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Last Updated: May 21, 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
>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.
>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
Psoriatic Arthritis 8
Crohn's Disease 8
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Condition MeSH

Condition MeSH for ustekinumab
Intervention Trials
Psoriasis 54
Crohn Disease 28
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 957
Canada 190
Germany 73
Poland 61
France 53
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Trials by US State

Trials by US State for ustekinumab
Location Trials
New York 45
California 45
Texas 43
Florida 42
Illinois 39
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Clinical Trial Progress for ustekinumab

Clinical Trial Phase

Clinical Trial Phase for ustekinumab
Clinical Trial Phase Trials
Phase 4 16
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 36
Not yet recruiting 13
[disabled in preview] 8
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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 109
Other 62
NIH 5
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