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1 Product |  |
7 Diseases | | 1 Product |
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1 Trial |  |
23 News |  |
- || namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Enrollment closed, Trial completion date, Trial primary completion date: RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - Apr 30, 2024
P2, N=107, Active, not recruiting, Sponsor: Kinevant Sciences GmbH
Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jun 2025 | Trial primary completion date: May 2024 --> Dec 2024
- namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Phase classification: RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - Nov 18, 2023
P2, N=1, Terminated, Sponsor: Kinevant Sciences GmbH
Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jun 2025 | Trial primary completion date: May 2024 --> Dec 2024 Phase classification: P2a --> P2
- |||| namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Clinical: First patient in the UK randomised and dosed with Namilumab for sarcoidosis at @KingsCollegeNHS @KingsCRF @kinevant @SarcoidosisUK @drjamesgalloway (Twitter) - Jul 26, 2023
- | namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - Dec 15, 2022
P2a, N=1, Terminated, Sponsor: Kinevant Sciences GmbH
Phase classification: P2a --> P2 N=30 --> 1 | Trial completion date: Jan 2024 --> Nov 2022 | Recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Nov 2022; Sponsor business decision not related to safety
- || namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Enrollment open: RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - Aug 9, 2022
P2a, N=30, Recruiting, Sponsor: Kinevant Sciences GmbH
N=30 --> 1 | Trial completion date: Jan 2024 --> Nov 2022 | Recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Nov 2022; Sponsor business decision not related to safety Not yet recruiting --> Recruiting
- | namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Trial initiation date: RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - Jun 1, 2022
P2a, N=30, Not yet recruiting, Sponsor: Kinevant Sciences GmbH
Not yet recruiting --> Recruiting Initiation date: Apr 2022 --> Jun 2022
- ||| namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Enrollment open: RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - May 3, 2022
P2, N=100, Recruiting, Sponsor: Kinevant Sciences GmbH
Initiation date: Apr 2022 --> Jun 2022 Not yet recruiting --> Recruiting
- || namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Trial completion date, Trial primary completion date: RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - Apr 29, 2022
P2, N=100, Not yet recruiting, Sponsor: Kinevant Sciences GmbH
Not yet recruiting --> Recruiting Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Nov 2023 --> May 2024
- || namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
New P2a trial: RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - Apr 28, 2022
P2a, N=30, Not yet recruiting, Sponsor: Kinevant Sciences GmbH
- |||| namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
New P2 trial: RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - Apr 5, 2022
P2, N=100, Not yet recruiting, Sponsor: Kinevant Sciences GmbH
- || Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, namilumab (IZN-101) / Amgen, Izana Biosci
Clinical, P2 data, Journal: Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial. (Pubmed Central) - Mar 11, 2022
Namilumab, but not infliximab, showed proof-of-concept evidence for reduction in inflammation-as measured by CRP concentration-in hospitalised patients with COVID-19 pneumonia. Namilumab should be prioritised for further investigation in COVID-19.
- || Review, Journal: Pharmaco-Immunomodulatory Therapy in COVID-19. (Pubmed Central) - Sep 18, 2020
Non-specific immune modulators include human immunoglobulin, corticosteroids such as dexamethasone, interferons, statins, angiotensin pathway modulators, macrolides (e.g. azithromycin, clarithromycin), hydroxychloroquine and chloroquine, colchicine, and prostaglandin D2 modulators such as ramatroban...Research efforts should focus not only on the most relevant immunomodulatory strategies but also on the optimal timing of such interventions to maximize therapeutic outcomes. In this review, we discuss the potential role and safety of these agents in the management of severe COVID-19, and their impact on survival and clinical symptoms.
- | namilumab (IZN-101) / Amgen, Izana Bio
Clinical, Journal: GM-CSF as a therapeutic target in psoriasis: randomised, controlled investigation using namilumab - a specific, human anti-GM-CSF monoclonal antibody. (Pubmed Central) - Jul 7, 2020
P2
In this review, we discuss the potential role and safety of these agents in the management of severe COVID-19, and their impact on survival and clinical symptoms. GM-CSF blockade is not critical for suppression of key inflammatory pathways underlying psoriasis (NCT02129777).
- |||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, namilumab (IZN-101) / Amgen, Izana Bio
The platform trial CATALYST (Bham-Oxford) in COVID-19 will open with Namilumab (anti-GMCSF mAb) and Remsima (biosimilar infliximab). Thoughts? @LCalabreseDO @EBRheum @ (Twitter) - Jun 13, 2020
- | namilumab (IZN-101) / Amgen, Izana Bio
Biomarker, Journal: Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an inadequate response or intolerance to an anti-TNF (tumour necrosis factor) biologic therapy: a randomized, controlled trial. (Pubmed Central) - May 15, 2020
P2
The study met its primary endpoint with a clear dose-response effect. An acceptable tolerability profile was demonstrated over the 12-week study.
- | namilumab (IZN-101) / Amgen, Izana Biosci, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
New P2 trial: A clinical trial to gather information on the safety and effectiveness of drugs in patients with the COVID-19 infection, that could be used in larger trials. (EUDRACT) - May 7, 2020
P2, N=84, Ongoing, Sponsor: University of Birmingham
- | Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
Review, Journal: Targeting Granulocyte-Monocyte Colony-Stimulating Factor Signaling in Rheumatoid Arthritis: Future Prospects. (Pubmed Central) - Apr 23, 2020
Mainly because of this reason, nowadays the development program of most GM-CSF blockers for RA has been discontinued, with the exception of otilimab, which is under evaluation in two phase III RCTs with a head-to head non-inferiority design against tofacitinib...Phase II trials are ongoing with the aim of evaluating mavrilimumab for the treatment of giant cell arteritis, and namilumab for the treatment of spondyloarthritis...This review aims to describe in detail the available evidence on the GM-CSF blocking pathway in RA management, paving the way to a possible alternative treatment for RA patients. Novel insights regarding the potential use of GM-CSF blockers for alternative indications will be also addressed.
- || namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Trial completion, Trial completion date, Trial primary completion date: NAMASTE: Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis (clinicaltrials.gov) - Apr 17, 2020
P2a, N=42, Completed, Sponsor: Izana Bioscience Ltd.
Novel insights regarding the potential use of GM-CSF blockers for alternative indications will be also addressed. Active, not recruiting --> Completed | Trial completion date: Nov 2019 --> Feb 2020 | Trial primary completion date: Nov 2019 --> Feb 2020
- | namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Enrollment closed, Trial primary completion date: NAMASTE: Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis (clinicaltrials.gov) - Aug 20, 2019
P2a, N=42, Active, not recruiting, Sponsor: Izana Bioscience Ltd.
Active, not recruiting --> Completed | Trial completion date: Nov 2019 --> Feb 2020 | Trial primary completion date: Nov 2019 --> Feb 2020 Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2019 --> Nov 2019
- | namilumab (IZN-101) / Amgen, Izana Bio
Journal: Namilumab improves RA symptoms. (Pubmed Central) - May 4, 2019
Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2019 --> Nov 2019 No abstract available
- || namilumab (IZN-101) / Amgen, Izana Biosci
Trial primary completion date, Combination therapy: NEXUS: Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Sep 14, 2018
P2, N=108, Completed, Sponsor: Takeda
No abstract available Trial primary completion date: Nov 2016 --> May 2016
- | namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Enrollment open: NAMASTE: Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis (clinicaltrials.gov) - Aug 13, 2018
P2a, N=42, Recruiting, Sponsor: Izana Bioscience Ltd.
Trial primary completion date: Nov 2016 --> May 2016 Not yet recruiting --> Recruiting
- | namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
New P2a trial: NAMASTE: Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis (clinicaltrials.gov) - Aug 9, 2018
P2a, N=42, Not yet recruiting, Sponsor: Izana Bioscience Ltd.
- |||| namilumab (IZN-101) / Amgen, Izana Biosci
Combination therapy: NEXUS: Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Feb 7, 2017
P2, N=108, Completed, Sponsor: Takeda
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial primary completion date: May 2017 --> Nov 2016
- | namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: TELLUS: Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate (clinicaltrials.gov) - Jan 30, 2017
P2, N=36, Completed, Sponsor: Takeda
Active, not recruiting --> Completed | Trial primary completion date: May 2017 --> Nov 2016 Active, not recruiting --> Completed
- namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Biomarker: Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study (clinicaltrials.gov) - Jan 18, 2017
P1, N=8, Completed, Sponsor: Takeda
Active, not recruiting --> Completed N=14 --> 8
- | namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Biomarker: Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study (clinicaltrials.gov) - Oct 19, 2016
P1, N=14, Completed, Sponsor: Takeda
N=14 --> 8 Not yet recruiting --> Completed | Trial primary completion date: Jan 2016 --> Apr 2016
- | namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: TELLUS: Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate (clinicaltrials.gov) - Sep 1, 2016
P2, N=36, Active, not recruiting, Sponsor: Takeda
Not yet recruiting --> Completed | Trial primary completion date: Jan 2016 --> Apr 2016 Recruiting --> Active, not recruiting
- || namilumab (IZN-101) / Amgen, Izana Biosci
Combination therapy: NEXUS: Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Sep 1, 2016
P2, N=108, Active, not recruiting, Sponsor: Takeda
Recruiting --> Active, not recruiting Trial primary completion date: Nov 2016 --> May 2017
- |||| namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis (clinicaltrials.gov) - Jul 24, 2016
P2, N=120, Completed, Sponsor: Takeda
Trial primary completion date: Nov 2016 --> May 2017 Recruiting --> Completed
- ||| namilumab (IZN-101) / Amgen, Izana Biosci
Combination therapy: NEXUS: Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Jul 11, 2016
P2, N=108, Active, not recruiting, Sponsor: Takeda
Recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: May 2017 --> Nov 2016
- ||| namilumab (IZN-101) / Amgen, Izana Biosci
Combination therapy: NEXUS: Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (clinicaltrials.gov) - May 25, 2016
P2, N=100, Recruiting, Sponsor: Takeda
Recruiting --> Active, not recruiting | Trial primary completion date: May 2017 --> Nov 2016 N=324 --> 100 | Trial primary completion date: Mar 2015 --> May 2017
- | namilumab (IZN-101) / Amgen, Izana Biosci, Roivant
Biomarker: Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study (clinicaltrials.gov) - Aug 19, 2015
P1, N=14, Not yet recruiting, Sponsor: Takeda
- ||| namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis (clinicaltrials.gov) - Jul 2, 2015
P2, N=120, Recruiting, Sponsor: Takeda
N=324 --> 100 | Trial primary completion date: Mar 2015 --> May 2017 N=100 --> 120
- | namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: TELLUS: Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate (clinicaltrials.gov) - Jun 16, 2015
P2, N=36, Recruiting, Sponsor: Takeda
N=100 --> 120 Not yet recruiting --> Recruiting
- | namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: TELLUS: Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate (clinicaltrials.gov) - Mar 19, 2015
P2, N=36, Not yet recruiting, Sponsor: Takeda
- ||||| namilumab (IZN-101) / Amgen, Izana Biosci
Combination therapy: NEXUS: Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Mar 5, 2015
P2, N=324, Recruiting, Sponsor: Takeda
- | namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: A Phase 1 MT203 Single-dose Study to Evaluate Safety, PK and PD (clinicaltrials.gov) - Feb 3, 2015
P1, N=32, Recruiting, Sponsor: Takeda
- |||| namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis (clinicaltrials.gov) - Sep 15, 2014
P2, N=100, Recruiting, Sponsor: Takeda
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis (clinicaltrials.gov) - Apr 30, 2014
P2, N=100, Not yet recruiting, Sponsor: Takeda
- | namilumab (IZN-101) / Amgen, Izana Biosci
Clinical: PRIORA: A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis (clinicaltrials.gov) - Aug 19, 2013
P1, N=24, Completed, Sponsor: Takeda
Not yet recruiting --> Recruiting Active, not recruiting --> Completed