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Patient with prurigo nodularis for Prurigo Nodularis (GLOBOSPIN Trial)
N/A
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to month 60
Awards & highlights
GLOBOSPIN Trial Summary
This study is a prospective, multinational, observational investigation designed to elucidate the real-world effectiveness and treatment patterns of dupilumab therapy in adult patients diagnosed with prurigo nodularis (PN). The primary objective of this study is to comprehensively characterize the real-world usage of dupilumab for the management of PN. In addition to this, the study aims to achieve several secondary objectives, including a detailed assessment of the medical history, socio-demographic and disease characteristics of dupilumab-treated PN patients, as well as the evaluation of the long-term real-world effectiveness of dupilumab therapy for PN.
Eligible Conditions
- Prurigo Nodularis
GLOBOSPIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to month 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to month 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of dupilumab treatment
Frequency of reasons for dupilumab treatment discontinuation
Frequency of reasons for dupilumab treatment initiation with the description of dosing
+4 moreSecondary outcome measures
Baseline Characteristics: PN-related medical history
Baseline Characteristics: Socio-demographics of PN patients
Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment
+23 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab
GLOBOSPIN Trial Design
1Treatment groups
Experimental Treatment
Group I: Patient with prurigo nodularisExperimental Treatment1 Intervention
Participants aged 18 years or older who start receiving dupilumab for prurigo nodularis (according to the country-specific prescribing information) prior to and independently of their participation in the study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,297 Total Patients Enrolled
1 Trials studying Prurigo Nodularis
18 Patients Enrolled for Prurigo Nodularis
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,511,930 Total Patients Enrolled
2 Trials studying Prurigo Nodularis
168 Patients Enrolled for Prurigo Nodularis
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,749 Total Patients Enrolled
1 Trials studying Prurigo Nodularis
150 Patients Enrolled for Prurigo Nodularis
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