Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04246762 | Nov 2021 → Jun 2022 | rheumatoid arthritis | R-Pharm International, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01262794 | Nov 2010 → Sep 2011 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01276119 | Sep 2008 → Oct 2009 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01009242 | Oct 2009 → Sep 2010 | rheumatoid arthritis | UCB Pharma | Completed | No outcome recorded |
| Phase 26 trials · 2 met primary | ||||||
| Phase 2 | NCT07517575 | Mar 2023 → Sep 2026 overdue | polyarticular juvenile idiopathic arthritis | R-Pharm International, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT01635621 | Jun 2012 → Aug 2013 | Crohn disease | UCB BIOSCIENCES, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT01533714 | Jan 2012 → Nov 2013 | rheumatoid arthritis | UCB BIOSCIENCES, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01463059 | Oct 2011 → Feb 2013 | rheumatoid arthritis | UCB Japan Co. Ltd. | Completed | Met primary |
| Phase 2 | NCT01296711 | Mar 2011 → May 2013 | rheumatoid arthritis | UCB BIOSCIENCES, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01242488 | Nov 2010 → Jun 2012 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT06440746 | Aug 2023 → Apr 2027 expected | interstitial lung disease | R-Pharm International, LLC | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04452474 | Jun → Nov 2020 | COVID-19 | R-Pharm | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04380519 | Apr → Jul 2020 | COVID-19 | R-Pharm International, LLC | Completed | Missed primary |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT07625384 | May 2026 → Dec 2027 expected | — | R-Pharm International, LLC | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07670546 | Jun 2025 → Apr 2026 overdue | polymyalgia rheumatica | R-Pharm International, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05187793 | Jul 2021 → Oct 2022 | COVID-19 | R-Pharm | Unknown | No outcome recorded |
| Phase 3 | NCT03120949 | Jul 2017 → Sep 2021 | rheumatoid arthritis | R-Pharm International, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02760433 | Jan 2017 → Sep 2019 | rheumatoid arthritis | R-Pharm International, LLC | Completed | Met primary |
| Phase 3 | NCT02760407 | Jun 2016 → Aug 2019 | rheumatoid arthritis | R-Pharm International, LLC | Completed | Met primary |
| Phase 3 | NCT02760368 | May 2016 → Aug 2018 | rheumatoid arthritis | R-Pharm International, LLC | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2021-11-10 | R-Pharm | Results «Р-Фарм» представил успешные результаты исследований Артлегиа на конгрессе ACR 2021 r-pharm.com ↗
Все вторичные конечные точки оценки эффективности также были достигнуты. |
| 2021-04-26 | R-Pharm | Regulatory Минздрав РФ утвердил расширенные показания к применению препарата Артлегиа r-pharm.com ↗
Министерство Здравоохранения РФ утвердило включение в инструкцию по применению препарата Артлегиа (олокизумаб) нового показания. |
| 2020-07-01 | R-Pharm | Results Олокизумаб достиг всех конечных точек в исследовании 3 фазы у пациентов с ревматоидным артритом r-pharm.com ↗ |
| 2019-11-28 | R-Pharm | Results Результаты исследования олокизумаба представлены на конгрессе ACR 2019 r-pharm.com ↗
Одним из самых важных результатов стало достижение первичной конечной точки — статистически значимого снижения выраженности симптомов по критериям ACR20 на 12 неделе терапии, по сравнению с группой плацебо. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-11-10 | R-Pharm | «Р-Фарм» представил успешные результаты исследований Артлегиа на конгрессе ACR 2021 r-pharm.com ↗ |
| 2021-04-26 | R-Pharm | Минздрав РФ утвердил расширенные показания к применению препарата Артлегиа r-pharm.com ↗ |
| 2020-07-01 | R-Pharm | Олокизумаб достиг всех конечных точек в исследовании 3 фазы у пациентов с ревматоидным артритом r-pharm.com ↗ |
| 2019-11-28 | R-Pharm | Результаты исследования олокизумаба представлены на конгрессе ACR 2019 r-pharm.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | olokizumab | “The purpose of this study is to evaluate the long term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis who...” NCT01296711 ↗15“The purpose of this study is to evaluate efficacy and safety of olokizumab (OKZ) compared to placebo in patients progressive fibrosing Interstitial lung diseases (ILD).” NCT06440746 ↗ “Olokizumab is a sterile solution for subcutaneous injection” NCT07517575 ↗ “CDP6038 (olokizumab)” NCT01533714 ↗ |
| Known as | Artlegia | “Artlegia (INN: Olokizumab)” NCT05187793 ↗ |
| Known as | CDP6038 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01009242 ↗ |
| Known as | OKZ | “The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or...” NCT03120949 ↗10“This analysis evaluated the effects of olokizumab (OKZ) on patient-reported outcomes (PROs) after up to 106 weeks of treatment in patients with active rheumatoid arthritis (RA)...” PMID 42142212 ↗ May 2026 “This phase II, dose-ranging, double-blind, placebo-controlled, randomized study (NCT01463059) evaluated efficacy and safety of olokizumab (OKZ), a humanized anti-interleukin 6...” PMID 26358841 ↗ Sep 2015 “To assess the efficacy and safety of olokizumab (OKZ), a monoclonal antibody against the interleukin-6 (IL-6) cytokine, versus placebo (PBO) in patients with prior inadequate...” PMID 36109142 ↗ Sep 2022 “Olokizumab (OKZ) has been shown to reverse the inhibitory effect of IL-6 on the activity of Cytochrome P450 (CYP450) isozymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4/5 in vitro.” NCT04246762 ↗ “The purpose of this study is to evaluate efficacy and safety of olokizumab (OKZ) compared to placebo in patients progressive fibrosing Interstitial lung diseases (ILD).” NCT06440746 ↗ “The primary objective of the study is to evaluate the efficacy and safety of goflikicept (GFC) and olokizumab (OKZ) in patients with Still's disease” NCT07625384 ↗ “Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection” NCT07517575 ↗ “olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).” PMID 34344706 ↗ Aug 2021 “Olokizumab (OKZ)” NCT01635621 ↗ “olokizumab (OKZ)” NCT05187793 ↗ |
| Action | Inhibit | “CDP6038 is a protein (antibody) that blocks interleukin-6 (IL-6)” NCT01242488 ↗ |
| Modality | Monoclonal antibody | “a humanized anti-interleukin 6 monoclonal antibody” PMID 26358841 ↗ Sep 2015 |
| Route | Intravenous | “1 mg/kg CDP6038 IV” NCT01009242 ↗ |
| Target | IL6 | “a monoclonal antibody against interleukin 6” PMID 34344706 ↗ Aug 2021 |