A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to … (NCT06293053) | Clinical Trial Compass
RecruitingPhase 3
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
United States18 participantsStarted 2024-05-15
Plain-language summary
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.
The study consists of 3 periods:
* Screening period: 2 to 4 weeks.
* Treatment period: 24 weeks.
* Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).
The total number of planned study visits for each participant will be 6.
Who can participate
Age range6 Months – 17 Years
SexALL
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Inclusion Criteria:
* Participants must be ≥6 months to \<18 years of age, at the time of signing the informed consent.
* A clinical diagnosis of prurigo nodularis (PN) at least 3 months prior to screening, an Investigator's global assessment for prurigo nodularis stage (IGA PN-S) score of ≥2 with presence of ≥6 pruriginous lesions at Baseline. The lesions should be present on ≥2 different body surface areas at Baseline.
* On the worst itch numerical rating scale (WI-NRS) (for participants aged ≥6 years to \<18 years old at the screening visit) or worst-scratch/itch NRS (for participants aged ≥6 months to \<6 years at the screening visit) ranging from 0 to 10, participants must have an average worst itch score of ≥7 in the 7 days prior to Day 1.
NOTE: Baseline pruritus NRS average score for maximum itch intensity will be determined based on the average of daily NRS scores for maximum intensity (the daily score ranges from 0 to 10) during the 7 days immediately preceding the Day 1/Baseline visit. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.
* Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study.
* Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
Participants are excluded from the study if any of the following cr…
What they're measuring
1
Concentration of dupilumab in serum
Timeframe: Day 1 to Week 40
Trial details
NCT IDNCT06293053
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-10-28
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)