POVORCITINIB for Hidradenitis suppurativa | Prurigo nodularis | Vitiligo

Inclusion criteria

• {"criterion_text":"- Ability to comprehend and willingness to sign a written ICF for the study."}
• {"criterion_text":"- Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment."}
• {"criterion_text":"- Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator."}
• {"criterion_text":"- Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements."}
• {"criterion_text":"- Willingness to avoid pregnancy or fathering children as per section 5.1.5 of the protocol."}
• {"criterion_text":"- Willingness and ability to comply with the study Protocol and procedures."}

Exclusion criteria

• {"criterion_text":"- Had been permanently discontinued from study treatment during the parent study."}
• {"criterion_text":"- Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study."}
• {"criterion_text":"- [Commercial Confidential Information]"}
• {"criterion_text":"- [Commercial Confidential Information]"}
• {"criterion_text":"- Women who are pregnant (or who are considering pregnancy) or breastfeeding."}
• {"criterion_text":"- Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code."}

Primary endpoints

• {"endpoint_text":"- TEAEs reported in participants receiving povorcitinib","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- For HS indication: ANdT count of 0-2 at each visit","definition_or_measurement_approach":""}
• {"endpoint_text":"- For vitiligo indication: Change from baseline of the initial parent study (INCB 54707-303 or INCB 54707-304) in F-VASI score at each visit","definition_or_measurement_approach":""}
• {"endpoint_text":"- For vitiligo indication: Change from baseline of the initial parent study (INCB 54707-303 or INCB 54707-304) in T-VASI score at each visit","definition_or_measurement_approach":""}
• {"endpoint_text":"- For PN indication: Itch NRS score of 0 or 1 at each visit","definition_or_measurement_approach":""}
• {"endpoint_text":"- For PN indication: IGA-CPG-S score of 0 or 1 at each visit","definition_or_measurement_approach":""}

Primary sponsor

Full Name

Incyte Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Sponsor duties codes: 1,12,13,15 (Concierge service),2,4,5,6 (study operations and site support as listed)

Name

PRA Hellas CRO A.E.

Responsibilities

Study start up, contract negotiation, monitoring activity in Greece

Name

Suvoda LLC

Responsibilities

sponsorDuties code: 3

Third parties

• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"packaging, labeling and batch release","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"multiple sponsorDuties codes (1,12,13,15 with value 'Concierge service', 2,4,5,6) including study operations and site support as listed","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"Study start up, contract negotiation, monitoring activity in Greece","organisation_type":"Pharmaceutical company"}