What side effects are associated with this type of intervention?

Common treatments for Graft-versus-Host Disease (GVHD) include corticosteroids, calcineurin inhibitors (like cyclosporine and tacrolimus), and selective JAK1 inhibitors such as Itacitinib. Known side effects of corticosteroids include hyperglycemia, hypertension, and increased risk of infections. Calcineurin inhibitors can cause nephrotoxicity, hypertension, and neurotoxicity. Selective JAK1 inhibitors like Itacitinib may cause side effects such as diarrhea, liver enzyme elevation, and bone marrow suppression. It is important to monitor patients closely for these adverse effects during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Graft-versus-Host Disease (GVHD), including ruxolitinib, a JAK1/JAK2 inhibitor, which is similar to Itacitinib in its mechanism of action. Ruxolitinib was approved for steroid-refractory acute GVHD based on its ability to inhibit the JAK-STAT pathway, reducing inflammation and immune response. Other treatments include corticosteroids and immunosuppressive agents like cyclosporine and tacrolimus. These treatments aim to modulate the immune system to prevent or mitigate the effects of GVHD.

What other types of research exist?

Promising novel alternatives to Itacitinib for Graft-versus-Host Disease (GvHD) patients include Ruxolitinib, a JAK1/2 inhibitor, which has shown efficacy in treating steroid-refractory acute GvHD. Additionally, other emerging treatments such as Belumosudil, a ROCK2 inhibitor, and Abatacept, a CTLA-4 Ig fusion protein, are being explored for their potential benefits in GvHD management.

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Janus Kinase (JAK) Inhibitor

Continued Itacitinib Treatment for Myelofibrosis

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Able to access itacitinib therapy commercially

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial provides the medication itacitinib to participants from previous studies who may benefit from continued treatment. Itacitinib helps reduce inflammation by blocking specific proteins that cause it.

Who is the study for?

This trial is for patients already taking itacitinib in other Incyte-sponsored studies, who are benefiting and tolerating the treatment well. They must understand and agree to study procedures, avoid pregnancy or fathering children, and not have any illness that could risk their safety or study compliance.

What is being tested?

The trial provides ongoing access to itacitinib for participants from previous related studies. It's an open-label study where all involved know they're receiving itacitinib at doses and schedules set by earlier trials as long as benefits continue and side effects remain manageable.

What are the potential side effects?

While specific side effects aren't listed here, continued use of itacitinib may include previously encountered adverse reactions such as immune system effects, liver issues, blood count changes or infections. Tolerance is assessed based on past experiences in the parent protocol.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can get itacitinib through a pharmacy or my doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment Emergent Adverse Events (TEAE's)

Side effects data

From 2023 Phase 2 trial • 4 Patients • NCT04629508

50%

Nephropathy toxic

50%

Hepatotoxicity

25%

Sinus bradycardia

25%

Mouth haemorrhage

25%

Insomnia

25%

Leukocytosis

25%

Thrombocytopenia

25%

Vomiting

25%

Intra-abdominal haematoma

25%

Acute myocardial infarction

25%

Interstitial lung disease

25%

Urinary tract infection

25%

Asthenia

25%

Blood bilirubin increased

25%

Blood creatinine increased

25%

Cardiac failure

25%

Atrial fibrillation

25%

Arthralgia

25%

Candida infection

25%

Fatigue

25%

Nausea

25%

Shock haemorrhagic

25%

Syncope

25%

Cytokine storm

25%

Diarrhoea

25%

Enterocolitis infectious

25%

Sepsis

25%

Hypoalbuminaemia

25%

Failure to thrive

25%

Anaemia

100%

80%

60%

40%

20%

Study treatment Arm

Total

Itacitinib 300 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: itacitinibExperimental Treatment1 Intervention

Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

itacitinib

2016

Completed Phase 2

~340

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Graft-versus-Host Disease (GVHD) include corticosteroids, calcineurin inhibitors (like cyclosporine and tacrolimus), and selective JAK1 inhibitors such as Itacitinib. Corticosteroids work by broadly suppressing the immune response, reducing inflammation and immune cell activity. Calcineurin inhibitors block T-cell activation by inhibiting the production of interleukin-2, a key cytokine in the immune response. Selective JAK1 inhibitors, like Itacitinib, specifically target the Janus kinase 1 (JAK1) pathway, which is involved in the signaling of several cytokines that drive the immune response in GVHD. By selectively inhibiting JAK1, these drugs can reduce the immune-mediated damage to tissues while potentially causing fewer side effects compared to broader immunosuppressants. Understanding these mechanisms is crucial for GVHD patients as it helps in selecting the most appropriate treatment that balances efficacy with the risk of adverse effects.