11
Subcutaneous immunotherapy systemic reaction events will be graded using the World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System. Each grade is based on organ system involved and severity. Organ systems are defined as cutaneous, conjunctival, upper respiratory, lower respiratory, gastrointestinal, cardiovascular and other. A reaction from a single organ system such as cutaneous, conjunctival or upper respiratory, but not asthma, gastrointestinal, or cardiovascular is classified as a grade 1. Symptom(s)/sign(s) from more than 1 organ system or asthma, gastrointestinal, or cardiovascular are classified as grades 2 or 3. Respiratory failure or hypotension with or without loss of consciousness define grade 4 and death grade 5. The grade is determined by the physician's clinical judgement.
Number of participants with specific local reactogenicity events
Time frame: Up to week 12
Participants will be asked to record local reactogenicity (pain, tenderness, erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (potentially life-threatening).
Number of participants with specific systemic reactogenicity events
Time frame: Up to week 12
Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (potentially life-threatening).
2 secondary outcomes
Change from baseline in immunological response to ASP2390 as assessed by HDM allergen-specific IgG4 levels
Time frame: Baseline and up to week 24
Number of participants with Adverse Events
Time frame: Up to 5 years
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 2 Sep 2026.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP2390 in people with Allergic to House Dust Mites, run by Astellas Pharma Global Development, Inc. at 2 sites in Germany.
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 15 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
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 with Adverse Events (AEs) (time frame: Up to week 63). The study lists 7 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 Sep 2026.