Rheumatologic DisorderPhase 2NCT03277703
Flu Vaccine Response in Patients on Biologic Therapies
A Phase 2 study testing Influenza vaccine in people with Rheumatologic Disorder and Inflammatory Bowel Diseases, run by Stony Brook University at 1 site in United States.
Trial summary
This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Read more about this study
- Who is it for?
- Ages 3 to 22 years
- Conditions the study is for
- Rheumatologic Disorder, Inflammatory Bowel Diseases, Immune Complex Diseases
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2017to 30 Dec 2019
- 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 3 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children ages 3-22 years
- Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows:
- TNF inhibitors [etanercept (Enbrel), adalimumab (Humira®), infliximab (Remicade®)]
- anti IL -1 [anakinra (Kineret®) or canakinumab (Ilaris®)]
- IL-6 tocilizumab (Actemra®)
- anti IL-12/23 ustekinumab (Stelara®)
Show all 14Show fewer
- anti CTLA-4 [abatacept (Orencia®)]
- vedolizumab (Entyvio®)
- azathioprine (Imuran®)
- 6 mercaptopurine (Purinethol®)
- Cyclosporine
- Leflunomide
- Mycophenolate
- methotrexate (Otrexup® or Rasuvo®)
Who cannot join
- Prior allergic reaction to any vaccine components
- Other contraindication to influenza vaccination
- Severe egg allergy
- Pregnancy
- Prior Guillain-Barre syndrome
- Therapy with oral corticosteroids ≥2 mg/mg/day within 4 weeks of study entry
Show all 11Show fewer
- Prior rituximab
- Prior cyclophosphamide
- Prior IVIG within 8 weeks
- Acute febrile illness at time of study evaluation
- No prior history of two doses of influenza in the past for ages 3-8 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center
East Setauket, New York, 11733
About this study
Official title: Booster Vaccine Strategy to Improve Serologic Responses to Influenza Vaccination in Children With Rheumatic Diseases and Inflammatory Bowel Disease Who Are Receiving Immunosuppressive Therapies
This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving immunosuppressive therapies. Subjects will be randomized to receive either one or two doses of influenza vaccination in year #1. In year# 2, all participants will be given two doses of influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination. This study will also assess the immunogenicity and safety of a booster vaccine strategy in the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose strategy will improve both clinical and serologic responses in this vulnerable population.
Read the detailed description
Patients receiving immunosuppressive therapies for rheumatologic diseases and inflammatory bowel disease (IBD) are at increased risk of serious infections, including influenza. Infections can also trigger flares of the underlying disease. Although newer biologic treatments are improving disease outcomes, these medications reduce vaccine responses, placing patients at high risk for vaccine-preventable illnesses. In a case-cohort study by Flannery et al. looking at influenza vaccine effectiveness from 2010-2014, only one in four children who died of laboratory-confirmed influenza were vaccinated, while a high prevalence (53%) had an underlying condition that put them at risk for severe influenza-related complications. Yearly influenza vaccination is recommended for all patients with rheumatologic diseases and IBD. However, these recommendations are based on studies that did not include patients receiving newer biologic therapies. Recent studies in organ transplant recipients, a group known to have suboptimal vaccine responses, have suggested a booster influenza vaccine strategy as a way of enhancing vaccine responses.
SPECIFIC AIMS:
The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.
Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population.
- Being tested
- Influenza vaccine
- Keywords
- Influenza vaccine, Booster dose, immunocompromised, Biologic therapy, Rheumatologic disease, inflammatory bowel disease
- Medical subject headings
- Collagen Diseases, Inflammatory Bowel Diseases, Immune Complex Diseases, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.
Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Booster - Year 1 | Experimental | Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 Receives: Biological: Influenza vaccine |
| Group 2 - Standard - Year 1 | Active comparator | Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 Receives: Biological: Influenza vaccine |
| Group 1 - Booster - Year 2 | Experimental | Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2 Receives: Biological: Influenza vaccine |
| Group 2 - Standard - Year 2 | Active comparator | Group 2 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2 Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza Hemagglutination Inhibition (HAI) Titer
immunological vaccine response
Measured: 4-6 weeks post final influenza vaccination dose (if participants received a booster, this was after the booster dose) in Year 1 and Year 2
Secondary outcomes (1)
Number of Participants With Decreased Influenza Rates Per Strain
decreased influenza rates - seroprotection
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start3 Nov 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
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 (8)Papers the sponsor has linked to this study.
- Other trials for Rheumatologic DisorderStudies 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
- Crossover
- Model description
- In Year 1, Group 1 receives influenza booster dose strategy whereas Group 2 receives influenza standard dose strategy. Then in Year 2 Group 1 receives booster dose strategy and Group 2 now also receives booster dose strategy
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Christy Beneri, Stony Brook University
- Investigators
- Christy A Beneri, DO, Principal investigator, Stony Brook Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277703
- Sponsor's protocol ID
- 1077651
- Status last verified
- Jul 2026
- First submitted
- 30 Aug 2017
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Walters HM, Pan N, Lehman TJ, Adams A, Huang WT, Sitaras L, Cunningham-Rundles S, Walsh TJ, Toussi SS. A prospective study comparing infection risk and disease activity in children with juvenile idiopathic arthritis treated with and without tumor necrosis factor-alpha inhibitors. Clin Rheumatol. 2015 Mar;34(3):457-64. doi: 10.1007/s10067-014-2779-8. Epub 2014 Sep 18.
PubMed 25227771Toussi SS, Pan N, Walters HM, Walsh TJ. Infections in children and adolescents with juvenile idiopathic arthritis and inflammatory bowel disease treated with tumor necrosis factor-alpha inhibitors: systematic review of the literature. Clin Infect Dis. 2013 Nov;57(9):1318-30. doi: 10.1093/cid/cit489. Epub 2013 Jul 29.
PubMed 23899685Carvalho LM, de Paula FE, Silvestre RV, Roberti LR, Arruda E, Mello WA, Ferriani VP. Prospective surveillance study of acute respiratory infections, influenza-like illness and seasonal influenza vaccine in a cohort of juvenile idiopathic arthritis patients. Pediatr Rheumatol Online J. 2013 Mar 7;11:10. doi: 10.1186/1546-0096-11-10. eCollection 2013.
PubMed 23510667Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.
PubMed 22089462Flannery B, Reynolds SB, Blanton L, Santibanez TA, O'Halloran A, Lu PJ, Chen J, Foppa IM, Gargiullo P, Bresee J, Singleton JA, Fry AM. Influenza Vaccine Effectiveness Against Pediatric Deaths: 2010-2014. Pediatrics. 2017 May;139(5):e20164244. doi: 10.1542/peds.2016-4244. Epub 2017 Apr 3.
PubMed 28557757Ogimi C, Tanaka R, Saitoh A, Oh-Ishi T. Immunogenicity of influenza vaccine in children with pediatric rheumatic diseases receiving immunosuppressive agents. Pediatr Infect Dis J. 2011 Mar;30(3):208-11. doi: 10.1097/INF.0b013e3181f7ce44.
PubMed 20861757deBruyn J, Fonseca K, Ghosh S, Panaccione R, Gasia MF, Ueno A, Kaplan GG, Seow CH, Wrobel I. Immunogenicity of Influenza Vaccine for Patients with Inflammatory Bowel Disease on Maintenance Infliximab Therapy: A Randomized Trial. Inflamm Bowel Dis. 2016 Mar;22(3):638-47. doi: 10.1097/MIB.0000000000000615.
PubMed 26595551Cordero E, Roca-Oporto C, Bulnes-Ramos A, Aydillo T, Gavalda J, Moreno A, Torre-Cisneros J, Montejo JM, Fortun J, Munoz P, Sabe N, Farinas MC, Blanes-Julia M, Lopez-Medrano F, Suarez-Benjumea A, Martinez-Atienza J, Rosso-Fernandez C, Perez-Romero P; TRANSGRIPE 1-2 Study Group. Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial. Clin Infect Dis. 2017 Apr 1;64(7):829-838. doi: 10.1093/cid/ciw855.
PubMed 28362949
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Booster Vaccine Strategy to Improve Serologic Responses to Influenza Vaccination in Children With Rheumatic Diseases and Inflammatory Bowel Disease Who Are Receiving Immunosuppressive Therapies
- ClinicalTrials.gov ID
- NCT03277703
- Acronym / sponsor ID
- 1077651
- Keywords
- Influenza vaccine, Booster dose, immunocompromised, Biologic therapy, Rheumatologic disease, inflammatory bowel disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving immunosuppressive therapies. Subjects will be randomized to receive either one or two doses of influenza vaccination in year #1. In year# 2, all participants will be given two doses of influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination. This study will also assess the immunogenicity and safety of a booster vaccine strategy in the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose strategy will improve both clinical and serologic responses in this vulnerable population.
Detailed description
Patients receiving immunosuppressive therapies for rheumatologic diseases and inflammatory bowel disease (IBD) are at increased risk of serious infections, including influenza. Infections can also trigger flares of the underlying disease. Although newer biologic treatments are improving disease outcomes, these medications reduce vaccine responses, placing patients at high risk for vaccine-preventable illnesses. In a case-cohort study by Flannery et al. looking at influenza vaccine effectiveness from 2010-2014, only one in four children who died of laboratory-confirmed influenza were vaccinated, while a high prevalence (53%) had an underlying condition that put them at risk for severe influenza-related complications. Yearly influenza vaccination is recommended for all patients with rheumatologic diseases and IBD. However, these recommendations are based on studies that did not include patients receiving newer biologic therapies. Recent studies in organ transplant recipients, a group known to have suboptimal vaccine responses, have suggested a booster influenza vaccine strategy as a way of enhancing vaccine responses.
SPECIFIC AIMS:
The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.
Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In Year 1, Group 1 receives influenza booster dose strategy whereas Group 2 receives influenza standard dose strategy. Then in Year 2 Group 1 receives booster dose strategy and Group 2 now also receives booster dose strategy
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Booster - Year 1 | Experimental | Biological: Influenza vaccineGroup 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 |
| Group 2 - Standard - Year 1 | Active comparator | Biological: Influenza vaccineGroup 2 subjects will be receive the standard single dose of influenza vaccine in year 1 |
| Group 1 - Booster - Year 2 | Experimental | Biological: Influenza vaccineGroup 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2 |
| Group 2 - Standard - Year 2 | Active comparator | Biological: Influenza vaccineGroup 2 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2 |
Who may qualify
- Ages
- 3 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Children ages 3-22 years
- Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows:
Key exclusion criteria (11 listed)
- Prior allergic reaction to any vaccine components
- Other contraindication to influenza vaccination
- Severe egg allergy
- Pregnancy
- Prior Guillain-Barre syndrome
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 |
|---|---|---|
| Influenza vaccineThe primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population | Biological | Group 1 - Booster - Year 1, Group 1 - Booster - Year 2, Group 2 - Standard - Year 1, Group 2 - Standard - Year 2 |
Primary outcome
Influenza Hemagglutination Inhibition (HAI) Titer
Time frame: 4-6 weeks post final influenza vaccination dose (if participants received a booster, this was after the booster dose) in Year 1 and Year 2
immunological vaccine response
1 secondary outcome
Number of Participants With Decreased Influenza Rates Per Strain
Time frame: through study completion, an average of 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25227771Walters HM, Pan N, Lehman TJ, Adams A, Huang WT, Sitaras L, Cunningham-Rundles S, Walsh TJ, Toussi SS. A prospective study comparing infection risk and disease activity in children with juvenile idiopathic arthritis treated with and without tumor necrosis factor-alpha inhibitors. Clin Rheumatol. 2015 Mar;34(3):457-64. doi: 10.1007/s10067-014-2779-8. Epub 2014 Sep 18.
- Background: PubMed 23899685Toussi SS, Pan N, Walters HM, Walsh TJ. Infections in children and adolescents with juvenile idiopathic arthritis and inflammatory bowel disease treated with tumor necrosis factor-alpha inhibitors: systematic review of the literature. Clin Infect Dis. 2013 Nov;57(9):1318-30. doi: 10.1093/cid/cit489. Epub 2013 Jul 29.
- Background: PubMed 23510667Carvalho LM, de Paula FE, Silvestre RV, Roberti LR, Arruda E, Mello WA, Ferriani VP. Prospective surveillance study of acute respiratory infections, influenza-like illness and seasonal influenza vaccine in a cohort of juvenile idiopathic arthritis patients. Pediatr Rheumatol Online J. 2013 Mar 7;11:10. doi: 10.1186/1546-0096-11-10. eCollection 2013.
- Background: PubMed 22089462Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.
- Background: PubMed 28557757Flannery B, Reynolds SB, Blanton L, Santibanez TA, O'Halloran A, Lu PJ, Chen J, Foppa IM, Gargiullo P, Bresee J, Singleton JA, Fry AM. Influenza Vaccine Effectiveness Against Pediatric Deaths: 2010-2014. Pediatrics. 2017 May;139(5):e20164244. doi: 10.1542/peds.2016-4244. Epub 2017 Apr 3.
- Background: PubMed 20861757Ogimi C, Tanaka R, Saitoh A, Oh-Ishi T. Immunogenicity of influenza vaccine in children with pediatric rheumatic diseases receiving immunosuppressive agents. Pediatr Infect Dis J. 2011 Mar;30(3):208-11. doi: 10.1097/INF.0b013e3181f7ce44.
- Background: PubMed 26595551deBruyn J, Fonseca K, Ghosh S, Panaccione R, Gasia MF, Ueno A, Kaplan GG, Seow CH, Wrobel I. Immunogenicity of Influenza Vaccine for Patients with Inflammatory Bowel Disease on Maintenance Infliximab Therapy: A Randomized Trial. Inflamm Bowel Dis. 2016 Mar;22(3):638-47. doi: 10.1097/MIB.0000000000000615.
- Background: PubMed 28362949Cordero E, Roca-Oporto C, Bulnes-Ramos A, Aydillo T, Gavalda J, Moreno A, Torre-Cisneros J, Montejo JM, Fortun J, Munoz P, Sabe N, Farinas MC, Blanes-Julia M, Lopez-Medrano F, Suarez-Benjumea A, Martinez-Atienza J, Rosso-Fernandez C, Perez-Romero P; TRANSGRIPE 1-2 Study Group. Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1-2, a Randomized Controlled Clinical Trial. Clin Infect Dis. 2017 Apr 1;64(7):829-838. doi: 10.1093/cid/ciw855.
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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.
Christy A Beneri, DO principal investigator
Stony Brook Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza vaccine in people with Rheumatologic Disorder and Inflammatory Bowel Diseases, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Aug 2026). 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?
Influenza Hemagglutination Inhibition (HAI) Titer (time frame: 4-6 weeks post final influenza vaccination dose (if participants received a booster, this was after the booster dose) in Year 1 and Year 2). 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 NCT03277703, which also lists 8 linked publications.
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 Aug 2026.