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Experimental drug itacitinib tested for lung transplant complication – study stopped early

NCT ID NCT03978637

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested the drug itacitinib in 23 people who developed bronchiolitis obliterans syndrome (a type of chronic lung rejection) after a double lung transplant. The goal was to see if itacitinib could safely improve lung function. However, the study was terminated early, so the full results are not available.

What this could mean

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

Active substance
itacitinib
What this could lead to
If it works, this could point toward a treatment to slow lung function decline in transplant patients with bronchiolitis obliterans syndrome.
What could go wrong
This was a very early, small study (23 people) that was terminated, so results are limited. Itacitinib may not improve lung function and could cause side effects like infections.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

23 people

The number who actually took part.

Started

Feb 2020

Finished

Oct 2023

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: * Double lung transplantation ≥ 1 year before informed consent. Confirmed BOS progression to Grade 1, 2, or 3 diagnosed within 1 year of screening \*Confirmed BOS progression to Grade 1, 2, or 3 diagnosed within 2 years of screening AND: * A ≥ 200 mL decrease in FEV1 in the previous 12 months OR \*A ≥ 50 mL decrease in FEV1 in the last 2 measurements. • Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * History of a single lung transplant * FEV1 decline attributable to cause(s) other than BOS. * Participants who have had any significant change (eg, addition of new agents) in an immunosuppressive regimen in the 4 weeks before screening. * Untreated and/or symptomatic gastroesophageal reflux disease. * Significant infectious comorbidities including invasive fungal disease, B. Cepacia, non TB mycobacteria, or TB. * Receipt of JAK inhibitor therapy after lung transplant for any indication. Treatment with a JAK inhibitor before lung transplant is permitted. * Laboratory values at screening outside the protocol-defined ranges. * Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (ie, positive HBsAg). * Known HIV infection. * History of active malignancy within 3 years of screening. * Women who are pregnant or breastfeeding. * Treatment with an investigational agent, procedure, or device within 30 days of enrollment, or within 5 half-lives of the investigational product, whichever is longer.

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Conditions

The condition(s) this trial relates to.

bronchiolitis obliterans syndrome

As listed by the trial registrant

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

Bronchiolitis obliterans syndrome

Contacts and locations

Locations

  • Brigham and Women'S Faulkner Hospitals Inc

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Health System

    Durham, North Carolina, 27710, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Temple University Department of Thoracic Medicine and Surgery

    Philadelphia, Pennsylvania, 19140, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000, Belgium

  • University Health Network Toronto General Hospital

    Toronto, Ontario, M5G 2N2, Canada

  • University of California, Los Angeles - David Geffen School of Medicine

    Los Angeles, California, 90095, United States

More trials for these conditions

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