Parkinson's DiseasePhase 1/2NCT06753331
A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
A Phase 1/2 study testing DSP-1083 implantation in people with Parkinson's Disease, run by Sumitomo Pharma America, Inc. at 3 sites in United States.
Trial summary
The Goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083. Study enrolls both male and female patients in 2 cohorts. This study will be held in approximately 5-8 study sites in United States Read more about this study
- Who is it for?
- Ages 40 to 72 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- DSP-1083 implantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Dec 2024to 15 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 40 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged ≥ 40 and ≤ 72 years at the time of informed consent with a clinically established diagnosis of Parkinson's disease in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease.
- Subject has a clinically established diagnosis of PD for ≥ 4 years.
- Subject has suboptimal control of PD symptoms, with optimized oral antiparkinsonian medication regimen including levodopa/carbidopa monotherapy or levodopa/carbidopa plus antiparkinsonian medications, with stable dosing for ≥ 2months prior to screening.
- Subject has a L-DOPA response of ≥ 30% without the influence of antiparkinsonian medications at Screening.
- Subject has a Modified Hoehn and Yahr stage 3 - 4 in the Off state.
- Subject has a pretreatment 18F-DOPA PET scan consistent with PD.
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- Subject has both On and Off states as demonstrated by the MDS-UPDRS Part III/IV and the Hauser patient daily diary.
- Subjects must meet the following race criteria: 2 of the up to 5 sentinel subjects will be of Asian race, defined as having at least 2 grandparents who are Japanese, Taiwanese, Korean, or Chinese. Subjects in Cohort 2 can be of any race.
- Subject is approved by the Enrollment Authorization Eligibility Committee following review of all required information collected during Screening.
Who cannot join
- Subject has atypical parkinsonian syndrome (eg, progressive supranuclear palsy [PSP], multiple system atrophy [MSA], dementia with Lewy bodies [DLB], corticobasal degeneration, Parkinson-plus syndrome, vascular parkinsonism, secondary parkinsonism, hereditary parkinsonism).
- Subject has non-PD neurological symptoms or evidence of non-PD brain disease (eg, tumor, inflammation, active or history of vascular disorder, history of cerebral hemorrhage, Alzheimer's disease, or other neurodegenerative disorder) based on neuroimaging and/or medical history that would preclude study participation.
- Subject has psychiatric symptoms, cognitive impairment, depression, dementia, or other behavioral disorder that would preclude study participation based on Investigator decision.
- Subject has received previous striatal or other extrapyramidal system PD treatments, including deep-brain stimulation, central nervous system (CNS) ablation (eg, pallidotomy, thalamotomy), implanted cell, or gene therapy, and/or focused ultrasound therapy.
- Subject has peak-dose dyskinesia of sufficient severity that precludes study participation, defined as any item score of ≥ 3 (moderate dyskinesia) on the UDysRS Part 1B (Patient Dyskinesia Questionnaire) AND/OR any item score of ≥ 2 (moderate dyskinesia) on Part 3 (Objective Evaluation of Dyskinesia Disability) Intensity Scale: Impairment. Subject has another type (eg, diphasic dyskinesia) or an unusual pattern of dyskinesia.
- Subject has a history of, or concurrent abnormal immune function that may adversely affect the engraftment of the cell implants and use of adjunctive immunosuppressants.
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- The subject has the following clinical laboratory test results at Screening:
- Neutrophil count < 2,000/μL.
- Platelet count < 5.0 × 104/μL.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3.0 × upper limit of normal.
- Total bilirubin > 1.5 × upper limit of normal.
- Persistent estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
- Poorly controlled blood glucose in diabetic subjects (glycosylated hemoglobin > 9.0%, or fasting serum glucose ≥ 200mg/dL).
- Subject has any disorder that would contraindicate general anesthesia, conscious sedation or stereotactic surgery.
- Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study. In cases in which the impact of the condition upon risk to subject or study results is unclear, the Medical Monitor should be consulted.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UCSD Medical Center
La Jolla, California, 92037
Miguel Alvendia, 858-249-4020, AlphaStemCellClinic@health.ucsd.edu
Isaac Rodriguez
- Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Lynne Cagle, 859-218-5443, Lynne.cagle@uky.edu
- Recruiting
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
Natasha Desai, 347-882-4315, Nd2528@cumc.columbia.edu
About this study
Official title: A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses Following Stereotactic Intracranial Implantation of DSP-1083 Into Subjects With Parkinson's Disease
The Goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083. Study enrolls both male and female patients in 2 cohorts. This study will be held in approximately 5-8 study sites in United States
Read the detailed description
This is a multicenter first-in-human (FIH) study designed to evaluate the safety, tolerability, and clinical responses following implantation of dopaminergic progenitor cells derived from induced pluripotent stem cells (DSP-1083) compared with sham surgery. Safety is measured based on adverse events, changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks.
Cohort 1 sentinel subject (SS1) will undergo 2 unilateral surgical procedures separated by approximately 28 weeks, whereas SS2 and all subsequent subjects will undergo 1 bilateral surgical procedure.
- Conditions
- Parkinson's Disease
- Being tested
- DSP-1083 implantation, Sham surgery treatment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-1083 implantationCombination product
DSP-1083 subjects will receive 2.7M viable cells per hemisphere; 5.4M total cell dose as implants.
Sham surgery treatmentProcedure or surgery
Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.
| Study group | Role | What they receive |
|---|---|---|
| DSP-1083 | Experimental | Implantation of DSP-1083 (2.7M viable cells per hemisphere; 5.4M total cell dose) Receives: Combination Product: DSP-1083 implantation |
| Sham Surgery | Sham comparator | Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration. Receives: Procedure: Sham surgery treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events.
Measured: Up to 104 weeks
Incidence of Serious Adverse Events (SAE).
Measured: Up to 104 weeks
Incidence and severity of Adverse Events of Special Interest (AESI).
Measured: Up to 104 weeks
Incidence and severity of Adverse Events leading to study discontinuation.
Measured: Up to 104 weeks
Change from baseline in cognition and neuropsychiatric status as assessed by Montreal Cognitive Assessment (MoCA).
The MoCA is a widely used, sensitive, validated screening test for detecting mild cognitive impairment and can also predict the presence of cognitive deterioration (ie, progression from mild cognitive impairment to dementia) in PD patients.
Measured: Up to 104 weeks
Change from baseline in cognition and neuropsychiatric status as assessed by Mattis Dementia Rating Scale (MDRS).
The MDRS has been utilized for early detection of dementia, differential diagnosis between Alzheimer's disease and other dementias. The 144-point scale is an aggregate score of 5 subscales: attention, initiation/perseveration (I/P), construction, conceptualization, and memory.The total score ranges from 0 to 144, with lower scores indicating greater cognitive impairment.
Measured: Up to 104 weeks
Change from baseline in Head Magnetic Resonance Imaging (MRI) (graft expansion/rejection) neuroimaging parameters.
Safety MRIs - are conducted to assess the safety of DSP-1083 including rejection, abnormal growth, and formation of mass lesions, which could indicate teratoma formation
Measured: Up to 104 weeks
Change from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters.
PET scans using F-DOPA will be performed at Screening and then post-surgery to follow the course of graft development and to provide a measure of dopaminergic nerve terminals in the striatum.
Measured: Up to 104 weeks
Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Scale (C-SSRS).
Measured: Up to 104 weeks
Observed values and change from baseline in clinical laboratory tests.
Laboratory results at each time point will be summarized using descriptive statistics (mean, standard deviation (SD), median, minimum, and maximum) by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in Heart Rate (HR).
12-lead ECG parameters ventricular HR at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in QT interval.
12-lead ECG parameters QT interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in PR interval.
12-lead ECG parameters PR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in QRS duration.
12-lead ECG parameters QRS duration at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in RR interval.
12-lead ECG parameters RR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in QTcF interval.
12-lead ECG parameters QTcF interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in body temperature.
Vital signs parameter body temperature will be summarized using descriptive statistics at each time point by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in respiratory rate.
Vital signs parameter supine respiratory rate will be summarized using descriptive statistics at each time point by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in pulse rate.
Vital signs parameter supine and standing pulse will be summarized using descriptive statistics at each time point by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in Systolic Blood Pressure.
Vital signs parameter Systolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Measured: Up to 104 weeks
Observed values and change from baseline in Diastolic Blood Pressure.
Vital signs parameter Diastolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start18 Dec 2024
- Primary completion15 Dec 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sentinel cohort of 3 to 5 subjects will be open-label and receive DSP-1083. Cohort 2 (20 subjects) will be randomized in a 1:1 ratio to receive either DSP-1083 during a surgical procedure, or sham surgery with no DSP-1083 administered.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753331
- Sponsor's protocol ID
- DD201101
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses Following Stereotactic Intracranial Implantation of DSP-1083 Into Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06753331
- Acronym / sponsor ID
- DD201101
- Conditions
- Parkinson's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 31 Dec 2024 (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.
The Goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083. Study enrolls both male and female patients in 2 cohorts. This study will be held in approximately 5-8 study sites in United States
Detailed description
This is a multicenter first-in-human (FIH) study designed to evaluate the safety, tolerability, and clinical responses following implantation of dopaminergic progenitor cells derived from induced pluripotent stem cells (DSP-1083) compared with sham surgery. Safety is measured based on adverse events, changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks.
Cohort 1 sentinel subject (SS1) will undergo 2 unilateral surgical procedures separated by approximately 28 weeks, whereas SS2 and all subsequent subjects will undergo 1 bilateral surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The sentinel cohort of 3 to 5 subjects will be open-label and receive DSP-1083. Cohort 2 (20 subjects) will be randomized in a 1:1 ratio to receive either DSP-1083 during a surgical procedure, or sham surgery with no DSP-1083 administered.
| Arm | Type | Receives |
|---|---|---|
| DSP-1083 | Experimental | Combination Product: DSP-1083 implantationImplantation of DSP-1083 (2.7M viable cells per hemisphere; 5.4M total cell dose) |
| Sham Surgery | Sham comparator | Procedure: Sham surgery treatmentSham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration. |
Who may qualify
- Ages
- 40 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women aged ≥ 40 and ≤ 72 years at the time of informed consent with a clinically established diagnosis of Parkinson's disease in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease.
- Subject has a clinically established diagnosis of PD for ≥ 4 years.
- Subject has suboptimal control of PD symptoms, with optimized oral antiparkinsonian medication regimen including levodopa/carbidopa monotherapy or levodopa/carbidopa plus antiparkinsonian medications, with stable dosing for ≥ 2months prior to screening.
- Subject has a L-DOPA response of ≥ 30% without the influence of antiparkinsonian medications at Screening.
- Subject has a Modified Hoehn and Yahr stage 3 - 4 in the Off state.
Key exclusion criteria (15 listed)
- Subject has atypical parkinsonian syndrome (eg, progressive supranuclear palsy [PSP], multiple system atrophy [MSA], dementia with Lewy bodies [DLB], corticobasal degeneration, Parkinson-plus syndrome, vascular parkinsonism, secondary parkinsonism, hereditary parkinsonism).
- Subject has non-PD neurological symptoms or evidence of non-PD brain disease (eg, tumor, inflammation, active or history of vascular disorder, history of cerebral hemorrhage, Alzheimer's disease, or other neurodegenerative disorder) based on neuroimaging and/or medical history that would preclude study participation.
- Subject has psychiatric symptoms, cognitive impairment, depression, dementia, or other behavioral disorder that would preclude study participation based on Investigator decision.
- Subject has received previous striatal or other extrapyramidal system PD treatments, including deep-brain stimulation, central nervous system (CNS) ablation (eg, pallidotomy, thalamotomy), implanted cell, or gene therapy, and/or focused ultrasound therapy.
- Subject has peak-dose dyskinesia of sufficient severity that precludes study participation, defined as any item score of ≥ 3 (moderate dyskinesia) on the UDysRS Part 1B (Patient Dyskinesia Questionnaire) AND/OR any item score of ≥ 2 (moderate dyskinesia) on Part 3 (Objective Evaluation of Dyskinesia Disability) Intensity Scale: Impairment. Subject has another type (eg, diphasic dyskinesia) or an unusual pattern of dyskinesia.
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 |
|---|---|---|
| DSP-1083 implantationDSP-1083 subjects will receive 2.7M viable cells per hemisphere; 5.4M total cell dose as implants. | Combination product | DSP-1083 |
| Sham surgery treatmentSham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration. | Procedure or surgery | Sham Surgery |
Primary outcome
Incidence and severity of Adverse Events.
Time frame: Up to 104 weeks
Incidence of Serious Adverse Events (SAE).
Time frame: Up to 104 weeks
Incidence and severity of Adverse Events of Special Interest (AESI).
Time frame: Up to 104 weeks
Incidence and severity of Adverse Events leading to study discontinuation.
Time frame: Up to 104 weeks
Change from baseline in cognition and neuropsychiatric status as assessed by Montreal Cognitive Assessment (MoCA).
Time frame: Up to 104 weeks
The MoCA is a widely used, sensitive, validated screening test for detecting mild cognitive impairment and can also predict the presence of cognitive deterioration (ie, progression from mild cognitive impairment to dementia) in PD patients.
Change from baseline in cognition and neuropsychiatric status as assessed by Mattis Dementia Rating Scale (MDRS).
Time frame: Up to 104 weeks
The MDRS has been utilized for early detection of dementia, differential diagnosis between Alzheimer's disease and other dementias. The 144-point scale is an aggregate score of 5 subscales: attention, initiation/perseveration (I/P), construction, conceptualization, and memory.The total score ranges from 0 to 144, with lower scores indicating greater cognitive impairment.
Change from baseline in Head Magnetic Resonance Imaging (MRI) (graft expansion/rejection) neuroimaging parameters.
Time frame: Up to 104 weeks
Safety MRIs - are conducted to assess the safety of DSP-1083 including rejection, abnormal growth, and formation of mass lesions, which could indicate teratoma formation
Change from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters.
Time frame: Up to 104 weeks
PET scans using F-DOPA will be performed at Screening and then post-surgery to follow the course of graft development and to provide a measure of dopaminergic nerve terminals in the striatum.
Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Scale (C-SSRS).
Time frame: Up to 104 weeks
Observed values and change from baseline in clinical laboratory tests.
Time frame: Up to 104 weeks
Laboratory results at each time point will be summarized using descriptive statistics (mean, standard deviation (SD), median, minimum, and maximum) by treatment group.
Observed values and change from baseline in Heart Rate (HR).
Time frame: Up to 104 weeks
12-lead ECG parameters ventricular HR at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QT interval.
Time frame: Up to 104 weeks
12-lead ECG parameters QT interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in PR interval.
Time frame: Up to 104 weeks
12-lead ECG parameters PR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QRS duration.
Time frame: Up to 104 weeks
12-lead ECG parameters QRS duration at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in RR interval.
Time frame: Up to 104 weeks
12-lead ECG parameters RR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QTcF interval.
Time frame: Up to 104 weeks
12-lead ECG parameters QTcF interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in body temperature.
Time frame: Up to 104 weeks
Vital signs parameter body temperature will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in respiratory rate.
Time frame: Up to 104 weeks
Vital signs parameter supine respiratory rate will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in pulse rate.
Time frame: Up to 104 weeks
Vital signs parameter supine and standing pulse will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in Systolic Blood Pressure.
Time frame: Up to 104 weeks
Vital signs parameter Systolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in Diastolic Blood Pressure.
Time frame: Up to 104 weeks
Vital signs parameter Diastolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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.
New York Presbyterian Hospital-Columbia University Medical Center
New York, United States
3 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 DSP-1083 implantation in people with Parkinson's Disease, run by Sumitomo Pharma America, Inc. at 3 sites 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events. (time frame: Up to 104 weeks). The study lists 21 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 Oct 2026.