Recruiting NCT06855498

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Phase III Interventional Hidradenitis Suppurativa (HS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: povorcitinib.
Who it may be relevant to: Registry conditions: Hidradenitis Suppurativa (HS). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.

Drug povorcitinib
Study drug will be taken orally as defined by the protocol.

Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 3 years]

Secondary outcome measures (1)

Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit [Time frame: Up to approximately 3 years]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No