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Selective Treatment of Oral Povorcitinib Long-Term Rollover Study (STOP-LTR)
EU CTIS ID: 2024-520107-12-00
What this study is testing
To continue evaluating the long-term safety of povorcitinib
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 per section 5.1.5 of the protocol.
- Willingness and ability to comply with the study Protocol and procedures.
You likely can't join if
- 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.
- [Commercial Confidential Information]
- [Commercial Confidential Information]
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.
See the full eligibility 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 per section 5.1.5 of the protocol.
- Willingness and ability to comply with the study Protocol and procedures.
- 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.
- [Commercial Confidential Information]
- [Commercial Confidential Information]
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) 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.
- The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Chile
- United Kingdom
- Switzerland
- Mexico
- Japan
- Korea, Republic of
- United States
- Australia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Chile; United Kingdom; Switzerland; Mexico; Japan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.