Drugs / Vixarelimab
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06693908 | Mar 2025 → Jul 2026 overdue | ulcerative colitis | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06137183 | May 2024 → Jun 2025 | ulcerative colitis | Genentech, Inc. | Terminated | Missed primary |
| Phase 2 | NCT05785624 | May 2023 → Jan 2026 | idiopathic pulmonary fibrosis, pulmonary systemic sclerosis | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03858634 | May 2019 → Apr 2020 | chronic idiopathic urticaria, lichen planus, neurodermatitis, psoriasis | Genentech, Inc. | Completed | Mixed |
| Phase 2 | NCT03816891 | Mar 2019 → Dec 2022 | prurigo nodularis | Genentech, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2020-11-16 | Kiniksa Pharmaceuticals International, plc | Regulatory Kiniksa Announces Breakthrough Therapy Designation Granted to Vixarelimab for the Treatment of Pruritus Associated with Prurigo Nodularis kiniksa.com ↗ |
| 2020-10-29 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Announces Phase 2 Clinical Data from Vixarelimab in Prurigo Nodularis Presented at European Academy of Dermatology and Venereology Virtual Congress kiniksa.com ↗
The Phase 2a trial met its primary efficacy endpoint: there was a statistically significant reduction in weekly-average Worst-Itch Numeric Rating Scale (WI-NRS) from baseline at Week 8 in vixarelimab recipients compared to placebo recipients. |
| 2020-05-11 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Reports Data for Mavrilimumab in COVID-19 Pneumonia and Hyperinflammation and for Vixarelimab in Diseases Characterized by Chronic Pruritus kiniksa.com ↗
Vixarelimab exploratory Phase 2 trial in diseases characterized by chronic pruritus showed encouraging efficacy results in 4 out of 5 cohorts ; plaque psoriasis cohort achieved statistically significant reduction in weekly-average Worst-Itch Numeric Rating Scale (WI-NRS) at Week 8 |
| 2020-04-22 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Announces Phase 2 Clinical Trial of Vixarelimab (KPL-716) in Prurigo Nodularis Meets Primary Efficacy Endpoint kiniksa.com ↗
The trial met its primary efficacy endpoint: the reduction in weekly-average WI-NRS from baseline at Week 8 was statistically significantly greater in patients who received vixarelimab versus those who received placebo. |
| 2019-09-19 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Presents Preclinical Data Supporting KPL-716 Clinical Development at the 49th Annual Meeting of the European Society of Dermatological Research kiniksa.com ↗ |
| 2019-08-12 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Announces Interim Data from KPL-716 Repeated-Single-Dose Phase 1b Clinical Trial kiniksa.com ↗ |
| 2019-05-13 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Presents Clinical and Preclinical Data for KPL-716 at the 77th Annual Meeting of the Society for Investigative Dermatology kiniksa.com ↗
KPL-716 data from a preclinical model exhibited dose- and time-dependent anti-pruritic effects. |
| 2018-09-15 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Presents KPL-716 Clinical Data at the 27th European Academy of Dermatology and Venereology kiniksa.com ↗
In this First-in-Human clinical trial, single intravenous (IV) and subcutaneous (SC) doses of KPL-716 were well-tolerated in both adult healthy volunteers and adult subjects with moderate-to-severe atopic dermatitis experiencing moderate-to-severe pruritus. |
All press releases naming this drug 13 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vixarelimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03816891 ↗ |
| Known as | 30C6 (N73D) IGG4P.AGLY/IGG1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594341 ↗ |
| Known as | BIIB-069 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594341 ↗ |
| Known as | KPL-716 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03858634 ↗ |
| Action | Inhibit | “inhibiting signalling of both interleukin 31 and oncostatin M” PMID 36816342 ↗ Feb 20231“Oncostatin-M-specific receptor subunit beta inhibitor” CHEMBL4594341 ↗ |
| Modality | Monoclonal antibody | “Vixarelimab, a human monoclonal antibody” PMID 36816342 ↗ Feb 2023 |
| Route | Subcutaneous | “Vixarelimab administered subcutaneously (SC)” NCT03816891 ↗ |
| Target | OSMR | “Oncostatin-M-specific receptor subunit beta inhibitor” CHEMBL4594341 ↗ |