Povorcitinib for Hidradenitis Suppurativa
(STOP-HS1 Trial)
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.12345
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.12356
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Povorcitinib or placebo for 12 weeks to evaluate efficacy and safety
Extension
Participants who received placebo switch to Povorcitinib, and all participants continue treatment for an additional 42 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Povorcitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
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