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New treatment option for Skin Diseases
Official title Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders
ClinicalTrials.gov ID: NCT05649098
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, being studied as a potential treatment for skin diseases.
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
- Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder.
- Phase 1: an early, usually small safety 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 and older
You may be able to join if
- Male or female \> 6 months of age at screening visit
- Clinical diagnosis of a genetic skin disorder at the screening visit, ideally with genetic or histological confirmation.
- Must have had the gene with one or more variants identified by genotyping. If the genotype has not been performed or has not been performed at a...
- Average Itch Numerical Rating Scale (NRS) ≥ 4 and Worst Itch NRS of at least 5 during the previous 7 days (self-reported if \>8 years old; proxy...
- Must be willing to provide information weekly about Average and Worst Itch/self- or proxy-assessed severity and wear the sensor device to track itch...
You likely can't join if
- people \< 6 months of age at screening visit.
- Unable to provide informed consent or assent (or who do not have consent from a Legally Authorized Representative if \< 18 years).
- Diagnosis of ichthyosis vulgaris as the sole inherited disorder
- Used of dupilumab within 5 drug half-lives (105 days) of baseline visit
- people who have used any of the following treatments within 4 weeks, or within a period equal to 5 times the half-life of the drug, before the...
- Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors...
See the full eligibility criteria
- Male or female \> 6 months of age at screening visit
- Clinical diagnosis of a genetic skin disorder at the screening visit, ideally with genetic or histological confirmation.
- Must have had the gene with one or more variants identified by genotyping. If the genotype has not been performed or has not been performed at a CLIA-approved laboratory, be willing to provide a sample (saliva, buccal...
- Average Itch Numerical Rating Scale (NRS) ≥ 4 and Worst Itch NRS of at least 5 during the previous 7 days (self-reported if \>8 years old; proxy reported if under 8 years)
- Must be willing to provide information weekly about Average and Worst Itch/self- or proxy-assessed severity and wear the sensor device to track itch and sleep weekly throughout the first 24 weeks of the trial (Parts A...
- Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- Subject, parent/caregiver or legal guardians, as appropriate, are able to understand and complete the study requirements and study-related questionnaires
- people \< 6 months of age at screening visit.
- Unable to provide informed consent or assent (or who do not have consent from a Legally Authorized Representative if \< 18 years).
- Diagnosis of ichthyosis vulgaris as the sole inherited disorder
- Used of dupilumab within 5 drug half-lives (105 days) of baseline visit
- people who have used any of the following treatments within 4 weeks, or within a period equal to 5 times the half-life of the drug, before the baseline visit, whichever is longer:
- Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.), systemic anti-inflammatory medication, or...
- Other biologics: within 5 half-lives (if known) or 16 weeks, whichever is longer
- Initiation of topical or systemic retinoids, topical keratolytics, or topical anti-inflammatory agents within 4 weeks before study start/Part A (systemic retinoids and topical medications/emollients can be used during...
- people with active infections or recent history of serious infections, malignancies or history of malignancies, or any severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac...
- Treatment with a live (attenuated) vaccine within 4 weeks before the Week 0 visit when dupilumab is initiated; use of vaccination during the study requires consultation with the study investigator and primary care...
- Active acute or chronic infection requiring treatment with systemic antibiotics/ anti-virals/ anti-fungals within 2 weeks before the initiation of dupilumab (start of dupilumab can be delayed). Delay in initiation...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.