Multiple SclerosisPhase 2NCT04767698
Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis
A Phase 2 study testing Belimumab, Short-course Ocrelizumab and Continued Ocrelizumab in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Multiple sclerosis is the most common inflammatory disease of the central nervous system and a common cause of disability in young adults. Depleting B cells from the circulation with an anti-cluster of differentiation (CD) 20 antibodies has proven to be an effective strategy in reducing relapses and disability in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Belimumab, Short-course Ocrelizumab and Continued Ocrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 10 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RRMS based on McDonald criteria 2017
- Age > 18
- A clinical relapse in the past 12 months OR an enhancing lesion on brain/ spinal cord MRI in the past 6 months OR a new T2/FLAIR lesion on a brain/spinal cord MRI obtained in the past 6 months (compared to a previous MRI obtained within one year from the latest MRI)
- Pre-existing pneumococcal antibody titers (>1.0 mg/mL) to =<9 of 23 vaccine serotypes
- Female Subjects: Not pregnant or nursing and at least one of the following conditions apply: a. Non- childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea. b. Child-bearing potential and agrees to use one of the contraception methods as described by the investigator or designee, from Day 0 until 24 weeks after the last dose of study medications (See details below).
- Liver function at the time of screening: alanine aminotransferase (ALT) < 2x upper limit of normal (ULN); bilirubin <= 1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Who cannot join
- Prior therapy at any time: has ever received any of the following: a) B-cell targeted therapy (e.g., rituximab, ocrelizumab, other anti-cluster of differentiation (CD)20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], B lymphocyte stimulator (BLyS)-receptor fusion protein [BR3], Transmembrane activator and calcium-modulating ligand (CAML) interaction (TACI) fragment, crystallizable (Fc), or belimumab)
- Prior use of cladribine, mitoxantrone, cyclophosphamide, or hematopoietic stem cell transplantation (HSCT)
- Lymphopenia: a lymphocyte count <500/ millimeter (mm)^3
- Neutrophils <1.5x 10E9/L.
- Drug sensitivity: a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergies including a previous anaphylactic reaction to parenteral administration contrast agents, human or murine proteins or monoclonal antibodies
- Treatment with steroids in the last 30 days
Show all 29Show fewer
- Clinically unstable medical or psychiatric disorder
- Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, poses a significant suicide risk
- Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
- Substance abuse: has evidence of current drug or alcohol abuse or dependence
- 365 Day prior therapy: has received a biologic investigational agent other than B-cell targeted therapy [e.g., abetimus sodium, anti CD40L antibody (e.g., BG9588/ IDEC-131; investigational agent applies to any drug not approved for sale in the country in which it is being used]
- 30 Day prior therapy: has received any of the following within 30 days before Day 0: a) Any other MS disease-modifying therapy, not mentioned above (including fumaric acid esters, sphingosine-1-phosphate (S1P) receptor modulators, teriflunomide, and natalizumab). Glatiramer acetate and interferons are permitted up to the day of starting the investigational medication. Intravenous, oral, and Inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed.
- 30 Day prior therapy: has received a live virus vaccine or a non-biologic investigational agent.
- Malignancy: has a history of malignancy in the past 5 years except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
- Have a history of a primary immunodeficiency
- Have a significant IgG deficiency (IgG level < 400 mg/dL)
- Have an IgA deficiency (IgA level < 10 mg/dL)
- Infection history:
- Currently on any suppressive therapy for chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria)
- Hospitalization for treatment of infection within 60 days of Day 0.
- Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) within 60 days of Day 0
- Other disease/conditions: has any of the following: a) clinical evidence of significant unstable or uncontrolled acute or chronic diseases (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk; b) a surgical procedure planned in the 6 months after Day 0; c) a known history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the investigator, makes the subject unsuitable for the study
- Hepatitis status:
- Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows: Patients positive for HBsAg or HBcAb are excluded
- A positive test for Hepatitis C antibody
- HIV: known to have a historically positive HIV test or tests positive at screening for HIV.
- Laboratory abnormalities: has an abnormal laboratory assessment, which is judged clinically significant by the investigator.
- Drug Sensitivity: has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergies including a previous anaphylactic reaction to parenteral administration contrast agents, human or murine proteins or monoclonal antibodies that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Any contraindication to undergoing MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Belimumab to B-cell Depletion to Produce Prolonged Remission of Relapsing-remitting Multiple Sclerosis Disease Activity
Multiple sclerosis is the most common inflammatory disease of the central nervous system and a common cause of disability in young adults. Depleting B cells from the circulation with an anti-cluster of differentiation (CD) 20 antibodies has proven to be an effective strategy in reducing relapses and disability in patients with the relapsing-remitting disease. However, continuous and long-term depletion of B-cells can result in reduced immunoglobulin levels, immunosuppression, and an increased tendency for severe infections and perhaps, even malignancy.
Blocking B-cell Activating Factor (BAFF) is effective for the treatment of several autoimmune disorders. Belimumab, a BAFF blocking antibody, has been approved by the Food and Drug Administration for the treatment of systemic lupus erythematosus. Belimumab has been shown to have immunomodulatory properties, without resulting in overt immunosuppression.
Read more
The investigators hypothesize that belimumab, given to patients who received a short course of treatment with B-cell depleting antibody (ocrelizumab), will be safe and equally effective in reducing MS disease activity (as compared to patients receiving continuous treatment with ocrelizumab); while resulting in less immunosuppression, as measured by antibody response to pneumococcal vaccination. Currently, available treatment strategies in relapsing MS sacrifice higher efficacy for long-term safety or vice versa. The proposed strategy in this application combines the long-term safety and high efficacy to treat patients with relapsing-remitting multiple sclerosis (RRMS) and, if eventually proven effective, can be adopted in a large proportion of patients with this chronic disease.
This is a randomized, open-labeled trial. Forty eligible participants will be randomized 1:1 to either receiving a form of standard of care, ocrelizumab (300 mg two infusions two weeks apart at baseline and then 600 mg as a single infusion every six months) or belimumab (200 mg subcutaneous (SC) weekly for 36 months) plus two courses of ocrelizumab (300 mg two infusions two weeks apart at baseline and 600 mg as a single infusion six months later). Co-primary outcomes of the study include pneumococcal vaccine antibody response, the return of MS disease activity, and proportions of patients with adverse events and serious adverse events.
- Conditions
- Multiple Sclerosis
- Being tested
- Belimumab, Short-course Ocrelizumab, Continued Ocrelizumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelimumabDrug
200 mg SC weekly for 36 months
Short-course OcrelizumabDrug
300 mg, two infusions two weeks apart and then 600 mg as a single infusion after six months (only one time) (total of two courses of treatment)
Continued OcrelizumabDrug
300 mg, two infusions two weeks apart and then 600 mg as a single infusion every six months for a total of 36 months
| Study group | Role | What they receive |
|---|---|---|
| Belimumab + short-term Ocrelizumab | Experimental | Participants will receive Belimumab and Ocrelizumab. Receives: Drug: Belimumab; Drug: Short-course Ocrelizumab |
| Continued Ocrelizumab | Active comparator | Participants will receive Ocrelizumab only. Receives: Drug: Continued Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumococcal Vaccine Antibody Response
The proportion of patients with positive antibody responses to >/=1 of the 23 pneumococcal vaccine serotypes measured four weeks post-vaccination (vaccination given at month 24). A positive antibody response is defined as a two-fold increase from pre-vaccination levels against >/=1 of the 23 pneumococcal serotypes measured.
Measured: Month 25
Safety as Assessed by Adverse Events
Adverse events (AEs) and serious adverse events (SAEs), including AEs of special interest (opportunistic infections, herpes zoster, malignancies, hypersensitivity and infusion reactions, suicidal ideation, intent or behavior and all-cause mortality).
Measured: 24 months
Secondary outcomes (12)
Difference Between the Two Treatment Groups in GM-CSF/IL-10 Ratio
Granulocyte-macrophage colony-stimulating factor (GM-CSF)/Interleukin (IL)-10 ratio (produced by stimulated repopulated B-cells).
Measured: Month 36
Difference Between the Two Treatment Groups in IL-6/IL-10 Ratio
IL-6/IL-10 ratio (produced by stimulated repopulated B-cells).
Measured: Month 36
Assessment of Return of Disease Activity by Month 24
Proportions of patients with a return of the disease activity, as objectively demonstrated by the development of new T2 hyperintense lesions or Gd-enhancing lesions on the MRI (noted on a scan performed more than six months after treatment initiation) or a clinical relapse, defined as new or worsening neurologic symptom(s) with an objective change on the EDSS of at least 1.5 points for participants with baseline EDSS scores of 0 or 0.5 and at least 1-point change for participants with EDSS of 1 or more, as determined by the examining neurologist. Symptoms must have been attributable to multiple sclerosis (MS), last ≥48 hours, been present at normal body temperature, and preceded by at least 30 days of clinical stability.
Measured: Month 24
Assessment of Return of Disease Activity by Month 36
Proportions of patients with a return of the disease activity, as objectively demonstrated by the development of new T2 hyperintense lesions or Gd-enhancing lesions on the MRI (noted on a scan performed more than six months after treatment initiation) or a clinical relapse, defined as new or worsening neurologic symptom(s) with an objective change on the EDSS of at least 1.5 points for participants with baseline EDSS scores of 0 or 0.5 and at least 1-point change for participants with EDSS of 1 or more, as determined by the examining neurologist. Symptoms must have been attributable to MS, last ≥48 hours, been present at normal body temperature, and preceded by at least 30 days of clinical stability.
Measured: Month 36
Assessment of Clinical Disease Activity by Month 24
Annualized relapse rate (ARR) which is the number of relapses divided by the number of follow up years.
Measured: Month 24
Assessment of Clinical Disease Activity by Month 36
Annualized relapse rate (ARR) which is the number of relapses divided by the number of follow up years.
Measured: Month 36
Proportion of Participants With a Three-month Confirmed Increase in EDSS Score
Assessment of disability progression by the proportion of participants with a three-month confirmed increase in Expanded Disability Status Scale (EDSS) score.
Measured: Month 24
Proportion of Participants With a Three-month Confirmed Increase in EDSS Score
Assessment of disability progression by the proportion of participants with a three-month confirmed increase in Expanded Disability Status Scale (EDSS) score.
Measured: Month 36
Proportion of Participants With a Three-month Confirmed Decrease in EDSS Score
Assessment of disability progression by the proportion of participants with a three-month confirmed decrease in EDSS score.
Measured: Month 24
Proportion of Participants With a Three-month Confirmed Decrease in EDSS Score
Assessment of disability progression by the proportion of participants with a three-month confirmed decrease in EDSS score.
Measured: Month 36
Change in Serum Neurofilament Light Chain (NfL) in pg/mL
Assessment of a serum biomarker of neuroaxonal degeneration.
Measured: Baseline and Month 24
Change in Serum Neurofilament Light Chain (NfL) in pg/mL
Assessment of a serum biomarker of neuroaxonal degeneration.
Measured: Baseline and Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Oct 2021
- Primary completion10 May 2022
- Study completion10 May 2022
Why it stopped: The funding source decided to stop funding the study.
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.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Pavan Bhargava, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767698
- Sponsor's protocol ID
- IRB00246563
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2021
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Belimumab to B-cell Depletion to Produce Prolonged Remission of Relapsing-remitting Multiple Sclerosis Disease Activity
- ClinicalTrials.gov ID
- NCT04767698
- Acronym / sponsor ID
- IRB00246563
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding source decided to stop funding the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis is the most common inflammatory disease of the central nervous system and a common cause of disability in young adults. Depleting B cells from the circulation with an anti-cluster of differentiation (CD) 20 antibodies has proven to be an effective strategy in reducing relapses and disability in patients with the relapsing-remitting disease. However, continuous and long-term depletion of B-cells can result in reduced immunoglobulin levels, immunosuppression, and an increased tendency for severe infections and perhaps, even malignancy.
Blocking B-cell Activating Factor (BAFF) is effective for the treatment of several autoimmune disorders. Belimumab, a BAFF blocking antibody, has been approved by the Food and Drug Administration for the treatment of systemic lupus erythematosus. Belimumab has been shown to have immunomodulatory properties, without resulting in overt immunosuppression.
The investigators hypothesize that belimumab, given to patients who received a short course of treatment with B-cell depleting antibody (ocrelizumab), will be safe and equally effective in reducing MS disease activity (as compared to patients receiving continuous treatment with ocrelizumab); while resulting in less immunosuppression, as measured by antibody response to pneumococcal vaccination. Currently, available treatment strategies in relapsing MS sacrifice higher efficacy for long-term safety or vice versa. The proposed strategy in this application combines the long-term safety and high efficacy to treat patients with relapsing-remitting multiple sclerosis (RRMS) and, if eventually proven effective, can be adopted in a large proportion of patients with this chronic disease.
This is a randomized, open-labeled trial. Forty eligible participants will be randomized 1:1 to either receiving a form of standard of care, ocrelizumab (300 mg two infusions two weeks apart at baseline and then 600 mg as a single infusion every six months) or belimumab (200 mg subcutaneous (SC) weekly for 36 months) plus two courses of ocrelizumab (300 mg two infusions two weeks apart at baseline and 600 mg as a single infusion six months later). Co-primary outcomes of the study include pneumococcal vaccine antibody response, the return of MS disease activity, and proportions of patients with adverse events and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belimumab + short-term Ocrelizumab | Experimental | Drug: Belimumab, Drug: Short-course OcrelizumabParticipants will receive Belimumab and Ocrelizumab. |
| Continued Ocrelizumab | Active comparator | Drug: Continued OcrelizumabParticipants will receive Ocrelizumab only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of RRMS based on McDonald criteria 2017
- Age > 18
- A clinical relapse in the past 12 months OR an enhancing lesion on brain/ spinal cord MRI in the past 6 months OR a new T2/FLAIR lesion on a brain/spinal cord MRI obtained in the past 6 months (compared to a previous MRI obtained within one year from the latest MRI)
- Pre-existing pneumococcal antibody titers (>1.0 mg/mL) to =<9 of 23 vaccine serotypes
- Female Subjects: Not pregnant or nursing and at least one of the following conditions apply: a. Non- childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea. b. Child-bearing potential and agrees to use one of the contraception methods as described by the investigator or designee, from Day 0 until 24 weeks after the last dose of study medications (See details below).
Key exclusion criteria (29 listed)
- Prior therapy at any time: has ever received any of the following: a) B-cell targeted therapy (e.g., rituximab, ocrelizumab, other anti-cluster of differentiation (CD)20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], B lymphocyte stimulator (BLyS)-receptor fusion protein [BR3], Transmembrane activator and calcium-modulating ligand (CAML) interaction (TACI) fragment, crystallizable (Fc), or belimumab)
- Prior use of cladribine, mitoxantrone, cyclophosphamide, or hematopoietic stem cell transplantation (HSCT)
- Lymphopenia: a lymphocyte count <500/ millimeter (mm)^3
- Neutrophils <1.5x 10E9/L.
- Drug sensitivity: a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergies including a previous anaphylactic reaction to parenteral administration contrast agents, human or murine proteins or monoclonal antibodies
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 |
|---|---|---|
| Belimumab200 mg SC weekly for 36 months | Drug | Belimumab + short-term Ocrelizumab |
| Short-course Ocrelizumab300 mg, two infusions two weeks apart and then 600 mg as a single infusion after six months (only one time) (total of two courses of treatment) | Drug | Belimumab + short-term Ocrelizumab |
| Continued Ocrelizumab300 mg, two infusions two weeks apart and then 600 mg as a single infusion every six months for a total of 36 months | Drug | Continued Ocrelizumab |
Primary outcome
Pneumococcal Vaccine Antibody Response
Time frame: Month 25
The proportion of patients with positive antibody responses to >/=1 of the 23 pneumococcal vaccine serotypes measured four weeks post-vaccination (vaccination given at month 24). A positive antibody response is defined as a two-fold increase from pre-vaccination levels against >/=1 of the 23 pneumococcal serotypes measured.
Safety as Assessed by Adverse Events
Time frame: 24 months
Adverse events (AEs) and serious adverse events (SAEs), including AEs of special interest (opportunistic infections, herpes zoster, malignancies, hypersensitivity and infusion reactions, suicidal ideation, intent or behavior and all-cause mortality).
12 secondary outcomes
Difference Between the Two Treatment Groups in GM-CSF/IL-10 Ratio
Time frame: Month 36
Difference Between the Two Treatment Groups in IL-6/IL-10 Ratio
Time frame: Month 36
Assessment of Return of Disease Activity by Month 24
Time frame: Month 24
Assessment of Return of Disease Activity by Month 36
Time frame: Month 36
Assessment of Clinical Disease Activity by Month 24
Time frame: Month 24
Assessment of Clinical Disease Activity by Month 36
Time frame: Month 36
Proportion of Participants With a Three-month Confirmed Increase in EDSS Score
Time frame: Month 24
Proportion of Participants With a Three-month Confirmed Increase in EDSS Score
Time frame: Month 36
Proportion of Participants With a Three-month Confirmed Decrease in EDSS Score
Time frame: Month 24
Proportion of Participants With a Three-month Confirmed Decrease in EDSS Score
Time frame: Month 36
Change in Serum Neurofilament Light Chain (NfL) in pg/mL
Time frame: Baseline and Month 24
Change in Serum Neurofilament Light Chain (NfL) in pg/mL
Time frame: Baseline and Month 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Pavan Bhargava, MD principal investigator
Johns Hopkins University
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 Belimumab, Short-course Ocrelizumab and Continued Ocrelizumab in people with Multiple Sclerosis, run by Johns Hopkins 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 6 inclusion and 29 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: stopped early, as of the sponsor's last update on 7 Mar 2023. 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 7 Mar 2023). 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?
Pneumococcal Vaccine Antibody Response (time frame: Month 25). 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?
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 7 Mar 2023.