Dupilumab for Chronic Spontaneous Urticaria

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Vital Prospects Clinical Research Institute, P.C.-Site Number:8400002, Tulsa, OK
Chronic Spontaneous Urticaria+3 More
Dupilumab - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This is a multicenter, single-arm, 24-week treatment, Phase 3 PKM16982 study. The purpose of this study is to investigate the Pharmacokinetics (PK) and safety of dupilumab in children diagnosed with CSU or CICU who remain symptomatic despite the use of H1-antihistamine treatment and/or appropriate preventive measures. Study details include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 8.

Eligible Conditions

  • Chronic Spontaneous Urticaria
  • Chronic Cold Urticaria

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Chronic Spontaneous Urticaria

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Week 12 and Week 24

Baseline to Week 24
Change from baseline in Children's Dermatology Quality Life Index (C-DLQI) in children from 4 years to less than 12 years of age at Week 24
Change from baseline in Infants' Dermatitis Quality of Life Index (IDQOL) in children from 2 years to less than 4 years of age at Week 24
Only for participants with CICU: Change from baseline in Wheal Intensity Likert Scale at Week 24
Only for participants with CSU: Change from baseline in the modified Hive Severity Score over 7 days (HSS7) at Week 24
Only for participants with CSU: Change from baseline in the modified Urticaria Activity Score (UAS7) at Week 24
Only for participants with CSU: Change from baseline in the modified itch severity score over 7 days (ISS7) at Week 24
Baseline to Week 36
Incidence of anti-drug antibodies (ADA) to dupilumab over time
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Week 24
Concentration of dupilumab in serum over time including Ctrough at Week 12 and Week 24
Week 24
Only for participants with CICU: Proportion of participants with negative ice cube provocation test at Week 24

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Chronic Spontaneous Urticaria

Side Effects for

Dupilumab 300 mg Q4W
19%Dermatitis atopic
12%Nasopharyngitis
8%Upper respiratory tract infection
6%Pharyngitis streptococcal
5%Headache
0%Influenza
0%Appendicitis
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT03054428) in the Dupilumab 300 mg Q4W ARM group. Side effects include: Dermatitis atopic with 19%, Nasopharyngitis with 12%, Upper respiratory tract infection with 8%, Pharyngitis streptococcal with 6%, Headache with 5%.

Trial Design

1 Treatment Group

Dupilumab
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Dupilumab · No Placebo Group · Phase 3

Dupilumab
Drug
Experimental Group · 1 Intervention: Dupilumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 3
~9450

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12 and week 24
Closest Location: Vital Prospects Clinical Research Institute, P.C.-Site Number:8400002 · Tulsa, OK
N/AFirst Recorded Clinical Trial
1 TrialsResearching Chronic Spontaneous Urticaria
0 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 2 years old, but not more than 12 years old.
You have had CSU for 6 weeks or more, and you have not responded to regular H1-antihistamine treatment.
You have a positive ice cube provocation test.
You are willing and able to comply with study visits and related procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.