Povorcitinib for HS

(STOP-LTR Trial)

Recruiting at 567 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must be taking: Povorcitinib

Must not be taking: Biologic immunomodulators, Live vaccines

Disqualifiers: Pregnancy, Breastfeeding, Hypersensitivity, 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: Up to approximately 3 years

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests povorcitinib for individuals who have already participated in an Incyte-sponsored study for the same drug. The goal is to further understand how povorcitinib benefits those with the conditions it was initially tested for by monitoring ongoing benefits and safety. It specifically targets participants who completed the original trial with positive results and no major side effects. Those who successfully completed a previous povorcitinib trial and experienced positive effects might be a good fit for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to the validation of a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain biologic drugs or live vaccines within 28 days before starting the study. It's best to discuss your specific medications with the study team.

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

Research has shown that povorcitinib is generally safe for people with hidradenitis suppurativa (HS). Studies have found no increased risk of unwanted side effects with different doses of povorcitinib. One study confirmed that povorcitinib did not cause more side effects, indicating its safety. While safety remains a priority, current evidence supports the use of povorcitinib for treating HS. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Povorcitinib is unique because it offers a new approach to treating Hidradenitis Suppurativa (HS), a painful skin condition. Most treatments for HS involve antibiotics or biologics like adalimumab, which target inflammation. However, povorcitinib works by inhibiting Janus kinase (JAK) enzymes, which play a crucial role in the inflammatory pathways associated with HS. Researchers are excited about this treatment because targeting JAK enzymes could provide a more direct and potentially effective way to reduce inflammation and manage symptoms compared to current options.

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

Research has shown that povorcitinib, the treatment under study in this trial, effectively treats hidradenitis suppurativa (HS), a painful skin condition. Studies found that after 24 weeks, 62% to 70% of patients taking povorcitinib reported little to no pain. In two different studies, more patients taking povorcitinib experienced a noticeable reduction in symptoms by week 12 compared to those taking a placebo (a treatment with no active ingredients). These results suggest that povorcitinib can lessen the severity and discomfort of HS over time. Additionally, povorcitinib did not increase side effects, making it a promising option for those with this condition. ^{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?

This trial is for individuals who have completed a previous Incyte-sponsored study of povorcitinib without safety concerns and benefited from its treatment, as judged by the researcher. Participants must be willing to prevent pregnancy or fathering children, follow the study's rules, understand and sign consent forms, and have shown good compliance with the earlier trial protocol.

Inclusion Criteria

Ability to comprehend and willingness to sign a written ICF for the study

Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements

Willingness to avoid pregnancy or fathering children as defined in the protocol

Exclusion Criteria

Had been permanently discontinued from study treatment during the parent study

Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class

Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Povorcitinib

Trial Overview The rollover study focuses on povorcitinib for those with Hidradenitis Suppurativa (HS), a chronic skin condition. It extends access to povorcitinib for participants who were previously in Incyte-sponsored trials and saw positive results.

How Is the Trial Designed?

Group I: povorcitinib Experimental Treatment 1 Intervention

Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.

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. 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 ... Across both STOP-HS1 and STOP-HS2, povorcitinib treatment resulted in continued clinically meaningful and statistically significant ...

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

Povorcitinib Shows Sustained Efficacy in HS at 24 Weeks By week 24, 62% to 70% of patients reported mild or no pain, a notable improvement from baseline. These findings suggest that povorcitinib not ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05620836?utm_source=trialradar

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 ...

6. 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 ...

7. 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 hidradenitis suppurativa (HS) will require long-term use, and safety of new treatments is a concern for physicians and patients. ○ What did ...

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 ...