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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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment Emergent Adverse Events (TEAE's)

Side effects data

From 2022 Phase 1 & 2 trial • 33 Patients • NCT02760485
47%
Fatigue
34%
Constipation
34%
Diarrhoea
31%
Decreased appetite
28%
Nausea
28%
Anaemia
25%
Dizziness
25%
Dyspnoea
22%
Contusion
22%
Cough
19%
Pyrexia
16%
Dehydration
16%
Muscular weakness
13%
Platelet count decreased
13%
Hypertension
13%
Asthenia
13%
Headache
13%
Oedema peripheral
13%
Vision blurred
13%
Epistaxis
13%
Rash
13%
Stomatitis
13%
Fall
13%
Hypotension
9%
Aspartate aminotransferase increased
9%
Confusional state
9%
Pruritus
9%
Sepsis
9%
Mental status changes
9%
Abdominal pain upper
9%
Neutropenia
9%
Thrombocytopenia
9%
Urinary tract infection
9%
Muscle spasms
9%
Pneumonia
9%
Dry mouth
9%
Dyspepsia
9%
Hypokalaemia
9%
Vomiting
6%
Alanine aminotransferase increased
6%
Anal incontinence
6%
Erythema
6%
Oropharyngeal pain
6%
Pain
6%
Rash maculo-papular
6%
Pulmonary embolism
6%
Abdominal discomfort
6%
Abdominal pain
6%
Blood cholesterol increased
6%
Chronic kidney disease
6%
Haematoma
6%
Neutrophil count decreased
6%
Upper respiratory tract infection
6%
Dizziness postural
6%
Increased tendency to bruise
6%
Febrile neutropenia
6%
Chills
6%
Insomnia
6%
Back pain
6%
Pneumonia aspiration
6%
Staphylococcal sepsis
6%
Blood creatinine increased
6%
Hypoglycaemia
6%
Hypomagnesaemia
6%
Pain in extremity
3%
Device related infection
3%
Impetigo
3%
Malignant neoplasm progression
3%
Palpitations
3%
Tongue eruption
3%
Bacteraemia
3%
Cytomegalovirus viraemia
3%
Respiratory failure
3%
Lymphocyte count decreased
3%
Blood alkaline phosphatase increased
3%
Breast cellulitis
3%
Cardio-respiratory arrest
3%
Postoperative respiratory failure
3%
Vestibular disorder
3%
Cheilitis
3%
Joint swelling
3%
Wound infection pseudomonas
3%
Failure to thrive
3%
Hypoxia
3%
Influenza
3%
Multiple organ dysfunction syndrome
3%
Pollakiuria
3%
Skin infection
3%
Hypercalcaemia
3%
Lung infiltration
3%
Disorientation
3%
Injection site bruising
3%
Muscle tightness
3%
Peripheral sensory neuropathy
3%
Tinnitus
3%
Tremor
3%
Atrial fibrillation
3%
Gastric ulcer
3%
Gastroenteritis
3%
Haematoma muscle
3%
Pleural effusion
3%
Transaminases increased
3%
Upper gastrointestinal haemorrhage
3%
Eye irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total
Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD
Phases 1 and 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD

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

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.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
373 Previous Clinical Trials
55,761 Total Patients Enrolled
Lance Leopold, MDStudy DirectorIncyte Corporation
14 Previous Clinical Trials
1,457 Total Patients Enrolled

Media Library

itacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04640025 — Phase 2
~6 spots leftby Jun 2026
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