Continuation of treatment with povorcitinib for previous trial participants

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 study allows participants who have previously completed a clinical trial involving povorcitinib to continue receiving the treatment. It focuses on individuals who have shown clinical benefit from the drug during their prior participation. The study aims to assess the ongoing safety and efficacy of povorcitinib in managing Hidradenitis Suppurativa. Participants must meet specific eligibility criteria, including having completed the parent study without safety concerns.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability to comprehend and willingness to sign a written ICF for the study.
* Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
* Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
* Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
* Willingness to avoid pregnancy or fathering children as defined in the protocol.
* Willingness and ability to comply with the study Protocol and procedures.

Exclusion Criteria:

* Had been permanently discontinued from study treatment during the parent study.
* Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
* Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:

  * Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
  * Live, attenuated vaccine.
* Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
* Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where it's running

• Investigative Site US086
  Birmingham, Alabama, United States Recruiting
• Investigative Site US098
  Montgomery, Alabama, United States Recruiting
• Investigative Site US004
  Phoenix, Arizona, United States Recruiting
• Investigative Site US076
  Fountain Valley, California, United States Recruiting
• Investigative Site US077
  Fremont, California, United States Recruiting
• Investigative Site US071
  Huntington Beach, California, United States Recruiting

+256 more sites. See ClinicalTrials.gov for the full list.

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.

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

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

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

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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.