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Recruiting

NCT Number: NCT06855498

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site AR002, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povorcitinib

Drug

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

Primary outcomes

  1. Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 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 outcomes

  1. Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit

    Time frame: Up to approximately 3 years

    ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Acronym: STOP-LTR

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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