A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX).

Start Date29 Sep 2017

Sponsor / Collaborator

Astellas Pharma, Inc.

NCT02698657 / CompletedPhase 1

A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid arthritis (RA) on methotrexate (MTX).

Start Date23 Feb 2016

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

100 Clinical Results associated with ASP-5094

100 Translational Medicine associated with ASP-5094

100 Patents (Medical) associated with ASP-5094

Literatures (Medical) associated with ASP-5094

01 Dec 2020·Arthritis Research & TherapyQ2 · MEDICINE

ASP5094, a humanized monoclonal antibody against integrin alpha-9, did not show efficacy in patients with rheumatoid arthritis refractory to methotrexate: results from a phase 2a, randomized, double-blind, placebo-controlled trial

Q2 · MEDICINE

ArticleOA

Author: Saito, Masako ; Higashitani, Chieri ; Erdman, Jay ; Lademacher, Christopher ; Takeuchi, Tsutomu ; Smulders, Ronald ; Tanaka, Yoshiya ; Kaneko, Yuichiro

AbstractBackgroundRheumatoid arthritis (RA) is a chronic, debilitating autoimmune condition characterized by joint synovial inflammation. Current treatments include methotrexate (MTX), biologic agents, and Janus kinase (JAK) inhibitors. However, these agents are not efficacious in all patients and there are concerns regarding side effects and risk of infection as these treatments target immune-related pathways. Overexpression and activation of integrin alpha-9 (α9) on fibroblast-like synoviocytes are associated with RA disease onset and exacerbation. The humanized immunoglobulin G1 monoclonal antibody ASP5094 was designed to inhibit human α9 and is currently under investigation for the treatment of RA.MethodsThis phase 2a, multicenter, randomized, placebo-controlled, double-blind, parallel-group study (NCT03257852) evaluated the efficacy, safety, and biological activity of intravenous ASP5094 10 mg/kg in patients with moderate to severe RA that was refractory to MTX. Patients received ASP5094 or placebo every 4 weeks for a total of three administrations. Both treatment groups used concomitant MTX. The primary efficacy endpoint was the proportion of patients who responded per American College of Rheumatology 50% improvement using C-reactive protein (ACR50-CRP) after 12 weeks of treatment. Biological activity of ASP5094 was assessed via pharmacokinetics and pharmacodynamics of known downstream effectors of α9. Safety was also assessed.ResultsSixty-six patients were enrolled and randomized to placebo (n = 33) or ASP5094 (n = 33). In the primary efficacy analysis, ACR50-CRP response rates were 6.3% and 18.2% at week 12 in the ASP5094 and placebo groups, respectively; a difference of − 11.9, which was not significant (2-sided P value = 0.258). No trends in ACR50 response rates were observed in subgroups based on demographics or baseline disease characteristics, and no significant differences between placebo and ASP5094 were identified in secondary efficacy or pharmacodynamic endpoints, despite achievement of target serum concentrations of ASP5094. Most treatment-emergent adverse events were mild to moderate in severity, and ASP5094 was considered safe and well tolerated overall.ConclusionAlthough no notable safety signals were observed in this study, ASP5094 was not efficacious in patients with moderate to severe RA with an inadequate response to MTX.Trial registrationClinicalTrials.gov, NCT03257852. Registered on 22 Aug. 2017

100 Deals associated with ASP-5094

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	JP	Astellas Pharma, Inc.	29 Sep 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03257852 (Pubmed \| J Rheumatol)	Phase 2	Rheumatoid Arthritis	66	ASP5094 10mg/kg	zddckaurhe(dzidfwqojk) = udjqewwduy ttantahvws (pdzcmiaujz )	Negative	21 Oct 2020
				Placebo	zddckaurhe(dzidfwqojk) = sbwuqbaqnd ttantahvws (pdzcmiaujz )

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