Plaque PsoriasisPhase 1NCT05332704
Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685
A Phase 1 study testing ONO-4685 in people with Plaque Psoriasis, run by Ono Pharmaceutical Co., Ltd. at 4 sites in 3 countries.
Trial summary
This is an early phase study to assess the safety and tolerability of ONO-4685 in patients with psoriasis. In addition, the study will assess how the drug is distributed and eliminated by the body (pharmacokinetics) and how the drug affects the body (pharmacodynamics). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ONO-4685
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 25 Mar 2022to 18 Jul 2024
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be willing and able to participate in the study
- A diagnosis of plaque-type psoriasis for ≥6 months.
- Plaque-type psoriasis involving ≥3% of body surface area (BSA) (Parts B and C).
- Willing to provide skin biopsies (Parts B and C).
- Subjects in good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests.
- Subjects willing to comply with the contraception and sperm and ova donation requirements of the protocol.
Who cannot join
- Subjects with any clinically significant abnormality in screening tests.
- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the psoriasis, or other skin condition (eg eczema).
- Presence or history of alcohol or drugs abuse.
- Heavy smokers (more than 20 cigarettes or use more than ½ ounce (12.5 grams) of tobacco each day).
- Subjects have had any 'live' vaccines (excluding COVID-19 vaccine) during the 3 months before the first dose of study medicine.
- Subjects have had a first COVID-19 vaccine within 6 weeks or second and booster COVID-19 vaccinations within 2 weeks before the first dose of study medicine.
Show all 11Show fewer
- Subjects have had any clinically significant disease or infection, including tuberculosis.
- Presence or history of malignancy (cancer) including lymphoproliferative disorders.
- Subject is pregnant, lactating, or breastfeeding.
- Subjects have received treatment with biologics in the last 3 months, immunosuppressant medicine or prescription medicine for psoriasis within 4 weeks before admission to the ward; have used phototherapy from 2 weeks before admission to the ward; have used highly potent or potent topical steroids within 2 weeks before admission to the ward.
- Subjects have used topical corticosteroids or Vitamin D analogues within 7 days before admission to the ward (Parts B and C).
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Hammersmith Medicines Research
London, NW10 7EW
Medicines Evaluation Unit
Manchester, M23 9QZ
About this study
Official title: A Randomised, Multi-centre, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Dose Study to Assess Safety, Tolerability, PK, PD & Preliminary Efficacy of IV Doses of ONO-4685 in Patients With Plaque Psoriasis
This is an early phase study to assess the safety and tolerability of ONO-4685 in patients with psoriasis. In addition, the study will assess how the drug is distributed and eliminated by the body (pharmacokinetics) and how the drug affects the body (pharmacodynamics). This will be done by measuring the amount of drug in the blood and measuring other markers in the body that might have been affected by ONO-4685. The study will also look at preliminary information on whether ONO-4685 might be effective in treating psoriasis.
The study will be split into three parts. Part A will assess a single dose of ONO-4685 in small groups of patients, each group planned to receive a higher dose than the last group. In Part B and C, patients will receive multiple doses of ONO-4685 over a period of 4 weeks.
- Conditions
- Plaque Psoriasis
- Being tested
- ONO-4685, Placebo
- Keywords
- Psoriasis, ONO-4685, PD-1, Bi-specific antibody, PD-1 Receptor, PD-1 Agonist
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4685Drug
-Part A: Single ascending doses of ONO-4685 as a single IV dose (Cohort A1-A5).
PlaceboDrug
-Part A: Single ascending doses of placebo as a single IV dose (Cohort A1-A5).
ONO-4685Drug
-Part B: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort B1 and B2)
PlaceboDrug
-Part B: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort B1 and B2).
ONO-4685Drug
-Part C: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort C1 and C2).
PlaceboDrug
-Part C: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort C1 and C2).
| Study group | Role | What they receive |
|---|---|---|
| Part A, Active | Experimental | Not described Receives: Drug: ONO-4685 |
| Part A, Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part B, Active | Experimental | Not described Receives: Drug: ONO-4685 |
| Part B, Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part C, Active | Experimental | Not described Receives: Drug: ONO-4685 |
| Part C, Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events (TEAEs) by severity
Number of participants with TEAEs. An adverse event is any untoward medical occurrence in a participant who receives study drug without regard to possible causal relationship.
Measured: End of Study (3 years)
Clinical laboratory tests
Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis).
Measured: End of Study (3 years)
Cytokines
Number of participants with elevated cytokines.
Measured: Up to day 8 post dosing day
Lymphocytes
Number of participants with depleted lymphocytes.
Measured: End of Study (3 years)
Vital signs (blood pressure)
Number of participants with clinically significant changes in vital signs (blood pressure)
Measured: End of Study (3 years)
Vital signs (respiration rate)
Number of participants with clinically significant changes in vital signs (respiration rate)
Measured: End of Study (3 years)
Vital signs (temperature)
Number of participants with clinically significant changes in vital signs (temperature)
Measured: End of Study (3 years)
Vital signs (pulse rate)
Number of participants with clinically significant changes in vital signs (pulse rate)
Measured: End of Study (3 years)
ECG parameters
Number of participants with ECG abnormalities.
Measured: End of Study (3 years)
Secondary outcomes (24)
Pharmacokinetics (Ceoi)
Assessment of the observed plasma concentration of ONO-4685 at the end of infusion (eoi).
Measured: Part A, Day 1 (day of dosing). Part B and C, Day 1 (day of first dose) and Day 15 or 22 (day of last dose) depending on weekly or bi-weekly dosing.
Pharmacokinetics, Cmax
Assessment of the maximum observed plasma concentration of ONO-4685.
Measured: Part A up to day 85, Part B and Part C up to day 113
Pharmacokinetics, Tmax
Assessment of the time of maximum plasma concentration of ONO-4685.
Measured: Part A up to day 85, Part B and Part C up to day 113
Pharmacokinetics, AUC last
Assessment of the area under the plasma ONO-4685 concentration-time curve from time 0 to time of the last quantifiable concentration.
Measured: Part A up to day 85
Pharmacokinetics, AUCinf
Assessment of the area under the plasma ONO-4685 concentration-time curve from time 0 to infinity.
Measured: Part A up to day 85
Pharmacokinetics, CL (Clearance)
Assessment of the plasma clearance of ONO-4685.
Measured: Part A up to day 85
Pharmacokinetics, Vss
Assessment of the volume of distribution at steady state of ONO-4685
Measured: Part A up to day 85
Pharmacokinetics, T1/2
Assessment of the terminal elimination half-life of ONO-4685 in plasma.
Measured: Part A up to day 85, and after the last dose administration (Day 15 or 22) in Part B and Part C up to day 113.
Pharmacokinetics, AUCtau
Assessment of the area under the plasma ONO-4685 concentration-time curve during the dosing interval.
Measured: Part B and C, after first (Day 1) and last (Day 15 or 22) dose
Pharmacokinetics, Ctrough
Assessment of the trough concentration of ONO-4685 in plasma.
Measured: Part B and C, prior to administration of each dose
Pharmacodynamics, lymphocytes
Assessment of total lymphocytes, including subsets CD4+ T cell, CD8+ T cell, B cell and NK cell.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Pharmacodynamics, immunoglobulin
Assessment of total immunoglobulin, IgA, IgG and IgM.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Pharmacodynamics, cytokines
Assessment of cytokines, including IL-2, IL-6, IL-10, TNF-α and INF-γ.
Measured: Part A up to day 8, Part B and Part C up to day 8 post last dose
Immunogenicity, Anti-ONO-4685-antibodies (ADA)
Assessment of antibodies generated to ONO-4685 to measure potential immunogenicity.
Measured: Part A up to day 85, Part B and Part C up to day 113
Efficacy, Psoriasis Area and Severity Index (PASI)
Assessment of change in PASI from baseline.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Psoriasis Area and Severity Index (PASI) 50
Assessment of number of subjects that achieve PASI 50, a 50% reduction in PASI from baseline.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Psoriasis Area and Severity Index (PASI) 75
Assessment of number of subjects that achieve PASI 75, a 75% reduction in PASI from baseline.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Psoriasis Area and Severity Index (PASI) 90
Assessment of number of subjects that achieve PASI 90, a 90% reduction in PASI from baseline.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Target Plaque Severity Score (TPSS)
Assessment of change in TPSS from baseline.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Physician's Global Assessment (PGA)
Assessment of change in PGA from baseline.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Physician's Global Assessment (PGA) 0/1
Assessment of the number of subjects that achieve PGA 0/1.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Physician's Global Assessment (PGA) 0/1 and a 2-point improvement
Assessment of the number of subjects that achieve PGA 0/1 and a 2-point improvement from baseline.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Body Surface Area (BSA)
Assessment of the change in plaque BSA from baseline
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Patient Reported Outcome, Dermatology Life Quality Index (DLQI)
Assessment of the change in DLQI from baseline.
Measured: Part A up to day 85, Part B up to day 113, Part C up to day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start25 Mar 2022
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a phase I, multi-centre study to assess the safety, tolerability, PK \& PD of ONO-4685. This study consists of: Part A single ascending dose, Part B an assessment of multiple doses \& Part C to undertake initial assessment of efficacy with multiple doses. The study will recruit patients, male \& female, with mild or moderate psoriasis diagnosed for at least 6 months. Following screening activities, patients are admitted to a clinical unit 1 day ahead of dosing and will stay at the unit for 4 nights. For patients receiving multiple doses, they will attend the clinic on the day of dosing and will stay for 3 nights. All patients will be followed up, for up to 24 weeks from 1st dose. The study will recruit 6 patients per cohort for part A \& B and 18 patients per cohort for part C. The overall active to placebo ratio will be 2:1.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332704
- Sponsor's protocol ID
- ONO-4685-02
- Other IDs
- 2021-002151-10
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multi-centre, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Dose Study to Assess Safety, Tolerability, PK, PD & Preliminary Efficacy of IV Doses of ONO-4685 in Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05332704
- Acronym / sponsor ID
- ONO-4685-02
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, ONO-4685, PD-1, Bi-specific antibody, PD-1 Receptor, PD-1 Agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 18 Apr 2022 (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 an early phase study to assess the safety and tolerability of ONO-4685 in patients with psoriasis. In addition, the study will assess how the drug is distributed and eliminated by the body (pharmacokinetics) and how the drug affects the body (pharmacodynamics). This will be done by measuring the amount of drug in the blood and measuring other markers in the body that might have been affected by ONO-4685. The study will also look at preliminary information on whether ONO-4685 might be effective in treating psoriasis.
The study will be split into three parts. Part A will assess a single dose of ONO-4685 in small groups of patients, each group planned to receive a higher dose than the last group. In Part B and C, patients will receive multiple doses of ONO-4685 over a period of 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- This is a phase I, multi-centre study to assess the safety, tolerability, PK \& PD of ONO-4685. This study consists of: Part A single ascending dose, Part B an assessment of multiple doses \& Part C to undertake initial assessment of efficacy with multiple doses. The study will recruit patients, male \& female, with mild or moderate psoriasis diagnosed for at least 6 months. Following screening activities, patients are admitted to a clinical unit 1 day ahead of dosing and will stay at the unit for 4 nights. For patients receiving multiple doses, they will attend the clinic on the day of dosing and will stay for 3 nights. All patients will be followed up, for up to 24 weeks from 1st dose. The study will recruit 6 patients per cohort for part A \& B and 18 patients per cohort for part C. The overall active to placebo ratio will be 2:1.
| Arm | Type | Receives |
|---|---|---|
| Part A, Active | Experimental | Drug: ONO-4685 |
| Part A, Placebo | Placebo comparator | Drug: Placebo |
| Part B, Active | Experimental | Drug: ONO-4685 |
| Part B, Placebo | Placebo comparator | Drug: Placebo |
| Part C, Active | Experimental | Drug: ONO-4685 |
| Part C, Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be willing and able to participate in the study
- A diagnosis of plaque-type psoriasis for ≥6 months.
- Plaque-type psoriasis involving ≥3% of body surface area (BSA) (Parts B and C).
- Willing to provide skin biopsies (Parts B and C).
- Subjects in good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests.
Key exclusion criteria (11 listed)
- Subjects with any clinically significant abnormality in screening tests.
- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the psoriasis, or other skin condition (eg eczema).
- Presence or history of alcohol or drugs abuse.
- Heavy smokers (more than 20 cigarettes or use more than ½ ounce (12.5 grams) of tobacco each day).
- Subjects have had any 'live' vaccines (excluding COVID-19 vaccine) during the 3 months before the first dose of study medicine.
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 |
|---|---|---|
| ONO-4685-Part A: Single ascending doses of ONO-4685 as a single IV dose (Cohort A1-A5). | Drug | Part A, Active |
| Placebo-Part A: Single ascending doses of placebo as a single IV dose (Cohort A1-A5). | Drug | Part A, Placebo |
| ONO-4685-Part B: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort B1 and B2) | Drug | Part B, Active |
| Placebo-Part B: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort B1 and B2). | Drug | Part B, Placebo |
| ONO-4685-Part C: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort C1 and C2). | Drug | Part C, Active |
| Placebo-Part C: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort C1 and C2). | Drug | Part C, Placebo |
Primary outcome
Treatment emergent adverse events (TEAEs) by severity
Time frame: End of Study (3 years)
Number of participants with TEAEs. An adverse event is any untoward medical occurrence in a participant who receives study drug without regard to possible causal relationship.
Clinical laboratory tests
Time frame: End of Study (3 years)
Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis).
Cytokines
Time frame: Up to day 8 post dosing day
Number of participants with elevated cytokines.
Lymphocytes
Time frame: End of Study (3 years)
Number of participants with depleted lymphocytes.
Vital signs (blood pressure)
Time frame: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (blood pressure)
Vital signs (respiration rate)
Time frame: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (respiration rate)
Vital signs (temperature)
Time frame: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (temperature)
Vital signs (pulse rate)
Time frame: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (pulse rate)
ECG parameters
Time frame: End of Study (3 years)
Number of participants with ECG abnormalities.
24 secondary outcomes
Pharmacokinetics (Ceoi)
Time frame: Part A, Day 1 (day of dosing). Part B and C, Day 1 (day of first dose) and Day 15 or 22 (day of last dose) depending on weekly or bi-weekly dosing.
Pharmacokinetics, Cmax
Time frame: Part A up to day 85, Part B and Part C up to day 113
Pharmacokinetics, Tmax
Time frame: Part A up to day 85, Part B and Part C up to day 113
Pharmacokinetics, AUC last
Time frame: Part A up to day 85
Pharmacokinetics, AUCinf
Time frame: Part A up to day 85
Pharmacokinetics, CL (Clearance)
Time frame: Part A up to day 85
Pharmacokinetics, Vss
Time frame: Part A up to day 85
Pharmacokinetics, T1/2
Time frame: Part A up to day 85, and after the last dose administration (Day 15 or 22) in Part B and Part C up to day 113.
Pharmacokinetics, AUCtau
Time frame: Part B and C, after first (Day 1) and last (Day 15 or 22) dose
Pharmacokinetics, Ctrough
Time frame: Part B and C, prior to administration of each dose
Pharmacodynamics, lymphocytes
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Pharmacodynamics, immunoglobulin
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Pharmacodynamics, cytokines
Time frame: Part A up to day 8, Part B and Part C up to day 8 post last dose
Immunogenicity, Anti-ONO-4685-antibodies (ADA)
Time frame: Part A up to day 85, Part B and Part C up to day 113
Efficacy, Psoriasis Area and Severity Index (PASI)
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Psoriasis Area and Severity Index (PASI) 50
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Psoriasis Area and Severity Index (PASI) 75
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Psoriasis Area and Severity Index (PASI) 90
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Target Plaque Severity Score (TPSS)
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Physician's Global Assessment (PGA)
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Physician's Global Assessment (PGA) 0/1
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Physician's Global Assessment (PGA) 0/1 and a 2-point improvement
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Efficacy, Body Surface Area (BSA)
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
Patient Reported Outcome, Dermatology Life Quality Index (DLQI)
Time frame: Part A up to day 85, Part B up to day 113, Part C up to day 169
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 21 Aug 2024.
- 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.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-4685 in people with Plaque Psoriasis, run by Ono Pharmaceutical Co., Ltd. at 4 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Moldova, Romania. 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 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.
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?
Treatment emergent adverse events (TEAEs) by severity (time frame: End of Study (3 years)). The study lists 9 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 21 Aug 2024.