Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men

Tanaka, Shingo; Harada, Sayaka; Hiramatsu, Naoto; Nakaya, Ryou; Kawamura, Masaki

doi:10.5414/cp203235

Cited by 7 publications

(2 citation statements)

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“…Namilumab (formerly known as MT203), an IgG1-neutralizing anti-GM-CSF mAb, has been investigated in double-blind, placebo controlled, randomized trials in healthy individuals (NCT02354599) 206 and in RA patients (NCT01317797), 207 which established that namilumab has an acceptable tolerability profile. 206 , 207 Phase 1b (NCT01317797) and phase II studies (NCT02379091) in RA demonstrated efficacy, with the latter study further reporting dose-response effects. 207 , 208 A phase II trial investigating the efficacy of namilumab in plaque psoriasis was also completed (NCT02129777) with no significant difference being recorded for this end point between placebo-treated and namilumab-treated individuals.…”

Section: Clinical Studies With the Blockade Of Gm-csf And Its Receptomentioning

confidence: 99%

<p>GM-CSF: A Promising Target in Inflammation and Autoimmunity</p>

Lee¹,

Achuthan²,

Hamilton³

2020

ITT

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The cytokine, granulocyte macrophage-colony stimulating factor (GM-CSF), was firstly identified as being able to induce in vitro the proliferation and differentiation of bone marrow progenitors into granulocytes and macrophages. Much preclinical data have indicated that GM-CSF has a wide range of functions across different tissues in its action on myeloid cells, and GM-CSF deletion/depletion approaches indicate its potential as an important therapeutic target in several inflammatory and autoimmune disorders, for example, rheumatoid arthritis. In this review, we discuss briefly the biology of GM-CSF, raise some current issues and questions pertaining to this biology, summarize the results from preclinical models of a range of inflammatory and autoimmune disorders and list the latest clinical trials evaluating GM-CSF blockade in such disorders.

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Section: Clinical Studies With the Blockade Of Gm-csf And Its Receptomentioning

confidence: 99%

<p>GM-CSF: A Promising Target in Inflammation and Autoimmunity</p>

Lee¹,

Achuthan²,

Hamilton³

2020

ITT

View full text Add to dashboard Cite

show abstract

“…Namilumab is a fully human IgG1 monoclonal antibody that binds with high affinity to GM-CSF and neutralizes its function ( 225 , 226 ). It has been evaluated in patients with rheumatoid arthritis ( 227 , 228 ), plaque psoriasis ( 229 ) and in hospitalized patients with severe COVID-19 pneumonia ( 230 ).…”

Section: Studies In Pulmonary Sarcoidosismentioning

confidence: 99%

Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches

et al. 2022

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Sarcoidosis is a systemic granulomatous inflammatory disease of unknown etiology. It affects the lungs in over 90% of patients yet extra-pulmonary and multi-organ involvement is common. Spontaneous remission of disease occurs commonly, nonetheless, over 50% of patients will require treatment and up to 30% of patients will develop a chronic progressive non-remitting disease with marked pulmonary fibrosis leading to significant morbidity and death. Guidelines outlining an immunosuppressive treatment approach to sarcoidosis were recently published, however, the strength of evidence behind many of the guideline recommended drugs is weak. None of the drugs currently used for the treatment of sarcoidosis have been rigorously studied and prescription of these drugs is often based on off-label” indications informed by experience with other diseases. Indeed, only two medications [prednisone and repository corticotropin (RCI) injection] currently used in the treatment of sarcoidosis are approved by the United States Food and Drug Administration. This situation results in significant reimbursement challenges especially for the more advanced (and often more effective) drugs that are favored for severe and refractory forms of disease causing an over-reliance on corticosteroids known to be associated with significant dose and duration dependent toxicities. This past decade has seen a renewed interest in developing new drugs and exploring novel therapeutic pathways for the treatment of sarcoidosis. Several of these trials are active randomized controlled trials (RCTs) designed to recruit relatively large numbers of patients with a goal to determine the safety, efficacy, and tolerability of these new molecules and therapeutic approaches. While it is an exciting time, it is also necessary to exercise caution. Resources including research dollars and most importantly, patient populations available for trials are limited and thus necessitate that several of the challenges facing drug trials and drug development in sarcoidosis are addressed. This will ensure that currently available resources are judiciously utilized. Our paper reviews the ongoing and anticipated drug trials in sarcoidosis and addresses the challenges facing these and future trials. We also review several recently completed trials and draw lessons that should be applied in future.

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Developmental drugs for sarcoidosis

Obi,

Saketkoo,

Maier

et al. 2024

Journal of Autoimmunity

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Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men

Abstract: Namilumab was well tolerated in Japanese and Caucasian subjects; namilumab 150 mg had similar pharmacokinetics in both populations, supporting further clinical development of this dose. .

Cited by 7 publications

References 0 publications

<p>GM-CSF: A Promising Target in Inflammation and Autoimmunity</p>

<p>GM-CSF: A Promising Target in Inflammation and Autoimmunity</p>

Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches

Developmental drugs for sarcoidosis

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About

Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men

Abstract: Namilumab was well tolerated in Japanese and Caucasian subjects; namilumab 150 mg had similar pharmacokinetics in both populations, supporting further clinical development of this dose. .

Cited by 7 publications

References 0 publications

<p>GM-CSF: A Promising Target in Inflammation and Autoimmunity</p>

<p>GM-CSF: A Promising Target in Inflammation and Autoimmunity</p>

Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches

Developmental drugs for sarcoidosis

Contact Info

Product

Resources

About

Abstract: Namilumab was well tolerated in Japanese and Caucasian subjects; namilumab 150 mg had similar pharmacokinetics in both populations, supporting further clinical development of this dose. .