INCB 39110-801 A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)

Phase 1

Recruiting

• Conditions: Myelofibrosis; postlung transplant (BOS); chronic graft-versus-host disease; MedDRA version: 23.0Level: LLTClassification code: 10083303Term: Bronchiolitis obliterans syndrome Class: 10038738; MedDRA version: 20.0Level: PTClassification code: 10028537Term: Myelofibrosis Class: 100000004864; MedDRA version: 20.1Level: PTClassification code: 10066261Term: Chronic graft versus host disease Class: 100000004870; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501661-47-00
• Lead Sponsor: Incyte Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified