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Rollover study offers continued itacitinib access for chronic disease patients

NCT ID NCT04640025

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study provides continued access to itacitinib for 18 patients who were already benefiting from the drug in earlier trials. Participants have myelofibrosis, chronic graft-versus-host disease, or bronchiolitis obliterans after lung transplant. They continue their same dose as long as they tolerate it and see benefit. The main goal is to track side effects over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
itacitinib (a drug taken orally as a tablet)
What this could lead to
If successful, this study could show that long-term itacitinib is safe and helps control these chronic conditions.
What could go wrong
This is a small, early-phase rollover study that was terminated early, so results may be limited. Itacitinib may cause side effects and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Mar 2021

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-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.. * 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.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans bronchiolitis obliterans syndrome chronic graft versus host disease myelofibrosis primary myelofibrosis transplant-related bronchiolitis obliterans

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic graft versus host disease Myelofibrosis Postlung transplant (bronchiolitis obliterans)

Contacts and locations

Locations

  • Anschutz Cancer Pavilion-University of Colorado

    Aurora, Colorado, 80045, United States

  • Aou San Giovanni Di Dio E Ruggi

    Salerno, 84131, Italy

  • Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

    Reggio Calabria, 89100, Italy

  • Azienda Policlinico Vittorio Emanuele

    Catania, 95123, Italy

  • City of Hope National Medical Center

    Duarte, California, 31010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120, Israel

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18012, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 04020, Austria

  • Parkview Cancer Institute

    Fort Wayne, Indiana, 46845, United States

  • Providence Health

    Vancouver, British Columbia, V6Z 2A5, Canada

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Temple University Department of Thoracic Medicine and Surgery

    Philadelphia, Pennsylvania, 19140, United States

  • Texas Oncology San Antonio

    San Antonio, Texas, 78240, United States

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000, Belgium

  • Universitatsklinikum Halle (Saale)

    Halle, D06120, Germany

  • University Hospital Mannheim

    Mannheim, 68167, Germany

  • University Hospital of West Attica - Attikon

    Chaïdári, 12462, Greece

  • University Medical Centre Hamburg-Eppendorf Centre of Oncology

    Hamburg, 20251, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.