Evaluating long-term safety and effectiveness of povorcitinib for hidradenitis suppurativa
A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
PHASE3 · Incyte Corporation · NCT06212999
This study is testing if povorcitinib is safe and effective for people with moderate to severe hidradenitis suppurativa who have already tried it for a year in earlier trials.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 960 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Incyte Corporation (industry) |
| Drugs / interventions | povorcitinib |
| Locations | 172 sites (Phoenix, Arizona and 171 other locations) |
| Trial ID | NCT06212999 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the long-term safety and efficacy of povorcitinib in patients with moderate to severe hidradenitis suppurativa who have previously completed a 54-week treatment in earlier Phase 3 studies. Participants will be monitored for their response to the treatment and any potential side effects over an extended period. The study focuses on individuals who have already been part of the initial trials, ensuring a consistent patient population for evaluation.
Who should consider this trial
Good fit: Ideal candidates are individuals who have completed the initial 54-week treatment in the parent studies and meet the inclusion criteria.
Not a fit: Patients who are pregnant, breastfeeding, or those who may face undue safety risks from participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new long-term treatment option for patients suffering from moderate to severe hidradenitis suppurativa.
How similar studies have performed: Other studies have shown promising results with similar treatments for hidradenitis suppurativa, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Further inclusion criteria apply. Exclusion Criteria: * Participation in the extension study could expose the participant to an undue safety risk. * Women who are pregnant (or who are considering pregnancy) or breastfeeding. * Further exclusion criteria apply.
Where this trial is running
Phoenix, Arizona and 171 other locations
- Investigative Site US303 — Phoenix, Arizona, United States (RECRUITING)
- Investigative Site US240 — Scottsdale, Arizona, United States (RECRUITING)
- Investigative Site US307 — Fort Smith, Arkansas, United States (RECRUITING)
- Investigative Site US214 — Rogers, Arkansas, United States (RECRUITING)
- Investigative Site US315 — Laguna Niguel, California, United States (RECRUITING)
- Investigative Site US223 — Los Angeles, California, United States (RECRUITING)
- Investigative Site US222 — Oakland, California, United States (RECRUITING)
- Investigative Site US226 — San Diego, California, United States (RECRUITING)
- Investigative Site US233 — Washington, District of Columbia, United States (WITHDRAWN)
- Investigative Site US309 — Clearwater, Florida, United States (RECRUITING)
- Investigative Site US317 — Hialeah, Florida, United States (RECRUITING)
- Investigative Site US306 — Hollywood, Florida, United States (RECRUITING)
- Investigative Site US320 — Hollywood, Florida, United States (RECRUITING)
- Investigative Site US316 — Maitland, Florida, United States (RECRUITING)
- Investigative Site US227 — Margate, Florida, United States (RECRUITING)
- Investigative Site US204 — Miami, Florida, United States (RECRUITING)
- Investigative Site US236 — Miami, Florida, United States (NOT_YET_RECRUITING)
- Investigative Site US321 — North Miami Beach, Florida, United States (RECRUITING)
- Investigative Site US200 — Ocala, Florida, United States (RECRUITING)
- Investigative Site US228 — Tampa, Florida, United States (RECRUITING)
- Investigative Site US201 — Tampa, Florida, United States (RECRUITING)
- Investigative Site US311 — Marietta, Georgia, United States (NOT_YET_RECRUITING)
- Investigative Site US220 — West Dundee, Illinois, United States (RECRUITING)
- Investigative Site US206 — Indianapolis, Indiana, United States (RECRUITING)
- Investigative Site US337 — Indianapolis, Indiana, United States (NOT_YET_RECRUITING)
- Investigative Site US341 — Bowling Green, Kentucky, United States (NOT_YET_RECRUITING)
- Investigative Site US209 — Louisville, Kentucky, United States (RECRUITING)
- Investigative Site US305 — Baton Rouge, Louisiana, United States (RECRUITING)
- Investigative Site US207 — Metairie, Louisiana, United States (RECRUITING)
- Investigative Site US229 — New Orleans, Louisiana, United States (RECRUITING)
- Investigative Site US224 — Baltimore, Maryland, United States (RECRUITING)
- Investigative Site US325 — Marriottsville, Maryland, United States (NOT_YET_RECRUITING)
- Investigative Site US225 — Boston, Massachusetts, United States (RECRUITING)
- Investigative Site US304 — Boston, Massachusetts, United States (RECRUITING)
- Investigative Site US310 — Brighton, Massachusetts, United States (RECRUITING)
- Investigative Site US221 — Quincy, Massachusetts, United States (RECRUITING)
- Investigative Site US213 — Fort Gratiot, Michigan, United States (RECRUITING)
- Investigative Site US217 — Waterford, Michigan, United States (RECRUITING)
- Investigative Site US212 — Minneapolis, Minnesota, United States (RECRUITING)
- Investigative Site US302 — Saint Louis, Missouri, United States (RECRUITING)
- Investigative Site US239 — Omaha, Nebraska, United States (WITHDRAWN)
- Investigative Site US318 — Portsmouth, New Hampshire, United States (RECRUITING)
- Investigative Site US230 — East Windsor, New Jersey, United States (RECRUITING)
- Investigative Site US324 — Kew Gardens, New York, United States (RECRUITING)
- Investigative Site US202 — New York, New York, United States (RECRUITING)
- Investigative Site US210 — Rochester, New York, United States (NOT_YET_RECRUITING)
- Investigative Site US205 — Chapel Hill, North Carolina, United States (RECRUITING)
- Investigative Site US215 — Bexley, Ohio, United States (RECRUITING)
- Investigative Site US339 — Bexley, Ohio, United States (NOT_YET_RECRUITING)
- Investigative Site US330 — Boardman, Ohio, United States (NOT_YET_RECRUITING)
+122 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Incyte Corporation Call Center (US)
- Email: medinfo@incyte.com
- Phone: 1.855.463.3463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hidradenitis Suppurativa, Hidradenitis, Acne inversa, HS, Povorcitinib, Long-Term Extension, INCB054707