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Janus Kinase (JAK) Inhibitor

Ruxolitinib for Graft-versus-Host Disease

Phase 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to lplv (approximately 5 years)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing ruxolitinib, a medication that reduces inflammation, in patients with chronic graft-versus-host disease who do not respond to steroids. Ruxolitinib works by calming down the overactive immune system. The goal is to see if it is more effective than the best available treatments.

Eligible Conditions
  • Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to lplv (approximately 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to lplv (approximately 5 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
Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit
Secondary study objectives
AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
BOR During Cross-over Treatment With Ruxolitinib
+20 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
33%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Haematoma
7%
Dyslipidaemia
7%
Pain in extremity
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Paraesthesia
3%
Bronchitis
3%
Cystitis
3%
Blood creatine phosphokinase increased
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Acute pulmonary oedema
2%
Peripheral artery thrombosis
2%
Vertigo
2%
Night sweats
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Ureterolithiasis
2%
Localised infection
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RuxolitinibExperimental Treatment1 Intervention
Ruxolitinib for the treatment period and extension period.
Group II: Best Available TherapyActive Control9 Interventions
Best available therapy for the treatment period and extension period, with optional crossover to ruxolitinib after Cycle 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1170

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
391 Previous Clinical Trials
63,505 Total Patients Enrolled
Fitzroy Dawkins, MDStudy DirectorIncyte Corporation
6 Previous Clinical Trials
238 Total Patients Enrolled
Rodica Morariu-ZamfirStudy DirectorIncyte Corporation
~40 spots leftby Nov 2025
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