Povorcitinib for Hidradenitis Suppurativa

(STOP-HS LTE Trial)

Recruiting at 296 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Disqualifiers: Pregnancy, Breastfeeding, Others

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

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: 54 weeks

960 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of povorcitinib, a potential new drug, for individuals with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps. It involves participants who have completed 54 weeks of treatment in earlier related studies. Participants will receive different doses of povorcitinib to assess its long-term effects. Suitable candidates for this trial have completed the previous studies and agree to follow the study rules, such as using contraception. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to bringing a new treatment to market.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that povorcitinib is likely to be safe for humans?

Research has shown that povorcitinib, an oral pill, may help treat hidradenitis suppurativa, a skin condition. In studies, it performed well at various doses without increasing the risk of side effects. Some participants experienced side effects such as low iron levels (anemia), inflamed hair follicles (folliculitis), and elevated levels of a muscle enzyme (CPK) in their blood. However, these side effects were uncommon. Most participants tolerated the treatment well, and only a few discontinued due to side effects. This suggests that povorcitinib is generally safe for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hidradenitis suppurativa?

Unlike the standard treatments for Hidradenitis Suppurativa, which include antibiotics, anti-inflammatory drugs, and biologics like adalimumab, Povorcitinib offers a new approach by targeting a specific pathway involved in inflammation. Povorcitinib is a selective inhibitor of the Janus kinase (JAK) pathway, which plays a crucial role in the inflammatory process that contributes to this condition. Researchers are excited because this targeted mechanism could potentially offer more effective relief for patients, reducing inflammation and associated symptoms with possibly fewer side effects than current options.

What evidence suggests that povorcitinib might be an effective treatment for hidradenitis suppurativa?

Research shows that povorcitinib has promising results for treating hidradenitis suppurativa (HS), a painful skin condition. In studies, povorcitinib met its main goals by successfully reducing symptoms like abscesses and swollen lumps. This trial will test povorcitinib at different dose strengths across various cohorts. Previous research indicates that both 45 mg and 75 mg doses significantly improved symptoms. Importantly, side effects did not increase, suggesting it is safe to use. Overall, povorcitinib's effectiveness in reducing HS symptoms makes it a strong option for treating this condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe hidradenitis suppurativa who finished the treatment period in earlier Phase 3 studies (INCB 54707-301 or INCB 54707-302). Participants must agree to use contraception and follow the study rules.

Inclusion Criteria

Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302)

Agreement to use contraception

Willing and able to comply with the study protocol and procedures

Exclusion Criteria

Participation in the extension study could expose the participant to an undue safety risk

Further exclusion criteria apply.

I am not pregnant, considering pregnancy, 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 for long-term safety and efficacy evaluation

54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive povorcitinib to assess long-term outcomes

56 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Povorcitinib

Trial Overview The trial is testing Povorcitinib's long-term safety and effectiveness. It's for those who've already been on it during previous trials, aiming to understand how well it works over a longer period and if there are any ongoing risks.

How Is the Trial Designed?

Group I: Cohort C Experimental Treatment 1 Intervention

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Group II: Cohort B Experimental Treatment 1 Intervention

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Group III: Cohort A Experimental Treatment 1 Intervention

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

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

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]

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 34 publications involving 105 patients with hidradenitis suppurativa (HS) found that TNF-alpha inhibitors, particularly infliximab, led to positive treatment outcomes in 90% of cases, indicating their potential efficacy in managing this challenging skin condition.

While side effects were reported in 8 out of 105 patients, they were similar to those seen in other studies with TNF-alpha inhibitors, suggesting a manageable safety profile; however, the need for more standardized reporting and randomized controlled trials is emphasized to better understand long-term effects and optimal treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. Haslund, P., Lee, RA., Jemec, GB.[2018]

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]

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]

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]

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]

A Canadian family of Armenian descent was found to have hidradenitis suppurativa linked to novel mutations in the MEVF and NOD2 genes, suggesting a genetic component to the condition.

The study recommends genetic testing for patients with a strong family history of hidradenitis suppurativa, especially when common triggers like smoking and obesity are absent, highlighting the importance of understanding genetic factors in this skin disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel variants of MEFV and NOD2 genes in familial hidradenitis suppurativa: A case report. Jfri, A., Litvinov, IV., Netchiporouk, E., et al.[2020]

Citations

1. 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 ... 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 ...

2. 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.

3. 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 ...

4. 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 ...

5. 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 ...

6. incytemi.com incytemi.com/document/Poster/SHSA%202024_Sayed_84-Week%20Safety%20Phase%202%20Povo%20in%20HS%20Study%20(3000368).pdf

Safety of Povorcitinib During 84 Weeks of Treatment † TEAEs leading to dose discontinuation were anemia. (n=2), acute myocardial infarction, folliculitis, increased blood CPK, pulmonary embolism, ...