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Last Updated: November 14, 2024

CLINICAL TRIALS PROFILE FOR USTEKINUMAB


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Biosimilar Clinical Trials for ustekinumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT04595409 ↗ A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis Active, not recruiting Bioeq GmbH Phase 3 2020-11-09 This is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, and immunogenicity of FYB202 compared to Stelara® in patients with Moderate-to-Severe Plaque Psoriasis.
NCT04744363 ↗ Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab) Recruiting Iqvia Pty Ltd Phase 1 2021-05-25 Protocol Title: A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects Short Title: A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects Rationale: Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.
NCT04744363 ↗ Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab) Recruiting Alvotech Swiss AG Phase 1 2021-05-25 Protocol Title: A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects Short Title: A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects Rationale: Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.
NCT04772274 ↗ A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects Recruiting Samsung Bioepis Co., Ltd. Phase 1 2021-02-04 This is a randomised, double-blind, three-arm, parallel group, single-dose study to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 compared to EU sourced Stelara® and US sourced Stelara® in healthy subjects
NCT04843631 ↗ Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults Recruiting Avance Clinical Pty Ltd. Phase 1 2021-04-01 BFI-751 is being developed by BioFactura Australia Pty Ltd as a biosimilar drug to Stelara® (EU licenced and US licenced) (ustekinumab) is a prescription biologic medicine used to treat people with Crohn's disease, Ulcerative Colitis, plaque psoriasis and psoriatic arthritis. Stelara® is an immune suppressant that reduces the effects of inflammatory proteins within the body. This is the first time BFI-751 will be given to humans. The primary purpose of this study is to compare the pharmacokinetics (the study of what the body does to the drug, referring to the movement of any drug going into, through, and out of the body) by checking to see if the blood levels of 751-BFI are comparable with US-Stelara® and EU-Stelara® following a single injection under the skin. The secondary purposes of this study are: - to assess the safety of BFI-751, - study how well the healthy volunteers tolerate it and - to also assess the immune response to it in healthy volunteers.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ustekinumab

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00265122 ↗ A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease Completed Centocor, Inc. Phase 2 2004-04-01 The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
NCT00267956 ↗ An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis Completed Centocor, Inc. Phase 2 2005-12-01 The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.
NCT00267969 ↗ A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis Completed Centocor Research & Development, Inc. Phase 3 2005-12-01 The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.
NCT00307437 ↗ A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis Completed Centocor Research & Development, Inc. Phase 3 2005-05-01 The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.
NCT00320216 ↗ A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis Completed Centocor, Inc. Phase 2 2003-11-01 The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ustekinumab

Condition Name

Condition Name for ustekinumab
Intervention Trials
Psoriasis 40
Crohn Disease 18
Crohn's Disease 9
Psoriatic Arthritis 8
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Condition MeSH

Condition MeSH for ustekinumab
Intervention Trials
Psoriasis 54
Crohn Disease 29
Arthritis, Psoriatic 14
Arthritis 13
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Clinical Trial Locations for ustekinumab

Trials by Country

Trials by Country for ustekinumab
Location Trials
United States 958
Canada 190
Germany 73
Poland 61
France 53
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Trials by US State

Trials by US State for ustekinumab
Location Trials
California 45
New York 45
Texas 43
Florida 42
Illinois 40
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Clinical Trial Progress for ustekinumab

Clinical Trial Phase

Clinical Trial Phase for ustekinumab
Clinical Trial Phase Trials
Phase 4 17
Phase 3 51
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for ustekinumab
Clinical Trial Phase Trials
Completed 59
Recruiting 37
Not yet recruiting 13
[disabled in preview] 16
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Clinical Trial Sponsors for ustekinumab

Sponsor Name

Sponsor Name for ustekinumab
Sponsor Trials
Janssen Research & Development, LLC 33
Centocor, Inc. 9
AbbVie 7
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Sponsor Type

Sponsor Type for ustekinumab
Sponsor Trials
Industry 110
Other 62
NIH 5
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