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Tests treatment safety and results for Prurigo Nodularis
Official title A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
ClinicalTrials.gov ID: NCT06293053
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for prurigo nodularis.
Also referred to as SAR231893, Dupixent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: Screening period: 2 to 4 weeks.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit...
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis...
- 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.
See the full eligibility 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...
- 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)...
- 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.
- 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...
- 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...
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Rancho Santa Margarita, California, United States
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Hialeah, Florida, United States
- Lutz, Florida, United States
- Tampa, Florida, United States
- Eagan, Minnesota, United States
- Saint Joseph, Missouri, United States
- Fargo, North Dakota, United States
- Tulsa, Oklahoma, United States
- Austin, Texas, United States
- Corpus Christi, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Rancho Santa Margarita, California, United States; Coral Gables, Florida, United States; Coral Springs, Florida, United States; Hialeah, Florida, United States; Lutz, Florida, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.