Phase 3: testing Dupilumab for Prurigo Nodularis
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: * Screening period: 2 to 4 weeks.
Official registry: https://clinicaltrials.gov/study/NCT06293053 · Sanofi · enrollment listed as 18
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Dupilumab. The registry lists allocation as na. This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.
They plan to enroll about 18 people at 15 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Dupilumab
Primary outcome (registry wording): Concentration of dupilumab in serum
Who it is for (from inclusion criteria)
- Ages 6 Months to 17 Years
- 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
Who the registry excludes
- Participants are excluded from the study if any of the following criteria apply:
- 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
- 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
Public study contact (from the registry)
Trial Transparency email recommended (Toll free for US & Canada)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
15 listed- Stanford University Medical Center (CTRU)- Site Number : 8400021 — Palo Alto, California (recruiting)
- Mission Dermatology Center- Site Number : 8400011 — Rancho Santa Margarita, California (recruiting)
- Golden State Dermatology - Walnut Creek - Ygnacio Valley Road- Site Number : 8400023 — Walnut Creek, California (recruiting)
- Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005 — Coral Gables, Florida (recruiting)
- Life Clinical Trials - Coral Springs- Site Number : 8400018 — Coral Springs, Florida (recruiting)
- Direct Helpers Research Center- Site Number : 8400015 — Hialeah, Florida (recruiting)
- SunCoast Skin Solutions - Lutz- Site Number : 8400008 — Lutz, Florida (recruiting)
- USF Health- Site Number : 8400003 — Tampa, Florida (recruiting)
- Tareen Dermatology - Eagan- Site Number : 8400022 — Eagan, Minnesota (recruiting)
- MediSearch Clinical Trials- Site Number : 8400004 — Saint Joseph, Missouri (recruiting)
- AXIS Clinicals - Fargo- Site Number : 8400013 — Fargo, North Dakota (recruiting)
- Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002 — Tulsa, Oklahoma (recruiting)
FAQ about this NCT record
Is NCT06293053 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06293053?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06293053?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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