Drugs / Otilimab
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05304130 | Feb → May 2023 | rheumatoid arthritis | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03028467 | Jan → Dec 2017 | rheumatoid arthritis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT01517282 | Jan 2012 → Jan 2014 | multiple sclerosis | MorphoSys AG | Completed | No outcome recorded |
| Phase 1/2 | NCT01023256 | Dec 2009 → Jun 2012 | rheumatoid arthritis | MorphoSys AG | Completed | No outcome recorded |
| Phase 24 trials · 2 missed | ||||||
| Phase 2 | NCT04376684 | May 2020 → Jul 2021 | severe acute respiratory syndrome | GlaxoSmithKline | Completed | Mixed |
| Phase 2 | NCT02799472 | Jun 2016 → Oct 2017 | rheumatoid arthritis | GlaxoSmithKline | Completed | Mixed |
| Phase 2 | NCT02683785 | Mar 2016 → Nov 2017 | osteoarthritis | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT02504671 | Jul 2015 → Dec 2017 | rheumatoid arthritis | GlaxoSmithKline | Completed | Missed primary |
| Phase 34 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT04333147 | May 2020 → Feb 2023 | rheumatoid arthritis | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT04134728 | Oct 2019 → Sep 2021 | rheumatoid arthritis | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT03970837 | Jun 2019 → Oct 2021 | rheumatoid arthritis | GlaxoSmithKline | Terminated | Met primary |
| Phase 3 | NCT03980483 | May 2019 → Sep 2021 | rheumatoid arthritis | GlaxoSmithKline | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2022-10-27 | GlaxoSmithKline | Results GSK provides update on ContRAst phase III programme for otilimab in the treatment of moderate to severe rheumatoid arthritis gsk.com ↗
Data from ContRAst-3, the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 in patients with inadequate response to biologic DMARDs and/or Janus Kinase inhibitors. |
| 2021-02-25 | GlaxoSmithKline | Results GSK announces results evaluating its investigational monoclonal antibody, otilimab, for the treatment of hospitalised adult patients with COVID-19 gsk.com ↗
Data from patients of all ages showed a treatment difference of 5.3% (95% CI= -0.8%, 11.4%) but this did not reach statistical significance. |
| 2018-10-21 | GlaxoSmithKline | Results GSK presents new efficacy and safety data of an anti GM-CSF antibody in patients with rheumatoid arthritis gsk.com ↗
For DAS28(CRP) < 2.6 at Week 24 (the primary endpoint of the study), a greater proportion of patients achieved efficacy although this did not reach statistical significance at Week 24 (16% for GSK165 180mg vs 3% for placebo, p=0.134). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-10-27 | GlaxoSmithKline | GSK provides update on ContRAst phase III programme for otilimab in the treatment of moderate to severe rheumatoid arthritis gsk.com ↗ |
| 2021-02-25 | GlaxoSmithKline | GSK announces results evaluating its investigational monoclonal antibody, otilimab, for the treatment of hospitalised adult patients with COVID-19 gsk.com ↗ |
| 2019-07-03 | GlaxoSmithKline | GSK announces phase III start for its anti GM-CSF antibody, otilimab, in patients with rheumatoid arthritis (RA) gsk.com ↗ |
| 2018-10-21 | GlaxoSmithKline | GSK presents new efficacy and safety data of an anti GM-CSF antibody in patients with rheumatoid arthritis gsk.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | otilimab | “We explored the efficacy, safety, and pharmacokinetics of an anti-GM-CSF antibody, otilimab, in patients with hand osteoarthritis.” PMID 38273625 ↗ Sep 20206“Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo” NCT04134728 ↗ “Biological: GSK3196165 (Otilimab)” NCT03970837 ↗ “GSK3196165 (Otilimab)” NCT03980483 ↗ |
| Known as | GSK3196165 | “Otilimab (GSK3196165)” NCT04333147 ↗ |
| Known as | MOR103 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01023256 ↗ |
| Action | Inhibit | “Several preclinical findings support an anti-GM-CSF therapy for RA.” NCT01023256 ↗1“Granulocyte-macrophage colony-stimulating factor inhibitor” CHEMBL2109433 ↗ |
| Modality | Monoclonal antibody | “MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor” PMID 24534756 ↗ Feb 2014 |
| Route | Intravenous | “trial of intravenous MOR103” PMID 24534756 ↗ Feb 2014 |
| Target | CSF2 | “Granulocyte-macrophage colony-stimulating factor inhibitor” CHEMBL2109433 ↗ |