Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Description

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

Conditions

Hidradenitis Suppurativa (HS)

Study Overview

Study Details

Study overview

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

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

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Condition
Hidradenitis Suppurativa (HS)
Intervention / Treatment

-

Contacts and Locations

Phoenix

Investigator Site US004, Phoenix, Arizona, United States, 85006

Scottsdale

Investigator Site US047, Scottsdale, Arizona, United States, 85255

Fort Smith

Investigator Site US045, Fort Smith, Arkansas, United States, 72916

Rogers

Investigator Site US009, Rogers, Arkansas, United States, 72758

Laguna Niguel

Investigator Site US020, Laguna Niguel, California, United States, 92677

Los Angeles

Investigator Site US036, Los Angeles, California, United States, 90033

Oakland

Investigator Site US037, Oakland, California, United States, 94611

San Diego

Investigator Site US032, San Diego, California, United States, 92103

Boca Raton

Investigator Site US002, Boca Raton, Florida, United States, 33486

Brandon

Investigator Site US035, Brandon, Florida, United States, 33511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2028-02-28