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ACTIVE NOT RECRUITING Phase 2

A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

NCT04640025 · View on ClinicalTrials.gov ↗

Study Summary

This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol". Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.

Interventions

  • DRUG itacitinib

Study Locations (20)

Other

  • Ordensklinikum Linz Gmbh Elisabethinen — Linz
  • Universitaire Ziekenhuis Leuven - Gasthuisberg — Leuven
  • Universitatsklinikum Halle (Saale) — Halle
  • University Medical Centre Hamburg-Eppendorf Centre of Oncology — Hamburg
  • University Hospital Mannheim — Mannheim
  • University Hospital of West Attica - Attikon — Chaïdári
  • Hadassah Hebrew University Medical Center Ein Karem Hadassah — Jerusalem
  • Azienda Policlinico Vittorio Emanuele — Catania
  • Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti — Reggio Calabria
  • Aou San Giovanni Di Dio E Ruggi — Salerno
  • Hospital Universitario Virgen de Las Nieves — Granada

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia
  • Temple University Department of Thoracic Medicine and Surgery — Philadelphia

California

  • City of Hope National Medical Center — Duarte

Colorado

  • Anschutz Cancer Pavilion-University of Colorado — Aurora

Indiana

  • Parkview Cancer Institute — Fort Wayne

Ohio

  • Cleveland Clinic — Cleveland

Tennessee

  • Sarah Cannon Research Institute — Nashville

Texas

  • Texas Oncology San Antonio — San Antonio

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2021-03-10
Est. Completion 2026-06-22
Phase Phase 2

Sponsor

Incyte Corporation

163 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04640025

The ClinicalTrials.gov registry entry for NCT04640025 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 1 intervention — of which itacitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04640025 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04640025 about?

NCT04640025 is a clinical study titled "A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib". This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per ...

What is the current status of trial NCT04640025?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2021-03-10. Estimated completion is 2026-06-22.

What conditions does trial NCT04640025 study?

This clinical trial studies the following conditions: Myelofibrosis, Chronic Graft Versus Host Disease, Postlung Transplant (Bronchiolitis Obliterans). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04640025?

The interventions under investigation include: itacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04640025?

This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04640025 being conducted?

This trial has 20 study locations across California, Colorado, Indiana, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial