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Last Updated: May 10, 2021

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CLINICAL TRIALS PROFILE FOR CLAZAKIZUMAB

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Clinical Trials for Clazakizumab

Trial ID Title Status Sponsor Phase Summary
NCT02015520 Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis Completed Alder Biopharmaceuticals, Inc. Phase 2 The primary purpose of this study is to identify an appropriate dose of study medication.
NCT03444103 A Pilot Trial of Clazakizumab in Late ABMR Recruiting Charite University, Berlin, Germany Phase 2 This bi-center study (Medical University of Vienna & Charité Berlin) is an investigator-driven pilot trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of humanized anti-IL-6 monoclonal antibody clazakizumab in kidney transplant recipients with late antibody-mediated rejection (ABMR). The study is designed as a phase 2 trial and has two subsequent sub-parts, a randomized placebo-controlled trial (part A) of 12 weeks, where recipients are allocated to receive either anti-IL-6 antibody clazakizumab (n=10) or placebo (n=10), followed by an open-label prospective study, where all 20 study patients will receive clazakizumab for a period of 40 weeks. Study protocol biopsies will be performed at the end of part A and part B.
NCT03444103 A Pilot Trial of Clazakizumab in Late ABMR Recruiting University of Alberta Phase 2 This bi-center study (Medical University of Vienna & Charité Berlin) is an investigator-driven pilot trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of humanized anti-IL-6 monoclonal antibody clazakizumab in kidney transplant recipients with late antibody-mediated rejection (ABMR). The study is designed as a phase 2 trial and has two subsequent sub-parts, a randomized placebo-controlled trial (part A) of 12 weeks, where recipients are allocated to receive either anti-IL-6 antibody clazakizumab (n=10) or placebo (n=10), followed by an open-label prospective study, where all 20 study patients will receive clazakizumab for a period of 40 weeks. Study protocol biopsies will be performed at the end of part A and part B.
NCT03444103 A Pilot Trial of Clazakizumab in Late ABMR Recruiting Vitaeris INC Phase 2 This bi-center study (Medical University of Vienna & Charité Berlin) is an investigator-driven pilot trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of humanized anti-IL-6 monoclonal antibody clazakizumab in kidney transplant recipients with late antibody-mediated rejection (ABMR). The study is designed as a phase 2 trial and has two subsequent sub-parts, a randomized placebo-controlled trial (part A) of 12 weeks, where recipients are allocated to receive either anti-IL-6 antibody clazakizumab (n=10) or placebo (n=10), followed by an open-label prospective study, where all 20 study patients will receive clazakizumab for a period of 40 weeks. Study protocol biopsies will be performed at the end of part A and part B.
NCT03444103 A Pilot Trial of Clazakizumab in Late ABMR Recruiting Medical University of Vienna Phase 2 This bi-center study (Medical University of Vienna & Charité Berlin) is an investigator-driven pilot trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of humanized anti-IL-6 monoclonal antibody clazakizumab in kidney transplant recipients with late antibody-mediated rejection (ABMR). The study is designed as a phase 2 trial and has two subsequent sub-parts, a randomized placebo-controlled trial (part A) of 12 weeks, where recipients are allocated to receive either anti-IL-6 antibody clazakizumab (n=10) or placebo (n=10), followed by an open-label prospective study, where all 20 study patients will receive clazakizumab for a period of 40 weeks. Study protocol biopsies will be performed at the end of part A and part B.
NCT03744910 Interleukin 6 Blockade Modifying Antibody-Mediated Graft Injury and Estimated Glomerular Filtration Rate (eGFR) Decline Not yet recruiting ICON Clinical Research Phase 3 This trial investigates whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Clazakizumab

Condition Name

Condition Name for
Intervention Trials
COVID-19 2
COVID 2
Antibody-mediated Rejection 2
COVID19 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Infection 4
Asthma 1
Arthritis, Rheumatoid 1
Arthritis 1
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Clinical Trial Locations for Clazakizumab

Trials by Country

Trials by Country for
Location Trials
United States 33
Japan 7
Mexico 4
Austria 3
Canada 2
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Trials by US State

Trials by US State for
Location Trials
New York 3
Ohio 2
North Carolina 2
Massachusetts 2
Florida 2
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Clinical Trial Progress for Clazakizumab

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2/Phase 3 1
Phase 2 9
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 4
Completed 1
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Clinical Trial Sponsors for Clazakizumab

Sponsor Name

Sponsor Name for
Sponsor Trials
Vitaeris INC 3
NYU Langone Health 2
Medical University of Vienna 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 18
Industry 5
NIH 1
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Serving leading biopharmaceutical companies globally:

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Medtronic

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