Itacitinib Clinical Trials (2026): 50 Studies for Hematologic and Lymphocytic Disorder & Solid Tumors
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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50 Itacitinib clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 43 indications (including Hematologic and Lymphocytic Disorder & Solid Tumors) and 2,966 total planned enrollment. 1 Phase 3 Itacitinib trial and 25 Phase 2 are listed. 3 Itacitinib clinical trials are actively recruiting at 4 U.S. sites across 4 states. Most recent activity: NCT05823571 (Mar 2030).
Where to Participate: All Itacitinib Trial Sites in the U.S. (4 sites across 4 states)
Every actively recruiting Itacitinibtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| FL | Moffitt Cancer Center | Tampa33617 | NCT05757219 | Map |
| NY | University of Rochester Wilmot Cancer Institute | Rochester14609 | NCT04061421 | Map |
| OR | Oregon Health Sciences University | Portland97239 | NCT04061421 | Map |
| TN | Vanderbilt-Ingram Cancer Center | Nashville37232 | NCT04061421 | Map |
Itacitinib clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | unknown | available | Total |
|---|---|---|---|---|---|---|---|---|
| P1 | 1 | 7 | 5 | 13 | ||||
| P1/P2 | 1 | 1 | 4 | 3 | 9 | |||
| P2 | 2 | 4 | 9 | 5 | 4 | 1 | 25 | |
| P2/P3 | 1 | 1 | ||||||
| P3 | 1 | 1 | ||||||
| N/A | 1 | 1 |
Recruiting Itacitinib clinical trials (3)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT04061421 | ABNL-MARROActive Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO) | P1/P2 | MDS/MPN | 94 | Nov 2021 |
| NCT05757219 | Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy | P2 | Diffuse Large B Cell Lymphoma | 27 | May 2023 |
| NCT04789850 | SCLERITASafety and Efficacy of Itacitinib in Adults With Systemic Sclerosis | P2 | Systemic Sclerosis | 74 | Feb 2023 |
Itacitinib clinical trials by indication
Myelofibrosis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04640025 | — | P2 | active not recruiting | A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib |
| NCT04629508 | LIMBER-213 | P2 | completed | To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) |
Chronic Graft-versus-host-disease (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04200365 | — | P2 | terminated | A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) |
| NCT04446182 | FLIGHT | P2 | terminated | Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD |
B-Cell Malignancies (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04509700 | INCB050465 | P2 | active not recruiting | Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) |
| NCT02018861 | CITADEL-101 | P1/P2 | completed | A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101) |
Acute Graft-versus-host Disease (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03721965 | — | P1/P2 | terminated | Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects |
| NCT03497273 | — | P1 | completed | Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects |
MPN (Myeloproliferative Neoplasms) (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01633372 | — | P2 | completed | An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis |
| NCT03144687 | — | P2 | completed | A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis |
Graft-versus-host Disease (GVHD) (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03139604 | GRAVITAS-301 | P3 | completed | GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease |
| NCT02614612 | — | P1 | completed | Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD |
Solid Tumors (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02559492 | — | P1 | terminated | Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors |
| NCT01858883 | INCB039110 | P1/P2 | completed | Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors |
Leukemia, Acute (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05823571 | — | P1 | active not recruiting | Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients |
Diffuse Large B Cell Lymphoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05757219 | — | P2 | recruiting | Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy |
Hematopoietic and Lymphoid Cell Neoplasm (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05660421 | — | P2 | withdrawn | Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors |
Systemic Sclerosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04789850 | SCLERITA | P2 | recruiting | Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis |
Acute Lymphoblastic Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05364762 | — | P2 | active not recruiting | Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants |
Adults Patients Having Non Severe HLH (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05063110 | HLH-JAK | P2 | completed | Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB |
Hematologic and Lymphocytic Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04859946 | — | P2 | active not recruiting | Itacitinib for the Prevention of Graft Versus Host Disease |
MDS/MPN (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04061421 | ABNL-MARRO | P1/P2 | recruiting | Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO) |
Bronchiolitis Obliterans (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04239989 | — | P1 | terminated | Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant |
Acute Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04339101 | — | P2 | completed | Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation |
Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04591431 | ROME | P2 | unknown | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy |
Allogeneic Stem Cell Transplant Recipient (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04127721 | — | P2 | withdrawn | Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation |
GVHD,Acute (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04220632 | — | P1/P2 | terminated | A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease |
Cytokine Release Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04071366 | — | P2 | completed | A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy |
Bronchiolitis Obliterans Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03978637 | — | P1/P2 | terminated | Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation |
Steroid Refractory GVHD (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04070781 | GVHD | P1 | terminated | Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease |
Recurrent T-Cell Prolymphocytic Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03989466 | — | P1 | completed | Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia |
Metastatic Leiomyosarcoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03670069 | — | P1 | terminated | Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas |
Acute Myelogenous Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03755414 | — | P1 | completed | Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation |
Low Risk Acute Graft-versus-host Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03846479 | — | P2 | completed | Itacitinib for Low Risk GVHD |
Classical Hodgkin Lymphoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03697408 | — | P1/P2 | active not recruiting | Itacitinib + Everolimus in Hodgkin Lymphoma |
Chronic Graft-versus-host Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03584516 | GRAVITAS-309 | P2/P3 | terminated | GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease |
Advanced Hepatocellular Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04358185 | JAKaL | P1 | completed | Itacitinib in Advanced Hepatocellular Carcinoma |
Moderate to Severe Ulcerative Colitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03627052 | — | P2 | withdrawn | A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis |
Non Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03425006 | INCB039110 | P2 | terminated | Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer |
Hematologic Malignancies (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03320642 | GRAVITAS-119 | P1 | terminated | GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease |
Lymphoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02760485 | INCB039110 | P1/P2 | completed | A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02917993 | — | P1/P2 | completed | An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer |
Colorectal Cancer (CRC) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02646748 | INCB039110 | P1 | completed | Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors |
Refractory Hodgkin Lymphoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02456675 | INCB039110 | P2 | terminated | INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma |
Solid Tumors and Hematologic Malignancy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02355431 | EGFR | P2 | withdrawn | Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations |
NSCLC (Non-small Cell Lung Carcinoma) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02257619 | — | P2 | terminated | Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer |
B-cell Malignancies (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01905813 | — | P1 | completed | Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies |
Plaque Psoriasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01634087 | — | P2 | completed | A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis |
Rheumatoid Arthritis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01626573 | — | P2 | completed | A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis |
STAT1 Gain-of-Function Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05561985 | GOF | N/A | available | Expanded Access Use of Itacitinib to Treat a Single Patient With STAT1 Gain of Function (GOF) Disease |
Itacitinib pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| GRAVITAS-301 | NCT03139604 | P3 | completed | Graft-versus-host Disease (GVHD) | 439 | PMID 34971577 |
| INCB050465 | NCT04509700 | P2 | active not recruiting | B-Cell Malignancies | 112 | — |
| SCLERITA | NCT04789850 | P2 | recruiting | Systemic Sclerosis | 74 | PMID 28478401 |
| HLH-JAK | NCT05063110 | P2 | completed | Adults Patients Having Non Severe HLH | 35 | PMID 22869151 |
| ROME | NCT04591431 | P2 | unknown | Breast Cancer | 400 | PMID 41963505 |
| LIMBER-213 | NCT04629508 | P2 | completed | Myelofibrosis | 4 | — |
| FLIGHT | NCT04446182 | P2 | terminated | Chronic Graft-versus-host-disease | 3 | — |
| INCB039110 | NCT03425006 | P2 | terminated | Non Small Cell Lung Cancer | 23 | — |
| INCB039110 | NCT02456675 | P2 | terminated | Refractory Hodgkin Lymphoma | 8 | — |
| EGFR | NCT02355431 | P2 | withdrawn | Solid Tumors and Hematologic Malignancy | 0 | — |
Terminated and withdrawn Itacitinib trials (18)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT04239989terminatedItacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant
- NCT05660421withdrawnItacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors
- NCT03670069terminatedItacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas
- NCT03584516terminatedGRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
- NCT03978637terminatedSafety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
- NCT04200365terminatedA Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)
- NCT04446182terminatedItacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD
- NCT03320642terminatedGRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
- NCT04070781terminatedItacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease
- NCT03425006terminatedPembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer
- NCT04220632terminatedA Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
- NCT04127721withdrawnItacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation
- NCT03721965terminatedSafety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
- NCT03627052withdrawnA Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
- NCT02559492terminatedItacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors
- NCT02456675terminatedINCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma
- NCT02257619terminatedStudy of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
- NCT02355431withdrawnItacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations
All Itacitinib trials (50)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT05823571 | Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients | P1 | active not recruiting | 32 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Jul 2023 | |
| NCT04061421 | ABNL-MARRO | Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO) | P1/P2 | recruiting | 94 | Michael Savona | Nov 2021 |
| NCT04509700 | INCB050465 | Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) | P2 | active not recruiting | 112 | Incyte Corporation | Aug 2020 |
| NCT03697408 | Itacitinib + Everolimus in Hodgkin Lymphoma | P1/P2 | active not recruiting | 23 | University of Pennsylvania | Feb 2019 | |
| NCT04859946 | Itacitinib for the Prevention of Graft Versus Host Disease | P2 | active not recruiting | 31 | M.D. Anderson Cancer Center | Jan 2022 | |
| NCT05364762 | Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants | P2 | active not recruiting | 20 | City of Hope Medical Center | Nov 2022 | |
| NCT05757219 | Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy | P2 | recruiting | 27 | H. Lee Moffitt Cancer Center and Research Institute | May 2023 | |
| NCT04640025 | A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib | P2 | active not recruiting | 18 | Incyte Corporation | Mar 2021 | |
| NCT04789850 | SCLERITA | Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis | P2 | recruiting | 74 | Assistance Publique - Hôpitaux de Paris | Feb 2023 |
| NCT01905813 | Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies | P1 | completed | 121 | Incyte Corporation | Jun 2013 | |
| NCT02917993 | An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer | P1/P2 | completed | 59 | Incyte Corporation | Dec 2016 | |
| NCT04239989 | Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant | P1 | terminated | 8 | M.D. Anderson Cancer Center | Oct 2021 | |
| NCT04339101 | Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation | P2 | completed | 59 | City of Hope Medical Center | Nov 2020 | |
| NCT05063110 | HLH-JAK | Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB | P2 | completed | 35 | Assistance Publique - Hôpitaux de Paris | May 2022 |
| NCT04591431 | ROME | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy | P2 | unknown | 400 | Fondazione per la Medicina Personalizzata | Oct 2020 |
| NCT05660421 | Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors | P2 | withdrawn | 0 | Douglas Johnson | Mar 2023 | |
| NCT03989466 | Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia | P1 | completed | 15 | M.D. Anderson Cancer Center | Jan 2020 | |
| NCT03755414 | Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation | P1 | completed | 55 | Washington University School of Medicine | Sep 2019 | |
| NCT03670069 | Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas | P1 | terminated | 27 | Fred Hutchinson Cancer Center | Sep 2019 | |
| NCT03584516 | GRAVITAS-309 | GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease | P2/P3 | terminated | 155 | Incyte Corporation | Jan 2019 |
| NCT03978637 | Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation | P1/P2 | terminated | 23 | Incyte Corporation | Feb 2020 | |
| NCT04200365 | A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) | P2 | terminated | 15 | SCRI Development Innovations, LLC | Jun 2020 | |
| NCT04629508 | LIMBER-213 | To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) | P2 | completed | 4 | Incyte Corporation | Jul 2021 |
| NCT04071366 | A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy | P2 | completed | 112 | Incyte Corporation | Feb 2020 | |
| NCT04358185 | JAKaL | Itacitinib in Advanced Hepatocellular Carcinoma | P1 | completed | 19 | Imperial College London | Dec 2018 |
| NCT04446182 | FLIGHT | Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD | P2 | terminated | 3 | University of Utah | Jan 2021 |
| NCT05561985 | GOF | Expanded Access Use of Itacitinib to Treat a Single Patient With STAT1 Gain of Function (GOF) Disease | — | available | 0 | Incyte Corporation | — |
| NCT02760485 | INCB039110 | A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma | P1/P2 | completed | 33 | Incyte Corporation | Dec 2016 |
| NCT03846479 | Itacitinib for Low Risk GVHD | P2 | completed | 70 | John Levine | Mar 2019 | |
| NCT03320642 | GRAVITAS-119 | GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease | P1 | terminated | 84 | Incyte Corporation | Feb 2018 |
| NCT04070781 | GVHD | Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease | P1 | terminated | 1 | Columbia University | Jan 2020 |
| NCT03425006 | INCB039110 | Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer | P2 | terminated | 23 | University of Pennsylvania | Jun 2018 |
| NCT01633372 | An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis | P2 | completed | 87 | Incyte Corporation | Jul 2012 | |
| NCT03144687 | A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis | P2 | completed | 23 | Incyte Corporation | Jan 2018 | |
| NCT02018861 | CITADEL-101 | A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101) | P1/P2 | completed | 88 | Incyte Corporation | Sep 2016 |
| NCT02646748 | INCB039110 | Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors | P1 | completed | 159 | Incyte Corporation | Jan 2016 |
| NCT04220632 | A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease | P1/P2 | terminated | 1 | Innovent Biologics (Suzhou) Co. Ltd. | Jun 2020 | |
| NCT04127721 | Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation | P2 | withdrawn | 0 | M.D. Anderson Cancer Center | Sep 2020 | |
| NCT03139604 | GRAVITAS-301 | GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease | P3 | completed | 439 | Incyte Corporation | Jul 2017 |
| NCT03721965 | Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects | P1/P2 | terminated | 2 | Incyte Corporation | Dec 2019 | |
| NCT03497273 | Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects | P1 | completed | 14 | Incyte Corporation | Mar 2018 | |
| NCT03627052 | A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | P2 | withdrawn | 0 | Incyte Corporation | Sep 2018 | |
| NCT02559492 | Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors | P1 | terminated | 142 | Incyte Corporation | Nov 2015 | |
| NCT02614612 | Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD | P1 | completed | 31 | Incyte Corporation | Dec 2015 | |
| NCT02456675 | INCB039110 | INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma | P2 | terminated | 8 | Incyte Corporation | Jun 2015 |
| NCT02257619 | Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer | P2 | terminated | 9 | Incyte Corporation | Sep 2014 | |
| NCT01858883 | INCB039110 | Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors | P1/P2 | completed | 55 | Incyte Corporation | Jun 2013 |
| NCT02355431 | EGFR | Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations | P2 | withdrawn | 0 | Incyte Corporation | Dec 2014 |
| NCT01626573 | A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis | P2 | completed | 106 | Incyte Corporation | Mar 2012 | |
| NCT01634087 | A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis | P2 | completed | 50 | Incyte Corporation | Jun 2012 |
Itacitinib clinical trials: frequently asked questions
- How many Itacitinib clinical trials are there?
- 50 Itacitinib clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 3 are actively recruiting participants. 21 are marked completed.
- Are Itacitinib clinical trials recruiting in 2026?
- Yes — 3 Itacitinib trials are actively recruiting in 2026, with 4 U.S. sites across 4 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Itacitinib being studied for?
- Itacitinib is being studied for Hematologic and Lymphocytic Disorder, Solid Tumors, B-Cell Malignancies, Non Small Cell Lung Cancer, NSCLC (Non-small Cell Lung Carcinoma) and 90 more. The trials are grouped by indication on this page.
- What phase is Itacitinib in?
- Itacitinib clinical trials span 1 Phase 3, 25 Phase 2, 13 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Itacitinib clinical trials?
- The lead sponsor across the most Itacitinib trials is Incyte Corporation, with 17 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Itacitinibas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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Related pages on Hipa.ai: