Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Purpose

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

Condition

  • Hidradenitis Suppurativa (HS)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
povorcitinib 		Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.
  • Drug: povorcitinib
    Study drug will be taken orally as defined by the protocol.

Recruiting Locations

Investigative Site US004
Phoenix 5308655, Arizona 5551752 85006

Investigative Site US020
Laguna Niguel 5364329, California 5332921 92677

Investigative Site US036
Los Angeles 5368361, California 5332921 90033

Investigative Site US067
Los Angeles 5368361, California 5332921 90045

Investigative Site US060
Northridge 5377985, California 5332921 91325

Investigative Site US002
Boca Raton 4148411, Florida 4155751 33486

Investigative Site US062
Coral Gables 4151871, Florida 4155751 33134

Investigative Site US017
Hialeah 4158476, Florida 4155751 33012

Investigative Site US019
Hollywood 4158928, Florida 4155751 33021-6746

Investigative Site US015
Miami 4164138, Florida 4155751 33136

Investigative Site US023
North Miami Beach 4166233, Florida 4155751 33162

Investigative Site US029
Ocala 4166673, Florida 4155751 34470

Investigative Site US035
Tampa 4174757, Florida 4155751 33609

Investigative Site US005
Tampa 4174757, Florida 4155751 33613

Investigative Site US001
Tampa 4174757, Florida 4155751 33615

Investigative Site US066
West Palm Beach 4177887, Florida 4155751 33401

Investigative Site US070
West Palm Beach 4177887, Florida 4155751 33401

Investigative Site US008
Indianapolis 4259418, Indiana 4921868 46250

Investigative Site US064
West Lafayette 4928096, Indiana 4921868 47906

Investigative Site US012
Baton Rouge 4315588, Louisiana 4331987 70809

Investigative Site US057
New Orleans 4335045, Louisiana 4331987 70115

Investigative Site US030
Boston 4930956, Massachusetts 6254926 02215

Investigative Site US048
Brighton 4931353, Massachusetts 6254926 02135

Investigative Site US061
Ann Arbor 4984247, Michigan 5001836 48103

Investigative Site US011
Minneapolis 5037649, Minnesota 5037779 55455

Investigative Site US016
St Louis 4407066, Missouri 4398678 63110

Investigative Site US007
Portsmouth 5091383, New Hampshire 5090174 03801

Investigative Site US034
New York 5128581, New York 5128638 10028-3135

Investigative Site US065
New York 5128581, New York 5128638 10128

Investigative Site US031
Chapel Hill 4460162, North Carolina 4482348 27516

Investigative Site US028
Bexley 4506487, Ohio 5165418 43209

Investigative Site US025
Cincinnati 4508722, Ohio 5165418 45219

Investigative Site US073
Columbus 4509177, Ohio 5165418 43215

Investigative Site US069
Plymouth Meeting 5206666, Pennsylvania 6254927 19462

Investigative Site US021
Bellaire 4673353, Texas 4736286 77401

Investigative Site US010
Dallas 4684888, Texas 4736286 75246

Investigative Site US063
South Jordan 5781770, Utah 5549030 84095

Investigative Site US027
Norfolk 4776222, Virginia 6254928 23502

Investigative Site US003
Spokane 5811696, Washington 5815135 99202

More Details

NCT ID
NCT06855498
Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

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Vanderbilt University Medical Center