Phase
Condition
Warts
Dermatitis, Atopic
Prurigo Nodularis
Treatment
Dupilumab
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be ≥6 months to <18 years of age, at the time of signing theinformed 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 bepresent 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 participantsaged ≥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
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-Diaryfor the duration of the study.
Contraceptive use by male and female participants should be consistent with localregulations regarding the methods of contraception for those participating inclinical studies.
Exclusion
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/orother skin conditions that may interfere with the PN diagnosis including but notlimited to the following: scabies, psoriasis, lymphomatoid papulosis, habitualpicking, 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 thescreening period.
NOTE: Participants may be rescreened after infection resolves.
Known or suspected immunodeficiency, including history of invasive opportunisticinfections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, andaspergillosis) despite infection resolution, or otherwise recurrent infections ofabnormal frequency or prolonged duration suggesting an immune compromised status, asjudged by the Investigator.
Severe concomitant illness(es) that, in the Investigator's judgment, would adverselyaffect the participant's participation in the study.
Planned or anticipated major surgical procedure during the participant'sparticipation in this clinical trial.
Participants who has taken biologic therapy/systemic immunosuppressant/immunomodulator within 4 weeks before the screening visit or 5 half-lives, whicheveris longer.
Current participation to any clinical trial of an investigational drug or device orparticipation within 3 months before the screening visit or 5 half-lives of theinvestigational compound, whichever is longer.
Participation in prior dupilumab clinical study or have been treated withcommercially available dupilumab.
Study Design
Connect with a study center
Mission Dermatology Center Site Number : 8400011
Rancho Santa Margarita, California 92688
United StatesActive - Recruiting
Mission Dermatology Center- Site Number : 8400011
Rancho Santa Margarita, California 92688
United StatesActive - Recruiting
Pediatric Center Of Excellence Site Number : 8400005
Coral Gables, Florida 33146
United StatesActive - Recruiting
Pediatric Center Of Excellence- Site Number : 8400005
Coral Gables, Florida 33146
United StatesActive - Recruiting
Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005
Coral Gables, Florida 33146
United StatesActive - Recruiting
Life Clinical Trials - Coral Springs- Site Number : 8400018
Coral Springs, Florida 33071
United StatesActive - Recruiting
Life Clinical Trials- Site Number : 8400018
Coral Springs, Florida 33071
United StatesActive - Recruiting
Direct Helpers Research Center- Site Number : 8400015
Hialeah, Florida 33012
United StatesActive - Recruiting
USF Health - Dermatology and Cutaneous Surgery - Davis Blvd Location (Pediatric Dermatology) Site Number : 8400003
Tampa, Florida 33606
United StatesActive - Recruiting
USF Health - Dermatology and Cutaneous Surgery - Davis Blvd Location (Pediatric Dermatology)- Site Number : 8400003
Tampa, Florida 33606
United StatesActive - Recruiting
USF Health- Site Number : 8400003
Tampa, Florida 33606
United StatesActive - Recruiting
MediSearch Clinical Trials (Dermatology) Site Number : 8400004
Saint Joseph, Missouri 64506
United StatesActive - Recruiting
MediSearch Clinical Trials- Site Number : 8400004
Saint Joseph, Missouri 64506
United StatesActive - Recruiting
AXIS Clinicals - Fargo- Site Number : 8400013
Fargo, North Dakota 58103
United StatesActive - Recruiting
Axis Clinicals Site Number : 8400013
Fargo, North Dakota 58103
United StatesActive - Recruiting
Axis Clinicals- Site Number : 8400013
Fargo, North Dakota 58103
United StatesActive - Recruiting
Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002
Tulsa, Oklahoma 74136
United StatesActive - Recruiting
Vital Prospects Clinical Research Institute, P.C. Site Number : 8400002
Tulsa, Oklahoma 74136
United StatesActive - Recruiting
Dell Children's Medical Center- Site Number : 8400007
Austin, Texas 78723
United StatesActive - Recruiting
Driscoll Children's Hospital- Site Number : 8400017
Corpus Christi, Texas 78411
United StatesActive - Recruiting
1960 Family Practice Site Number : 8400009
Houston, Texas 77090
United StatesActive - Recruiting
1960 Family Practice- Site Number : 8400009
Houston, Texas 77090
United StatesActive - Recruiting
Texas Dermatology and Laser Specialists- Site Number : 8400020
San Antonio, Texas 78218
United StatesActive - Recruiting
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