A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)
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|ClinicalTrials.gov Identifier: NCT05526521|
Recruitment Status : Recruiting
First Posted : September 2, 2022
Last Update Posted : August 28, 2023
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spontaneous Urticaria||Drug: Dupilumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)|
|Actual Study Start Date :||August 25, 2022|
|Estimated Primary Completion Date :||March 1, 2025|
|Estimated Study Completion Date :||July 7, 2025|
Administered subcutaneously (SC) every 4 weeks (Q4W) or every 2 weeks (Q2W) with or without an initial loading dose based on weight and age
Injection solution Subcutaneous
Other Name: Dupixent
- Concentration of dupilumab in serum over time including Ctrough at Week 12 and Week 24 [ Time Frame: Week 12 and Week 24 ]Concentration of dupilumab in serum over time including Ctrough at Week 12 and Week 24.
- Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) [ Time Frame: Baseline to Week 36 ]Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs).
- Incidence of anti-drug antibodies (ADA) to dupilumab over time [ Time Frame: Baseline to Week 36 ]Incidence of anti-drug antibodies (ADA) to dupilumab over time.
- 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 [ Time Frame: Baseline to Week 24 ]The C-DLQI is a validated questionnaire designed to measure the impact of skin disease on children's Health-Related Quality of Life (HRQoL). The questionnaire is validated for children aged ≥4 to <16 years. The C-DLQI total score ranges 0 to 30. The higher the score, the greater the impact is on the child's HRQoL.
- 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 [ Time Frame: Baseline to Week 24 ]The IDQOL is a validated questionnaire designed for use in children aged <4 years. The IDLQI total score ranges 0 to 30. The higher the score, the greater the impact is on the child's HRQoL.
- Change from baseline in the modified Urticaria Activity Score (UAS7) at Week 24 [ Time Frame: Baseline to Week 24 ]The UAS is a validated patient reported outcome (PRO) measure. A modified version of the UAS (mUAS) will be used in this study to account for the smaller body surface area of child and adolescent patients. Daily mUAS scores are summed over 7-day period to create the mUAS7, ranging from 0 to 42. The higher score indicates the greater urticaria activity.
- Change from baseline in the modified itch severity score over 7 days (ISS7) at Week 24 [ Time Frame: Baseline to Week 24 ]ISS ranges from 0 (absent) to 3 (intense). Daily ISS scores are summed over 7-day period to create the ISS7, ranging from 0 to 21.
- Change from baseline in the modified Hive Severity Score over 7 days (HSS7) at Week 24 [ Time Frame: Baseline to Week 24 ]HSS ranges from 0 (absent) to 3 (intense, (>30 wheals/24 hours or large confluent areas of wheals). Daily HSS scores are summed over 7-day period to create the HSS7, ranging from 0 to 21.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05526521
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext option 6||Contact-US@sanofi.com|
|United States, Idaho|
|The Allergy Group-Site Number:8400019||Recruiting|
|Boise, Idaho, United States, 83706|
|United States, Missouri|
|Washington University School of Medicine-Site Number:8400004||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Columbia University Irving Medical Center-Site Number:8400003||Recruiting|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center - PIN-Site Number:8400001||Recruiting|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Oklahoma|
|Vital Prospects Clinical Research Institute, P.C.-Site Number:8400002||Recruiting|
|Tulsa, Oklahoma, United States, 74136|
|Investigational Site Number :1240009||Recruiting|
|Calgary, Alberta, Canada, T2W 4X9|
|Investigational Site Number :1240010||Recruiting|
|Edmonton, Alberta, Canada, T5J 3S9|
|Investigational Site Number :1240006||Recruiting|
|Winnipeg, Manitoba, Canada, R3A 1M3|
|Investigational Site Number :1240007||Recruiting|
|Hamilton, Ontario, Canada, L8S1G5|
|Investigational Site Number :1240001||Recruiting|
|Montreal, Quebec, Canada, H4A 3J1|
|Investigational Site Number :3920001||Recruiting|
|Yokohama-shi, Kanagawa, Japan, 232-8555|
|Investigational Site Number :3920002||Recruiting|
|Tsu-shi, Mie, Japan, 514-0125|