Continuation of treatment with povorcitinib for previous trial participants
A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
PHASE3 · Incyte Corporation · NCT06855498
This study lets people who have already benefited from the medication povorcitinib in a previous trial keep using it to see if it continues to help with their Hidradenitis Suppurativa.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Incyte Corporation (industry) |
| Drugs / interventions | adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab, povorcitinib |
| Locations | 318 sites (Birmingham, Alabama and 317 other locations) |
| Trial ID | NCT06855498 on ClinicalTrials.gov |
What this trial studies
This study allows participants who have previously completed a clinical trial involving povorcitinib to continue receiving the treatment. It focuses on individuals who have shown clinical benefit from the drug during their prior participation. The study aims to assess the ongoing safety and efficacy of povorcitinib in managing Hidradenitis Suppurativa. Participants must meet specific eligibility criteria, including having completed the parent study without safety concerns.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in Incyte-sponsored trials of povorcitinib and demonstrated clinical benefit.
Not a fit: Patients who experienced safety or efficacy issues during their previous treatment with povorcitinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide continued access to an effective treatment for patients with Hidradenitis Suppurativa.
How similar studies have performed: Previous studies involving povorcitinib have shown promising results, indicating a potential for continued success in this rollover study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment. * Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator. * Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements. * Willingness to avoid pregnancy or fathering children as defined in the protocol. * Willingness and ability to comply with the study Protocol and procedures. Exclusion Criteria: * Had been permanently discontinued from study treatment during the parent study. * Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study. * Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study: * Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab). * Live, attenuated vaccine. * Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug. * Women who are pregnant (or who are considering pregnancy) or breastfeeding. * 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. * Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Where this trial is running
Birmingham, Alabama and 317 other locations
- Investigative Site US086 — Birmingham, Alabama, United States (RECRUITING)
- Investigative Site US098 — Montgomery, Alabama, United States (NOT_YET_RECRUITING)
- Investigative Site US004 — Phoenix, Arizona, United States (RECRUITING)
- Investigative Site US047 — Scottsdale, Arizona, United States (NOT_YET_RECRUITING)
- Investigative Site US124 — Scottsdale, Arizona, United States (NOT_YET_RECRUITING)
- Investigative Site US115 — Tucson, Arizona, United States (NOT_YET_RECRUITING)
- Investigative Site US113 — Fayetteville, Arkansas, United States (NOT_YET_RECRUITING)
- Investigative Site US009 — Rogers, Arkansas, United States (NOT_YET_RECRUITING)
- Investigative Site US076 — Fountain Valley, California, United States (RECRUITING)
- Investigative Site US077 — Fremont, California, United States (RECRUITING)
- Investigative Site US071 — Huntington Beach, California, United States (NOT_YET_RECRUITING)
- Investigative Site US020 — Laguna Niguel, California, United States (RECRUITING)
- Investigative Site US036 — Los Angeles, California, United States (RECRUITING)
- Investigative Site US067 — Los Angeles, California, United States (RECRUITING)
- Investigative Site US060 — Northridge, California, United States (RECRUITING)
- Investigative Site US037 — Oakland, California, United States (RECRUITING)
- Investigative Site US089 — Santa Monica, California, United States (RECRUITING)
- Investigative Site US080 — Sherman Oaks, California, United States (NOT_YET_RECRUITING)
- Investigative Site US129 — Aventura, Florida, United States (NOT_YET_RECRUITING)
- Investigative Site US116 — Boca Raton, Florida, United States (NOT_YET_RECRUITING)
- Investigative Site US002 — Boca Raton, Florida, United States (RECRUITING)
- Investigative Site US062 — Coral Gables, Florida, United States (RECRUITING)
- Investigative Site US084 — Coral Gables, Florida, United States (RECRUITING)
- Investigative Site US017 — Hialeah, Florida, United States (RECRUITING)
- Investigative Site US019 — Hollywood, Florida, United States (RECRUITING)
- Investigative Site US044 — Margate, Florida, United States (NOT_YET_RECRUITING)
- Investigative Site US015 — Miami, Florida, United States (RECRUITING)
- Investigative Site US059 — Miami, Florida, United States (NOT_YET_RECRUITING)
- Investigative Site US072 — Miami Lakes, Florida, United States (RECRUITING)
- Investigative Site US079 — Miami Lakes, Florida, United States (NOT_YET_RECRUITING)
- Investigative Site US023 — North Miami Beach, Florida, United States (RECRUITING)
- Investigative Site US029 — Ocala, Florida, United States (RECRUITING)
- Investigative Site US035 — Tampa, Florida, United States (RECRUITING)
- Investigative Site US133 — Tampa, Florida, United States (NOT_YET_RECRUITING)
- Investigative Site US005 — Tampa, Florida, United States (RECRUITING)
- Investigative Site US001 — Tampa, Florida, United States (RECRUITING)
- Investigative Site US066 — West Palm Beach, Florida, United States (RECRUITING)
- Investigative Site US070 — West Palm Beach, Florida, United States (RECRUITING)
- Investigative Site US051 — Marietta, Georgia, United States (NOT_YET_RECRUITING)
- Investigative Site US103 — Sandy Springs, Georgia, United States (NOT_YET_RECRUITING)
- Investigative Site US100 — Stonecrest, Georgia, United States (NOT_YET_RECRUITING)
- Investigative Site US125 — Chicago, Illinois, United States (NOT_YET_RECRUITING)
- Investigative Site US093 — Chicago, Illinois, United States (RECRUITING)
- Investigative Site US049 — Skokie, Illinois, United States (NOT_YET_RECRUITING)
- Investigative Site US039 — West Dundee, Illinois, United States (RECRUITING)
- Investigative Site US108 — Indianapolis, Indiana, United States (NOT_YET_RECRUITING)
- Investigative Site US008 — Indianapolis, Indiana, United States (RECRUITING)
- Investigative Site US064 — West Lafayette, Indiana, United States (RECRUITING)
- Investigative Site US056 — Bowling Green, Kentucky, United States (NOT_YET_RECRUITING)
- Investigative Site US012 — Baton Rouge, Louisiana, United States (RECRUITING)
+268 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, INCB054707, povorcitinib, Hidradenitis, HS