Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Phase 3

Recruiting

• Conditions: Hidradenitis Suppurativa (HS)
• Interventions: Drug: povorcitinib

• Registration Number: NCT06855498
• Lead Sponsor: Incyte Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Study Start: 2025-02-28
• Study First Posted: 2025-03-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-18
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
povorcitinib	povorcitinib	Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)	Up to approximately 3 years	Adverse events either reported for the first time in this Protocol or any AE ongoing and defined as treatment-emergent from the parent Protocol.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit	Up to approximately 3 years	ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.

Trial Locations

Locations (341)

Investigative Site US086; 🇺🇸 Birmingham, Alabama, United States

Investigative Site US098; 🇺🇸 Montgomery, Alabama, United States

Investigative Site US004; 🇺🇸 Phoenix, Arizona, United States

Investigative Site US047; 🇺🇸 Scottsdale, Arizona, United States

Investigative Site US124; 🇺🇸 Scottsdale, Arizona, United States

Investigative Site US115; 🇺🇸 Tucson, Arizona, United States

Investigative Site US045; 🇺🇸 Fort Smith, Arkansas, United States

Investigative Site US110; 🇺🇸 Hot Springs, Arkansas, United States

Investigative Site US009; 🇺🇸 Rogers, Arkansas, United States

Investigative Site US076; 🇺🇸 Fountain Valley, California, United States

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