CLINICAL TRIALS PROFILE FOR USTEKINUMAB

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

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.

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

Condition MeSH

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

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

Trials by US State

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

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

Clinical Trial Status

Clinical Trial Status for ustekinumab
Clinical Trial Phase	Trials
Completed	59
Recruiting	37
Not yet recruiting	13

Clinical Trial Sponsors for ustekinumab

Sponsor Name

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

Sponsor Type

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

Ustekinumab Market Analysis and Financial Projection

Ustekinumab: A Comprehensive Overview of the Market, Clinical Trials, and Future Projections

Introduction to Ustekinumab

Ustekinumab, marketed under the brand name Stelara, is a monoclonal antibody that targets the interleukin-12 and interleukin-23 pathways. It is widely used for treating various autoimmune diseases, including moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis[1][3][4].

Market Size and Forecast

The ustekinumab market has been experiencing significant growth, driven by the increasing prevalence of autoimmune diseases. As of 2023, the market size was valued at USD 11.4 billion and is projected to reach USD 18.03 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.90% during the forecast period of 2024-2031[2][3][5].

Market Segmentation

By End-User

The ustekinumab market is segmented by end-users, including hospitals, specialty clinics, and homecare settings. Hospitals represent a significant portion due to their comprehensive patient management capabilities, while specialty clinics focus on specialized care in fields such as dermatology and rheumatology[2].

By Geography

The market is also segmented geographically into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America, particularly the United States, is a major market due to its strong healthcare infrastructure and high levels of research investment. Europe and the Asia-Pacific region are also significant, with the latter showing burgeoning growth due to rising incidences of autoimmune diseases and expanding healthcare access[2][3].

Key Players

The ustekinumab market is dominated by several major players, including AbbVie, Celltrion, Samsung Bioepis, Pfizer, Mylan, Lupin, BioXpress Therapeutics, Outlook Therapeutics, NeuClone, Formycon AG, and STADA Arzneimittel AG. These companies are involved in various strategies such as partnerships, collaborations, and the development of biosimilars to enhance market presence[2][3].

Biosimilars and Recent Approvals

The FDA has recently approved several biosimilars of ustekinumab, including ustekinumab-ttwe (Pyzchiva), ustekinumab-auub (Wezlana), and ustekinumab-aekn (Selarsdi). These biosimilars are expected to launch in the US market by early 2025, providing cost-effective alternatives and increasing accessibility for patients. Ustekinumab-ttwe, for instance, has been approved for all the same indications as the reference medication and has also been granted a provisional determination for interchangeability designation[1][4].

Clinical Trials and Efficacy

Ustekinumab has been extensively studied in clinical trials for its efficacy in treating various autoimmune diseases. It has shown significant therapeutic benefits by targeting the interleukin-12 and interleukin-23 pathways. Recent developments include expanded indications and ongoing clinical trials exploring its efficacy in other diseases, such as ankylosing spondylitis. The drug is also being investigated in combination with other therapies to enhance treatment outcomes in patients with complex autoimmune conditions[3].

Combination Therapies

Research indicates that using ustekinumab alongside conventional therapies or other biologics may lead to improved efficacy and reduced disease activity. This synergistic approach can address the multifaceted nature of autoimmune diseases, which often require a combination of therapeutic strategies for optimal management. By exploring various combination therapies, healthcare providers can offer more personalized treatment plans that cater to individual patient needs, ultimately improving quality of life[3].

Market Trends

Increasing Prevalence of Autoimmune Diseases

The ustekinumab market is evolving rapidly, fueled by the increasing prevalence rates of autoimmune diseases such as psoriasis, Crohn’s disease, and ulcerative colitis. This trend is expected to continue, driving the demand for innovative therapies like ustekinumab[3].

Advancements in Formulation and Delivery

Advancements in formulation and delivery methods are enhancing patient compliance and outcomes. For example, ustekinumab is available in various forms, including subcutaneous injections and intravenous infusions, which cater to different patient needs and preferences[1].

Telemedicine Integration

The integration of telemedicine is also a notable trend, especially in the context of managing chronic inflammatory conditions. Telemedicine can improve patient monitoring and adherence to treatment plans, which is crucial for the effective management of autoimmune diseases[3].

Challenges and Limitations

Despite the growth and positive trends, the ustekinumab market faces several challenges. Adverse effects such as seizures, vision changes, and difficulty in breathing are significant concerns that could hamper market growth. Additionally, economic factors, healthcare infrastructure challenges, and varying levels of regulatory approval in certain regions impact accessibility and market penetration[5].

Future Projections

The ustekinumab market is poised for continued expansion as healthcare providers increasingly recognize its potential to improve the quality of life for patients with complex autoimmune diseases. The launch of biosimilars, advancements in combination therapies, and improvements in patient monitoring and personalized medicine are expected to drive substantial growth in the market.

"The ustekinumab market is evolving rapidly, fueled by increasing prevalence rates of autoimmune diseases such as psoriasis, Crohn’s disease, and ulcerative colitis. This monoclonal antibody, effective in targeting interleukin-12 and interleukin-23, is gaining popularity for its significant therapeutic benefits and favorable safety profile."[3]

Key Takeaways

• The ustekinumab market is projected to grow from USD 11.4 billion in 2023 to USD 18.03 billion by 2031, with a CAGR of 5.90%.
• Biosimilars such as ustekinumab-ttwe, ustekinumab-auub, and ustekinumab-aekn are expected to launch in the US market by early 2025.
• The drug is approved for treating moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
• Combination therapies and advancements in formulation and delivery methods are enhancing patient outcomes.
• Increasing prevalence of autoimmune diseases and improvements in healthcare infrastructure are driving market growth.

FAQs

What are the primary indications for ustekinumab?

Ustekinumab is primarily indicated for treating adults with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. It is also approved for pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis[1].

What is the expected market size of ustekinumab by 2031?

The ustekinumab market is projected to reach USD 18.03 billion by 2031, growing at a CAGR of 5.90% during the forecast period of 2024-2031[2][3].

Which companies are major players in the ustekinumab market?

Major players include AbbVie, Celltrion, Samsung Bioepis, Pfizer, Mylan, Lupin, BioXpress Therapeutics, Outlook Therapeutics, NeuClone, Formycon AG, and STADA Arzneimittel AG[2][3].

What are the recent developments in ustekinumab biosimilars?

Several biosimilars, including ustekinumab-ttwe, ustekinumab-auub, and ustekinumab-aekn, have been approved by the FDA and are expected to launch in the US market by early 2025[1][4].

What are the potential challenges facing the ustekinumab market?

Adverse effects, economic factors, healthcare infrastructure challenges, and varying levels of regulatory approval in certain regions are significant challenges that could impact market growth[5].

How is the integration of telemedicine affecting the ustekinumab market?

Telemedicine is improving patient monitoring and adherence to treatment plans, which is crucial for the effective management of autoimmune diseases. This trend is expected to enhance patient outcomes and drive market growth[3].

Sources

1. Drug Topics: "Third Ustekinumab Biosimilar Gains FDA Approval"
2. Verified Market Research: "Ustekinumab Market Size, Scope, Share, Trends & Forecast"
3. Data Bridge Market Research: "Ustekinumab Market Size, Scope, Outlook & Growth Trends By 2031"
4. HCPLive: "New Presentation of Ustekinumab Biosimilar Approved for Crohn's, Ulcerative Colitis"
5. Allied Market Research: "Ustekinumab Market Size & Growth Forecast by 2030"