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Tests treatment safety and results for Hidradenitis Suppurativa (HS)
Official title Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07213973
What this study is testing
What is Povorcitinib?
Povorcitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hidradenitis suppurativa (hs).
Also referred to as INCB054707.
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
- The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- Aged ≥ 12 to \< 18 years at the time of informed consent/assent signing.
- Body weight ≥ 30 kg at both screening and baseline visits.
- Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
- Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits.
- HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits.
You likely can't join if
- Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit.
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain...
- Laboratory values outside of the protocol-defined ranges.
- Further exclusion criteria apply.
See the full eligibility criteria
- Aged ≥ 12 to \< 18 years at the time of informed consent/assent signing.
- Body weight ≥ 30 kg at both screening and baseline visits.
- Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
- Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits.
- HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits.
- Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication...
- Agreement to use contraception.
- Willing and able to comply with the study protocol and procedures.
- Further apply.
- Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit.
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical...
- Laboratory values outside of the protocol-defined ranges.
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Farmington, Connecticut, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Sandy Springs, Georgia, United States
- Skokie, Illinois, United States
- Leawood, Kansas, United States
- Bowling Green, Kentucky, United States
- Baltimore, Maryland, United States
- Gambrills, Maryland, United States
- Boston, Massachusetts, United States
- Auburn Hills, Michigan, United States
- Detroit, Michigan, United States
- Troy, Michigan, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Missoula, Montana, United States
- Albuquerque, New Mexico, United States
- Danville, Pennsylvania, United States
+ 8 more site(s).
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, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Farmington, Connecticut, United States; Miami, Florida, United States; Tampa, Florida, United States; Sandy Springs, Georgia, United States and 22 more location(s). 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.