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Respiratory Diseases

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Infectious Diseases	2
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Monoclonal antibody	2

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IL-33(Interleukin-33)	1
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评价与安慰剂相比，amlitelimab 对头发脱落 50% 或以上的斑秃（AA）成人受试者脱发再生的疗效。评价与安慰剂相比，amlitelimab 对头发脱落 50% 或以上的 AA 成人受试者的体征、症状和生活质量改善方面的疗效；评估 amlitelimab 治疗在 AA 受试者中的安全性和耐受性；表征 AA 受试者接受 amlitelimab SC 给药的 PK 特征；表征 AA 受试者接受 amlitelimab SC 给药的免疫原性。

[Translation]

To evaluate the efficacy of amlitelimab in regrowth of hair in adult subjects with alopecia areata (AA) who have lost 50% or more of their hair compared to placebo. To evaluate the efficacy of amlitelimab in improving signs, symptoms, and quality of life in adult subjects with AA who have lost 50% or more of their hair compared to placebo; To assess the safety and tolerability of amlitelimab treatment in AA subjects; To characterize the PK profile of amlitelimab SC-administered in AA subjects; To characterize the immunogenicity of amlitelimab SC-administered in AA subjects.

Start Date11 Oct 2024

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

[+2]

CTR20241770

/ RecruitingPhase 3

一项 Ⅲ 期、随机、双盲、安慰剂对照、平行组、3 组、多国家、多中心研究，旨在评价以外用糖皮质激素为背景治疗且对既往生物治疗或口服 Janus 激酶（JAK）抑制剂治疗反应不充分的 12 岁及以上中重度特应性皮炎（AD）受试者皮下接受 amlitelimab 治疗的疗效和安全性

[Translation] A phase III, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of subcutaneous amlitelimab in subjects aged 12 years and older with moderate to severe atopic dermatitis (AD) who were on background topical corticosteroids and had an inadequate response to previous biologic therapy or oral Janus kinase (JAK) inhibitor therapy

主要目的: 证明与安慰剂相比，以外用药为背景治疗且对既往生物治疗或口服 JAK 抑制剂（JAKi）治疗反应不充分的 12 岁及以上中重度特应性皮炎（AD）受试者接受 amlitelimab 给药的疗效。次要目的：评估与安慰剂相比，以外用药为背景治疗且对既往生物治疗或口服 JAKi 治疗反应不充分的 12 岁及以上中重度 AD 受试者接受 amlitelimab 给药对其体征、症状、生活质量和精神健康的影响。评估以外用药为背景治疗且对既往生物治疗或口服 JAKi 治疗反应不充分的 12 岁及以上中重度 AD 受试者接受 amlitelimab 给药的安全性特征。表征以外用药为背景治疗且对既往生物治疗或口服 JAKi 治疗反应不充分的 12 岁及以上中重度 AD 受试者接受 amlitelimab 给药的药代动力学特征。表征以外用药为背景治疗且对既往生物治疗或口服 JAKi 治疗反应不充分的 12 岁及以上中重度 AD 受试者接受 amlitelimab 给药的免疫原性。

[Translation]

Primary Objectives: To demonstrate the efficacy of amlitelimab compared to placebo in subjects 12 years and older with moderate to severe atopic dermatitis (AD) who have an inadequate response to prior biologic therapy or oral JAKi therapy and who are taking background therapy with topical medications. Secondary Objectives: To assess the effects of amlitelimab compared to placebo on signs, symptoms, quality of life, and mental well-being in subjects 12 years and older with moderate to severe AD who have an inadequate response to prior biologic therapy or oral JAKi therapy and who are taking background therapy with topical medications. To assess the safety profile of amlitelimab in subjects 12 years and older with moderate to severe AD who have an inadequate response to prior biologic therapy or oral JAKi therapy and who are taking background therapy with topical medications. To characterize the pharmacokinetic profile of amlitelimab in subjects 12 years and older with moderate to severe AD who have an inadequate response to prior biologic therapy or oral JAKi therapy and who are taking background therapy with topical medications. To characterize the immunogenicity of amlitelimab in subjects 12 years and older with moderate to severe AD who are on background therapy with exogenous medications and have an inadequate response to prior biologic or oral JAKi therapy.

Start Date13 Aug 2024

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

[+2]

CTR20212556

/ CompletedPhase 4

一项评价艾而赞®（拉罗尼酶）作为酶替代疗法在中国黏多糖贮积症I型（MPS I）受试者中的安全性和疗效的IV期、单臂、开放标签研究

[Translation] A Phase IV, single-arm, open-label study evaluating the safety and efficacy of Alejandro® (laronidase) as an enzyme replacement therapy in Chinese subjects with mucopolysaccharidosis type I (MPS I)

主要目的：评价艾而赞在中国MPS I受试者中的安全性和耐受性；评价艾而赞在中国MPS I受试者中治疗26周后对于尿糖胺聚糖（uGAG）的疗效。次要目的：评价在中国MPS I受试者中对于uGAG水平的作用；评价中国MPS I受试者接受艾而赞治疗后的肝脏体积（肝肿大）情况。

[Translation]

Primary objectives: To evaluate the safety and tolerability of Aleza in Chinese MPS I subjects; to evaluate the efficacy of Aleza on urinary glycosaminoglycans (uGAG) in Chinese MPS I subjects after 26 weeks of treatment. Secondary objectives: To evaluate the effect on uGAG levels in Chinese MPS I subjects; to evaluate the liver volume (hepatomegaly) of Chinese MPS I subjects after Aleza treatment.

Start Date28 Oct 2021

Sponsor / Collaborator

Genzyme Europe BV

[+3]

100 Clinical Results associated with Genzyme Ireland Ltd.

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0 Patents (Medical) associated with Genzyme Ireland Ltd.

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100 Deals associated with Genzyme Ireland Ltd.

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100 Translational Medicine associated with Genzyme Ireland Ltd.

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Pipeline

Pipeline Snapshot as of 10 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 3 Clinical

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