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Dupilumab

Phase 2

Cholinergic Urticaria | Small molecule | Dermatology |Pulmonx Corporation|Last Updated: Sep 6, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Dupilumab · 1 trial · 1 indication

Phase 2 1
NCT03749148Cholinergic Urticaria - Efficacy of DupilumabCholinergic Urticaria
COMPLETED48 Analytics
PHASE2COMPLETED
Cholinergic Urticaria - Efficacy of Dupilumab
Cholinergic Urticaria
NCT0374914848
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Study Endpoints

Primary Endpoints

cholinergic Urticaria activity score over 7 days (CholUAS7)
Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)]

0-42 points total range, higher values equal more disease activity

Secondary Endpoints

Global assessment
Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)]
provocation urticaria activity score (pUAS; 0 - no activity; 3 - high activity)
Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)]
weekly pruritus score (PS7; 0 - no activity; 21 - high activity)
Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)]
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DupilumabACTIVE_COMPARATORDupilumab, s.c. administration 2 injections (600mg) as loading dose, 1 injection (300mg) every 14 days for a total of 16 weeks
PlaceboPLACEBO_COMPARATORmatching Placebo, s.c. administration 2 injections as loading dose, 1 injection every 14 days for a total of 16 weeks

Interventions

NameTypeDescription
DupilumabDRUGanti-IL4-Receptor alpha
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: Diagnosis: cholinergic urticaria (ongoing disease) 1. Patient is informed about study procedures and medications and has given written informed consent before any assessment. 2. Patient is able to communicate with the investigator, understands and complies with the requirements...

Countries:Germany
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