Clinical trial NCT06855498: Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Official title: A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa (HS)
Keywords: INCB054707
povorcitinib
Hidradenitis Suppurativa
Hidradenitis
HS
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site US086
state: Alabama
city: Montgomery
country: United States
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state: Alabama
city: Phoenix
country: United States
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city: Quebec City
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country: Germany
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city: Witten
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city: Athens
country: Greece
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country: Hungary
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country: Italy
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country: Spain
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country: Spain
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city: Santiago de Compostela
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country: Switzerland
facility: Investigative Site CH003
city: Buochs
country: Switzerland
facility: Investigative Site CH001
city: Zurich
country: Switzerland
facility: Investigative Site CH002
city: Birmingham
country: United Kingdom
facility: Investigative Site GB003
city: Dudley
country: United Kingdom
facility: Investigative Site GB001
city: Ipswich
country: United Kingdom
facility: Investigative Site GB011
city: Leeds
country: United Kingdom
facility: Investigative Site GB002
city: Leicester
country: United Kingdom
facility: Investigative Site GB009
city: Liverpool
country: United Kingdom
facility: Investigative Site GB013
city: London
country: United Kingdom
facility: Investigative Site GB012
city: London
country: United Kingdom
facility: Investigative Site GB005
city: London
country: United Kingdom
facility: Investigative Site GB014
city: Poole
country: United Kingdom
facility: Investigative Site GB006
city: Salford
country: United Kingdom
facility: Investigative Site GB004
city: Wolverhampton
country: United Kingdom
facility: Investigative Site GB008
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: