Povorcitinib for adolescents with moderate to severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 open-label trial gives adolescents with moderate to severe hidradenitis suppurativa oral povorcitinib for up to 54 weeks to measure pharmacokinetics, safety, and clinical response. Eligible participants are 12–17 years old, weigh at least 30 kg, have at least five abscesses or inflammatory nodules and meet refined Hurley stages IB–III, and must have a history of inadequate response or intolerance to prior systemic therapy. The protocol involves regular clinic visits for lesion counts, laboratory monitoring, and adverse event reporting at participating sites. There is no placebo arm and dosing and monitoring follow the trial protocol.

Why it matters

Who can join: the full rules

Inclusion 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 to, a conventional systemic therapy for treatment of their HS).
* Agreement to use contraception.
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.

Exclusion Criteria:

* 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 conditions at the discretion of the investigator.
* Laboratory values outside of the protocol-defined ranges.
* Further exclusion criteria apply.

Where it's running

• University of Alabama At Birmingham
  Birmingham, Alabama, United States Recruiting
• Medical Dermatology Specialists Phoenix
  Phoenix, Arizona, United States Recruiting
• Saguaro Dermatology
  Phoenix, Arizona, United States Recruiting
• Uconn Health
  Farmington, Connecticut, United States Recruiting
• University of Miami Miller School of Medicine
  Miami, Florida, United States Recruiting
• Skin Research of South Florida, Llc
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Continuation of treatment with povorcitinib for previous trial participants

  This study lets people who have already benefited from the medication povorcitinib in a previous trial keep using it to see if it continues to help with their Hidradenitis Suppurativa.

  Recruiting at 247 sites Phase 3 Incyte Corporation · Birmingham, Alabama and 305 other locations · NCT06855498

• Soquelitinib in adults with hidradenitis suppurativa

  This study tests whether oral soquelitinib can help adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting at 9 sites Phase 1 Corvus Pharmaceuticals, Inc. · West Lafayette, Indiana and 10 other locations · NCT07828860

• ORKA-002 versus placebo for moderate-to-severe hidradenitis suppurativa

  A study tests ORKA-002 against placebo in adults with moderate-to-severe hidradenitis suppurativa to see if it helps reduce symptoms.

  Recruiting at 25 sites Phase 2 Oruka Therapeutics, Inc. · Birmingham, Alabama and 24 other locations · NCT07783542

• SPY072 in adults with moderate to severe hidradenitis suppurativa

  This study tests whether SPY072 can help adults with moderate to severe hidradenitis suppurativa when added to their current care, compared with a placebo over 16 weeks.

  Recruiting at 7 sites Phase 2 Spyre Therapeutics, Inc. · Birmingham, Alabama and 33 other locations · NCT07766005

• Brain activity patterns in people with hidradenitis suppurativa and how treatments may relate to changes

  This study tests whether adults with hidradenitis suppurativa show different resting brain activity than healthy people and whether these brain patterns relate to symptoms like pain and mood, and whether they change after 3 months of standard biologic or small-molecule treatment.

  Recruiting Second Xiangya Hospital of Central South University · Changsha, Hunan · NCT07755670

• Roflumilast 0.3% Foam for Hidradenitis Suppurativa in Teens and Adults

  This study tests a topical roflumilast foam to see if it improves HS in adolescents and adults over 16 weeks.

  Recruiting Phase 2 Harrison Dermatology · Missouri City, Texas · NCT07689188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.