- |||||||||| otilimab (GSK3196165) / GSK
Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date: A Study in Healthy Japanese Participants to Evaluate the Safety and Pharmacokinetics of Otilimab (clinicaltrials.gov) - Jan 26, 2023 P1, N=0, Withdrawn, GSK has decided not to progress with regulatory submissions. N=12 --> 0 | Trial completion date: Jun 2022 --> May 2023 | Initiation date: Mar 2022 --> Feb 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2022 --> May 2023
- |||||||||| otilimab (GSK3196165) / GSK
Journal: A Randomised trial of anti-GM-CSF Otilimab in severe COVID-19 pneumonia (OSCAR). (Pubmed Central) - Oct 14, 2022 P2 There was no significant difference in the proportion of patients alive and free of respiratory failure at Day 28. However, despite the lack of clinical benefit, a reduction in inflammatory markers was observed with otilimab, in addition to an acceptable safety profile.
- |||||||||| otilimab (GSK3196165) / GSK
Journal: Detection and Modulation of Olfactory Sensing Receptors in Carnivorous Rainbow Trout (Oncorhynchus mykiss) Fed from First Feeding with Plant-Based Diet. (Pubmed Central) - Mar 15, 2022 Gene expression after feeding demonstrated the importance in olfactory sensing perception of some OLFC (olfcg6) and MOR (mor103, -107, -112, -113, -133) receptor family genes in RT...Results indicated an impact of a plant-based diet on the regulation of olfactory sensing pathways as well as influence on monoaminergic neurotransmission in brain areas related to olfactory-driven behaviors. The overall findings suggest that feeding behavior is mediated through olfactory sensing detection and olfactory-driven behavior pathways in RT.
- |||||||||| otilimab (GSK3196165) / GSK
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: contRAst 3: Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors (clinicaltrials.gov) - Aug 18, 2021 P3, N=550, Active, not recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Sep 2021 Recruiting --> Active, not recruiting | Trial completion date: Jul 2022 --> Feb 2022 | Trial primary completion date: Mar 2022 --> Sep 2021
- |||||||||| otilimab (GSK3196165) / GSK
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: OSCAR: Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease (clinicaltrials.gov) - Mar 8, 2021 P2, N=1150, Recruiting, Trial completion date: May 2022 --> Nov 2022 | Trial primary completion date: May 2022 --> Dec 2021 Active, not recruiting --> Recruiting | N=800 --> 1150 | Trial completion date: Jan 2021 --> Aug 2021 | Trial primary completion date: Jan 2021 --> Aug 2021
- |||||||||| otilimab (GSK3196165) / GSK
Clinical: Study of 222 RA pts on MTX given anti-GMCSF (otilimab) 22·5 mg, 45 mg, 90 mg, 135 mg, 180 mg, or PBO weekly x 5 wks, then EOW. @wk 24 DAS28-CRP <2·6 5%, 16%. 19%, 14%, 14% respectively and 3% in PBO. Otilimab failed to meet primary endpoint. https://t.co/14QqyeTcuP (Twitter) - Oct 8, 2020
- |||||||||| 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.
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