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)
CompletedPhase 3Results postedLast updated 25 November 2025
What this trial tests
Phase 3 trial testing Dupilumab in Chronic Spontaneous Urticaria in 15 participants. Completed in 3 February 2025.
Adults 2 to 11, any sex, with Chronic Spontaneous Urticaria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Serum Concentration of Dupilumab at Weeks 12 and 24Primary· Weeks 12 and 24
Blood samples were collected at specified timepoints to obtain dupilumab concentration.
Week 12
Group
Value
95% CI
Dupilumab 200 mg Q4W
67700
Dupilumab 300 mg Q4W
105000
Dupilumab 300 mg Q4W, 600 mg Loading Dose
45800
± 12400
Dupilumab 200 mg Q2W, 400 mg Loading Dose
91600
± 23000
Week 24
Group
Value
95% CI
Dupilumab 200 mg Q4W
116000
Dupilumab 300 mg Q4W
141000
± 30100
Dupilumab 300 mg Q4W, 600 mg Loading Dose
51100
± 20100
Dupilumab 200 mg Q2W, 400 mg Loading Dose
78500
± 31600
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)Secondary· From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that
TEAEs
Group
Value
95% CI
Dupilumab 200 mg Q4W
1
Dupilumab 300 mg Q4W
2
Dupilumab 300 mg Q4W, 600 mg Loading Dose
2
Dupilumab 200 mg Q2W, 400 mg Loading Dose
7
TESAEs
Group
Value
95% CI
Dupilumab 200 mg Q4W
0
Dupilumab 300 mg Q4W
0
Dupilumab 300 mg Q4W, 600 mg Loading Dose
0
Dupilumab 200 mg Q2W, 400 mg Loading Dose
0
Number of Participants With Anti-drug Antibodies (ADAs) to DupilumabSecondary· From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks
Blood samples were collected at specified timepoints and ADA samples were assayed using validated methods. Treatment-emergent ADA response was defined as a positive response in the ADA assay post first dose when baseline results were negative or missing. Number of participants with treatment-emergent ADA response is presented.
Group
Value
95% CI
Dupilumab 200 mg Q4W
0
Dupilumab 300 mg Q4W
0
Dupilumab 300 mg Q4W, 600 mg Loading Dose
0
Dupilumab 200 mg Q2W, 400 mg Loading Dose
0
Change From Baseline in Children's Dermatology Life Quality Index (C-DLQI) in Participants Aged 4 Years to <12 Years at Week 24Secondary· Baseline (Day 1) and Week 24
The C-DLQI assesses impact of skin disease on children's health-related quality of life (HRQoL) over the previous week, contains 10 questions related to symptoms feelings associated with disease, impact of disease on leisure, school or holidays, personal relationships, sleep, and side effects of treatment for the skin disease. All questions were scored on 4-point Likert scale:0 (not at all),1 (a little),2 (a lot),3 (very much). Total C-DLQI was calculated by summing the score of each question and ranged from 0 (no impact) to 30 (severe impact). Higher scores indicated poor HRQoL. Mean is prese
Group
Value
95% CI
Dupilumab 200 mg Q4W
-3.0
Dupilumab 300 mg Q4W
-6.0
Dupilumab 300 mg Q4W, 600 mg Loading Dose
-10.5
± 3.5
Dupilumab 200 mg Q2W, 400 mg Loading Dose
-7.3
± 4.3
Change From Baseline in Infant's Dermatitis Quality of Life Index (IDQOL) in Participants Aged 2 Years to <4 Years at Week 24Secondary· Baseline (Day 1) and Week 24
The IDQOL questionnaire is completed by child's caregiver/guardian with a recall period of 7 days;consists of 10 questions focusing on life quality index (LQI) scored on 4-point Likert scale. An additional question on dermatitis severity is scored on a 5-point Likert scale (0 \[none\] to 4 \[extremely severe\]); it is not considered for calculating total IDQOL. For LQI, score ranges are as follows: Questions 1, 5 to 10: 0 (none) to 3 (all the time/very much). Question 2: 0 (happy), 1 (slightly fretful), 2 (very fretful),3 (always crying). Question 3: 0 (0-15 minutes), 1 (15 minutes-1 hour), 2
Group
Value
95% CI
Dupilumab 300 mg Q4W
-3.0
Change From Baseline in Modified Urticaria Activity Score Over 7 Days (mUAS7) at Week 24Secondary· Baseline (Day -7 to Day 1) and Week 24
A modified version of the UAS (mUAS) was used for the smaller body surface area of child and adolescent participants. The mUAS was derived from the sum of daily hives severity score (HSS) (ranging from 0 to 3 \[0 = absent; 1 = mild {1 to \<10 wheals/24 hours}; 2 = moderate: {10 to 30 wheals/24 hours}; and 3 = intense: {\>30 wheals/24 hours or large confluent areas of wheals}\]) and daily itch severity score (ISS) (ranging from 0 = none to 3 = intense). Daily mUAS total scores range from 0 to 6 (0 to 3 for ISS and 0 to 3 for HSS). Daily mUAS scores were summed over 7-day period to create total
Group
Value
95% CI
Dupilumab 200 mg Q4W
-8.0
Dupilumab 300 mg Q4W
-21.4
± 1.9
Dupilumab 300 mg Q4W, 600 mg Loading Dose
-2.8
± 1.8
Dupilumab 200 mg Q2W, 400 mg Loading Dose
-7.8
± 6.6
Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 24Secondary· Baseline (Day -7 to Day 1) and Week 24
The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. Mean is presented. Baseline was defined as sum of the 7 daily measurements obtained within the 7 days prior to first study intervention administration.
Group
Value
95% CI
Dupilumab 200 mg Q4W
-5.0
Dupilumab 300 mg Q4W
-9.6
± 3.7
Dupilumab 300 mg Q4W, 600 mg Loading Dose
-1.6
± 0.6
Dupilumab 200 mg Q2W, 400 mg Loading Dose
-3.4
± 3.2
Change From Baseline in Hive Severity Score Over 7 Days (HSS7) at Week 24Secondary· Baseline (Day -7 to Day 1) and Week 24
The HSS7 score is the sum of daily HSS ranging from ranging from 0 to 3 (0 = absent; 1 = mild \[1 to \<10 wheals/24 hours\]; 2 = moderate \[10 to 30 wheals/24 hours\]; and 3 = intense: \[\>30 wheals/24 hours or large confluent areas of wheals\]) recorded by a participant at the same time of each day over 7 days with an overall scale of 0 (no hives) to 21 (severe hives). Higher scores indicate greater intensity of hives. Mean is presented. Baseline was defined as sum of the 7 daily measurements obtained within the 7 days prior to first study intervention administration.
Group
Value
95% CI
Dupilumab 200 mg Q4W
-3.0
Dupilumab 300 mg Q4W
-11.8
± 1.8
Dupilumab 300 mg Q4W, 600 mg Loading Dose
-1.2
± 1.2
Dupilumab 200 mg Q2W, 400 mg Loading Dose
-4.4
± 3.6
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07316114 — A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spont
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NCT07277322 — Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases
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NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit
· recruiting
NCT07399067 — A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
· Phase 2
· recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
Other recruiting trials for Chronic Spontaneous Urticaria
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 25 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05526521.