 |
24 Diseases |  |
21 Trials |
|
21 Trials |  |
500 News |  |
| «123456789» |
- | itacitinib (INCB039110) / Incyte
Journal, PD(L)-1 Biomarker, IO biomarker: JAK inhibition in a patient with a STAT1 gain-of-function variant reveals STAT1 dysregulation as a common feature of aplastic anemia. (Pubmed Central) - May 29, 2022
P=N/A
These findings raise the possibility that STAT1 hyperactivition defines a subset of idiopathic aplastic anemia patients for whom JAK inhibition may be an efficacious therapy.
- | itacitinib (INCB039110) / Incyte, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment change, Metastases: Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 27, 2022
P2, N=31, Terminated, Sponsor: University of Pennsylvania
These findings raise the possibility that STAT1 hyperactivition defines a subset of idiopathic aplastic anemia patients for whom JAK inhibition may be an efficacious therapy. N=23 --> 31
- Olumiant (baricitinib) / Incyte, Eli Lilly, itacitinib (INCB039110) / Incyte
NANOPARTICLES SPECIFIC FOR SLAN+ MONOCYTES AS POTENTIAL THERAPEUTIC TOOLS IN SLE (ALEXANDRA TRIANTI) - May 25, 2022 - Abstract #AUTO2022AUTO_39;
Suggesting the potential role of these nanoparticles to target monocytes and possibly more specifically SlanMos for the treatment of SLE. Conclusions The uptake of PLGA-WGA nanoparticles by monocytes suggests the potential role of these nanoparticles to target these cells and possibly more specifically SlanMo for the treatment of SLE.
- | itacitinib (INCB039110) / Incyte
Journal: Zhuye Shigao Decoction Combined with Qingqi Huatan Pills in Alleviating the Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Phlegm-Heat Stagnating in the Lungs) via the IL-6-Mediated JAK1/STAT3 Signaling Pathway. (Pubmed Central) - May 17, 2022
However, after the addition of itacitinib (JAK1 inhibitor), the efficacy in each group was evidently impaired compared with herbs alone. Taken together, Zhuye Shigao Decoction combined with Qingqi Huatan Pills could improve the persistent airflow limitation and reduce lung inflammation and pathological changes of COPD possibly by regulating the expression of the IL-6-mediated JAK1/STAT3 pathway.
- Campath (alemtuzumab) / Sanofi, itacitinib (INCB039110) / Incyte
A PHASE IB TRIAL OF ITACITINIB COMBINED WITH ALEMTUZUMAB IN PATIENTS WITH T-CELL PROLYMPHOCYTIC LEUKEMIA (T-PLL) () - May 13, 2022 - Abstract #EHA2022EHA_1015;
Response rates with the combination were encouraging in frontline and salvage, with favorable OS. Further study of the combination without a 2-week window (of itacitinib alone) and with objective measurement of patient reported symptoms is planned.
- | itacitinib (INCB039110) / Incyte
New P2 trial, Post-transplantation: NCI-2022-03765: Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants (clinicaltrials.gov) - May 6, 2022
P2, N=50, Not yet recruiting, Sponsor: City of Hope Medical Center
- | itacitinib (INCB039110) / Incyte, Actemra IV (tocilizumab) / Roche, JW Pharma
Trial completion date, Trial primary completion date, Combination therapy: Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease (clinicaltrials.gov) - May 4, 2022
P1, N=24, Recruiting, Sponsor: Amer Assal
Further study of the combination without a 2-week window (of itacitinib alone) and with objective measurement of patient reported symptoms is planned. Trial completion date: May 2022 --> May 2024 | Trial primary completion date: May 2022 --> May 2024
- | parsaclisib (INCB50465) / Incyte
Trial completion date, Trial primary completion date: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov) - May 3, 2022
P2, N=31, Recruiting, Sponsor: Incyte Corporation
Trial completion date: May 2022 --> May 2024 | Trial primary completion date: May 2022 --> May 2024 Trial completion date: Aug 2025 --> Mar 2024 | Trial primary completion date: Aug 2025 --> Mar 2024
- |||||| Benlysta (belimumab) / GSK, itacitinib (INCB039110) / Incyte
Interview: Fantastic interview with @DiPersioLab of @wustlmed - Belimumab for chronic #GvHD prophylaxis - Itacitinib for the prophylaxis of GvHD and CRS in T-cell Replete haploidentical PBSCT - Potential CARs for T-ALL #Tandem22 @ASTCT @CIBMTR #ALLsm #BMTsm #LEUsm #Leukemia (Twitter) - Apr 23, 2022
- itacitinib (INCB039110) / Incyte
Trial completion date, Combination therapy: GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease (clinicaltrials.gov) - Apr 7, 2022
P1, N=84, Terminated, Sponsor: Incyte Corporation
Trial completion date: Aug 2025 --> Mar 2024 | Trial primary completion date: Aug 2025 --> Mar 2024 Trial completion date: Feb 2021 --> Feb 2022
- || itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte, epacadostat (INCB024360) / Incyte
Biomarker, Clinical, P1 data, Journal, Combination therapy, Tumor microenvironment: Exploring the safety, effect on the tumor microenvironment, and efficacy of itacitinib in combination with epacadostat or parsaclisib in advanced solid tumors: a phase I study. (Pubmed Central) - Apr 5, 2022
P1
Trial completion date: Feb 2021 --> Feb 2022 Adverse events with JAK1 inhibition combined with either IDO1 or PI3Kδ inhibition were manageable, but the combinations demonstrated limited clinical activity or enhancement of immune activation in the tumor microenvironment.
- ||| itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte
Biomarker, Trial completion, Tumor microenvironment, Metastases: Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors (clinicaltrials.gov) - Mar 31, 2022
P1, N=159, Completed, Sponsor: Incyte Corporation
Adverse events with JAK1 inhibition combined with either IDO1 or PI3Kδ inhibition were manageable, but the combinations demonstrated limited clinical activity or enhancement of immune activation in the tumor microenvironment. Active, not recruiting --> Completed
- ||| itacitinib (INCB039110) / Incyte
Enrollment change, Trial completion date, Trial primary completion date, Cytokine release syndrome: INCB 39110-211: A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy (clinicaltrials.gov) - Mar 23, 2022
P2, N=108, Recruiting, Sponsor: Incyte Corporation
Active, not recruiting --> Completed N=62 --> 108 | Trial completion date: Jul 2022 --> Sep 2023 | Trial primary completion date: Jul 2022 --> Sep 2023
- || Enbrel (etanercept) / Pfizer, Amgen
Clinical, Review: A Scoping Review on Use of Drugs Targeting the JAK/STAT Pathway in Psoriasis. (Pubmed Central) - Mar 15, 2022
Nine different drugs administered through various routes were identified (systemic: peficitinib, baricitinib, solcitinib, itacitinib, abrocitinib, deucravacitinib, and brepocitinib; topical: ruxolitinib; and both: tofacitinib)...Only tofacitinib and deucravacitinib have undergone phase III clinical trials, being the only ones tested with active comparators etanercept and apremilast, respectively...Psoriasis treatment is currently symptomatic and could potentially present a significant risk of toxicity. Therefore, the design of principal efficacy outcome measures considering the impact of the outcome on quality of life and a drug assessment methodology aimed at improving safety would probably strengthen the evidence and decision-making process.
- ||||| itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte, epacadostat (INCB024360) / Incyte
Biomarker, Clinical, Combination therapy, Tumor microenvironment: New #JITC article: Exploring the safety, effect on the tumor microenvironment, and efficacy of itacitinib in combination with epacadostat or parsaclisib in advanced solid tumors: a phase I study https://t.co/qsjRucFXsm @ANaingMD @jasonlukemd @jordanberlin5 (Twitter) - Mar 14, 2022
- | itacitinib (INCB039110) / Incyte
Preclinical, Journal: Itacitinib prevents xenogeneic GVHD in humanized mice. (Pubmed Central) - Mar 11, 2022
In addition, itacitinib-treated mice had higher frequencies of human regulatory T cells (Treg) on days 21 and 28 after transplantation. In summary, our data indicate that itacitinib decreases human T-cell engraftment, increases Treg frequencies and attenuates xGVHD in NSG mice transplanted with hPBMC.
- ||| itacitinib (INCB039110) / Incyte
Enrollment change, Trial completion date, Trial primary completion date: Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation (clinicaltrials.gov) - Mar 10, 2022
P1/2, N=23, Active, not recruiting, Sponsor: Incyte Corporation
In summary, our data indicate that itacitinib decreases human T-cell engraftment, increases Treg frequencies and attenuates xGVHD in NSG mice transplanted with hPBMC. N=79 --> 23 | Trial completion date: Jan 2024 --> Sep 2022 | Trial primary completion date: Dec 2022 --> Sep 2022
- || itacitinib (INCB039110) / Incyte
Trial primary completion date, Combination therapy, Metastases: An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Mar 10, 2022
P1/2, N=59, Active, not recruiting, Sponsor: Incyte Corporation
N=79 --> 23 | Trial completion date: Jan 2024 --> Sep 2022 | Trial primary completion date: Dec 2022 --> Sep 2022 Trial primary completion date: Jun 2022 --> Dec 2022
- ||| itacitinib (INCB039110) / Incyte
Trial primary completion date: GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - Mar 10, 2022
P2/3, N=157, Active, not recruiting, Sponsor: Incyte Corporation
Trial primary completion date: Jun 2022 --> Dec 2022 Trial primary completion date: Jan 2024 --> Apr 2024
- || itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date: A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (clinicaltrials.gov) - Mar 10, 2022
P2, N=100, Recruiting, Sponsor: Incyte Corporation
Trial primary completion date: Jan 2024 --> Apr 2024 Trial completion date: Dec 2024 --> Jun 2026 | Trial primary completion date: Dec 2024 --> Jun 2026
- | Journal: Unraveling the Molecular Mechanism of Recognition of Selected Next-Generation Antirheumatoid Arthritis Inhibitors by Janus Kinase 1. (Pubmed Central) - Mar 1, 2022
The JAK1/baricitinib complex shows the highest probability of the highest-ranked community, indicating a compact network of the JAK1/baricitinib complex, consistent with its higher stability than the rest of the four systems. Overall, our study may be crucial for the rational design of JAK1-selective inhibitors with better affinity.
- | itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date: 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 (clinicaltrials.gov) - Feb 21, 2022
P2a, N=59, Recruiting, Sponsor: City of Hope Medical Center
Overall, our study may be crucial for the rational design of JAK1-selective inhibitors with better affinity. Trial completion date: Mar 2022 --> Dec 2023 | Trial primary completion date: Mar 2022 --> Dec 2023
- || dezapelisib (INCB040093) / Incyte
Trial completion date, Trial primary completion date: Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - Feb 15, 2022
P1, N=121, Active, not recruiting, Sponsor: Incyte Corporation
Trial completion date: Mar 2022 --> Dec 2023 | Trial primary completion date: Mar 2022 --> Dec 2023 Trial completion date: Dec 2021 --> Feb 2023 | Trial primary completion date: Dec 2021 --> Feb 2023
- || itacitinib (INCB039110) / Incyte
Enrollment open, Trial initiation date: Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) - Feb 7, 2022
P1, N=30, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Dec 2021 --> Feb 2023 | Trial primary completion date: Dec 2021 --> Feb 2023 Not yet recruiting --> Recruiting | Initiation date: Sep 2021 --> Jan 2022
- | itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date, Combination therapy: A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Feb 1, 2022
P1/2, N=33, Active, not recruiting, Sponsor: Incyte Corporation
Not yet recruiting --> Recruiting | Initiation date: Sep 2021 --> Jan 2022 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- itacitinib (INCB039110) / Incyte, Actemra IV (tocilizumab) / Roche, JW Pharma
A PHASE 2 STUDY OF ITACITINIB FOR THE PREVENTION OF CYTOKINE RELEASE SYNDROME (CRS) INDUCED BY IMMUNE EFFECTOR CELL (IEC) THERAPY: PRELIMINARY RESULTS (North Hall / Virtual Hall 6) - Jan 30, 2022 - Abstract #EBMT2022EBMT_971;
P2
Preliminary results demonstrate itacitinib 200 mg QD as prophylaxis is generally well tolerated, with promising activity for preventing grade ≥2 CRS/severe ICANS. The study was expanded with a randomized, double-blind, placebo-controlled portion of itacitinib 200 mg twice a day with plans to enroll 46 patients with DLBCL receiving axicabtagene ciloleucel.
- ||| parsaclisib (INCB50465) / Incyte
Enrollment change, Trial completion date, Trial primary completion date: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov) - Jan 26, 2022
P2, N=41, Recruiting, Sponsor: Incyte Corporation
The study was expanded with a randomized, double-blind, placebo-controlled portion of itacitinib 200 mg twice a day with plans to enroll 46 patients with DLBCL receiving axicabtagene ciloleucel. N=31 --> 41 | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
- ||||| itacitinib (INCB039110) / Incyte
Enrollment closed, Enrollment change: GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - Jan 21, 2022
P2/3, N=157, Active, not recruiting, Sponsor: Incyte Corporation
N=31 --> 41 | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025 Recruiting --> Active, not recruiting | N=431 --> 157
- ||| itacitinib (INCB039110) / Incyte
Clinical, P3 data, Journal, Combination therapy: Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301): a randomised, multicentre, double-blind, phase 3 trial. (Pubmed Central) - Jan 18, 2022
P3
The observed improvement in ORR at day 28 with the addition of itacitinib versus placebo to corticosteroids did not reach the prespecified significance level. Further studies might provide additional insight into the utility of selective JAK1 inhibition for the treatment of acute GVHD.
- ||| itacitinib (INCB039110) / Incyte, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Pan tumor: Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO) (clinicaltrials.gov) - Jan 11, 2022
P1/2, N=105, Recruiting, Sponsor: Michael Savona
Further studies might provide additional insight into the utility of selective JAK1 inhibition for the treatment of acute GVHD. Not yet recruiting --> Recruiting
- itacitinib (INCB039110) / Incyte
A Single-Arm, Open-Label, Pilot Study of the JAK1 Selective Inhibitor Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome in T-Cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation (Salt Palace Convention Center Hall A) - Jan 9, 2022 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_1125;
P1
An extension cohort of 20 additional patients is enrolling. Multi-platform correlative studies are underway, comparing samples from haplo-HCT patients treated with and without itacitinib.
- | itacitinib (INCB039110) / Incyte
Journal: Rab1A promotes IL-4R/JAK1/STAT6-dependent metastasis and determines JAK1 inhibitor sensitivity in non-small cell lung cancer. (Pubmed Central) - Jan 8, 2022
Collectively, these findings demonstrated that Rab1A plays a critical role in the aggressive properties of NSCLC, revealing a unique mechanism by which it promotes metastasis. In addition, we found that Rab1A is a determinant of JAK1 inhibitor sensitivity, which could be explored for improving JAK1-targeted cancer therapy.
- ||||| itacitinib (INCB039110) / Incyte
Clinical: Itacitinib (JAK1 inhibitor) vs placebo + corticosteroids for initial Rx of acute GVHD (GRAVITAS-301 trial). N=439. Day 28 ORR: 74 vs. 66% (p=0.078). >/= grade 3 AE: 86 vs. 82% #bmtsm #GVHD @TheLancetHaem https://t.co/GaWeaMvkUd (Twitter) - Dec 29, 2021
- || itacitinib (INCB039110) / Incyte
PK/PD data, Journal: Effect of Hepatic Impairment on the Pharmacokinetics of Itacitinib. (Pubmed Central) - Dec 22, 2021
There were no serious or fatal treatment-related adverse events. The results of this study combined with exposure, efficacy, and safety data from the pivotal study in the relevant patient population will inform final dosing recommendations.
- | itacitinib (INCB039110) / Incyte
Journal, CAR T-Cell Therapy, Cytokine release syndrome: Itacitinib (INCB039110), a JAK1 inhibitor, Reduces Cytokines Associated with Cytokine Release Syndrome Induced by CAR T-Cell Therapy. (Pubmed Central) - Dec 16, 2021
P2
The results of this study combined with exposure, efficacy, and safety data from the pivotal study in the relevant patient population will inform final dosing recommendations. Together, these data suggest that itacitinib has potential as a prophylactic agent for the prevention of CAR T-cell-induced CRS, and a phase II clinical trial of itacitinib for prevention of CRS induced by CAR T-cell therapy has been initiated (NCT04071366).
- | itacitinib (INCB039110) / Incyte
Trial completion date, Trial initiation date, Trial primary completion date: SCLERITA: Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis (clinicaltrials.gov) - Nov 22, 2021
P2, N=74, Not yet recruiting, Sponsor: Assistance Publique - H
Together, these data suggest that itacitinib has potential as a prophylactic agent for the prevention of CAR T-cell-induced CRS, and a phase II clinical trial of itacitinib for prevention of CRS induced by CAR T-cell therapy has been initiated (NCT04071366). Trial completion date: Jun 2024 --> Jan 2025 | Initiation date: Jun 2021 --> Jan 2022 | Trial primary completion date: Jun 2024 --> Jan 2025
- | itacitinib (INCB039110) / Incyte, Keytruda (pembrolizumab) / Merck (MSD)
Trial termination, Trial primary completion date, Metastases: Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 17, 2021
P2, N=23, Terminated, Sponsor: University of Pennsylvania
Trial completion date: Jun 2024 --> Jan 2025 | Initiation date: Jun 2021 --> Jan 2022 | Trial primary completion date: Jun 2024 --> Jan 2025 Active, not recruiting --> Terminated | Trial primary completion date: Oct 2021 --> Jun 2021; Administrative reasons
- | itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date, Combination therapy: A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Nov 15, 2021
P1/2, N=33, Active, not recruiting, Sponsor: Incyte Corporation
Active, not recruiting --> Terminated | Trial primary completion date: Oct 2021 --> Jun 2021; Administrative reasons Trial completion date: Oct 2021 --> Dec 2021 | Trial primary completion date: Oct 2021 --> Dec 2021
- || itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date, Combination therapy, Metastases: An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 12, 2021
P1/2, N=59, Active, not recruiting, Sponsor: Incyte Corporation
Trial completion date: Oct 2021 --> Dec 2021 | Trial primary completion date: Oct 2021 --> Dec 2021 Trial completion date: Sep 2021 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Jun 2022
- || Mekinist (trametinib) / Novartis, BeiGene, itacitinib (INCB039110) / Incyte, Tafinlar (dabrafenib) / Novartis, BeiGene
Enrollment closed, Enrollment change, Combination therapy: INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors. (clinicaltrials.gov) - Nov 8, 2021
P1, N=1, Active, not recruiting, Sponsor: Massachusetts General Hospital
Trial completion date: Sep 2021 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Jun 2022 Recruiting --> Active, not recruiting | N=38 --> 1
- Dynamic Stromal Changes in Myelofibrosis Patients Pre/Post JAK Inhibition Is Revealed in Clinically Archived Bone Marrow Biopsies By Smooth Muscle Actin (SMA)-CD34 Dual Immunohistochemistry (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4961;
SMA-CD34 IHC stratifies MF bone marrow biopsies differentially from standard WHO reticulin/trichome grading providing a practical formalin-fixed paraffin embedded (FFPE) tissue-based biomarker for assessing fibrosis related bone marrow niche elements from archived clinical samples. While our pilot numbers precluded statistical evaluation by JAKi-type, clinical response and NGS mutational profile at this time, further studies are underway to validate the SMA-CD34 signature on a larger MF cohort.
- Campath (alemtuzumab) / Sanofi, itacitinib (INCB039110) / Incyte
A Phase Ib Pilot Study of Itacitinib Combined with Alemtuzumab in Patients with T-Cell Prolymphocytic Leukemia (T-PLL) (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2944;
Single-agent itacitinib was associated with patient reported improvements in B-symptoms, rash, appetite, and exam findings of reduced splenomegaly. Response rates with the combination were similar to historical expectations in frontline and salvage, but OS and EFS appear favorable, with short follow up.
- itacitinib (INCB039110) / Incyte
A Single-Arm, Open-Label, Pilot Study of the JAK1 Selective Inhibitor Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome in T-Cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation (GWCC - B302-B303, Level 3) - Nov 5, 2021 - Abstract #ASH2021ASH_1318;
P1
Rates of acute and chronic GVHD were low, without increased risk of relapse or transplant related mortality. Severe CRS was not seen in this trial, and no anti-IL6 or steroid therapy was used.
- || itacitinib (INCB039110) / Incyte
Enrollment closed, Trial completion date, Trial primary completion date: Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation (clinicaltrials.gov) - Oct 14, 2021
P1/2, N=79, Active, not recruiting, Sponsor: Incyte Corporation
Severe CRS was not seen in this trial, and no anti-IL6 or steroid therapy was used. Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jan 2024 | Trial primary completion date: Feb 2022 --> Dec 2022
- | itacitinib (INCB039110) / Incyte
Enrollment open: Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant (clinicaltrials.gov) - Oct 11, 2021
P1, N=15, Recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jan 2024 | Trial primary completion date: Feb 2022 --> Dec 2022 Not yet recruiting --> Recruiting
- |||| itacitinib (INCB039110) / Incyte
New P2 trial: HLH-JAK: Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB (clinicaltrials.gov) - Sep 30, 2021
P2, N=63, Not yet recruiting, Sponsor: Assistance Publique - Hôpitaux de Paris
- || itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date, Cytokine release syndrome: INCB 39110-211: A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy (clinicaltrials.gov) - Sep 30, 2021
P2, N=62, Recruiting, Sponsor: Incyte Corporation
Not yet recruiting --> Recruiting Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Mar 2022 --> Jul 2022
- | itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date: A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov) - Sep 16, 2021
P2, N=40, Recruiting, Sponsor: SCRI Development Innovations, LLC
Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Mar 2022 --> Jul 2022 Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
- | itacitinib (INCB039110) / Incyte
Enrollment closed, Monotherapy: Itacitinib for Low Risk GVHD (clinicaltrials.gov) - Sep 1, 2021
P2, N=70, Active, not recruiting, Sponsor: John Levine
Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024 Recruiting --> Active, not recruiting
- ||| itacitinib (INCB039110) / Incyte
Trial completion, Trial completion date: An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis (clinicaltrials.gov) - Aug 30, 2021
P2, N=87, Completed, Sponsor: Incyte Corporation
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Jun 2021