Povorcitinib for Hidradenitis Suppurativa

(STOP-HS1 Trial)

Not currently recruiting at 144 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must not be taking: Antibiotics, Antiseptics

Disqualifiers: Pregnancy, Cancer, Infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new drug, Povorcitinib, for individuals with moderate to severe Hidradenitis Suppurativa (HS), a skin condition causing painful lumps under the skin. Participants will receive one of two doses of Povorcitinib or a placebo (a dummy treatment) for 54 weeks. Eligibility requires having HS for at least three months, with at least five painful lumps in two different body areas, and a history of unsuccessful treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to help potentially bring a new treatment to market.

Will I have to stop taking my current medications?

The trial requires that participants do not use topical and systemic antibiotics for treating Hidradenitis Suppurativa during the placebo-controlled period. It does not specify about other medications, so you may need to discuss your current medications with the trial team.

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 with hidradenitis suppurativa (HS). Studies have found that Povorcitinib reduces symptoms like abscesses and nodules without causing more side effects than other treatments. In fact, different doses tested did not lead to increased negative side effects. This suggests that Povorcitinib is a safe choice for treating HS, as it works effectively without adding extra risks. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for Hidradenitis Suppurativa?

Researchers are excited about povorcitinib for treating hidradenitis suppurativa because it works differently from current treatments. Most standard therapies, like antibiotics and anti-inflammatory drugs, aim to reduce symptoms but don't address the underlying causes. Povorcitinib is unique as it targets the JAK1 pathway, which plays a crucial role in inflammation. By directly intervening in this pathway, povorcitinib has the potential to reduce flare-ups more effectively and offer longer-lasting relief. This novel mechanism of action could represent a significant advancement in managing this chronic skin condition.

What evidence suggests that Povorcitinib might be an effective treatment for Hidradenitis Suppurativa?

This trial will evaluate the effectiveness of Povorcitinib for treating hidradenitis suppurativa (HS). Participants may receive Povorcitinib at different dosages or a placebo. Studies have shown that Povorcitinib effectively treats HS, with patients experiencing fewer painful lumps, swollen areas, and leaking tunnels compared to those on a placebo. In another study, more patients on Povorcitinib showed significant improvement in their HS symptoms. The treatment blocks a specific protein that causes inflammation. Importantly, these studies found no increase in side effects, indicating that Povorcitinib appears safe as well as effective. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe Hidradenitis Suppurativa (HS) who haven't responded well to other treatments. Participants need at least 5 abscesses or nodules, must avoid certain HS treatments during the study, and agree to use contraception. It's not for those with more than 20 draining tunnels, pregnant or breastfeeding women, or individuals with specific medical conditions.

Inclusion Criteria

Agreement to use contraception

You have at least 5 abscesses and inflammatory nodules at the screening and baseline visits.

I have been diagnosed with moderate to severe HS for at least 3 months.

Exclusion Criteria

Your test results are not within the specified normal ranges.

I have more than 20 draining tunnels (fistulas).

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Povorcitinib or placebo for 12 weeks to evaluate efficacy and safety

12 weeks

Extension

Participants who received placebo switch to Povorcitinib, and all participants continue treatment for an additional 42 weeks

42 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Povorcitinib

Trial Overview

The study tests Povorcitinib's effectiveness and safety in treating HS over a 12-week period against a placebo. After that, there's a 42-week extension phase. The goal is to see if Povorcitinib can help reduce symptoms of HS better than no treatment.

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.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 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

Published Research Related to This Trial

Secukinumab, an anti-IL-17A monoclonal antibody, has been approved for treating moderate to severe Hidradenitis suppurativa (HS), marking a significant advancement in therapy for this chronic inflammatory skin disorder affecting 0.4% to 2.5% of the global population.

Clinical trials have demonstrated the safety and efficacy of secukinumab in HS, providing a new treatment option alongside the previously approved adalimumab, which targets a different inflammatory pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biology of Interleukin-17 and Novel Therapies for Hidradenitis Suppurativa. Sabat, R., Gudjonsson, JE., Brembilla, NC., et al.[2023]

JAK inhibitors, particularly INCB054707, upadacitinib, and tofacitinib, show promising efficacy and safety in treating hidradenitis suppurativa (HS), based on a review of 25 relevant studies.

Despite the encouraging results, the current evidence is limited due to the small number of studies and participants, highlighting the need for larger real-life studies to establish effective treatment options for HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis Suppurativa and JAK Inhibitors: A Review of the Published Literature. Martora, F., Scalvenzi, M., Ruggiero, A., et al.[2023]

IL-17 inhibitors, particularly secukinumab and brodalumab, show promising efficacy in treating hidradenitis suppurativa (HS), with response rates of 57.1% and 100% respectively among 128 patients studied.

These treatments can be effective for patients who do not respond to other therapies, highlighting the need for standardized outcome measures to improve future research and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. Kashetsky, N., Mufti, A., Alabdulrazzaq, S., et al.[2022]

The BATMAN consortium is developing a comprehensive approach to understand hidradenitis suppurativa (HS) by identifying genetic variants and biological pathways linked to the disease, which could lead to personalized treatment options.

The project aims to create advanced cellular models and a smartphone application for remote patient monitoring, enhancing diagnosis and treatment strategies for HS through the integration of various scientific disciplines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holistic health record for Hidradenitis suppurativa patients. Tricarico, PM., Moltrasio, C., Gradišek, A., et al.[2022]

A systematic review of 65 studies involving 459 patients indicates that TNF-α inhibitors, particularly infliximab, show moderate to good efficacy in treating hidradenitis suppurativa, with 82% of patients responding positively to infliximab, 76% to adalimumab, and 68% to etanercept.

Infliximab is recommended as the preferred treatment option due to its superior efficacy, while etanercept is discouraged, and adalimumab may be effective at higher doses, highlighting the need for careful consideration of treatment choices in severe cases of hidradenitis suppurativa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The off-label treatment of severe hidradenitis suppurativa with TNF-α inhibitors: a systematic review. van Rappard, DC., Limpens, J., Mekkes, JR.[2018]

In two phase 2 trials involving patients with moderate-to-severe hidradenitis suppurativa (HS), the oral JAK1-selective inhibitor povorcitinib showed significant transcriptomic changes, particularly at the 30 mg dose, indicating its potential efficacy in altering disease-related gene expression.

Povorcitinib treatment led to a dose-dependent downregulation of inflammatory markers and reversal of gene signatures associated with HS, suggesting that JAK1 inhibition could effectively target the underlying mechanisms of HS pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Disease-Associated Pathways in Hidradenitis Suppurativa by the Janus Kinase 1 Inhibitor Povorcitinib: Transcriptomic and Proteomic Analyses of Two Phase 2 Studies. Liu, H., Santos, LL., Smith, SH.[2023]

In a study of patients with moderate to severe hidradenitis suppurativa (HS) treated with adalimumab (ADA) for at least 12 weeks, those carrying the common GGG haplotype had a significantly better response rate (71.8%) compared to those with minor frequency SNP haplotypes (50.0%).

Carriers of minor frequency SNP haplotypes showed a reduced decrease in inflammatory lesion count during treatment, suggesting that genetic factors may influence the efficacy of ADA in HS and could guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Single Nucleotide Polymorphisms of the Promoter of the TNF Gene on Adalimumab Treatment Responses in Hidradenitis Suppurativa. Argyropoulou, M., Trigoni, A., Kaffenberger, J., et al.[2023]

In patients with severe hidradenitis suppurativa (HS), there is an increase in specific inflammatory monocytes and a unique cytokine profile, indicating a complex immune response that could guide treatment choices.

Treatment with etanercept, a TNF blocker, showed clinical improvement linked to increased production of IL-1β and IL-17 in blood cells, suggesting that monitoring these cytokines could help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. Kanni, T., Tzanetakou, V., Savva, A., et al.[2018]

Citations

1.

pubmed.ncbi.nlm.nih.gov

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

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

Povorcitinib demonstrated efficacy in HS, with no evidence of increased incidence of adverse events among doses.

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investor.incyte.com

investor.incyte.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 ...

A significantly higher proportion of patients treated with povorcitinib once daily (QD) versus placebo achieved Hidradenitis Suppurativa ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04476043

Study Details | NCT04476043 | To Assess the Efficacy and ...

To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0190962223030372

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

Povorcitinib, an oral, selective Janus kinase 1 inhibitor, reduced abscess, inflammatory nodule, and draining tunnel counts compared with placebo and was ...

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rheumatologyadvisor.com

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

Povorcitinib Improves Hidradenitis Suppurativa in Two ...

“The positive phase 3 data highlight the potential of povorcitinib as an effective oral treatment option for people living with HS.” According ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06212999

NCT06212999 | A Study to Evaluate the Long-Term Safety ...

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who ...