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Last Updated: June 25, 2021

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CLINICAL TRIALS PROFILE FOR OLUMIANT

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All Clinical Trials for Olumiant

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04131738 Baricitinib for the Prophylaxis of Graft-Versus-Host Disease After Peripheral Blood Hematopoietic Cell Transplantation Not yet recruiting Washington University School of Medicine Phase 1 2020-01-31 In this trial, the investigators will begin to explore the possibility that, as in mice, JAK1/2 inhibition with hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) while retaining engraftment and Graft-versus-Leukemia (GVL). Both preclinical and clinical data suggest that inhibition of IFNy and IL-6, directly and using downstream JAK Inhibitors, may be an effective strategy to decrease toxicities and improve disease control for patients undergoing Allogeneic HSCT. Baricitinib, as a JAK1/2 inhibitor, has shown superiority to other JAK inhibitors in preclinical GVHD models. The purpose of this pilot study is to determine the safety of baricitinib with HSCT measured by the effect on engraftment and grade III-IV acute graft-versus-host-disease (aGVHD).
NCT04345289 Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia Not yet recruiting Thomas Benfield Phase 3 2020-04-20 CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel treatment option of moderate-severe COVID-19. Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma, sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
NCT04390464 mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R) Recruiting Cambridge University Hospitals NHS Foundation Trust Phase 4 2020-05-08 TACTIC-R is a randomised, parallel arm, open-label platform trial for investigating potential treatment for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop severe complications. Most tissue damage following infection with COVID19 appears to be due to a later, exaggerated, host immune response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage. Most people who develop these severe complications still have virus present in their respiratory tract at the time-point when the disease starts to evolve. Immune modulation in the presence of active infection has potential to cause more harm than benefit. Safety considerations when studying immune modulation strategies are paramount. Therefore, this study proposes to assess the efficacy of immunomodulatory agents that target dysregulated immune response that drive the severe lung, and other organ, damage. The medications investigated for efficacy in this trial are Baricitinib and Ravulizumab. Reference: Gralinski and Baric 2015. Molecular pathology of emerging coronavirus infections. J Pathol 2015: 235: 185-195; DOI: 10.1002/path.4454
NCT04399798 Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial Not yet recruiting IRCCS Policlinico S. Matteo Phase 2 2020-05-15 The objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia. This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.
NCT04832880 Factorial Randomized Trial of Rendesivir and Baricitinib Plus Dexamethasone for COVID-19 (the AMMURAVID Trial) Not yet recruiting ASST Fatebenefratelli Sacco Phase 3 2021-04-06 Background: In the current worldwide medical emergency, a rapid identification of effective therapeutic strategy is crucial. So far, therapy with dexamethasone, remdesivir and baricitinib have been associated with evidence of impact on the clinical impact on COVID-19, but the effect of baricitinib and remdesivir in combination with dexamethasone. The AAMMURAVID trial is endorced and supported by the Italian Regulatory agency (AIFA-Agenzia Italiana del Farmaco)
NCT04891133 EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial Not yet recruiting Epidemiological and Clinical Research Information Network Phase 2/Phase 3 2021-05-01 EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.
NCT04891133 EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial Not yet recruiting Institut National de la Santé Et de la Recherche Médicale, France Phase 2/Phase 3 2021-05-01 EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Olumiant

Condition Name

Condition Name for Olumiant
Intervention Trials
Covid19 2
Corona Virus Infection 2
Graft Vs Host Disease 1
Emerging Infectious Disease 1
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Condition MeSH

Condition MeSH for Olumiant
Intervention Trials
Pneumonia 2
Coronavirus Infections 2
Severe Acute Respiratory Syndrome 2
Infection 1
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Clinical Trial Locations for Olumiant

Trials by Country

Trials by Country for Olumiant
Location Trials
Italy 2
Denmark 1
Belgium 1
Hungary 1
Norway 1
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Trials by US State

Trials by US State for Olumiant
Location Trials
Missouri 1
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Clinical Trial Progress for Olumiant

Clinical Trial Phase

Clinical Trial Phase for Olumiant
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Olumiant
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 1
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Clinical Trial Sponsors for Olumiant

Sponsor Name

Sponsor Name for Olumiant
Sponsor Trials
Cambridge University Hospitals NHS Foundation Trust 1
Thomas Benfield 1
Oslo University Hospital 1
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Sponsor Type

Sponsor Type for Olumiant
Sponsor Trials
Other 8
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