Bordetella Pertussis, Whooping CoughPhase 2NCT05116241
Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children
A Phase 2 study testing BPZE1 pertussis vaccine and Boostrix in people with Bordetella Pertussis, Whooping Cough, run by ILiAD Biotechnologies at 16 sites in 3 countries.
Trial summary
This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Bordetella Pertussis, Whooping Cough
- What is being tested?
- BPZE1 pertussis vaccine and Boostrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 11 Nov 2021to 15 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female subject 6 to 17 years of age on Day 1.
- Subject must provide informed consent (assent, depending on age) prior to participation in study and comply with protocol requirements.
- If female, the subject is not pregnant or lactating. If female of childbearing potential, the subject must agree to either be heterosexually inactive or follow birth control methods per protocol from at least 21 days prior to enrollment and through 90 days following any study vaccination.
- Subject has a stable health status, as established by physical examination, vital sign measurements, and medical history.
- Subject (and/or legal guardian) has access to a consistent and reliable means of electronic or telephone contact, which may be in the home, workplace, school, or by personal mobile electronic device.
- Subject is willing to refrain from routine nasal sprays (including steroid sprays) or washes for at least 7 days following any study vaccination.
Who cannot join
- The subject has a history of whole-cell pertussis vaccination in lifetime, acellular pertussis-containing vaccination (inclusive of school vaccination programs) within 3 years prior to Day 1, documented B. pertussis infection within 3 years prior to Day 1, or a history of Td-containing vaccination (without pertussis vaccine component) within 1 month prior to Day 1.
- Chronic significant illness actively being treated or a history of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator).
- History of cancer (malignancy).
- Congenital, hereditary, or acquired disease or disorder classified as autoimmune, immunodeficient, coagulopathy, hepatic, renal, neurologic, or cognitive.
- Currently uses smoking products (including vaping and e-cigarettes) and is unwilling to refrain from use from Day 1 through Day 29 following study vaccination.
- Subject received immunoglobulin, blood-derived products, systemic corticosteroids (at a dose of >10 mg per day for more than 10 days), or other immunosuppressant drugs within 90 days of Day 1.
Show all 11Show fewer
- Chronic pulmonary disease requiring active medication or pulmonary therapies except exercise-induced bronchospasm, if currently well controlled, and willing to refrain from intense exercise for 7 days following study vaccination, or intermittent asthma classification who have not had an exacerbation requiring oral systemic corticosteroids in the past year; have an forced expiratory volume (FEV1) documented to be >80%; do not have restrictions in normal activity due to breathing issues; and have used a short-acting beta-agonist less than or equal to 2 days per week over the past 2 months.
- History of oro/nasopharynx surgery (eg, adenoidectomy, tonsillectomy) within 60 days prior to Day 1.
- Known hypersensitivity to latex or any component of any study vaccine. Specific to Boostrix: hypersensitivity to neomycin or polymyxin; hypersensitivity after previous administration of diphtheria, tetanus, or pertussis vaccines; or has experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus.
- Subject has routine and/or repeated contact with, or is currently living in a household with, an immunocompromised individual.
- Subject resides in a residence where an infant less than 6 months of age resides or may reside.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United Kingdom8 sites
Birmingham Children's Hospital NHS Foundation Trust
Birmingham
Bradford Royal Infirmary
Bradford
Bristol Royal Hospital For Children
Bristol
Addenbrooke's Hospital
Cambridge
Leicester Children's Hospital, Ward 14, Level 4,
Leicester
St George's Healthcare NHS Trust
London
Oxford Vaccine Group
Oxford
University Hospital Southampton NHS Foundation Trust
Southampton
Australia5 sites
University of Melbourne
Melbourne, Victoria
Telethon Kids Institute
Nedlands, Western Australia
Women's and Children's Hospital
North Adelaide, South Australia
Sydney Children's Hospital
Randwick, New South Wales
Sydney Children's Hospital
Westmead, New South Wales
Costa Rica3 sites
CSA Clinica San Augustin
San José
IICIMED Instituto de Investigacion en Ciencias Medicas
San José
MRI, Metropolitan Research Institute
San José
About this study
Official title: Phase 2b Placebo-Controlled Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess Immunological Response and Safety of a Single Dose BPZE1 With/Without Coadministration of Tdap (Boostrix™)
This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety follow-up after the first vaccination.
Read the detailed description
This multi-center, randomized, placebo- and active-comparator-controlled study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease. Healthy school-age children will be randomly assigned to 1 of 3 different study treatment groups to receive the intranasal BPZE1 vaccine, the intramuscular Boostrix vaccine, or both. Subjects will first receive the intranasal vaccine (BPZE1 or placebo) using a small, cone-shaped device that attaches to a syringe and sprays the vaccine into the nose. After a 10-minute waiting period, subjects will receive the intramuscular vaccine (Boostrix or placebo) in the upper arm. As this is the first study in school-age children, a staggered enrollment is planned with the first 45 subjects in the older age group of 11-17 years designated as the safety lead-in cohort. After reactogenicity results from the first 7 days after vaccination of the safety lead-in cohort are reviewed by the safety monitoring committee, the remainder of the subjects will be enrolled. Subjects who choose to take part in a small sub-study of revaccination/attenuated challenge will receive BPZE1 intranasal vaccine (open-label) 3 months after the first vaccination. Safety will be monitored for 6 months after the first vaccination.
- Conditions
- Bordetella Pertussis, Whooping Cough
- Being tested
- BPZE1 pertussis vaccine and placebo, BPZE1 pertussis vaccine and Boostrix, Placebo and Boostrix
- Keywords
- Bordetella pertussis (B. pertussis), Whooping Cough, BPZE1, Boostrix, Vaccine, Children, Booster, Live attenuated vaccine
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPZE1 pertussis vaccine and placeboBiological
Live attenuated pertussis vaccine and placebo
BPZE1 pertussis vaccine and BoostrixBiological
Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine
Placebo and BoostrixBiological
Tetanus, diphtheria, and aP vaccine and placebo
| Study group | Role | What they receive |
|---|---|---|
| BPZE1 intranasal and Placebo intramuscular | Experimental | Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo. Receives: Biological: BPZE1 pertussis vaccine and placebo |
| BPZE1 intranasal and Boostrix intramuscular | Experimental | Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis [aP] vaccine). Receives: Biological: BPZE1 pertussis vaccine and Boostrix |
| Placebo intranasal and Boostrix intramuscular | Active comparator | Individual will receive an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator). Receives: Biological: Placebo and Boostrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29
Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix) at Day 29.
Measured: Day 29
Safety: Solicited Adverse Events (AEs)
Solicited AEs (local injection site, nasal/respiratory, and systemic reactogenicity events)
Measured: Through 7 days following first study vaccination.
Secondary outcomes (8)
Serum IgG: Proportion of Subjects With Antibody Concentration ≥0.1 Immunogenicity Serum IgG for Diphtheria, Tetanus
Serum IgG levels against diphtheria, tetanus by treatment groups (BPZE1 + Boostrix vs Boostrix)
Measured: Day 29
Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens
Serum IgG levels against acellular pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin [PRN]) by treatment groups (BPZE1 + Boostrix vs Boostrix)
Measured: Day 29
Mucosal Immunogenicity S-IgA GMR
Induction of normalized S-IgA against WCE, PT, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development (fimbriae serotype 2 and 3; FIM 2/3) using GMR
Measured: Baseline, Day 29
Mucosal Immunogenicity S-IgA GMFR
Induction of normalized S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development (FIM 2/3) using GMFR
Measured: Day 29
Serum Immunogenicity IgA and IgG GMC
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development (FIM 2/3) using GMC
Measured: Baseline, Day 29
Serum Immunogenicity IgA and IgG GMFR
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development (FIM 2/3) using GMFR
Measured: Baseline, Day 29
Safety: Reactogenicity and AEs
To describe reactogenicity events during the 7 days following any study vaccination (7 days after Day 1 study vaccination and 7 days after Day 85 attenuated challenge with open-label BPZE1), all AEs through 28 days following Day 1 study vaccination and Day 85 attenuated challenge with open-label BPZE1, medically-attended AEs (MAAE) through 84 days following Day 1 study vaccination and Day 85 attenuated challenge with open-label BPZE1, AEs of special interest (AESIs) and serious adverse events (SAE) through Day 169 (EOS).
Measured: Through 7 days, 28 days, and 169 days (EOS) following any study vaccination respectively
Colonization (Substudy Only)
Proportion of subjects with positive B. pertussis by culture or polymerase chain reaction [PCR]) following re-vaccination/attenuated challenge (BPZE1, BPZE1 + Boostrix, BPZE1 and BPZE1 + Boostrix, Boostrix control)
Measured: Day 92 or Day 99.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start11 Nov 2021
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bordetella Pertussis, Whooping CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- ILiAD Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116241
- Sponsor's protocol ID
- IB-201P
- Status last verified
- Oct 2025
- First submitted
- 20 Oct 2021
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Faust SN, Cespedes J, Avila L, Ivankovich-Escoto G, Marshall HS, Richmond P, Nolan T, Bernatoniene J, Bandi S, Shenoy A, Rayner S, Weissfeld L, Lang W, Samal V, Goldstein P, Rubin K, Locht C, Noviello S; SUPER Trial Investigators. Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, evaluated with and without tetanus-reduced diphtheria-acellular pertussis vaccine in healthy children aged 6-17 years: a randomised, active-controlled and placebo-controlled, phase 2b trial. Lancet Infect Dis. 2026 Oct 1:S1473-3099(26)00470-6. doi: 10.1016/S1473-3099(26)00470-6. Online ahead of print.
PubMed 42822488
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Placebo-Controlled Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess Immunological Response and Safety of a Single Dose BPZE1 With/Without Coadministration of Tdap (Boostrix™)
- ClinicalTrials.gov ID
- NCT05116241
- Acronym / sponsor ID
- IB-201P
- Conditions
- Bordetella Pertussis, Whooping Cough
- Keywords
- Bordetella pertussis (B. pertussis), Whooping Cough, BPZE1, Boostrix, Vaccine, Children, Booster, Live attenuated vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- ILiAD BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety follow-up after the first vaccination.
Detailed description
This multi-center, randomized, placebo- and active-comparator-controlled study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease. Healthy school-age children will be randomly assigned to 1 of 3 different study treatment groups to receive the intranasal BPZE1 vaccine, the intramuscular Boostrix vaccine, or both. Subjects will first receive the intranasal vaccine (BPZE1 or placebo) using a small, cone-shaped device that attaches to a syringe and sprays the vaccine into the nose. After a 10-minute waiting period, subjects will receive the intramuscular vaccine (Boostrix or placebo) in the upper arm. As this is the first study in school-age children, a staggered enrollment is planned with the first 45 subjects in the older age group of 11-17 years designated as the safety lead-in cohort. After reactogenicity results from the first 7 days after vaccination of the safety lead-in cohort are reviewed by the safety monitoring committee, the remainder of the subjects will be enrolled. Subjects who choose to take part in a small sub-study of revaccination/attenuated challenge will receive BPZE1 intranasal vaccine (open-label) 3 months after the first vaccination. Safety will be monitored for 6 months after the first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BPZE1 intranasal and Placebo intramuscular | Experimental | Biological: BPZE1 pertussis vaccine and placeboIndividual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo. |
| BPZE1 intranasal and Boostrix intramuscular | Experimental | Biological: BPZE1 pertussis vaccine and BoostrixIndividual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis [aP] vaccine). |
| Placebo intranasal and Boostrix intramuscular | Active comparator | Biological: Placebo and BoostrixIndividual will receive an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female subject 6 to 17 years of age on Day 1.
- Subject must provide informed consent (assent, depending on age) prior to participation in study and comply with protocol requirements.
- If female, the subject is not pregnant or lactating. If female of childbearing potential, the subject must agree to either be heterosexually inactive or follow birth control methods per protocol from at least 21 days prior to enrollment and through 90 days following any study vaccination.
- Subject has a stable health status, as established by physical examination, vital sign measurements, and medical history.
- Subject (and/or legal guardian) has access to a consistent and reliable means of electronic or telephone contact, which may be in the home, workplace, school, or by personal mobile electronic device.
Key exclusion criteria (11 listed)
- The subject has a history of whole-cell pertussis vaccination in lifetime, acellular pertussis-containing vaccination (inclusive of school vaccination programs) within 3 years prior to Day 1, documented B. pertussis infection within 3 years prior to Day 1, or a history of Td-containing vaccination (without pertussis vaccine component) within 1 month prior to Day 1.
- Chronic significant illness actively being treated or a history of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator).
- History of cancer (malignancy).
- Congenital, hereditary, or acquired disease or disorder classified as autoimmune, immunodeficient, coagulopathy, hepatic, renal, neurologic, or cognitive.
- Currently uses smoking products (including vaping and e-cigarettes) and is unwilling to refrain from use from Day 1 through Day 29 following study vaccination.
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 |
|---|---|---|
| BPZE1 pertussis vaccine and placeboLive attenuated pertussis vaccine and placebo | Biological | BPZE1 intranasal and Placebo intramuscular |
| BPZE1 pertussis vaccine and BoostrixLive attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine | Biological | BPZE1 intranasal and Boostrix intramuscular |
| Placebo and BoostrixTetanus, diphtheria, and aP vaccine and placebo | Biological | Placebo intranasal and Boostrix intramuscular |
Primary outcome
Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29
Time frame: Day 29
Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix) at Day 29.
Safety: Solicited Adverse Events (AEs)
Time frame: Through 7 days following first study vaccination.
Solicited AEs (local injection site, nasal/respiratory, and systemic reactogenicity events)
8 secondary outcomes
Serum IgG: Proportion of Subjects With Antibody Concentration ≥0.1 Immunogenicity Serum IgG for Diphtheria, Tetanus
Time frame: Day 29
Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens
Time frame: Day 29
Mucosal Immunogenicity S-IgA GMR
Time frame: Baseline, Day 29
Mucosal Immunogenicity S-IgA GMFR
Time frame: Day 29
Serum Immunogenicity IgA and IgG GMC
Time frame: Baseline, Day 29
Serum Immunogenicity IgA and IgG GMFR
Time frame: Baseline, Day 29
Safety: Reactogenicity and AEs
Time frame: Through 7 days, 28 days, and 169 days (EOS) following any study vaccination respectively
Colonization (Substudy Only)
Time frame: Day 92 or Day 99.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42822488Faust SN, Cespedes J, Avila L, Ivankovich-Escoto G, Marshall HS, Richmond P, Nolan T, Bernatoniene J, Bandi S, Shenoy A, Rayner S, Weissfeld L, Lang W, Samal V, Goldstein P, Rubin K, Locht C, Noviello S; SUPER Trial Investigators. Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, evaluated with and without tetanus-reduced diphtheria-acellular pertussis vaccine in healthy children aged 6-17 years: a randomised, active-controlled and placebo-controlled, phase 2b trial. Lancet Infect Dis. 2026 Oct 1:S1473-3099(26)00470-6. doi: 10.1016/S1473-3099(26)00470-6. Online ahead of print.
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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.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPZE1 pertussis vaccine and Boostrix in people with Bordetella Pertussis, Whooping Cough, run by ILiAD Biotechnologies at 16 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 6 inclusion and 11 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 6 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 16 sites in United Kingdom, Australia, Costa Rica. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29 (time frame: Day 29). 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?
On the ClinicalTrials.gov record for NCT05116241, which also lists 1 linked publication.
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 6 Nov 2025.