Povorcitinib for Hidradenitis Suppurativa

Not yet recruiting at 30 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Disqualifiers: Pregnancy, Thrombocytopenia, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 54 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment called povorcitinib for teenagers with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps under the skin. Over 54 weeks, participants will receive one of two different doses to evaluate its effects on their bodies and its impact on their skin condition. Suitable candidates for this trial are teenagers who have had the condition for at least 3 months and have not responded well to other treatments like antibiotics or biologics. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that povorcitinib is generally safe for people. Studies have found that using povorcitinib to treat hidradenitis suppurativa, a skin condition, does not increase side effects, even at different doses. Earlier studies reported consistent safety for povorcitinib, with no major safety problems. Overall, the treatment appears safe based on current information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Povorcitinib for Hidradenitis Suppurativa because it works differently from current treatments. Most available options, like antibiotics and anti-inflammatory drugs, aim to reduce infection and inflammation but don't always tackle the root cause of the disease. Povorcitinib is unique because it targets specific pathways involved in the inflammatory process, potentially offering more effective relief. This targeted approach could mean fewer side effects and a more significant impact on the condition's progression, which is why researchers are hopeful about its potential.

What evidence suggests that this trial's treatments could be effective for hidradenitis suppurativa?

Research has shown that povorcitinib offers promising results for treating hidradenitis suppurativa (HS), a skin condition that causes painful lumps. In one study, nearly 60% of patients experienced significant improvement by week 24. This trial will test povorcitinib at different doses, with participants receiving either Dose A or Dose B for 54 weeks. Previous studies have demonstrated that both doses were more effective than a placebo (a harmless pill used for comparison). By week 16, patients noticed a clear reduction in abscesses and swollen bumps on their skin. Overall, these findings suggest povorcitinib could be effective for people with moderate to severe HS. ^{1 2 6 7 8}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

Adolescents aged 12-17 with moderate to severe hidradenitis suppurativa (HS), weighing at least 30 kg, who haven't responded well to traditional treatments. Participants must have had HS for a minimum of three months and have at least five abscesses or nodules. They should be able to follow the study rules and agree to use contraception.

Inclusion Criteria

I agree to use birth control.

I am willing and able to follow the study's rules and procedures.

I understand there are more criteria I need to meet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive povorcitinib for 54 weeks to evaluate pharmacokinetics, safety, and efficacy

54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Povorcitinib

Trial Overview

The trial is testing Povorcitinib's effects on adolescents with HS over a period of 54 weeks. It aims to understand how the body processes the drug, its safety, and how effective it is in treating symptoms.

How Is the Trial Designed?

Group I: Povorcitinib Dose B Experimental Treatment 1 Intervention

Participants will receive povorcitinib dose B for 54 weeks.

Group II: Povorcitinib Dose A Experimental Treatment 1 Intervention

Participants will receive povorcitinib dose A for 54 weeks.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1.

dermatologytimes.com

dermatologytimes.com/view/povorcitinib-shows-sustained-efficacy-in-hs-at-24-weeks

Povorcitinib Shows Sustained Efficacy in HS at 24 Weeks

STOP-HS1 and STOP-HS2 phase 3 trials showed nearly 60% of patients achieving HiSCR50 by week 24, according to a presentation at EADV 2025.

2.

incytecorp.gcs-web.com

incytecorp.gcs-web.com/news-releases/news-release-details/incyte-announces-new-24-week-phase-3-data-stop-hs-clinical-trial

Incyte Announces New 24-Week Phase 3 Data from the STOP ...

As previously reported, both STOP-HS1 and STOP-HS2 studies met their primary endpoint at each tested dose (45 mg and 75 mg). A significantly ...

3.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/povorcitinib-improves-hidradenitis-suppurativa-in-two-phase-3-trials/

Povorcitinib Improves Hidradenitis Suppurativa in Two ...

Results showed a greater percentage of povorcitinib-treated patients (at both tested doses) achieved HiSCR50 compared with placebo at week 12 ( ...

4.

incytemi.com

incytemi.com/document/Poster/SHSA%202025_Sayed_STOP-HS%2024-wk%20Effect%20on%20HiSQoL.pdf

HiSQoL Improvements in the Povorcitinib Phase 3 Studies

Hidradenitis suppurativa (HS) is a long-lasting disease that causes swollen bumps and/or tunnels in the skin. People with HS often experience ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37871805/

Efficacy and safety of the oral Janus kinase 1 inhibitor ...

At week 16, povorcitinib significantly reduced abscess and inflammatory nodule count from baseline (least squares mean [SE] change: 15 mg, -5.2 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05620836

NCT05620836 | A Study to Evaluate the Efficacy and ...

The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa ...

7.

incytemi.com

incytemi.com/document/Poster/EADV%202025_Porter_STOP-HS%20Week%2024%20Interim%20Phase%203%20Results.pdf

Povorcitinib for Moderate to Severe Hidradenitis Suppurativa

Safety up to Week 24. ○ Povorcitinib was well tolerated; the safety profile was consistent with that seen in the PC period. † TEAEs reported ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0190962223030372

Efficacy and safety of the oral Janus kinase 1 inhibitor ...

In conclusion, povorcitinib demonstrated rapid clinical efficacy for HS, with no evidence of increased risk of AEs across doses evaluated. Povorcitinib was also ...