Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Phase 2RecruitingNCT07213973

Incyte Corporation40 enrolled

Overview

The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hidradenitis Suppurativa (HS)

Interventions

PovorcitinibDRUG

Oral; Tablet

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged ≥ 12 to \< 18 years at the time of informed consent/assent signing. * Body weight ≥ 30 kg at both screening and baseline visits. * Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit. * Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits. * HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits. * Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS). * Agreement to use contraception. * Willing and able to comply with the study protocol and procedures. * Further inclusion criteria apply. Exclusion Criteria: * Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit. * Women who are pregnant (or who are considering pregnancy) or breastfeeding. * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * Laboratory values outside of the protocol-defined ranges. * Further exclusion criteria apply.

Locations (29)

Outcomes

Primary Outcomes

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

TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.

Time frame: Baseline through Week 54

Apparent clearance

Time frame: Up to Week 24

Apparent volume of distribution

Time frame: Up to Week 24

Apparent oral absorption rate constant

Time frame: Up to Week 24

Absorption lag time

Time frame: Up to Week 24

Maximum plasma drug concentration at steady state

Time frame: Up to Week 24

Average plasma drug concentration at steady state

Time frame: Up to Week 24

Plasma concentration at steady state for the dosing interval

Time frame: Up to Week 24

Time to maximum plasma concentration at steady state

Time frame: Up to Week 24

Terminal half-life

Time frame: Up to Week 24

Secondary Outcomes

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

Central Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423 eumedinfo@incyte.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

University of Alabama At Birmingham

Birmingham, Alabama, United States

NOT_YET_RECRUITING

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, United States

RECRUITING

Saguaro Dermatology

Phoenix, Arizona, United States

RECRUITING

Uconn Health

Farmington, Connecticut, United States

NOT_YET_RECRUITING

University of Miami Miller School of Medicine

Miami, Florida, United States

RECRUITING

Skin Research of South Florida, Llc

Miami, Florida, United States

RECRUITING

Trueblue Clinical Research

Tampa, Florida, United States

RECRUITING

Advanced Medical Research Pc

Sandy Springs, Georgia, United States

RECRUITING

Endeavor Health Medical Group

Skokie, Illinois, United States

RECRUITING

Dermatology Skin Cancer Center Leawood

Leawood, Kansas, United States

RECRUITING

...and 19 more locations

HiSCR50 is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

Time frame: 54 weeks

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

Time frame: 54 weeks

Mean change from baseline in abscess count at each visit

Defined as mean change of abscess count relative to baseline.

Time frame: 54 weeks

Mean percentage change from baseline in abscess count at each visit

Defined as mean percentage change from baseline in abscess count.

Time frame: 54 weeks

Mean change from baseline in inflammatory nodule count at each visit

Defined as mean change of inflammatory nodule count relative to baseline.

Time frame: 54 weeks

Mean percentage change from baseline in inflammatory nodule count at each visit

Defined as mean percentage change from baseline in inflammatory nodule count.

Time frame: 54 weeks

Mean change from baseline in draining tunnel count at each visit

Defined as mean change of draining tunnel count relative to baseline.

Time frame: 54 weeks

Mean percentage change from baseline in draining tunnel count at each visit

Defined as mean percentage change from baseline in draining tunnel count.

Time frame: 54 weeks

Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3

Defined as participants with a Skin Pain NRS score of at least 3 at baseline and who achieve Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

Time frame: 54 weeks

Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score among participants with baseline Skin Pain NRS score ≥ 3

Participants with a Skin Pain score of at least 3 at baseline and who experience at least a 3-point decrease in Skin Pain score.

Time frame: 54 weeks

Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit

The CDLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days, across symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment.

Time frame: 54 weeks