Clinical trial NCT06293053: A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Official title: A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prurigo Nodularis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2024-03-05
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 criteria apply:

* Presence of active moderate to severe lesions of atopic dermatitis (AD), and/or other skin conditions that may interfere with the PN diagnosis including but not limited to the following: scabies, psoriasis, lymphomatoid papulosis, habitual picking, dermatitis herpetiformis, sporotrichosis, and bullous disease.
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.

NOTE: Participants may be rescreened after infection resolves.

* Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.
* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
* Planned or anticipated major surgical procedure during the participant's participation in this clinical trial.
* Participants who has taken biologic therapy/systemic immunosuppressant/ immunomodulator within 4 weeks before the screening visit or 5 half-lives, whichever is longer.
* Current participation to any clinical trial of an investigational drug or device or participation within 3 months before the screening visit or 5 half-lives of the investigational compound, whichever is longer.
* Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.

Primary outcomes:
measure: Concentration of dupilumab in serum
timeFrame: Day 1 to Week 40
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
timeFrame: Date of signed ICF (2-4 weeks before Day 1) to Week 40
measure: Incidence of anti-drug antibodies (ADA) to dupilumab over time
timeFrame: Day 1 to Week 40
Other outcomes:
Locations:
city: Rancho Santa Margarita
country: United States
facility: Mission Dermatology Center- Site Number : 8400011
state: California
city: Coral Gables
country: United States
facility: Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005
state: Florida
city: Coral Springs
country: United States
facility: Life Clinical Trials- Site Number : 8400018
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center- Site Number : 8400015
state: Florida
city: Tampa
country: United States
facility: USF Health- Site Number : 8400003
state: Florida
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials- Site Number : 8400004
state: Missouri
city: Fargo
country: United States
facility: AXIS Clinicals - Fargo- Site Number : 8400013
state: North Dakota
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002
state: Oklahoma
city: Austin
country: United States
facility: Dell Children's Medical Center- Site Number : 8400007
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital- Site Number : 8400017
state: Texas
city: Houston
country: United States
facility: 1960 Family Practice- Site Number : 8400009
state: Texas
Study officials:
References: