Coronavirus InfectionPhase 1/2NCT04447781
Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19
A Phase 1/2 study testing INO-4800, CELLECTRA® 2000 and Saline-sodium citrate (SSC) buffer in people with Coronavirus Infection and SARS-CoV 2, run by International Vaccine Institute at 2 sites in South Korea.
Trial summary
This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, SARS-CoV 2
- What is being tested?
- INO-4800, CELLECTRA® 2000 and Saline-sodium citrate (SSC) buffer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 Jul 2020to 25 May 2022
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures
- Adults aged 19 to 50 years (for Part A) or aged 19 to 64 (for Part B)
- Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening
- Able and willing to comply with all study procedures
- Screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the Investigator
- Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening
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- Screening ECG and Chest X-ray deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
- Must meet one of the following criteria with respect to reproductive capacity:
- Women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months b. Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c. Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose. Acceptable methods include (but not limited to): c-1. hormonal contraception including implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)
Who cannot join
- Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose
- Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing
- Is currently participating in or has participated in a study with an investigational product within 6 months preceding Day 0
- Receipt of an investigational product for prophylaxis or treatment of COVID-19, MERS or SARS
- Body mass index (BMI) <18 or >30
- Current or history of the following medical conditions:
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- Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease);
- Hypertension, resting systolic blood pressure >150 mm Hg or a diastolic blood pressure >95 mm Hg
- Malignancy within 5 years of screening
- Cardiovascular diseases (e.g., myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias)
- Diabetes mellitus
- Use of immunoglobulin or blood products in last 6 months
- History of severe allergic reaction or anaphylaxis after immunization
- Immunosuppression as a result of underlying illness or treatment including:
- Primary immunodeficiencies
- Long term use (≥7 days) of oral or parenteral glucocorticoids at a dose of ≥20 mg/day of prednisone equivalent (use of inhaled, topical, nasal, otic, and ophthalmic corticosteroids are allowed)
- Current or anticipated during clinical trial use of disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease modifying drugs such as TNF-α inhibitors (e.g., infliximab, adalimumab or etanercept)
- History of solid organ or bone marrow transplantation
- Any prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease that may jeopardize the safety of the subject or require therapy that would interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results.
- Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:
- Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site
- Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist)
- Any metal implants or implantable medical device within the electroporation site
- Prisoners or subjects who are compulsorily detained (involuntary incarceration)
- Reported active drug or alcohol or substance abuse or dependence.
- Current smoker or vaper (use of cigarette or e-cigarette at least once in last 30 days)
- Healthcare worker who may provide medical care to SARS-CoV-2 cases or occupationally in high risk for SARS-CoV-2 exposure during the study period
- Other condition deemed ineligible for the study at the discretion of investigator
- Employee of the study center directly involved with the proposed study or with study investigators
- Previously been laboratory-confirmed as SARS-CoV-2 infection or determined to be a close-contact of SARS-CoV-2 confirmed case by public health authorities (for Part A only)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
About this study
Official title: A Phase I/IIa, Dose-Ranging Trial to Evaluate Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers
This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.
Read the detailed description
[Part A] Part A is open-label, dose-ranging study, enrolling total of 40 subjects. Part A is divided into two arm, low dose (Group 1) and high dose (Group 2). The subjects will be contacted by telephone to report adverse events or other reactions the day following the first vaccination. Once these first five subjects in Group 1 complete the Week 1 visit, all available clinical laboratory and adverse event data will be reviewed by the Data Safety Monitoring Board (DSMB). Further enrollment into Group 1 will be paused during this DSMB review. If DSMB determines there are no safety findings judged to be of clinical concern and no dose limiting toxicities nor any stopping events observed, enrollment will be opened for the remaining subjects in Group 1. Once Group 1 enrollment is completed [i.e., 20 total subjects enrolled], Group 2 will open to enrollment. Daily safety assessment of all enrolled subjects will be supported by the Study Medical Monitor on an ongoing basis while the first five subjects are being enrolled, if needed. The subjects will be contacted by telephone to report adverse events or other reactions the day following the first vaccination. Once the first five subjects Group 2 complete the Week 1 visit, all available clinical laboratory and adverse event data from these first five subjects, along with the safety data from subjects in Group 1, will be reviewed by the DSMB. However, enrollment may continue while this DSMB review is conducted, without any pause to enrollment of the remaining subjects in Group 2.
Once all subjects in Part A Group 1 and Group 2 complete the Week 8 visit, all available clinical laboratory, adverse event, immunogenicity data from all subjects will be reviewed by the DSMB. The DSMB will additionally review serious adverse events (SAEs) and adverse events of special interest (AESIs) date throughout the study. With DSMB's recommendation, the optimal dose for Part B will be selected by the Sponsor based on the following criteria which may be adjusted over the course of the study. Percentage immunogenic seroconversionRelative immunogenicity between INO-4800 Study Arms (Low dose vs. High dose)Safety profile of each INO-4800 Study Arms (Low dose vs. High dose). All subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.
[Part B] Part B is divided into two arm, IP Arm (Group 3) and Placebo Arm (Group 4). Part B will be randomized, double-blind, placebo-controlled trial, enrolling 60 subjects in IP arm, and 20 subjects in Placebo arm in 19-50 age group, and 30 subjects in IP arm, and 10 subjects in Placebo arm in 51-64 age group, for total of 90 subjects in IP arm, and 30 subjects in Placebo arm. At dosing visit, subjects will be randomized to either Group 3 or Group 4. The subjects will be contacted by telephone to report adverse events or other reactions the day following the first vaccination. DSMB review of safety findings will be performed according to the DSMB charter. All subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.Should the criteria for any dose limiting toxicity or stopping rule be met, at any time, further enrollment and administration of INO-4800 will be paused for further evaluation. The Sponsor will consult the DSMB, if needed, to determine whether to enroll and/or dose the remainder of the subjects. All subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.
- Conditions
- Coronavirus Infection, SARS-CoV 2
- Being tested
- INO-4800, CELLECTRA® 2000, Saline-sodium citrate (SSC) buffer
- Keywords
- Coronavirus Infection, SARS-CoV 2, INO-4800
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-4800Biological
- Manufacturer: Inovio Pharmaceuticals Inc.
CELLECTRA® 2000Device
- Manufacturer: Inovio Pharmaceuticals Inc.
Saline-sodium citrate (SSC) bufferOther
Also called Placebo
- Manufacturer: Inovio Pharmaceuticals Inc.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Part A) | Experimental | * Number of Subjects: 20 subjects
* ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) Receives: Biological: INO-4800; Device: CELLECTRA® 2000 |
| Group 2 (Part A) | Experimental | * Number of Subjects: 20 subjects
* ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) Receives: Biological: INO-4800; Device: CELLECTRA® 2000 |
| Group 3 (Part B) | Experimental | * Number of Subjects: 90 subjects
* ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) Receives: Biological: INO-4800; Device: CELLECTRA® 2000 |
| Group 4 (Part B, Placebo) | Placebo comparator | * Number of Subjects: 30 subjects
* ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) Receives: Device: CELLECTRA® 2000; Other: Saline-sodium citrate (SSC) buffer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures
- Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays [Immunogenicity]
- Incidence of adverse events among participants during the study period [Safety and Tolerability]
- Percentage of Participants with Administration (Injection) Site Reactions [Safety and Tolerability]
- Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period [Safety and Tolerability]
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start15 Jul 2020
- Primary completion12 Jul 2021
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Coalition for Epidemic Preparedness Innovations, Inovio Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Myoung-don Oh, MD, Principal investigator, Seoul National University HospitalEu Suk Kim, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447781
- Sponsor's protocol ID
- IVI COVID19-001
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2020
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data dictionaries and all collected IPD will be anonymized and may be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Dose-Ranging Trial to Evaluate Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04447781
- Acronym / sponsor ID
- IVI COVID19-001
- Conditions
- Coronavirus Infection, SARS-CoV 2
- Keywords
- Coronavirus Infection, SARS-CoV 2, INO-4800
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Coalition for Epidemic Preparedness Innovations, Inovio Pharmaceuticals
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 25 Jun 2020 (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 I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.
Detailed description
[Part A] Part A is open-label, dose-ranging study, enrolling total of 40 subjects. Part A is divided into two arm, low dose (Group 1) and high dose (Group 2). The subjects will be contacted by telephone to report adverse events or other reactions the day following the first vaccination. Once these first five subjects in Group 1 complete the Week 1 visit, all available clinical laboratory and adverse event data will be reviewed by the Data Safety Monitoring Board (DSMB). Further enrollment into Group 1 will be paused during this DSMB review. If DSMB determines there are no safety findings judged to be of clinical concern and no dose limiting toxicities nor any stopping events observed, enrollment will be opened for the remaining subjects in Group 1. Once Group 1 enrollment is completed [i.e., 20 total subjects enrolled], Group 2 will open to enrollment. Daily safety assessment of all enrolled subjects will be supported by the Study Medical Monitor on an ongoing basis while the first five subjects are being enrolled, if needed. The subjects will be contacted by telephone to report adverse events or other reactions the day following the first vaccination. Once the first five subjects Group 2 complete the Week 1 visit, all available clinical laboratory and adverse event data from these first five subjects, along with the safety data from subjects in Group 1, will be reviewed by the DSMB. However, enrollment may continue while this DSMB review is conducted, without any pause to enrollment of the remaining subjects in Group 2.
Once all subjects in Part A Group 1 and Group 2 complete the Week 8 visit, all available clinical laboratory, adverse event, immunogenicity data from all subjects will be reviewed by the DSMB. The DSMB will additionally review serious adverse events (SAEs) and adverse events of special interest (AESIs) date throughout the study. With DSMB's recommendation, the optimal dose for Part B will be selected by the Sponsor based on the following criteria which may be adjusted over the course of the study. Percentage immunogenic seroconversionRelative immunogenicity between INO-4800 Study Arms (Low dose vs. High dose)Safety profile of each INO-4800 Study Arms (Low dose vs. High dose). All subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.
[Part B] Part B is divided into two arm, IP Arm (Group 3) and Placebo Arm (Group 4). Part B will be randomized, double-blind, placebo-controlled trial, enrolling 60 subjects in IP arm, and 20 subjects in Placebo arm in 19-50 age group, and 30 subjects in IP arm, and 10 subjects in Placebo arm in 51-64 age group, for total of 90 subjects in IP arm, and 30 subjects in Placebo arm. At dosing visit, subjects will be randomized to either Group 3 or Group 4. The subjects will be contacted by telephone to report adverse events or other reactions the day following the first vaccination. DSMB review of safety findings will be performed according to the DSMB charter. All subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.Should the criteria for any dose limiting toxicity or stopping rule be met, at any time, further enrollment and administration of INO-4800 will be paused for further evaluation. The Sponsor will consult the DSMB, if needed, to determine whether to enroll and/or dose the remainder of the subjects. All subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Part A) | Experimental | Biological: INO-4800, Device: CELLECTRA® 2000* Number of Subjects: 20 subjects * ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) |
| Group 2 (Part A) | Experimental | Biological: INO-4800, Device: CELLECTRA® 2000* Number of Subjects: 20 subjects * ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) |
| Group 3 (Part B) | Experimental | Biological: INO-4800, Device: CELLECTRA® 2000* Number of Subjects: 90 subjects * ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) |
| Group 4 (Part B, Placebo) | Placebo comparator | Device: CELLECTRA® 2000, Other: Saline-sodium citrate (SSC) buffer* Number of Subjects: 30 subjects * ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures
- Adults aged 19 to 50 years (for Part A) or aged 19 to 64 (for Part B)
- Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening
- Able and willing to comply with all study procedures
- Screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the Investigator
Key exclusion criteria (30 listed)
- Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose
- Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing
- Is currently participating in or has participated in a study with an investigational product within 6 months preceding Day 0
- Receipt of an investigational product for prophylaxis or treatment of COVID-19, MERS or SARS
- Body mass index (BMI) <18 or >30
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 |
|---|---|---|
| INO-4800- Manufacturer: Inovio Pharmaceuticals Inc. | Biological | Group 1 (Part A), Group 2 (Part A), Group 3 (Part B) |
| CELLECTRA® 2000- Manufacturer: Inovio Pharmaceuticals Inc. | Device | Group 1 (Part A), Group 2 (Part A), Group 3 (Part B), Group 4 (Part B, Placebo) |
| Saline-sodium citrate (SSC) bufferAlso: Placebo- Manufacturer: Inovio Pharmaceuticals Inc. | Other | Group 4 (Part B, Placebo) |
Primary outcome
Primary Outcome Measures
Time frame: Baseline up to Week 52
* Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays [Immunogenicity] * Incidence of adverse events among participants during the study period [Safety and Tolerability] * Percentage of Participants with Administration (Injection) Site Reactions [Safety and Tolerability] * Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period [Safety and Tolerability]
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 18 Jul 2022.
- Individual participant dataSharing planned: Yes. Data dictionaries and all collected IPD will be anonymized and may be made available upon reasonable request.
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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.
Myoung-don Oh, MD principal investigator
Seoul National University Hospital
Eu Suk Kim, MD principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INO-4800, CELLECTRA® 2000 and Saline-sodium citrate (SSC) buffer in people with Coronavirus Infection and SARS-CoV 2, run by International Vaccine Institute at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Primary Outcome Measures (time frame: Baseline up to Week 52). 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 18 Jul 2022.