Itacitinib

Generic Name: Itacitinib

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₃F_₄N_₉O

CAS Number: 1334298-90-6

Unique Ingredient Identifier: 19J3781LPM

Background: Itacitinib has been used in trials studying the treatment of Melanoma, Carcinoma, Metastatic Cancer, Endometrial Cancer, and B-cell Malignancies, among others.

Clinical Trials

Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients

Phase 1

Recruiting

Conditions: T-cell Prolymphocytic Leukemia
Myelomonocytic Leukemia, Chronic
CML
Plasma Cell Leukemia
Leukemia, Acute
Myelodysplastic Syndromes
Multiple Myeloma
Myeloproliferative Disorders

Interventions: Drug: Itacitinib

First Posted Date: 2023-04-21

Last Posted Date: 2024-03-08

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 32

Registration Number: NCT05823571

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy

Phase 2

Recruiting

Conditions: Diffuse Large B Cell Lymphoma

Interventions: Drug: Itacitinib
Biological: Chimeric antigen receptor (CAR) T-cell therapy

First Posted Date: 2023-03-07

Last Posted Date: 2025-03-13

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 27

Registration Number: NCT05757219

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors

Phase 2

Withdrawn

Conditions: Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm

Interventions: Drug: Itacitinib
Drug: Corticosteroid
Procedure: Endoscopic Procedure
Procedure: Skin biopsy
Procedure: Biospecimen Collection

First Posted Date: 2022-12-21

Last Posted Date: 2024-10-31

Lead Sponsor: Douglas Johnson

Target Recruit Count: 25

Registration Number: NCT05660421

Locations: 🇺🇸
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Expanded Access Use of Itacitinib to Treat a Single Patient With STAT1 Gain of Function (GOF) Disease

Conditions: STAT1 Gain-of-Function Disease

First Posted Date: 2022-09-30

Last Posted Date: 2024-06-06

Lead Sponsor: Incyte Corporation

Registration Number: NCT05561985

Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants

Phase 2

Recruiting

Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Primary Myelofibrosis
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Secondary Myelofibrosis

Interventions: Drug: Cyclophosphamide
Drug: Itacitinib
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Quality-of-Life Assessment
Drug: Tacrolimus

First Posted Date: 2022-05-06

Last Posted Date: 2024-08-05

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 50

Registration Number: NCT05364762

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB

Phase 2

Conditions: Adults Patients Having Non Severe HLH

Interventions: Drug: Itacitinib

First Posted Date: 2021-09-30

Last Posted Date: 2022-08-23

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 63

Registration Number: NCT05063110

Locations: 🇫🇷
Hôpital Avicenne, Bobigny, France

Itacitinib for the Prevention of Graft Versus Host Disease

Phase 1

Active, not recruiting

Conditions: Hematologic and Lymphocytic Disorder

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Itacitinib
Drug: Tacrolimus
Drug: Thiotepa

First Posted Date: 2021-04-26

Last Posted Date: 2025-04-08

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 31

Registration Number: NCT04859946

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis

Phase 2

Recruiting

Conditions: Systemic Sclerosis

Interventions: Drug: Itacitinib
Drug: Placebo

First Posted Date: 2021-03-10

Last Posted Date: 2024-05-31

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 74

Registration Number: NCT04789850

Locations: 🇫🇷
CH de Cornouaille, Quimper, France
🇫🇷
CH Amiens, Amiens, France
🇫🇷
CHU Angers, Angers, France

and more 39 locations

A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

Phase 2

Active, not recruiting

Conditions: Myelofibrosis
Postlung Transplant (Bronchiolitis Obliterans)
Chronic Graft Versus Host Disease

Interventions: Drug: itacitinib

First Posted Date: 2020-11-23

Last Posted Date: 2025-02-27

Lead Sponsor: Incyte Corporation

Target Recruit Count: 18

Registration Number: NCT04640025

Locations: 🇩🇪
University Hospital Mannheim, Mannheim, Germany
🇮🇹
Azienda Policlinico Vittorio Emanuele, Catania, Italy
🇮🇹
Aou San Giovanni Di Dio E Ruggi, Salerno, Italy

and more 18 locations

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)

Phase 2

Completed

Conditions: Polycythemia Vera
Thrombocythemia
Myelofibrosis

Interventions: Drug: itacitinib

First Posted Date: 2020-11-16

Last Posted Date: 2023-08-30

Lead Sponsor: Incyte Corporation

Target Recruit Count: 4

Registration Number: NCT04629508

Locations: 🇮🇹
Treviso Hospital, Treviso, Italy
🇺🇸
Vanderbilt University, Nashville, Tennessee, United States
🇮🇹
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milan, Italy

and more 18 locations

Drug Development Updates

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