Rhinitis, AllergicMISTNCT05922176
Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients with Allergic Rhinitis
An observational study of Rhinitis, Allergic, run by Yonsei University at 1 site in South Korea.
Trial summary
Allergic rhinitis is a disease in which the nasal mucous membrane overreacts to allergens, resulting in symptoms such as spasmodic and repetitive sneezing, rhinorrhea, and stuffy nose, and can be treated with immunotherapy for radical treatment. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Evaluation of clinical indicators, Sample collection before& after immunotherapy and Sample collection before& after immunotherapy
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2023to 31 Mar 2026
- Phase
- Observational
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. Adult male and female patients aged 19 to 60 with allergic rhinitis caused by house dust mite antigen in the U.S. (If house dust mite is positive for MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L) 2. Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma)
Who may be able to join
- A. patient group of House dust mite
- Adult male and female patients aged 19 to 60 with allergic rhinitis caused by the antigen of the American house dust mite (It is judged that the positive for the house dust mite is MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L)
- Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma)
- A person who has signed a written consent to participate in this clinical trial at his/her own discretion after fully explaining the purpose, contents, characteristics of the test drug, and expected adverse reactions prior to participation in the clinical trial B. Control group (Normal person)
- <!-- -->
- Adults 19 years of age or older who are judged to be free from skin diseases or allergic diseases through medical examination and visual observation by a specialist
- A person who agrees to provide samples derived from the human body
- A person who voluntarily agreed to this study and prepared a consent form after approval of the IRB
Who cannot join
- A. patient group of House dust mite
- Patients who are taking drugs that may affect efficacy evaluation (but can participate if there is no change in the drug taken during the study period)
- Within six months of participation in the study, other clinical trial drugs or biological equivalence test drugs, biological agents (e.g. Anti-IgE) were administered
- If there is a skin disease or tattoo in the area where the medication is applied
- Immunosuppressive therapy or systemic steroid therapy for acute and chronic inflammatory skin diseases
- A person in charge of testing or a person in charge of testing deemed inappropriate to participate in the test due to other reasons B. Control (Normal person)
Show all 9Show fewer
- <!-- -->
- Patients with allergic diseases such as atopic dermatitis or allergic asthma and rhinitis
- A person who voluntarily disagrees with this study after approval of the IRB and has not completed the consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
Kyung Hee Park, +82-2-2228-1947, white182@yuhs.ac
Im Shin, +82-2-2228-5884, si1011@yuhs.ac
About this study
Allergic rhinitis is a disease in which the nasal mucous membrane overreacts to allergens, resulting in symptoms such as spasmodic and repetitive sneezing, rhinorrhea, and stuffy nose, and can be treated with immunotherapy for radical treatment. Immunotherapy treatments include subcutaneous injections, sublingual tablets, and sublingual fluids, and subcutaneous injections have the risk of anaphylaxis, the hassle of daily administration at home, and local allergic reactions. Transdermal absorption immunotherapy (DF19001) that can compensate for the shortcomings of these existing immunotherapy drugs is currently under clinical research in Korea (Severance Hospital IRB No. 4-2021-1345).
Immunotherapy requires periodic monitoring, such as analyzing immunological changes through sample collection and determining the dose and cycle of administration, because the treatment period is long and individual immune responses are different. Existing methods for confirming immune responses in samples used invasive skin biopsy and blood collection methods, but in-blood evaluation indicators have the disadvantage of being ineffective as initial efficacy evaluations or predictive evaluations before treatment. In addition, skin biopsy should be performed by a specialist, and there is a disadvantage that resistance occurs because the patient's pain is accompanied, and scars or bruises may remain. Therefore, since it is a biopsy through minimal invasion compared to a tissue biopsy, the investigators would like to use a method of collecting skin samples through a microstructure (micro needle patch), a method that has little pain and no scars. Through this study, RNA is obtained from patients with house dust mite allergic rhinitis through minimally invasive skin samples, and immunotherapy response evaluation biomarkers are screened according to immunotherapy implementation, and its use as an indicator of immunotherapy prognosis in allergic diseases.
Read the detailed description
Allergic rhinitis is a disease in which the nasal mucosa overreacts to allergens, resulting in symptoms such as seizure and repetitive sneezing, runny nose, and stuffy nose. Typical treatments include avoiding causative substances and anti-allergic medication. Immunotherapy may not be sufficient for treatment satisfaction with existing treatments, it is practically impossible to avoid allergens, or allergen specific immunotherapy may be performed for more root treatment.
Immunotherapy is known as the only way to change the natural course of allergic diseases by increasing the amount of substances that cause allergic reactions to allergic patients from a small amount and reducing allergic reactions through repeated administration for three to five years. Immunotherapy treatments include hypodermic injections, hypodermic tablets, and hypodermic fluids, and each has its pros and cons. Subcutaneous injection immunotherapy requires regular visits to a medical institution for injection, and there is a risk of anaphylaxis. Although sublingual immunotherapy has a low risk of anaphylaxis, it is cumbersome to administer it daily at home, and the incidence of local allergic reactions in the oral cavity is high due to 30 to 70 times less absorption in the body than injection treatments. Transdermal absorption immunotherapy (DF19001) that can compensate for the shortcomings of these existing immunotherapy drugs is currently under clinical research in Korea (Serbans Hospital IRB No. 4-2021-1345).
These immunotherapy require periodic monitoring, such as analyzing immunological changes through sample collection and determining administration dose and cycle, because the treatment period is long at 3-5 years and individual immune responses are different. Most of the existing methods for confirming immune responses in samples used invasive skin biopsy or blood collection methods, but allergen specific IgE (allergen specific IgG4, blocking factors) have the disadvantage of being ineffective as an initial efficacy evaluation or a pre-treatment prediction evaluation of a subject. In addition, various analysis methods can be used through skin biopsy to see changes in the initial immune response of the inoculation site, but this must be performed by a specialist, and has the disadvantage of being resistant to patient pain and scarring or bruising.
Therefore, in order to overcome these difficulties through this clinical study, the investigators would like to use a method of collecting skin samples through a microstructure (micro needle patch). When the microstructure patch is applied to the skin surface for 5 minutes, it passes through the microstructure's fine needle (<0.5 mm long) keratin layer and enters the inside of the skin as shown in the image below. Various immunological indicators are analyzed by collecting skin factors remaining in the patch by applying the patch for a sufficient time for various factors in the epidermis and dermis layer to be adsorbed through the microstructure that has entered the skin.
Since this method is a biopsy through minimal invasion compared to conventional tissue biopsy, there is little pain and no scarring, and previous studies have confirmed that a small amount of RNA can be separated from skin samples using microstructure patches and microarray can be performed. In addition, in the same way, the detection of protein biomarkers according to the test collection method for determining treatment in patients with atopic dermatitis was observed.
Therefore, this study aims to obtain RNA from patients with house dust mite allergic rhinitis through minimally invasive skin samples, screen the biomarker for immunotherapy response evaluation through immunotherapy and confirm its use as an indicator of immunotherapy prognosis in allergic diseases.
- Conditions
- Rhinitis, Allergic
- Being tested
- Evaluation of clinical indicators, Sample collection before& after immunotherapy, Sample collection before& after immunotherapy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of clinical indicators, Sample collection before& after immunotherapyOther
- Evaluation of clinical indicators before immunotherapy
- Symptom Scale for Rhinitis: Total Nasal Symptom Score (TNSS), Rhnitis Quality of Life Questionnaire(RQLQ)
- American house dust mite-specific immunogloblin G4 (sIgG4)
- American house dust mite-specific immunogloblin E (sIgE)
- Sample collection before immunotherapy
- Skin: Skin test using minimally invasive microstructure patch stripping method
- Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.)
- Evaluation of clinical indicators 4 to 6 months after immunotherapy
: Treatment is performed for about 4 months, and the progress of treatment is evaluated through the evaluation of the following clinical indicators.
same as examination in 'A'
- Sample collection after 4 to 6 months of immunotherapy same as examination in 'B'
Sample collection before& after immunotherapyOther
- Sample collection before immunotherapy
- Skin: Skin test using minimally invasive microstructure patch stripping method
- Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.)
- Sample collection after 4 to 6 months of immunotherapy
- Skin: Skin test using minimally invasive microstructure patch stripping method
- Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.)
| Study group | Role | What they receive |
|---|---|---|
| patient group of House dust mist allergic rhinitis | 1. Adult male and female patients aged 19 to 60 with allergic rhinitis caused by the antigen of the American house dust mite (It is judged that the positive for the house dust mite is MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L)
2. Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma)
3. A person who has signed a written consent to participate in this clinical trial at his/her own discretion after fully explaining the purpose, contents, characteristics of the test drug, and expected adverse reactions prior to participation in the clinical trial Receives: Other: Evaluation of clinical indicators, Sample collection before& after immunotherapy | |
| control group | 1. Adults 19 years of age or older who are judged to be free from skin diseases or allergic diseases through medical examination and visual observation by a specialist
2. A person who agrees to provide samples derived from the human body
3. A person who voluntarily agreed to this study and prepared a consent form after approval of the IRB Receives: Other: Sample collection before& after immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of transcriptomic profiles based on RNA
Based on RNA extracted from skin samples, transcriptomic profiles are analyzed to identify related RNAs that show meaningful changes compared to normal people and immunotherapy using heatmap, and it is estimated that Th2 or Treg-related RNA profiles will be significantly different
Measured: 4-6 months after baseline
Secondary outcomes (1)
Differences in immunological efficacy by type of immunotherapy (subcutaneous, sublingual, percutaneous)
Whether there is a difference in immunological efficacy by type of immunotherapy (subcutaneous, sublingual, percutaneous) is confirmed through pre- and post-group comparisons.
Measured: 4-6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start22 May 2023
- Primary completion7 Feb 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Park Kyung Hee, Yonsei University
- Investigators
- Kyung Hee Park, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922176
- Sponsor's protocol ID
- 4-2023-0353
- Acronym
- MIST
- Status last verified
- Mar 2025
- First submitted
- 18 Jun 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients with Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05922176
- Acronym / sponsor ID
- MIST / 4-2023-0353
- Conditions
- Rhinitis, Allergic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 22 May 2023 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 28 Jun 2023 (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.
Allergic rhinitis is a disease in which the nasal mucous membrane overreacts to allergens, resulting in symptoms such as spasmodic and repetitive sneezing, rhinorrhea, and stuffy nose, and can be treated with immunotherapy for radical treatment. Immunotherapy treatments include subcutaneous injections, sublingual tablets, and sublingual fluids, and subcutaneous injections have the risk of anaphylaxis, the hassle of daily administration at home, and local allergic reactions. Transdermal absorption immunotherapy (DF19001) that can compensate for the shortcomings of these existing immunotherapy drugs is currently under clinical research in Korea (Severance Hospital IRB No. 4-2021-1345).
Immunotherapy requires periodic monitoring, such as analyzing immunological changes through sample collection and determining the dose and cycle of administration, because the treatment period is long and individual immune responses are different. Existing methods for confirming immune responses in samples used invasive skin biopsy and blood collection methods, but in-blood evaluation indicators have the disadvantage of being ineffective as initial efficacy evaluations or predictive evaluations before treatment. In addition, skin biopsy should be performed by a specialist, and there is a disadvantage that resistance occurs because the patient's pain is accompanied, and scars or bruises may remain. Therefore, since it is a biopsy through minimal invasion compared to a tissue biopsy, the investigators would like to use a method of collecting skin samples through a microstructure (micro needle patch), a method that has little pain and no scars. Through this study, RNA is obtained from patients with house dust mite allergic rhinitis through minimally invasive skin samples, and immunotherapy response evaluation biomarkers are screened according to immunotherapy implementation, and its use as an indicator of immunotherapy prognosis in allergic diseases.
Detailed description
Allergic rhinitis is a disease in which the nasal mucosa overreacts to allergens, resulting in symptoms such as seizure and repetitive sneezing, runny nose, and stuffy nose. Typical treatments include avoiding causative substances and anti-allergic medication. Immunotherapy may not be sufficient for treatment satisfaction with existing treatments, it is practically impossible to avoid allergens, or allergen specific immunotherapy may be performed for more root treatment.
Immunotherapy is known as the only way to change the natural course of allergic diseases by increasing the amount of substances that cause allergic reactions to allergic patients from a small amount and reducing allergic reactions through repeated administration for three to five years. Immunotherapy treatments include hypodermic injections, hypodermic tablets, and hypodermic fluids, and each has its pros and cons. Subcutaneous injection immunotherapy requires regular visits to a medical institution for injection, and there is a risk of anaphylaxis. Although sublingual immunotherapy has a low risk of anaphylaxis, it is cumbersome to administer it daily at home, and the incidence of local allergic reactions in the oral cavity is high due to 30 to 70 times less absorption in the body than injection treatments. Transdermal absorption immunotherapy (DF19001) that can compensate for the shortcomings of these existing immunotherapy drugs is currently under clinical research in Korea (Serbans Hospital IRB No. 4-2021-1345).
These immunotherapy require periodic monitoring, such as analyzing immunological changes through sample collection and determining administration dose and cycle, because the treatment period is long at 3-5 years and individual immune responses are different. Most of the existing methods for confirming immune responses in samples used invasive skin biopsy or blood collection methods, but allergen specific IgE (allergen specific IgG4, blocking factors) have the disadvantage of being ineffective as an initial efficacy evaluation or a pre-treatment prediction evaluation of a subject. In addition, various analysis methods can be used through skin biopsy to see changes in the initial immune response of the inoculation site, but this must be performed by a specialist, and has the disadvantage of being resistant to patient pain and scarring or bruising.
Therefore, in order to overcome these difficulties through this clinical study, the investigators would like to use a method of collecting skin samples through a microstructure (micro needle patch). When the microstructure patch is applied to the skin surface for 5 minutes, it passes through the microstructure's fine needle (<0.5 mm long) keratin layer and enters the inside of the skin as shown in the image below. Various immunological indicators are analyzed by collecting skin factors remaining in the patch by applying the patch for a sufficient time for various factors in the epidermis and dermis layer to be adsorbed through the microstructure that has entered the skin.
Since this method is a biopsy through minimal invasion compared to conventional tissue biopsy, there is little pain and no scarring, and previous studies have confirmed that a small amount of RNA can be separated from skin samples using microstructure patches and microarray can be performed. In addition, in the same way, the detection of protein biomarkers according to the test collection method for determining treatment in patients with atopic dermatitis was observed.
Therefore, this study aims to obtain RNA from patients with house dust mite allergic rhinitis through minimally invasive skin samples, screen the biomarker for immunotherapy response evaluation through immunotherapy and confirm its use as an indicator of immunotherapy prognosis in allergic diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group of House dust mist allergic rhinitis | – | Other: Evaluation of clinical indicators, Sample collection before& after immunotherapy1. Adult male and female patients aged 19 to 60 with allergic rhinitis caused by the antigen of the American house dust mite (It is judged that the positive for the house dust mite is MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L) 2. Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma) 3. A person who has signed a written consent to participate in this clinical trial at his/her own discretion after fully explaining the purpose, contents, characteristics of the test drug, and expected adverse reactions prior to participation in the clinical trial |
| control group | – | Other: Sample collection before& after immunotherapy1. Adults 19 years of age or older who are judged to be free from skin diseases or allergic diseases through medical examination and visual observation by a specialist 2. A person who agrees to provide samples derived from the human body 3. A person who voluntarily agreed to this study and prepared a consent form after approval of the IRB |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Adult male and female patients aged 19 to 60 with allergic rhinitis caused by house dust mite antigen in the U.S. (If house dust mite is positive for MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L) 2. Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma)
Key inclusion criteria (8 listed)
- A. patient group of House dust mite
- <!-- -->
Key exclusion criteria (9 listed)
- A. patient group of House dust mite
- <!-- -->
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 |
|---|---|---|
| Evaluation of clinical indicators, Sample collection before& after immunotherapyA. Evaluation of clinical indicators before immunotherapy 1. Symptom Scale for Rhinitis: Total Nasal Symptom Score (TNSS), Rhnitis Quality of Life Questionnaire(RQLQ) 2. American house dust mite-specific immunogloblin G4 (sIgG4) 3. American house dust mite-specific immunogloblin E (sIgE) B. Sample collection before immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.) C. Evaluation of clinical indicators 4 to 6 months after immunotherapy : Treatment is performed for about 4 months, and the progress of treatment is evaluated through the evaluation of the following clinical indicators. same as examination in 'A' D. Sample collection after 4 to 6 months of immunotherapy same as examination in 'B' | Other | patient group of House dust mist allergic rhinitis |
| Sample collection before& after immunotherapyB. Sample collection before immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.) D. Sample collection after 4 to 6 months of immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.) | Other | control group |
Primary outcome
Analysis of transcriptomic profiles based on RNA
Time frame: 4-6 months after baseline
Based on RNA extracted from skin samples, transcriptomic profiles are analyzed to identify related RNAs that show meaningful changes compared to normal people and immunotherapy using heatmap, and it is estimated that Th2 or Treg-related RNA profiles will be significantly different
1 secondary outcome
Differences in immunological efficacy by type of immunotherapy (subcutaneous, sublingual, percutaneous)
Time frame: 4-6 months after baseline
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Rhinitis, Allergic
Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
Not yet recruitingObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
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.
Kyung Hee Park principal investigator
Yonsei University Health System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic, run by Yonsei University at 1 site in South Korea.
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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Kyung Hee Park (+82-2-2228-1947, white182@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of transcriptomic profiles based on RNA (time frame: 4-6 months after baseline). 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 11 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.