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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/NCT05492578
Registration number
NCT05492578
Ethics application status
Date submitted
5/08/2022
Date registered
8/08/2022
Date last updated
10/05/2024
Titles & IDs
Public title
Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
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Scientific title
A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.
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Secondary ID [1]
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U1111-1269-6490
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Secondary ID [2]
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LTS17367
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Universal Trial Number (UTN)
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Trial acronym
RIVER-AD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Other interventions - Topical corticosteroids
Other interventions - Topical calcineurin inhibitors
Other interventions - Oral corticosteroids
Experimental: Amlitelimab - Subcutaneous injection Q4W
Treatment: Drugs: Amlitelimab
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Other interventions: Topical corticosteroids
Pharmaceutical form: Topical Route of administration: Topical
Other interventions: Topical calcineurin inhibitors
Pharmaceutical form: Topical Route of administration: Topical
Other interventions: Oral corticosteroids
Pharmaceutical form: Oral Route of administration: Oral
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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Percentage of participants who experienced treatment-emergent adverse event (TEAE)
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Assessment method [1]
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Percentage of participants who experienced TEAE
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Timepoint [1]
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Baseline to Week 120
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Secondary outcome [1]
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Percentage of participants who experienced treatment-emergent SAEs
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Assessment method [1]
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Percentage of participants who experienced treatment-emergent SAEs
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Timepoint [1]
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Baseline to Week 120
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Secondary outcome [2]
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Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)
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Assessment method [2]
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Percentage of participants who experienced treatment-emergent AESI
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Timepoint [2]
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Baseline to Week 120
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Secondary outcome [3]
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Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
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Assessment method [3]
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
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Timepoint [3]
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DRI17366 Baseline to Week 104
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Secondary outcome [4]
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Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
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Assessment method [4]
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
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Timepoint [4]
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DRI17366 Baseline to Week 104
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Secondary outcome [5]
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Proportion of participants with EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24
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Assessment method [5]
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
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Timepoint [5]
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DRI17366 Baseline to Week 104
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Secondary outcome [6]
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Proportion of participants with a response of validated investigator global assessment (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24
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Assessment method [6]
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The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
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Timepoint [6]
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Baseline to Week 104
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Secondary outcome [7]
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Absolute change from parent study baseline in EASI score at pre-specified timepoints in all participants entering the study
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Assessment method [7]
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
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Timepoint [7]
0
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Baseline to Week 104
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Secondary outcome [8]
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Percent change from parent study baseline in EASI score at pre-specified timepoints in all participants entering the study
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Assessment method [8]
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
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Timepoint [8]
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Baseline to Week 104
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Secondary outcome [9]
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Proportion of participants with EASI50/ EASI75/ EASI90/ EASI100 at pre-specified timepoints in all participants entering the studyPercent change from parent study baseline in EASI score at pre-specified timepoints in all participants entering the study
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Assessment method [9]
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI50: >= 50% reduction in score from baseline; EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
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Timepoint [9]
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Baseline to Week 104
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Secondary outcome [10]
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Time to first EASI75/EASI90/EASI100 in those participants who had not achieved it by the time of LTS17367 entry in all participants entering the study
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Assessment method [10]
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
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Timepoint [10]
0
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Baseline to Week 104
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Secondary outcome [11]
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Time to first remission after LTS17367 enrolment (achieving vIGA-AD 0/1) in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 entry in all participants entering the study
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Assessment method [11]
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The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
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Timepoint [11]
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Baseline to Week 104
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Secondary outcome [12]
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Proportion of participants with vIGA-AD score 0/1 at each visit in all participants entering the study
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Assessment method [12]
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The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
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Timepoint [12]
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Baseline to Week 104
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Secondary outcome [13]
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Proportion of participants with low disease activity state (e.g., vIGA-AD =2) at each visit in all participants entering the study
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Assessment method [13]
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The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
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Timepoint [13]
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Baseline to Week 104
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Secondary outcome [14]
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Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study
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Assessment method [14]
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Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study.
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Timepoint [14]
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Baseline to Week 120
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Secondary outcome [15]
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Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study
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Assessment method [15]
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Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study.
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Timepoint [15]
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Baseline to Week 120
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Secondary outcome [16]
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Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study
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Assessment method [16]
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Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study.
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Timepoint [16]
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Baseline to Week 120
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Secondary outcome [17]
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Number of days on topical medication (per patient-year) in all participants entering the study
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Assessment method [17]
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Number of days on topical medication (per patient-year) in all participants entering the study.
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Timepoint [17]
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Baseline to Week 120
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Secondary outcome [18]
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Change from parent study baseline to prespecified time points through the end of the study: atopic dermatitis control tool (ADCT) in all participants entering the study
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Assessment method [18]
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ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicate worsening disease control.
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Timepoint [18]
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Baseline to Week 104
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Secondary outcome [19]
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Change from parent study baseline to prespecified time points through the end of the study: dermatology life quality index (DLQI) in all participants entering the study
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Assessment method [19]
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The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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Timepoint [19]
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Baseline to Week 104
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Secondary outcome [20]
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Change from parent study baseline to prespecified time points through the end of the study: patient oriented eczema measure (POEM) in all participants entering the study
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Assessment method [20]
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.
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Timepoint [20]
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Baseline to Week 104
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Secondary outcome [21]
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Serum amlitelimab concentration assessed at prespecified time points through the end of the study
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Assessment method [21]
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Serum amlitelimab concentration assessed at prespecified time points through the end of the study.
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Timepoint [21]
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Baseline to Week 104
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Secondary outcome [22]
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Anti-amlitelimab antibody titre in participants with positive response
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Assessment method [22]
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Anti-amlitelimab antibody titre in participants with positive response.
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Timepoint [22]
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Baseline to Week 120
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Secondary outcome [23]
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Number of participants with positive anti-drug antibody response
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Assessment method [23]
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Number of participants with positive anti-drug antibody response.
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Timepoint [23]
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Baseline to Week 120
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Eligibility
Key inclusion criteria
- Participant must be 18 years of age, inclusive, or older at the time
of signing the informed consent.
- Participated in an amlitelimab clinical trial for moderate to severe AD and received
study treatment, adequately completed the assessments required for the treatment
period.
- Have reached the rollover timepoint to LTS17367 at the last visit of the
treatment period of their parent study SFY17915
- Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:
- The first group: participants at Week 24 in the DRI17336 study who have not
achieved an = Eczema Area and Skin Severity Index (EASI)-75 and are
Investigator Global Assessment (IGA) = 2.
- The second group: participants entering LTS17367 between Week 28 and Week 52
of the parent study, due to loss of clinical response in the part 2 of the
parent study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44,
48 or 52. For DRI17366 loss of clinical response is defined as the first
instance of < EASI 50 during the second study period and where rescue
therapy is no longer permitted.
- The third group: participants at Week 24 in DRI17366 who have been re-randomized
and who subsequently complete the study to Week 52, enter safety follow-up and
experience worsening of their AD during safety follow-up or thereafter
- Provide signed informed consent and able to comply with the requirements of the
protocol
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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
Participants are excluded from the study if any of the following criteria apply:
- Developed a medical condition that would preclude participation as described in the
permanent discontinuation
- Known history of or suspected significant current immunosuppression, including history
of invasive opportunistic infections or helminthic infections despite infection
resolution or otherwise recurrent infections of abnormal frequency or prolonged
duration
- History of solid organ or stem cell transplant
- Any malignancies or history of malignancies prior to Baseline (except for non-melanoma
skin cancer that has been excised and completely cured for more than 5 years prior to
Baseline)
- Participants positive for human immunodeficiency virus; participants with any of the
following results at Screening (Visit 1) or at any point during the parent study:
presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or
presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by
positive HCV RNA
- History (within last 2 years prior to Baseline) of prescription drug or substance
abuse, including alcohol, considered significant by the Investigator
- Participants with active TB, latent TB, a history of incompletely treated TB,
suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at
high risk of contracting TB (such as close contact with individuals with active or
latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks
prior to screening
- Participants with an intermediate or a positive IGRA test are excluded from the study
unless all of the following conditions are met:
1. Have a history of prior documented completed chemoprophylaxis for latent TB
infection (with a treatment regimen as per local guidelines), OR treated for
active TB infection
2. Have been in written form approved for participation in the present trial by a TB
specialist who ruled out latent or active TB infection or other mycobacterial
infection in the participant
3. For whom review and approval from Sponsor have been granted are eligible
- Severe concomitant illness that would in the Investigator's opinion inhibit the
patient's participation in the study, including for example, but not limited to,
hypertension, renal disease, neurological conditions, heart failure and pulmonary
disease
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- Any medical or psychiatric condition which, in the opinion of the Investigator may
present an unreasonable risk to the study patient as a result of his/her participation
in this clinical study, may make patient's participation unreliable, or may interfere
with study assessments
- In the Investigator's opinion, medical conditions related to prior AD medications that
have not healed/fully recovered for more than 2 weeks before screening visit,
including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions,
arthralgia, herpes zoster, thrombosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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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
22/08/2022
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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
18/04/2028
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Actual
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Sample size
Target
450
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Investigational Site Number : 0363002 - Carlton
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Recruitment hospital [2]
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Investigational Site Number : 0363003 - East Melbourne
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Recruitment hospital [3]
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Investigational Site Number : 0363001 - Parkville
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Recruitment postcode(s) [1]
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3053 - Carlton
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment postcode(s) [3]
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3050 - Parkville
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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]
0
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United States of America
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State/province [2]
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Georgia
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Country [3]
0
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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Oklahoma
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Country [5]
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United States of America
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State/province [5]
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Tennessee
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Country [6]
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Bulgaria
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State/province [6]
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Pleven
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Country [7]
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Bulgaria
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State/province [7]
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Sofia
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
0
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Czechia
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State/province [9]
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Brno
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Country [10]
0
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Czechia
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State/province [10]
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Kutna Hora
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Country [11]
0
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Czechia
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State/province [11]
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Ostrava
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Country [12]
0
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Czechia
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State/province [12]
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Praha 10
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Country [13]
0
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Czechia
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State/province [13]
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Praha 2
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Country [14]
0
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Czechia
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State/province [14]
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Praha 3
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Country [15]
0
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Germany
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State/province [15]
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Berlin
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Country [16]
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Germany
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State/province [16]
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Blankenfelde-Mahlow
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0
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Germany
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State/province [17]
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Gera
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Country [18]
0
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Germany
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State/province [18]
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Kiel
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Country [19]
0
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Germany
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State/province [19]
0
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Münster
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Country [20]
0
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Hungary
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State/province [20]
0
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Debrecen
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Country [21]
0
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Hungary
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State/province [21]
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Gyula
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Country [22]
0
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Hungary
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State/province [22]
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Szolnok
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0
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Japan
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State/province [23]
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Hokkaido
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Country [24]
0
0
Japan
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State/province [24]
0
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Kagoshima
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Country [25]
0
0
Japan
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State/province [25]
0
0
Kanagawa
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Country [26]
0
0
Japan
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State/province [26]
0
0
Kyoto
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Country [27]
0
0
Japan
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State/province [27]
0
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Osaka
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Country [28]
0
0
Japan
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State/province [28]
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Tochigi
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0
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Japan
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State/province [29]
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Tokyo
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Country [30]
0
0
Japan
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State/province [30]
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Habikino-Shi
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Country [31]
0
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Poland
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State/province [31]
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Dolnoslaskie
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Country [32]
0
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Poland
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State/province [32]
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Lódzkie
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Country [33]
0
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Poland
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State/province [33]
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Malopolskie
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0
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Poland
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State/province [34]
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Mazowieckie
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Country [35]
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Poland
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State/province [35]
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Podkarpackie
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Country [36]
0
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Poland
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State/province [36]
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Podlaskie
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Country [37]
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Poland
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State/province [37]
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Pomorskie
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Country [38]
0
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Poland
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State/province [38]
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Slaskie
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Country [39]
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Poland
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State/province [39]
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Zachodniopomorskie
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Poland
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Krakow
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Spain
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Galicia [Galicia]
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Spain
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State/province [42]
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Madrid, Comunidad De
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Country [43]
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Spain
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State/province [43]
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Alicante
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Country [44]
0
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Spain
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State/province [44]
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Córdoba
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Country [45]
0
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Taiwan
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State/province [45]
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Kaohsiung Hsien,
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Country [46]
0
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Taiwan
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State/province [46]
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Taichung
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Country [47]
0
0
Taiwan
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State/province [47]
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Tao Yuan County
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Country [48]
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United Kingdom
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State/province [48]
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London, City Of
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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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
This is a single group, Phase 2, long-term extension study for treatment. The purpose of this
study is to characterize the safety and efficacy of amlitelimab in treated adult participants
with moderate to severe AD who have previously been enrolled in an amlitelimab clinical
trial. Visits during the on-treatment period will be at Week 0, 1, 2, 4 and every 4 weeks
(Q4W) thereafter. If remote visits are considered appropriate for participants instead of
clinic visits at the timepoints indicated in the schedule of activities (SoA)
participants/caregivers/legally authorized representatives (LAR) are allowed to perform
participant-injections at home according to the schedule of dosing. This decision is at the
discretion of the investigator.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05492578
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Public notes
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Contacts
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Trial Transparency email recommended (Toll free number for US & Canada)
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800-633-1610
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[email protected]
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05492578
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