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DEFINITIONS
Trial Review
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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05327114
Registration number
NCT05327114
Ethics application status
Date submitted
7/04/2022
Date registered
14/04/2022
Date last updated
9/11/2023
Titles & IDs
Public title
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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Scientific title
Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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Secondary ID [1]
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80202135CDP3001
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Secondary ID [2]
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CR109195
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
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Condition category
Condition code
Neurological
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Other neurological disorders
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Inflammatory and Immune System
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Autoimmune diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Neurological
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Neurodegenerative diseases
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Nipocalimab
Treatment: Drugs - Placebo
Experimental: Nipocalimab - Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Placebo Comparator: Placebo - Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Treatment: Drugs: Nipocalimab
Nipocalimab will be administered intravenously.
Treatment: Drugs: Placebo
Placebo will be administered intravenously.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Stage B: Time to First Occurrence of a Relapse Event
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Assessment method [1]
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Stage B time to first occurrence of a relapse event will be reported.
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Timepoint [1]
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Up to 52 weeks
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Secondary outcome [1]
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Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
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Assessment method [1]
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Time to initial confirmed ECI will be reported.
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Timepoint [1]
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12 weeks
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Secondary outcome [2]
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Stage A: Percentage of Responders as Determined by ECI
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Assessment method [2]
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Stage A percentage of responders as determined by ECI will be reported.
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score
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Assessment method [3]
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Change from Stage A baseline over time in adjusted INCAT disability scale score will be reported. The INCAT disability scale is a clinician-rated assessment that measures activity limitation and degree of functional disability. The INCAT scale is an ordinal scale scored from 0 to 10, with higher scores indicating more disability.
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Timepoint [3]
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Baseline to 12 weeks
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Secondary outcome [4]
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Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score
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Assessment method [4]
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Change from Stage A baseline over time in MRC muscle grading scale sum score will be reported. The MRC muscle grading scale is a clinician-rated outcome that provides a strength rating (on a scale from 0 [no visible contraction] to 5 [normal]) in 6 muscles collected bilaterally: deltoid, biceps, wrist extensors, iliopsoas, quadriceps, tibialis anterior. Lower scores indicate greater impairment.
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Timepoint [4]
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Baseline to 12 weeks
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Secondary outcome [5]
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Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score
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Assessment method [5]
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Change from Stage A baseline over time in I-RODS centile score will be reported. The I-RODS comprises of 24 items representing common daily activities that address upper and lower limb disability and range in difficulty from very easy to very difficult. Lower scores indicate greater activity and social participation limitations.
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Timepoint [5]
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Baseline to 12 weeks
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Secondary outcome [6]
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Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
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Assessment method [6]
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Change from Stage A baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).
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Timepoint [6]
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Baseline to 12 weeks
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Secondary outcome [7]
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Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
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Assessment method [7]
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Change from Stage A baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).
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Timepoint [7]
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Baseline to 12 weeks
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Secondary outcome [8]
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Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline
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Assessment method [8]
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Time to first adjusted INCAT disability scale score deterioration relative to Stage B baseline will be reported.
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Timepoint [8]
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Up to 52 weeks
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Secondary outcome [9]
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Stage B: Time to First Switch to Intravenous Immunoglobulin (IVIg) or Other Standard of Care (SoC) as a Result of Investigator-assessed Lack of Efficacy as Confirmed by an Independent RAC Relative to Baseline
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Assessment method [9]
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Time to first switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent Relapse Adjudication Committee (RAC) relative to Stage B baseline will be reported.
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Timepoint [9]
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Up to 52 weeks
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Secondary outcome [10]
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Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score
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Assessment method [10]
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Change from Stage B baseline over time in adjusted INCAT disability score will be reported.
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Timepoint [10]
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Up to 52 weeks
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Secondary outcome [11]
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Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score
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Assessment method [11]
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Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score will be reported.
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Timepoint [11]
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Up to 52 weeks
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Secondary outcome [12]
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Stage B: Change from Baseline Over Time in I-RODS Centile Score
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Assessment method [12]
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Change from Stage B baseline over time in I-RODS centile score will be reported.
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Timepoint [12]
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Up to 52 weeks
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Secondary outcome [13]
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Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
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Assessment method [13]
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Change from Stage B baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).
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Timepoint [13]
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Up to 52 weeks
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Secondary outcome [14]
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Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
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Assessment method [14]
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Change from Stage B baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).
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Timepoint [14]
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Up to 52 weeks
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Secondary outcome [15]
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Stage B: Number of Participants with Binary Response Endpoint Satisfying all 4 Conditions: a) An Improved Adjusted INCAT Disability Score Compared to Baseline; b) Not Relapsing; c) Not Switching to SoC; d) Not Discontinuing Treatment
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Assessment method [15]
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Number of participants with Binary response endpoint satisfying all 4 conditions: a) an improved adjusted INCAT Disability Score compared to Stage B baseline; b) not relapsing; c) not switching to SoC; d) not discontinuing treatment, will be reported.
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Timepoint [15]
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Up to 52 weeks
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Secondary outcome [16]
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Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
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Assessment method [16]
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An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment
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Timepoint [16]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [17]
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Percentage of Participants with Serious Adverse Events (SAEs)
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Assessment method [17]
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SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
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Timepoint [17]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [18]
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Number of Participants with Change in Electrocardiogram (ECG) Values Over Time
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Assessment method [18]
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Number of participants with change in ECG values over time will be reported.
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Timepoint [18]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [19]
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Number of Participants with Change in Vital Signs Values Over Time
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Assessment method [19]
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Number of participants with change in vital signs values over time will be reported.
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Timepoint [19]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [20]
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Number of Participants with Change in Clinical Laboratory Values Over Time
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Assessment method [20]
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Number of participants with change in clinical laboratory values over time will be reported.
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Timepoint [20]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [21]
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Number of Participants with Clinically Significant ECG Abnormalities
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Assessment method [21]
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Number of participants in clinically significant ECG abnormalities will be reported.
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Timepoint [21]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [22]
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Number of Participants with Clinically Significant Vital Signs Abnormalities
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Assessment method [22]
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Number of participants in clinically significant vital signs abnormalities will be reported.
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Timepoint [22]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [23]
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Number of Participants with Clinically Significant Clinical Laboratory Abnormalities
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Assessment method [23]
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Number of participants in clinically significant clinical laboratory abnormalities will be reported.
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Timepoint [23]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [24]
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Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
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Assessment method [24]
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Percentage of participants with suicidal ideation or suicidal behavior based on the C-SSRS will be reported.
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Timepoint [24]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [25]
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Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention
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Assessment method [25]
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Serum nipocalimab concentrations over time in participants receiving active study intervention will be reported.
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Timepoint [25]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [26]
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Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab
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Assessment method [26]
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Number of participants with ADA to Nipocalimab will be reported.
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Timepoint [26]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [27]
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Titers of ADA to Nipocalimab
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Assessment method [27]
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Titers of ADA to nipocalimab will be reported.
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Timepoint [27]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [28]
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Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab
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Assessment method [28]
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Number of participants with NAb to Nipocalimab will be reported.
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Timepoint [28]
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Stage A: 12 weeks; Stage B: Up to 52 weeks
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Secondary outcome [29]
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Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time
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Assessment method [29]
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Change from baseline in total serum IgG concentrations levels over time will be reported.
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Timepoint [29]
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Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks
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Eligibility
Key inclusion criteria
- Adults greater than or equal to (>=) 18 years of age at the time of consent and as
applicable, must also meet the legal age of consent in the jurisdiction in which the
study is taking place
- Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to
criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021,
progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent
committee during screening period
- Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between
2 and 9 (a score of 2 has to be exclusively from leg disability)
- Fulfilling any of the following treatment conditions: a) Currently treated with pulsed
corticosteroids, oral corticosteroids and/or intravenous immunoglobulin (IVIg) or
subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue or
taper this treatment at the first run-in visit; or b) Without previous treatment
(treatment naive); or treatment with corticosteroids and/or IVIg or SCIg discontinued
at least 3 months prior to screening (untreated)
- Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3
- Other protocol-defined inclusion criteria will apply
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has a history of severe and/or uncontrolled hepatic (example,
viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease),
gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or
musculoskeletal disorder, hypertension and/or any other medical or uncontrolled
autoimmune disorder(s) (example, diabetes mellitus) or clinically significant
abnormalities in screening laboratory that, might interfere with the participants full
participation in the study, or might jeopardize the safety of the participant or the
validity of the study results
- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS
definition)
- Any other disease that could better explain the participant's signs and symptoms, such
as significant persisting neurological deficits from stroke or central nervous system
(CNS) trauma or peripheral neuropathy from another cause such as connective tissue
disease or systemic lupus erythematosus
- Polyneuropathy of other causes, including the following: Multifocal motor neuropathy
(MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated
glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor
neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP);
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change
syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to
diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or
toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes
(example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if
chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main
diagnosis, as determined by the investigator and confirmed by the adjudication
committee
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Other protocol-defined exclusion criteria will apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2028
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Kansas
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Country [3]
0
0
United States of America
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State/province [3]
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0
New York
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Country [4]
0
0
United States of America
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State/province [4]
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0
North Carolina
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Texas
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Country [6]
0
0
China
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State/province [6]
0
0
Beijing
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Country [7]
0
0
China
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State/province [7]
0
0
Changchun
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Country [8]
0
0
China
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State/province [8]
0
0
Jinan
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Country [9]
0
0
China
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State/province [9]
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0
Nanchang
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Country [10]
0
0
China
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State/province [10]
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0
Xi'an
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Country [11]
0
0
Czechia
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State/province [11]
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0
Hradec Králové
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Country [12]
0
0
Czechia
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State/province [12]
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Ostrava
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Country [13]
0
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Czechia
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State/province [13]
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Pardubice
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Country [14]
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France
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State/province [14]
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Bron
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Country [15]
0
0
France
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State/province [15]
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0
Le Kremlin Bicêtre
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Country [16]
0
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France
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State/province [16]
0
0
Strasbourg
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Country [17]
0
0
Japan
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State/province [17]
0
0
Asahikawa
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Country [18]
0
0
Japan
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State/province [18]
0
0
Bunkyo-Ku
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Country [19]
0
0
Japan
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State/province [19]
0
0
Chiba-shi
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Country [20]
0
0
Japan
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State/province [20]
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0
Hamamatsu
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Country [21]
0
0
Japan
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State/province [21]
0
0
Hyogo
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Country [22]
0
0
Japan
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State/province [22]
0
0
Isehara
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Country [23]
0
0
Japan
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State/province [23]
0
0
Koshigaya
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Country [24]
0
0
Japan
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State/province [24]
0
0
Kumamoto
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Country [25]
0
0
Japan
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State/province [25]
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0
Nagoya-shi
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Country [26]
0
0
Japan
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State/province [26]
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0
Nagoya
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Country [27]
0
0
Japan
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State/province [27]
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0
Osaka-Sayama-shi
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Country [28]
0
0
Japan
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State/province [28]
0
0
Shimotsuga-gun
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Country [29]
0
0
Japan
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State/province [29]
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0
Tenri
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Country [30]
0
0
Japan
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State/province [30]
0
0
Toyama-shi
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Country [31]
0
0
Japan
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State/province [31]
0
0
Ube
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Country [32]
0
0
Korea, Republic of
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State/province [32]
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0
Seoul
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Country [33]
0
0
Poland
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State/province [33]
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0
Chorzów
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Country [34]
0
0
Poland
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State/province [34]
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0
Kraków
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Country [35]
0
0
Taiwan
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State/province [35]
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0
Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared
to placebo in delaying relapse in adults with chronic inflammatory demyelinating
polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05327114
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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Phone
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0
844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05327114
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