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JAK Inhibitor
Itacitinib for Graft-versus-Host Disease
Phase 2 & 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial will test a new drug to see if it's effective and safe for treating moderate or severe chronic graft-versus-host disease.
Eligible Conditions
- Chronic Graft-versus-Host Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 : Dose Determination: Number of dose-limiting toxicities
Part 1 : Dose Expansion: Number of dose-limiting toxicities
Part 2 : Response rate
Secondary outcome measures
Part 1, 1 expansion, and Part 2: Cmax of itacitinib when administered in combination with corticosteroids
Part 1, 1 expansion, and Part 2: Cmin of itacitinib when administered in combination with corticosteroids
Other outcome measures
Part 1, 1 expansion, and Part 2: Duration of response
Part 1, 1 expansion, and Part 2: Nonrelapse mortality
Part 1, 1 expansion, and Part 2: Overall survival
+3 moreSide effects data
From 2020 Phase 3 trial • 439 Patients • NCT0313960434%
Thrombocytopenia
29%
Anaemia
25%
Oedema peripheral
22%
Hyperglycaemia
21%
Hypertension
20%
Diarrhoea
19%
Hypokalaemia
18%
Platelet count decreased
18%
Nausea
17%
Neutropenia
16%
Cytomegalovirus viraemia
16%
Pyrexia
15%
Cough
14%
Alanine aminotransferase increased
14%
Hypertriglyceridaemia
13%
Dyspnoea
13%
Fatigue
13%
Hypomagnesaemia
13%
Tremor
12%
Cytomegalovirus infection reactivation
12%
Abdominal pain
12%
Blood creatinine increased
12%
Constipation
11%
Decreased appetite
11%
Arthralgia
11%
Aspartate aminotransferase increased
11%
Dizziness
11%
Muscular weakness
11%
Vomiting
10%
Insomnia
9%
Fall
9%
Headache
8%
Upper respiratory tract infection
8%
Dry eye
8%
Dysuria
8%
Anxiety
8%
Back pain
7%
Blood cholesterol increased
7%
Hypotension
7%
Hyponatraemia
7%
Hypophosphataemia
7%
Pain in extremity
7%
Urinary tract infection
7%
Hypocalcaemia
7%
Neutrophil count decreased
7%
Dry mouth
7%
Cytomegalovirus infection
6%
Hypoalbuminaemia
6%
Pruritus
6%
White blood cell count decreased
6%
Asthenia
6%
Blood alkaline phosphatase increased
5%
Acute kidney injury
5%
Pneumonia
5%
Gamma-glutamyltransferase increased
5%
Oral candidiasis
5%
Rash
5%
Weight decreased
5%
Pancytopenia
5%
Dysgeusia
5%
Dyspepsia
5%
Epstein-Barr virus infection reactivation
4%
Hyperkalaemia
4%
Epistaxis
3%
Febrile neutropenia
3%
Oedema
3%
Rhinorrhoea
3%
Dry skin
3%
Leukopenia
3%
Nasopharyngitis
3%
Neuropathy peripheral
3%
Vision blurred
2%
Cystitis haemorrhagic
2%
Syncope
2%
Sepsis
1%
Graft versus host disease in gastrointestinal tract
1%
Thrombotic microangiopathy
1%
Viral haemorrhagic cystitis
1%
Bronchopulmonary aspergillosis
1%
Adenovirus infection
1%
Escherichia sepsis
1%
Failure to thrive
1%
Malignant neoplasm progression
1%
Ophthalmic herpes zoster
1%
Oral herpes
1%
Pulmonary embolism
1%
Septic shock
1%
Pneumonia influenzal
1%
Myopathy
1%
Steroid diabetes
1%
Pseudomonal sepsis
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus Corticosteroids
Itacitinib Plus Corticosteroids
Total
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 1 : Dose expansion of itacitinibExperimental Treatment4 Interventions
itacitinib administered in combination with corticosteroids or corticosteroids alone.
Group II: Part 1 : Dose determination of itacitinibExperimental Treatment3 Interventions
itacitinib administered in combination with corticosteroids.
Group III: Part 2 : itacitinib recommended dose from part 1Placebo Group3 Interventions
itacitinib or placebo administered in combination with corticosteroids
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~910
Methylprednisolone
2015
Completed Phase 4
~2280
Placebo
1995
Completed Phase 3
~2670
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,010 Total Patients Enrolled
Rodica Morariu-Zamfir, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
570 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken a medication called Janus kinase (JAK) inhibitor for a condition called acute GVHD. If you have taken this medication, you can still participate if you have stopped taking it for at least 8 weeks and your condition has improved.You have received any other type of treatment for chronic graft-versus-host disease (cGVHD), including a treatment called extracorporeal photopheresis (ECP).You are willing to avoid pregnancy or fathering children based on protocol-defined criteria.You have a score of 60% or more on the Karnofsky Performance Status.You have chronic graft-versus-host disease (cGVHD) that developed after receiving a donor lymphocyte infusion (DLI) that was not part of your scheduled treatment plan for cancer recurrence.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 : itacitinib recommended dose from part 1
- Group 2: Part 1 : Dose expansion of itacitinib
- Group 3: Part 1 : Dose determination of itacitinib
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other examples of Itacitinib being tested in a medical setting?
"As of now, 436 different clinical trials are being conducted to study the efficacy of Itacitinib. 117 of those trials are currently in Phase 3. The majority of research locations for Itacitinib are based in Duarte, California; however, there are a total of 17265 locations running trials for this medication."
Answered by AI
What is the conventional use for Itacitinib?
"Itacitinib is most often used to treat ulcerative colitis, but it has also been used to fight off varicella-zoster virus acute retinal necrosis, tuberculous meningitis, and subarachnoid block."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
65+
What site did they apply to?
St David'S South Austin Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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