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A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS1)
EU CTIS ID: 2022-501752-29-00
What this study is testing
To evaluate the efficacy and safety of povorcitinib for the treatment of hidradenitis suppurativa
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability to comprehend and willingness to sign a written ICF for the study.
- Willing and able to comply with the study protocol and procedures.
- Age ≥ 18 years at the time of signing the ICF.
- 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 in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits.
You likely can't join if
- Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
- Evidence of infection with Mycobacterium tuberculosis
- Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as confirmed positive anti-HIV antibody test
- Evidence of HBV or HCV infection or risk of reactivation
- Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
- Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee'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.
See the full eligibility criteria
Who can join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Willing and able to comply with the study protocol and procedures.
- Age ≥ 18 years at the time of signing the ICF.
- 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 in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage 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 NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period (unless the systemic antibiotic rescue criterion is met).
- Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
- Agreement to use contraception
What rules you out
- Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
- Evidence of infection with Mycobacterium tuberculosis
- Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as confirmed positive anti-HIV antibody test
- Evidence of HBV or HCV infection or risk of reactivation
- Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
- Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee'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.
- 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.
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Concurrent conditions or history of other diseases (as per section 5.2 of the protocol)
- A screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment (eg, acute myocardial infarction, serious tachyarrhythmias or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff-Parkinson-White syndrome) or criteria associated with Q wave interval (QT)/Fridericia-corrected Q wave interval (QTcF) abnormalities.
- Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
- History of treatment failure with any systemic or topical JAK inhibitor for HS or any other inflammatory condition
- Receipt of medical treatment or investigational drugs before the baseline visit within the intervals specified in section 5.2 of the protocol
- At the screening visit, any of the laboratory abnormalities defined in the protocol Table 9
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.