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Purpose

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

Condition

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 US086
Birmingham, Alabama 35244

Investigative Site US004
Phoenix, Arizona 85006

Investigative Site US076
Fountain Valley, California 92708-3701

Investigative Site US077
Fremont, California 94538

Investigative Site US020
Laguna Niguel, California 92677

Investigative Site US036
Los Angeles, California 90033

Investigative Site US067
Los Angeles, California 90045

Investigative Site US060
Northridge, California 91325

Investigative Site US037
Oakland, California 94611

Investigative Site US089
Santa Monica, California 90403

Investigative Site US002
Boca Raton, Florida 33486

Investigative Site US062
Coral Gables, Florida 33134

Investigative Site US084
Coral Gables, Florida 33146

Investigative Site US017
Hialeah, Florida 33012

Investigative Site US019
Hollywood, Florida 33021-6746

Investigative Site US015
Miami, Florida 33136

Investigative Site US072
Miami Lakes, Florida 33014

Investigative Site US023
North Miami Beach, Florida 33162

Investigative Site US029
Ocala, Florida 34470

Investigative Site US035
Tampa, Florida 33607

Investigative Site US005
Tampa, Florida 33613

Investigative Site US001
Tampa, Florida 33615

Investigative Site US066
West Palm Beach, Florida 33401

Investigative Site US070
West Palm Beach, Florida 33401

Investigative Site US051
Marietta, Georgia 30060-1047

Investigative Site US093
Chicago, Illinois 60657

Investigative Site US039
West Dundee, Illinois 60118

Investigative Site US008
Indianapolis, Indiana 46250

Investigative Site US064
West Lafayette, Indiana 47906

Investigative Site US012
Baton Rouge, Louisiana 70809

Investigative Site US057
New Orleans, Louisiana 70115

Investigative Site US038
Baltimore, Maryland 21287-0876

Investigative Site US030
Boston, Massachusetts 02215

Investigative Site US048
Brighton, Massachusetts 02135

Investigative Site US061
Ann Arbor, Michigan 48103

Investigative Site US091
Troy, Michigan 48084

Investigative Site US042
Waterford, Michigan 48328

Investigative Site US011
Minneapolis, Minnesota 55455

Investigative Site US088
Saint Joseph, Missouri 64506

Investigative Site US016
St Louis, Missouri 63110

Investigative Site US007
Portsmouth, New Hampshire 03801

Investigative Site US082
East Syracuse, New York 13057

Investigative Site US034
New York, New York 10028-3135

Investigative Site US081
New York, New York 10075

Investigative Site US065
New York, New York 10128

Investigative Site US031
Chapel Hill, North Carolina 27516

Investigative Site US028
Bexley, Ohio 43209

Investigative Site US025
Cincinnati, Ohio 45219

Investigative Site US073
Columbus, Ohio 43215

Investigative Site US085
Oklahoma City, Oklahoma 73170

Investigative Site US069
Plymouth Meeting, Pennsylvania 19462

Investigative Site US021
Bellaire, Texas 77401

Investigative Site US078
Dallas, Texas 75230

Investigative Site US010
Dallas, Texas 75246

Investigative Site US083
San Antonio, Texas 78218

Investigative Site US068
Webster, Texas 77598

Investigative Site US063
South Jordan, Utah 84095

Investigative Site US027
Norfolk, Virginia 23502

Investigative Site US094
Richmond, Virginia 23226

Investigative Site US003
Spokane, Washington 99202

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.