ITACITINIB ( DrugBank: Itacitinib )


4 diseases
IDDisease name (Link within this page)Number of trials
46Malignant rheumatoid arthritis1
51Scleroderma2
97Ulcerative colitis3
228Bronchiolitis obliterans3

46. Malignant rheumatoid arthritis


Clinical trials : 4,356 Drugs : 2,567 - (DrugBank : 415) / Drug target genes : 192 - Drug target pathways : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01626573
(ClinicalTrials.gov)
March 20123/5/2012A 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 ArthritisA Double- Blind, Placebo Controlled 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 ArthritisRheumatoid ArthritisDrug: Itacitinib;Drug: Itacitinib PlaceboIncyte CorporationNULLCompleted18 Years75 YearsAll106Phase 2United States;Puerto Rico

51. Scleroderma


Clinical trials : 525 Drugs : 565 - (DrugBank : 148) / Drug target genes : 114 - Drug target pathways : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04789850
(ClinicalTrials.gov)
February 2, 202310/2/2021Safety and Efficacy of Itacitinib in Adults With Systemic SclerosisSafety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled TrialSystemic SclerosisDrug: Itacitinib;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll74Phase 2France
2EUCTR2019-003430-16-FR
(EUCTR)
28/07/202002/06/2020Safety and efficacy of itacitinib in adults with systemic sclerosisSafety and efficacy of itacitinib in adults with systemic sclerosis: a phase II, randomized, controlled trial - SCLERITA - SCLERITA Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Itacitinib
Product Code: INCB039110
INN or Proposed INN: ITACITINIB
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
74Phase 2France

97. Ulcerative colitis


Clinical trials : 2,630 Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004491-35-RO
(EUCTR)
30/01/202018/03/2022A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative ColitisA Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Itacitinib
Product Code: INCB039110
INN or Proposed INN: ITACITINIB ADIPATE
Other descriptive name: ITACITINIB ADIPATE
Incyte CorporationNULLNot RecruitingFemale: yes
Male: yes
206Phase 2United States;Czechia;Poland;Romania;Germany
2EUCTR2018-004491-35-PL
(EUCTR)
19/08/201903/07/2019A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative ColitisA Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Itacitinib
Product Code: INCB039110
INN or Proposed INN: ITACITINIB ADIPATE
Other descriptive name: ITACITINIB ADIPATE
Incyte CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
206 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Czech Republic;Poland;Romania;Germany
3NCT03627052
(ClinicalTrials.gov)
September 20, 20188/8/2018A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative ColitisA Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative ColitisModerate to Severe Ulcerative ColitisDrug: Itacitinib;Drug: PlaceboIncyte CorporationNULLWithdrawn18 Years74 YearsAll0Phase 2United States

228. Bronchiolitis obliterans


Clinical trials : 97 Drugs : 118 - (DrugBank : 32) / Drug target genes : 33 - Drug target pathways : 156
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04239989
(ClinicalTrials.gov)
April 8, 202130/12/2019Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell TransplantA Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplant (HCT)Bronchiolitis ObliteransDrug: Itacitinib;Drug: Itacitinib AdipateM.D. Anderson Cancer CenterNULLRecruiting18 Years75 YearsAll15Phase 1United States
2NCT04640025
(ClinicalTrials.gov)
March 10, 202118/11/2020A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of ItacitinibA Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)Myelofibrosis;Postlung Transplant (Bronchiolitis Obliterans);Chronic Graft Versus Host DiseaseDrug: itacitinibIncyte CorporationNULLRecruiting18 YearsN/AAll100Phase 2United States;Austria;Belgium;Canada;Germany;Greece;Israel;Italy;Spain
3NCT03978637
(ClinicalTrials.gov)
February 4, 20205/6/2019Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung TransplantationAn Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung TransplantationBronchiolitis Obliterans SyndromeDrug: ItacitinibIncyte CorporationNULLActive, not recruiting18 YearsN/AAll23Phase 1/Phase 2United States;Belgium;Canada