Atopic DermatitisPhase 1/2adoredNCT05003804
Allergic Disease Onset Prevention Study
A Phase 1/2 study testing STMC-103H in people with Atopic Dermatitis and Type 1 Hypersensitivity, run by Siolta Therapeutics, Inc. at 31 sites in 3 countries.
Trial summary
This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk for developing allergic disease (Type 1 hypersensitivity). Subjects will be enrolled in a three-part sequential approach. Read more about this study
- Who is it for?
- Ages 0 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Type 1 Hypersensitivity
- What is being tested?
- STMC-103H
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 283 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 1 Sep 2021to 21 Oct 2025
- Phase
- Phase 1/2
- 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 0 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All Parts (A1, A2, B)
- Subject's parent(s)/legal representative(s) providing consent must be 18 years or older
- Biological mother and/or biological father and/or full sibling(s), have a history of asthma, atopic dermatitis, food allergy, or allergic rhinitis as determined by the screening questionnaire
- Subject's parent(s)/legal representative(s) (if appropriate according to local laws) is/are willing and able to give informed consent for participation in the study
- Subject's parent(s)/legal representative(s) (if appropriate according to local laws) is/are willing and able, in the PI's opinion, to comply with all study requirements
- Part A1 Only
Show all 12Show fewer
- 5 (A1). Subject is between 1 year and < 6 years old at the time of enrollment
- Part A2 Only
- 5 (A2). Subject is between 28 days and < 12 months of life at the time of enrollment 6 (A2). Subject's parent(s)/legal representative(s) do not plan to give probiotics (including infant formula that contain probiotics) to the subject during the trial
- Part B Only
- 5 (B). Subject is ≤ 14 days of life at the time of enrollment. Sites should make every effort to enroll newborns as soon as possible after birth.
- 6 (B). Subject has a birthweight ≥ 2.5 kg and ≤ 4.5 kg 7 (B). Subject's parent(s)/legal representative(s) do not plan to give probiotics (including infant formula that contain probiotics) to the subject from the time of birth to the end of the trial.
Who cannot join
- All Parts (A1, A2, B)
- Subject's twin (or higher order multiple) is enrolled in STMC-103H-102
- Subject has any congenital abnormalities or condition, significant disease, illness, physical exam finding, or disorder that, in the opinion of the PI, may put the subject at safety risk or is likely to hinder feeding or affect metabolism that may influence the results of the study. (Neonatal hyperbilirubinemia (jaundice), including jaundice that requires phototherapy, should not be considered exclusionary).
- Subject is acutely ill or on systemic antibiotics at the time of enrollment
- Subject is participating in another interventional clinical study involving investigational medication, formula, probiotic, or prebiotic use within 30 days (or five half-lives, whichever is longer) of this study
- Subject has evidence of immune deficiency/immune compromise in the judgment of the investigator
- Part B Only
- 6 (B). Subject was born at < 35 weeks' gestation 7 (B). Biological maternal medical condition during the pregnancy that, in the opinion of the PI, may put the subject at risk because of participation in the study. (Maternal antibiotics during the time of delivery should not be considered exclusionary.)
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
United States24 sites
University of Michigan Health
Ann Arbor, Michigan, 48104
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Children's Hospital Colorado
Aurora, Colorado, 80045
Dell Medical School at UT Austin
Austin, Texas, 78723
Johns Hopkins University School of Medicine
Baltimore, MD, Maryland, 21205
Boston Children's Hospital
Boston, Massachusetts, 02215
Lurie Children's Hospital
Chicago, Illinois, 60611
University of Chicago Medicine
Chicago, Illinois, 60637
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
UT Southwestern/Children's Health
Dallas, Texas, 75235
Northwell Healthcare
Great Neck, New York, 11021
Tribe Clinical Research
Greenville, South Carolina, 29607
Riley Children's Health at University of Indiana
Indianapolis, Indiana, 46202
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
UCLA Health
Los Angeles, California, 90095
Univ. of Wisconsin-Madison/Jackson Research Group
Madison, Wisconsin, 53792
NYU Langone Fink Children's
New York, New York, 10016
Mt. Sinai Jaffe Allergy Institute
New York, New York, 10029
University of Rochester Medical Center
Rochester, New York, 14642
Rady Children's Hospital - San Diego
San Diego, California, 92123
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Seattle Allergy and Asthma Research Institute
Seattle, Washington, 98115
Coastal Pediatrics Research
Summerville, South Carolina, 29486
University of Arizona Health Sciences
Tucson, Arizona, 85724
Australia6 sites
The Women's and Children's Hospital
Adelaide, South Australia, 5000
Monash Children's Hospital
Clayton, Victoria, 3168
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Murdoch Children's Research Institute
Parkville, Victoria, 3052
Queensland Children's Hospital
South Brisbane, Queensland, 4101
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Puerto Rico1 site
Centro de Neumologia Pediatrica
Caguas, Puerto Rico, 00725
About this study
Official title: A Phase 1b/2, Randomized, Double-blind, Placebo-controlled, Multi-center Study of STMC-103H in Neonates and Infants at Risk for Developing Allergic Disease
This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk for developing allergic disease (Type 1 hypersensitivity). Subjects will be enrolled in a three-part sequential approach. Participants in the safety-run portion of the study (Part A1: 1 year to <6 years of age and A2: 1 month to <12 months of age) will receive 28 days of treatment with STMC-103H or placebo, followed by 28 days of follow-up. A Data and Safety Monitoring Committee (DSMC) will review safety data after all patients in each part complete 28 days of therapy prior to enrolling the next part. After A2, Part B will enroll 224 patients for 336 days of treatment with STMC-103H or placebo, followed by 336 days of follow-up. Stool, blood, and optional samples will be collected in Parts A2 and part B. Primary safety endpoints are frequency, type and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), as well as findings on physical exams, vitals, and safety laboratories. The primary efficacy endpoint is incidence of physician-diagnosed atopic dermatitis at day 336.
- Conditions
- Atopic Dermatitis, Type 1 Hypersensitivity
- Being tested
- STMC-103H, Placebo
- Medical subject headings
- Dermatitis, Atopic, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STMC-103HBiological
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
PlaceboBiological
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
| Study group | Role | What they receive |
|---|---|---|
| STMC-103H Part A1 | Experimental | Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days Receives: Biological: STMC-103H |
| Placebo Part A1 | Placebo comparator | Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days Receives: Biological: Placebo |
| STMC-102H Part A2 | Experimental | Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days Receives: Biological: STMC-103H |
| Placebo Part A2 | Placebo comparator | Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days Receives: Biological: Placebo |
| STMC-103H Part B | Experimental | Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days Receives: Biological: STMC-103H |
| Placebo Part B | Placebo comparator | Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A1 and A2: Assess safety and tolerability of STMC-103H in children and infants at risk for development of allergic disease by assessing adverse events (AE), serious adverse events (SAE), and AEs of special interest
Frequency, type, and severity of AEs and SAEs, including AEs of special interest (AESI) as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale)
Measured: Through 56 days of study
Part B: Assess the safety, tolerability of STMC-103H in neonate and infants subjects at risk for development of atopic disease by monitoring AEs, SAEs, AESI, physical exam findings, and clinical safety laboratories.
Frequency, type and severity of AEs, SAEs, and AESIs as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale), as well as clinically significant findings on physical examinations including growth (length, weight, height and head circumference) and vital signs (RR, HR, and temperature); clinical safety laboratories including complete blood count with manual differential and blood chemistry
Measured: Through 672 days of study
Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days
Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo
Measured: Day 336
Secondary outcomes (12)
Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis
Incidence of physician-diagnosed atopic dermatitis
Measured: At days 168 and 672
Part B - Secondary Efficacy Endpoint - atopic disease assessments
Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)
Measured: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen
Incidence of sensitization to food and aeroallergen as measured by specific serum IgE levels
Measured: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma
Incidence of physician-diagnosed food allergy, allergic rhinitis/conjunctivitis, urticaria and wheezing illnesses/asthma using physician assessment, Allergic Disease Assessment and Diagnosis questionnaire, and Allergic Disease Diagnostic Criteria \& Severity Evaluation
Measured: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis
Time to atopic dermatitis diagnosis by physician assessment
Measured: Through 672 days of study
Part B Secondary Efficacy Endpoint - Time to first wheezing episode
Time to first wheezing episode by physician assessment
Measured: Through 672 days of study
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment
Severity of atopic dermatitis by IGAxBSA assessment
Measured: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment
Severity of atopic dermatitis by SCORAD assessment
Measured: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
Severity of wheezing illness/asthma by Wheezing Severity Assessment
Measured: At days 68, 336, and 672 days
Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis
Concomitant medications prescribed/used for allergic symptoms or diagnosis and use of rescue medications for atopic dermatitis and wheezing/asthma
Measured: Through 672 days of study
Part B Secondary Efficacy Endpoint - Total Serum IgE
Total serum IgE levels
Measured: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
Peripheral eosinophil counts by automated differential
Measured: At day 336
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Sep 2021
- Primary completion26 Nov 2024
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled in a three-part sequential approach (Parts A1, A2, and B). Part A will enroll at risk participants of 1 year to less than 6 years of age; after safety review, Part A2 will enroll at risk participants of 1 month to less than 12 months of age; and after safety review, Part B will enroll at -risk participants between 0 and 14 days of life.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siolta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003804
- Sponsor's protocol ID
- STMC-103H-102
- Acronym
- adored
- Status last verified
- Nov 2025
- First submitted
- 4 Aug 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Randomized, Double-blind, Placebo-controlled, Multi-center Study of STMC-103H in Neonates and Infants at Risk for Developing Allergic Disease
- ClinicalTrials.gov ID
- NCT05003804
- Acronym / sponsor ID
- adored / STMC-103H-102
- Conditions
- Atopic Dermatitis, Type 1 Hypersensitivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Siolta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk for developing allergic disease (Type 1 hypersensitivity). Subjects will be enrolled in a three-part sequential approach. Participants in the safety-run portion of the study (Part A1: 1 year to <6 years of age and A2: 1 month to <12 months of age) will receive 28 days of treatment with STMC-103H or placebo, followed by 28 days of follow-up. A Data and Safety Monitoring Committee (DSMC) will review safety data after all patients in each part complete 28 days of therapy prior to enrolling the next part. After A2, Part B will enroll 224 patients for 336 days of treatment with STMC-103H or placebo, followed by 336 days of follow-up. Stool, blood, and optional samples will be collected in Parts A2 and part B. Primary safety endpoints are frequency, type and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), as well as findings on physical exams, vitals, and safety laboratories. The primary efficacy endpoint is incidence of physician-diagnosed atopic dermatitis at day 336.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants will be enrolled in a three-part sequential approach (Parts A1, A2, and B). Part A will enroll at risk participants of 1 year to less than 6 years of age; after safety review, Part A2 will enroll at risk participants of 1 month to less than 12 months of age; and after safety review, Part B will enroll at -risk participants between 0 and 14 days of life.
| Arm | Type | Receives |
|---|---|---|
| STMC-103H Part A1 | Experimental | Biological: STMC-103HOnce daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days |
| Placebo Part A1 | Placebo comparator | Biological: PlaceboOnce daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days |
| STMC-102H Part A2 | Experimental | Biological: STMC-103HOnce daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days |
| Placebo Part A2 | Placebo comparator | Biological: PlaceboOnce daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days |
| STMC-103H Part B | Experimental | Biological: STMC-103HOnce daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days |
| Placebo Part B | Placebo comparator | Biological: PlaceboOnce daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- All Parts (A1, A2, B)
- Part A1 Only
- 5 (A1). Subject is between 1 year and < 6 years old at the time of enrollment
- Part A2 Only
- 5 (A2). Subject is between 28 days and < 12 months of life at the time of enrollment 6 (A2). Subject's parent(s)/legal representative(s) do not plan to give probiotics (including infant formula that contain probiotics) to the subject during the trial
Key exclusion criteria (8 listed)
- All Parts (A1, A2, B)
- Part B Only
- 6 (B). Subject was born at < 35 weeks' gestation 7 (B). Biological maternal medical condition during the pregnancy that, in the opinion of the PI, may put the subject at risk because of participation in the study. (Maternal antibiotics during the time of delivery should not be considered exclusionary.)
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 |
|---|---|---|
| STMC-103HSTMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria | Biological | STMC-102H Part A2, STMC-103H Part A1, STMC-103H Part B |
| PlaceboPowder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide. | Biological | Placebo Part A1, Placebo Part A2, Placebo Part B |
Primary outcome
Part A1 and A2: Assess safety and tolerability of STMC-103H in children and infants at risk for development of allergic disease by assessing adverse events (AE), serious adverse events (SAE), and AEs of special interest
Time frame: Through 56 days of study
Frequency, type, and severity of AEs and SAEs, including AEs of special interest (AESI) as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale)
Part B: Assess the safety, tolerability of STMC-103H in neonate and infants subjects at risk for development of atopic disease by monitoring AEs, SAEs, AESI, physical exam findings, and clinical safety laboratories.
Time frame: Through 672 days of study
Frequency, type and severity of AEs, SAEs, and AESIs as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale), as well as clinically significant findings on physical examinations including growth (length, weight, height and head circumference) and vital signs (RR, HR, and temperature); clinical safety laboratories including complete blood count with manual differential and blood chemistry
Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days
Time frame: Day 336
Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo
12 secondary outcomes
Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis
Time frame: At days 168 and 672
Part B - Secondary Efficacy Endpoint - atopic disease assessments
Time frame: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen
Time frame: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma
Time frame: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis
Time frame: Through 672 days of study
Part B Secondary Efficacy Endpoint - Time to first wheezing episode
Time frame: Through 672 days of study
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment
Time frame: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment
Time frame: At days 168, 336 and 672
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
Time frame: At days 68, 336, and 672 days
Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis
Time frame: Through 672 days of study
Part B Secondary Efficacy Endpoint - Total Serum IgE
Time frame: At days 168, 336, and 672
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
Time frame: At day 336
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STMC-103H in people with Atopic Dermatitis and Type 1 Hypersensitivity, run by Siolta Therapeutics, Inc. at 31 sites in 3 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 8 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Australia, Puerto Rico. 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 combined 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part A1 and A2: Assess safety and tolerability of STMC-103H in children and infants at risk for development of allergic disease by assessing adverse events (AE), serious adverse events (SAE), and AEs of special interest (time frame: Through 56 days of study). The study lists 3 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 20 Nov 2025.