INCB 39110-801 A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)
Key facts
- Where
- Halle (Saale) és Mannheim, NémetországSee the 2 sites
- Phase
- 2. fázis
Where in Németország
- Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), NémetországNo longer taking part
- Universitaetsklinikum Mannheim GmbHMannheim, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Incyte Corp.
- Trial code
- EU 2022-501661-47-00
- Record updated
- 2025. szeptember 10.
- Original description
To provide continued treatment and evaluation of safety in participants who are receiving clinical benefit with an itacitinib-based therapy in an Incyte-sponsored clinical study.Read full original descriptionShow less
To provide continued treatment and evaluation of safety in participants who are receiving clinical benefit with an itacitinib-based therapy in an Incyte-sponsored clinical study.
Inclusion: Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB 39110)-based clinical study (parent protocol); Currently tolerating treatment as defined by the parent protocol; Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator; Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements; Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol; Willingness to avoid pregnancy or fathering children based on criteria in Section 5. l ; Ability to comprehend and willingness to sign an ICF.
Exclusion: Able to access itacitinib therapy commercially; Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol; Pregnant or breastfeeding women; Any personal status that would prohibit clinical trial participation under local regulations.