A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase 2/3 Study of Efficacy and Safety of Olokizumab in Subjects With Progressive Fibrosing Interstitial Lung Diseases

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).

Start Date23 Aug 2023

Sponsor / Collaborator

R-Pharm International, LLC

[+4]

NCT04246762

/ CompletedPhase 1

A Phase 1, Open-label, Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4

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.
The goal of the study was to assess the effect of OKZ on the pharmacokinetics (PK) of the CYP450 probe substrates, caffeine (CYP1A2), S-warfarin (CYP2C9), omeprazole (CYP2C19), and midazolam (CYP3A4) in subjects with rheumatoid arthritis (RA).

Start Date16 Nov 2021

Sponsor / Collaborator

R-Pharm International, LLC

[+1]

NCT05196477

/ CompletedNot Applicable

Multicentre Non-interventional Retrospective Cohort Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection

The study purpose was to assess the outcomes of therapy with olokizumab within complex therapy of Coronavirus disease 2019 (COVID-19) in hospitalised patients in real clinical practice setting. The study investigated patients' characteristics, disease progression, and efficacy and safety of olokizumab therapy.

Start Date14 Jul 2021

Sponsor / Collaborator

R-Pharm JSC

[+2]

100 Clinical Results associated with Olokizumab

100 Translational Medicine associated with Olokizumab

100 Patents (Medical) associated with Olokizumab

Literatures (Medical) associated with Olokizumab

27 Nov 2024·Annals of the rheumatic diseases

Correction: Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment.

Article

01 Nov 2024·British Journal of Clinical Pharmacology

Inflammation‐mediated drug interactions of olokizumab and cytochrome P450 activities in patients with rheumatoid arthritis

Article

Author: Mould, Diane ; Lemak, Maria ; Samsonov, Mikhail ; Grishin, Sergey ; Agachi, Svetlana ; Beloukhova, Marina

AbstractAimsIn patients with rheumatoid arthritis (RA), interleukin (IL)‐6 affects the activity of cytochrome P450 (CYP) enzymes. Treatment with anti‐IL‐6 therapy can reverse the IL‐6‐mediated downregulation of CYP enzymes, resulting in changes in plasma levels of CYP substrates. The primary objective of this study was to evaluate the impact of the IL‐6 inhibitor olokizumab on the pharmacokinetics of CYP probe substrates in subjects with active RA.MethodsSeventeen patients with active RA were orally administered a phenotyping cocktail of midazolam (CYP3A4 substrate), omeprazole (CYP2C19 substrate), warfarin (CYP2C9 substrate) and caffeine (CYP1A2 substrate) alone and 2 weeks after a single subcutaneous injection of 128 mg olokizumab. The pharmacokinetic parameters of each substrate were calculated using noncompartmental analysis.ResultsSixteen of 17 enrolled patients received the complete doses of the cocktail drugs and olokizumab and were eligible for the pharmacokinetic evaluations. After single‐dose administration of olokizumab, the exposure of midazolam and omeprazole decreased by 30‐33% and 26‐32%, respectively, compared to when the substrates were administered along via cocktail. In the presence of olokizumab, caffeine exposure increased by 19‐23% compared to caffeine administration alone. There were no significant changes in S‐warfarin exposure.ConclusionIn patients with active RA, olokizumab potentially reverses the IL‐6‐mediated suppression of CYP3A4 and CYP2C19. According to FDA guidance, olokizumab is considered a weak inducer of CYP3A4 and CYP2C19.

01 Nov 2024·Annals of the Rheumatic Diseases

Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment

Article

Author: Luggen, Michael ; Feist, Eugen ; Kuzkina, Sofia ; Fatenejad, Saeed ; Nasonov, Evgeniy ; Samsonov, Mikhail ; Grishin, Sergey ; Smolen, Josef S ; Fleischmann, Roy M ; Bukhanova, Daria

ObjectiveTo report long-term safety and tolerability of olokizumab (OKZ) in combination with methotrexate (MTX) in subjects with active rheumatoid arthritis (RA), using pooled data from three randomised clinical trials (RCT) followed by open-label extension (OLE) study.MethodsCumulative data from three phase 3 core trials and their OLE were analysed. Safety variables assessed included treatment-emergent adverse events (AEs), serious AEs (SAEs), AEs of special interest and laboratory results. Efficacy assessments included ACR20/50/70 responses, Disease Activity Score 28 (C-reactive protein) <3.2, CDAI remission and low disease activity (LDA), SDAI remission and LDA, HAQ-DI decrease of 0.22 unit and Boolean 2.0 remission.ResultsA total of 2304 patients received OKZ in combination with MTX either once every 2 weeks or once every 4 weeks. Event rates per 100 patient-years in OKZ every 2 weeks and OKZ every 4 weeks, respectively, were 9.57 and 9.13 for SAEs; 2.95 and 2.34 for serious infections; 0.09 and 0.05 for gastrointestinal perforations; 0.58 and 0.83 for major adverse cardiovascular events; and 0.45 and 0.50 for malignancies. No increase in the rate of any AE was observed over 106 weeks of treatment. The evaluation of laboratory variables demonstrated the expected changes, like neutropenia, elevation of liver enzymes and blood lipids. Clinical response rates remained stable during the OLE.ConclusionThe long-term safety and tolerability of OKZ in combination with MTX remained stable. The efficacy of OKZ was maintained through week 106. These findings support OKZ as a treatment option for patients with active RA.

News (Medical) associated with Olokizumab

09 Jan 2023

·www.prnewswire.com

Rheumatoid Arthritis Market is Expected to Showcase Significant Growth in the 7MM at a Minimal CAGR of 1.9% During the Study Period (2019-2032), Predicts DelveInsight

The dynamics of the rheumatoid arthritis market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like GlaxoSmithKline [Otilimab (MOR103/GSK3196165)], Taisho Pharmaceutical [Ozoralizumab (TS-152)], Aclaris Therapeutics [Zunsemetinib (ATI-450)], Abivax [ABX464], and others with their key candidates are in the late clinical and filing stage. LAS VEGAS, Jan. 9, 2023 /PRNewswire/ -- DelveInsight's Rheumatoid Arthritis Market Insights report includes a comprehensive understanding of current treatment practices, rheumatoid arthritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into the 7MM [the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Rheumatoid Arthritis Market Report As per DelveInsight analysis, the rheumatoid arthritis market size in the 7MM was approximately USD 27 billion in 2021. According to the assessment done by DelveInsight, the estimated total rheumatoid arthritis prevalent population in the 7MM was approximately 4. 7 million in 2021. Leading rheumatoid arthritis companies such as Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec/Genosco, Mesoblast, Pfizer Akros Pharma/Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, and others are developing novel rheumatoid arthritis drugs that can be available in the rheumatoid arthritis market in the coming years. The promising rheumatoid arthritis therapies in the pipeline include Ozoralizumab (TS-152), Artlegia (Olokizumab), Otilimab (GSK3196165/MOR103), Zunsemetinib (ATI-450), Ritlecitinib (PF-06651600), ABX464, Branebrutinib, Cevidoplenib (SKI-O-703), MPC-300-IV, PF-06650833, JTE -051, ABBV-154, TAS5315, MBS2320, AMT-101, AP1189, Rabeximod (Rob 803), and others. In June 2022, Cyxone received a response from a Type B Pre-IND meeting with the US FDA. The response from the FDA facilitates Cyxone to continue planning the Phase IIb study with Rabeximod in RA. In December 2021, Taisho Pharmaceuticals presented the interim results from a 24-week administration in Phase II/III clinical trial (OHZORA study) of ozoralizumab in adult patients with RA at the annual meeting of the Japanese Society for Clinical Rheumatology and Related Research. Discover which therapies are expected to grab the major rheumatoid arthritis market share @ Rheumatoid Arthritis Market Report Rheumatoid Arthritis Overview Rheumatoid arthritis is a type of autoimmune disease. It happens when our immune system, which is supposed to defend us, malfunctions and starts attacking our own tissues. It causes inflammation in the joint lining (the synovium). As a result, joints may become red, warm, swollen, and painful, which are all symptoms of rheumatoid arthritis. The precise causes of rheumatoid arthritis are still unknown. Because the early signs and symptoms of rheumatoid arthritis are similar to those of many other diseases, it can be difficult to detect in its early stages. There is no single blood test or physical finding that can confirm the diagnosis of rheumatoid arthritis. There is no known cure for rheumatoid arthritis. However, clinical trials of rheumatoid arthritis show that remission of symptoms is more common when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines begins early (DMARDs). Rheumatoid Arthritis Epidemiology Segmentation DelveInsight estimates that there were approximately 4.7 million prevalent cases of rheumatoid arthritis in the 7MM in 2021. Among the EU4 and the UK countries, Germany accounted for the highest number of rheumatoid arthritis cases, whereas France accounted for the lowest cases in 2021 The rheumatoid arthritis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases Total Diagnosed Prevalent Cases Gender-specific Prevalent Cases Age-specific Prevalent Cases Severity-specific Prevalent Cases Patients on Targeted Therapies Line-Wise Treated Cases Download the report to understand which factors are driving rheumatoid arthritis epidemiology trends @ Rheumatoid Arthritis Epidemiological Insights Rheumatoid Arthritis Treatment Market Over the last few years, there has been a dramatic improvement in rheumatoid arthritis outcomes as a direct result of paradigm shifts in rheumatoid arthritis treatment. At the moment, the main rheumatoid arthritis treatment options are Medicine (for long-term relief of symptoms and slowing the progression of the condition), Supportive treatments (including physiotherapy and occupational therapy, to help keep the patient mobile and manage any problems related to daily activities), and Surgery (to correct any joint problems that develop over a period of time). Nonsteroidal anti-inflammatory drugs (NSAIDs) are typically used only for symptomatic treatment until a rheumatoid arthritis diagnosis is established because they reduce pain and stiffness in patients but have no effect on disease progression. Moreover, disease-modifying antirheumatic drugs (DMARDs) are used to target inflammation and prevent further joint damage and disease progression. DMARDs are a class of drugs that have been shown to affect the underlying cause of rheumatoid arthritis by reducing immune system overactivity, thereby alleviating pain, swelling, and stiffness and preventing joint changes. DMARDs can be prescribed singly or in combination as an initial part of treatment. Methotrexate is the first-line DMARD agent for the majority of rheumatoid arthritis patients. It has a relatively quick onset of action at therapeutic doses (6-8 weeks), good efficacy, a low toxicity profile, is easy to administer, and is relatively inexpensive. To know more about rheumatoid arthritis guidelines, visit @ Rheumatoid Arthritis Management Rheumatoid Arthritis Pipeline Therapies and Key Companies Artlegia (Olokizumab): R-Pharm TS-152 (Ozoralizumab): Taisho Pharmaceuticals Otilimab (GSK3196165/MOR103): GlaxoSmithKline ATI-450 (Zunsemetinib/CDD-450): Aclaris Therapeutics Branebrutinib: Bristol Myers Squibb LY3462817: Eli Lilly and Company TAS5315: Taiho Pharmaceutical Rabeximod (Rob 803): Cyxone GS-5718: Gilead Sciences KPL-404: Kiniksa Pharmaceuticals MBS2320: Istesso AMT-101: Applied Molecular Transport Dazodalibep (HZN-4920): Horizon Therapeutics Cevidoplenib (SKI-O-703): Genosco/Oscotec HB-AdMSCs: Hope Biosciences ABX464: Abivax MPC-300-IV: Mesoblast PF-06650833: Pfizer JTE 051: Akros Pharma/Japan Tobacco Dekavil (F8IL10): Pfizer/Philogen ABBV-154: AbbVie PF-06651600 (Ritlecitinib): Pfizer AP1189: SynAct Pharma Learn more about the FDA-approved drugs for rheumatoid arthritis @ Drugs for Rheumatoid Arthritis Treatment Rheumatoid Arthritis Market Dynamics The dynamics of the rheumatoid arthritis market is anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading companies working in the rheumatoid arthritis market space. Moreover, current therapies, such as biological DMARDs, have shown promising results in treating rheumatoid arthritis patients, and market penetration is expected to increase in the future, driving rheumatoid arthritis market growth. Furthermore, there is still a high demand for therapies with a similar efficacy profile to current therapies but a better safety profile and a more patient-friendly RoA. Oral classes, such as JAKi and the upcoming BTKi, are expected to contribute to the rheumatoid arthritis market growth due to patient-friendly RoA. However, several factors are likely to hamper the rheumatoid arthritis market growth. The rheumatoid arthritis market is highly competitive, and new entrants are expected to face some resistance and low uptake because anti-TNFs currently dominate the rheumatoid arthritis market, and the entry of biosimilars will pose significant challenges to new and upcoming treatment options in the rheumatoid arthritis market. In addition, the entry of biosimilars has already begun in the US and EU (i.e., Remicade biosimilars), and as a result, sales value has started to decline. The impact will be more pronounced when biosimilars/ generics of some blockbuster drugs, such as Humira (i.e., 2023 in the US), Xeljanz (i.e., 2025 in the US), will enter the rheumatoid arthritis market, and this will significantly impact the growth of the rheumatoid arthritis market. Scope of the Rheumatoid Arthritis Market Report Therapeutic Assessment: Rheumatoid Arthritis current marketed and emerging therapies Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Rheumatoid Arthritis Market Access and Reimbursement Discover more about rheumatoid arthritis drugs in development @ Rheumatoid Arthritis Clinical Trials Table of Contents Related Reports Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products and the key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Juvenile Rheumatoid Arthritis Market Juvenile Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Psoriatic Arthritis Market Psoriatic Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market Related Healthcare Blogs Rheumatoid Arthritis Emerging Drugs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juvenile Idiopathic Arthritis Therapy Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Clinical Result

20 May 2021

·www.biospace.com

Global Roundup: Russia-Developed RA Drug Shows Significant Promise in Phase III Study

Russia-based R-Pharm Group announced a new rheumatoid arthritis (RA) drug, olokizumab, has been found to offer significant benefits to patients. Findings from the Phase III CREDO study were presented at the British Society of Rheumatology Annual Conference. The results showed significant improvements to the signs and symptoms of RA patients compared to those in the placebo and methotrexate group, not only in biologically naïve patients, but also among the difficult to treat population with active RA inadequately controlled by TNF-α inhibitor therapy, the company announced. Olokizumab is a monoclonal antibody specific for the interleukin-6 (IL-6) cytokine. It targets the IL-6 ligand rather than the receptor, and selectively blocks the final assembly of the signaling complex, the company announced. Olokizumab is the first direct inhibitor of interleukin-6 (IL-6) authorized for commercial use for this indication. Treatment with olokizumab was well-tolerated and consistent with the established safety profile of anti-IL-6 agents, the company announced. In May 2020, olokizumab received a market authorization from Russia’s Ministry of Health under the trade name "Artlegia." R-Pharm is currently establishing GMP-certified olokizumab production at facilities in France and Germany to enable prompt approval of the drug in the American and European markets. Elsewhere around the globe: IcanoMAB – Germany-based IcanoMAB received positive regulatory advice for the clinical development path of its anti-IL-1R7 antibody in late-stage COVID-19. IcanoMAB has published the pre-clinical proof-of-concept for the anti-IL-1R7 antibody that blocks the signal transduction of the interleukin-18 (IL-18) receptor. Recently, the company secured positive regulatory advice for its clinical development plan in late-stage COVID-19. IcanoMAB is currently entering discussions with interested parties for a development partnership of its anti IL-1R7 antagonist antibody. Memo Therapeutics – Switzerland’s Memo Therapeutics announced its COVID-19 antibody MTX-COVAB has shown efficacy against both the original virus as well as the UK variant (B.1.1.7). Memo is now preparing MTX-COVAB for clinical evaluation. Using its microfluidic, single-cell molecular cloning and screening technologies to enable antibody repertoire mining and antibody discovery, Memo can discover novel antibodies at unprecedented speed, efficiency and sensitivity derived from recovered patient samples. This approach has enabled the company to also identify a very promising antibody candidate against the South African variant (B.1.351). Sphere Fluidics – U.K.-based Sphere Fluidics, which develops single cell analysis systems, announced it has enhanced the capability and performance of its Cyto-Mine System. The updated design provides improvements that will help streamline workflows, reduce costs, increase throughput, and enable high-value clones to be captured in a single run, the company said. Cyto-Mine is an automated platform which integrates single cell screening, sorting, dispensing, imaging and clone verification. The new electronics design improves system performance, reliability, and stability, while the updated software features help to provide a better user experience, reduce user-instrument interaction, and allow for more robust data analysis. Holborn – Also based in the U.K., AI Solutions company Holborn will launch a dedicated business unit in India dubbed Holborn Wells India. Holborn said the launch is in response to an increasing need for “high-quality and cost-effective molecular In Vitro Diagnostics (IVD) in the country due to ongoing COVID-19 concerns.” Holborn Wells India will develop and deliver IVD products for infectious diseases by leveraging data and innovative diagnostic capabilities, with continued pressure on the nation’s health service as a result of the pandemic accelerating the need for operational capacity. Holborn Wells India already signed a deal with an Indian-based company to produce Holborn Wells’ IVD products in order to assist until a fully operational manufacturing location can be established. Milestone Pharmaceuticals – Canada’s Milestone Pharmaceuticals Inc. announced an exclusive license and collaboration with Shanghai-based Ji Xing Pharmaceuticals. The companies will develop and commercialize the investigational drug etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) and additional cardiovascular conditions in Greater China. Under terms of the deal, Milestone will receive an upfront cash payment consisting of $15 million and a $5 million equity investment. In addition, Milestone is eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China. BioMed X – Germany’s BioMed X extended its collaboration agreement with Merck. Under terms of the new agreement, Merck will start up to six additional research projects at the BioMed X Institute, building on ongoing research projects in the fields of oncology and autoimmunity. The next joint global crowdsourcing project will explore mechanisms of immune senescence and mitochondrial dysfunction in regulatory T cells and other T cell subsets that are shared in human autoimmunity and aging, BioMed X announced. Evolve Biologics – Canada-based Evolve Biologics Inc. selected DPR Construction to act as the General Contractor for construction of its new state-of-the-art commercial facility to be built in Texas. The new facility will produce plasma-derived therapeutics, initially Intravenous Immunoglobulin (IVIG) and Human Serum Albumin (HSA), using Evolve’s innovative and proprietary technology, PlasmaCap EBA. The company expects to break ground this summer. Owlstone Medical – Breath biopsy company Owlstone, based in the U.K., announced agreements with Functional Gut Clinic (FGC) and Functional Gut Diagnostics (FGD), leading providers of smart solutions for the diagnosis of gut health problems. The partnership will combine Owlstone’s expertise in breath-based testing with FGC and FGD’s leadership in digestive health, to strengthen the provision of efficient and high-quality at-home breath testing through a UK Lab Services Agreement and accelerate development of future breath tests in digestive health through a Collaboration Agreement. BD -- BD (Becton, Dickinson and Company) will build a €165 million ($200 million USD) high-tech manufacturing facility in Spain. When operational, the company said the site will employ up to 600 jobs by 2030. Construction is expected to begin later this year. The site will initially have a workforce of 150 people and encompass an area of 86,000 square feet. When fully operational in 2030, the facility will have an area of 323,000 square feet. Galapagos NV – Belgium-based Galapagos announced that the first patient has been enrolled in the FILOSOPHY Phase 4 European real-world outcomes study. The goal of the FILOSOPHY study is to advance understanding of the effectiveness and safety of filgotinib as it is used with patients with rheumatoid arthritis (RA) in clinical practice. Basilea Pharmaceutica International – Switzerland-based Basilea was awarded $2.7 million from CARB-X to develop a novel class of antibiotics to treat Gram-negative bacterial infections. Gram-negative bacteria, often called ‘superbugs’ because they have developed resistance at an alarming pace to existing antibiotics, kill an estimated 700,000 people each year around the world.

CollaborateAntibody

100 Deals associated with Olokizumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Olokizumab	-	DB13127

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	NDA/BLA	RU	R-Pharm Overseas, Inc.	30 Jan 2022
Neoplasms	Phase 2	HU	R-Pharm International, LLC	25 Jan 2017
Neoplasms	Phase 2	MX	R-Pharm International, LLC	25 Jan 2017
Neoplasms	Phase 2	PL	R-Pharm International, LLC	25 Jan 2017
Neoplasms	Phase 2	DE	R-Pharm International, LLC	25 Jan 2017
Neoplasms	Phase 2	US	R-Pharm International, LLC	25 Jan 2017
Neoplasms	Phase 2	CO	R-Pharm International, LLC	25 Jan 2017
Neoplasms	Phase 2	KR	R-Pharm International, LLC	25 Jan 2017
Neoplasms	Phase 2	CZ	R-Pharm International, LLC	25 Jan 2017
Neoplasms	Phase 2	BR	R-Pharm International, LLC	25 Jan 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04246762 (CTgov)	Phase 1	Rheumatoid Arthritis	17	Olokizumab	irltfmvmjs(bncbxbvcjp) = jpirxemjdz wadbaliims (lesmdnivmb, ajkoasnywk - mwnejmbpqt) View more	-	15 Aug 2024
NCT02760407 (CREDO-2, EULAR2023)	Phase 3	Charlson Comorbidity Index	1,402	Olokizumab	(njrgdgwbkm) = pmvksfhrkk kqbuglpnoe (abrznjyhrc ) View more	-	31 May 2023
				Adalimumab	(njrgdgwbkm) = vbzhseuetm kqbuglpnoe (abrznjyhrc ) View more
NCT03120949 (EULAR2023)	Phase 3	Rheumatoid Arthritis	2,104	Olokizumab 64mg q2w	zhpflkqzld(jgcykjsiqh) = fowumbhhsq czhdmmxsqj (tlzmzwpndk ) View more	-	31 May 2023
				Olokizumab 64mg q4w	zhpflkqzld(jgcykjsiqh) = paikztofoj czhdmmxsqj (tlzmzwpndk ) View more
NCT03120949 (CREDO 4, CTgov)	Phase 3	Rheumatoid Arthritis	2,106	Concomitant treatment+Olokizumab 64 mg SC q4w (Treatment Arm 1: OKZ 64 mg q4w + MTX)	(ebmzlybkzn) = jprankxqef mretcejmyv (uqxgrzptzh, xqfdigzwfi - nstxshvijm) View more	-	07 Jun 2022
				Concomitant treatment+Olokizumab 64 mg SC q2w (Treatment Arm 2: OKZ 64 mg q2w + MTX)	(ebmzlybkzn) = dbhwaqkobi mretcejmyv (uqxgrzptzh, pvuvzikabh - uhgjyrpivo) View more
NCT02760433 (CREDO 3, EULAR2022)	Phase 3	Rheumatoid Arthritis TNF-IR	368	Olokizumab 64mg q2w	(qhrrzdnunh) = exwdbabuoj ubmoonrijq (tueqvzxzbq ) View more	-	01 Jun 2022
				Olokizumab 64mg q4w	(qhrrzdnunh) = dbbflqwmlg ubmoonrijq (tueqvzxzbq ) View more
NCT02760407 (CREDO 2, EULAR2022)	Phase 3	Rheumatoid Arthritis	1,648	Olokizumab 64mg q2w	(jpoptovgoc): LSM difference = -0.03 (97.5% CI, -0.12 to 0.05)	Positive	01 Jun 2022
				Adalimumab 40mg q2w
NCT04380519 (CTgov)	Phase 2/3	COVID-19 \| Severe Acute Respiratory Syndrome	372	RPH-104 80 mg (RPH -104 80 mg)	dfyusfugvl(kzsgvrawfe) = exbpdxpybb yryzhqpccc (lopwzmbjzt, oakpkjfqhm - kujsswlnky) View more	-	24 Jan 2022
				Olokizumab 64 mg (Olokizumab 64 mg)	dfyusfugvl(kzsgvrawfe) = cklwhjjofd yryzhqpccc (lopwzmbjzt, lzhhavjpdp - bpmdadctqo) View more
NCT02760407 (CREDO 2 \| CREDO2 \| CREDO-2, CTgov)	Phase 3	Rheumatoid Arthritis	1,648	Methotrexate+Olokizumab (Arm 1: Olokizumab q4w + Methotrexate)	fbaohvihfn(wxbenxscmf) = vtowwueeoh fujgzqnzpo (ajvlspuiqh, wpjrmstxwe - edwdxcqept) View more	-	30 Apr 2021
				Methotrexate+Olokizumab (Arm 2: Olokizumab q2w + Methotrexate)	fbaohvihfn(wxbenxscmf) = tfkkxzqqox fujgzqnzpo (ajvlspuiqh, evxugrxteg - kcmmgirhdc) View more
NCT02760368 (CREDO 1 \| CREDO-1, CTgov)	Phase 3	Rheumatoid Arthritis	428	Methotrexate+Olokizumab (Arm 1: Olokizumab q4w + Methotrexate)	tjwgutvcoz(xifzrxhhef) = ucqvgliypd olxzyebppc (xhngcuprib, qcolvjzjkz - txtnimakka) View more	-	30 Oct 2020
				Methotrexate+Olokizumab (Arm 2: Olokizumab q2w + Methotrexate)	tjwgutvcoz(xifzrxhhef) = rwlvrqcldh olxzyebppc (xhngcuprib, mewvoqvpfq - umuhkxalzb) View more
EULAR2012	Not Applicable	Rheumatoid Arthritis CD161+ \| CD4+ \| CD45RO+ ... View more	81	anti-IL-6 (Untreated RA patients)	ipyyugfqmf(fyplfckudb) = tsqgzwqrzd pfqujlanyd (mqainyusrl )	-	06 Jun 2012
				anti-IL-6 (Healthy adults (HA))	ipyyugfqmf(fyplfckudb) = sqagpxdygq pfqujlanyd (mqainyusrl )

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis