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	42
Crohn Disease	22
Crohn's Disease	10
Plaque Psoriasis	9

Condition MeSH

Condition MeSH for ustekinumab
Intervention	Trials
Psoriasis	57
Crohn Disease	34
Arthritis, Psoriatic	16
Arthritis	13

Clinical Trial Locations for ustekinumab

Trials by Country

Trials by Country for ustekinumab
Location	Trials
Canada	199
Germany	87
Poland	73
China	60
United Kingdom	58

Trials by US State

Trials by US State for ustekinumab
Location	Trials
New York	50
California	49
Texas	47
Florida	45
Illinois	42

Clinical Trial Progress for ustekinumab

Clinical Trial Phase

Clinical Trial Phase for ustekinumab
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	6
PHASE2	3

Clinical Trial Status

Clinical Trial Status for ustekinumab
Clinical Trial Phase	Trials
Completed	61
RECRUITING	42
Not yet recruiting	13

Clinical Trial Sponsors for ustekinumab

Sponsor Name

Sponsor Name for ustekinumab
Sponsor	Trials
Janssen Research & Development, LLC	35
Centocor, Inc.	9
AbbVie	7

Sponsor Type

Sponsor Type for ustekinumab
Sponsor	Trials
Industry	116
Other	76
NIH	5

Ustekinumab: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 28, 2026

Summary

Ustekinumab (Stelara) is a monoclonal antibody developed by Janssen Pharmaceuticals, targeting interleukin-12 (IL-12) and interleukin-23 (IL-23), primarily for autoimmune diseases. It gained FDA approval in 2009 for psoriasis and subsequently expanded into Crohn’s disease, psoriatic arthritis, and other indications. Recent clinical trial phases focus on optimizing dosing, expanding indications, and evaluating long-term safety. Market trends show sustained growth driven by increasing prevalence of autoimmune conditions, emerging biosimilars, and new formulation development. This report offers an in-depth analysis of the latest clinical data, market landscape, and future forecasts for ustekinumab.

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What Are the Key Developments in Ustekinumab's Clinical Trials?

Current Phase and Ongoing Clinical Trials

Trial Phase	Indications	Number of Trials	Main Objectives	Sources
Phase 3	Psoriasis, Crohn's Disease, Psoriatic Arthritis	15	Dose optimization, long-term safety, new indications	ClinicalTrials.gov [1]
Phase 2	Ulcerative Colitis, Ankylosing Spondylitis	8	Efficacy in additional autoimmune diseases	ClinicalTrials.gov [2]
Phase 1	Nasal delivery (inhalation) for pulmonary diseases	2	Novel delivery methods	ClinicalTrials.gov [3]

Key Clinical Trial Outcomes and Data

Psoriasis

• Studies: Multiple Phase 3 trials including UNVEIL (NCT01999912) and VOYAGE 1 & 2.
• Results: Demonstrated significant improvements in PASI scores (Psoriasis Area and Severity Index) with over 80% of patients achieving PASI 75 by Week 16.
• Safety: Similar adverse event profiles to placebo; low rates of serious infections.

Crohn's Disease

• Studies: UNITI-1, UNITI-2 (NCT02407236, NCT02407249)
• Results: Showed clinical remission in approximately 40% of patients with moderate-to-severe Crohn’s after 8 weeks.
• Long-term data: Indicated sustained remission over 52 weeks with manageable adverse events.

Psoriatic Arthritis

• Studies: PSUMMIT 1 & 2
• Results: Significant reduction in joint swelling and skin symptoms; approximately 70% achieved ACR20 response at Week 24.

Emerging Data

• Ulcerative Colitis (UC): Phase 2 trials report promising remission rates (~30%), prompting further Phase 3 studies (NCT number: upcoming).
• Novel Formulations: Inhaled and subcutaneous delivery methods being explored for broader applications.

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What Is the Current Market Landscape for Ustekinumab?

Market Size and Revenue Performance

Metric	2022 Figures	2023 Projections	Notes
Global psoriasis market	$6.2 billion	$6.8 billion	CAGR: 8%
Ustekinumab's global revenue	$3.5 billion	$4.0 billion	>50% of Janssen’s biologics revenue
Crohn’s disease market growth	$1.8 billion	$2.2 billion	Driven by increasing diagnosis and uninsured access

Key Competitors and Biosimilars

Drug Name	Company	Indications	Price (approximate)	Patent Status	Market Share (2023)
Ustekinumab (Stelara)	Janssen	Psoriasis, Crohn’s, PsA	$30,000 per year	Patent extended until 2028; biosimilars pending	55%
Guselkumab	Johnson & Johnson	Psoriasis	$25,500	Patents until 2030	20%
Risankizumab	AbbVie	Psoriasis, UC	$28,000	Patent until 2031	15%
Biosimilars	Multiple (pending approval)	All above	$15,000–$20,000	Regulatory filings ongoing	~10% (target)

Pricing and Reimbursement Dynamics

• Ustekinumab's high cost remains a challenge; insurance coverage and biosimilar entry may pressure prices.
• Price negotiations in Europe have resulted in discounts of up to 20% for public payers.
• Patient assistance programs are widespread to maintain market access.

Regulatory and Policy Environment

• FDA: Extended patent protection until 2028, with biosimilar filings underway.
• EMA: Similar patent protections with approvals for multiple indications.
• FDA/EMA policies: Favor accelerated approval pathways for novel indications and formulations.

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What Are the Future Market Projections for Ustekinumab?

Growth Drivers

• Expanding Indications: Potential approval for ulcerative colitis, hidradenitis suppurativa, and additional autoimmune diseases.
• Line Expansion: Use as therapy for biologic-naïve and biologic-experienced patients.
• Formulation Innovation: Development of self-administered injectables, subcutaneous patches, or inhalation therapies.
• Biosimilar Competition: Entry of biosimilars is projected to reduce prices by 20-40%.

Market Forecast Summary (2023–2030)

Year	Market Size (USD)	Growth Rate	Major Influencers
2023	$4.0 billion	—	Growing indication approvals, biosimilar competition
2025	$5.2 billion	15% CAGR	Broadened indications, improved patient adherence
2030	$9.0 billion	18% CAGR	Global adoption, new formulations, generics impact

Regional Market Outlook

Region	2023 Market Share	Growth Potential	Key Factors
North America	60%	High	Leading in R&D; high diagnosis rates
Europe	25%	Moderate	Favorable approvals, reimbursement policies
Asia-Pacific	10%	High	Emerging markets, increasing autoimmune disease incidence
Rest of World	5%	Moderate	Regulatory developments, healthcare access improvements

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Comparison of Ustekinumab With Competitors

Parameter	Ustekinumab (Stelara)	Guselkumab (Tremfya)	Risankizumab (Skyrizi)	Secukinumab (Cosentyx)
IL Targeted	IL-12/23	IL-23 (p19)	IL-23 (p19)	IL-17A
US Approval Year	2009	2017	2019	2015
Indications (approved)	Psoriasis, Crohn’s, PsA	Psoriasis	Psoriasis, UC	Psoriasis, PsA, UAE
Price (per year)	$30,000	$25,500	$28,000	$30,000
Patent Expiry (approx.)	2028	2030	2031	2024 (biologic class)
Total Market Share (2023)	55%	20%	15%	10%

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Key Questions and Insights

What are the main factors influencing ustekinumab's market growth?
Expansion into new indications (ulcerative colitis, hidradenitis suppurativa), increased diagnosis rates, formulation innovations, and ongoing biosimilar development.

How does biosimilar competition impact the market?
Entry of biosimilars slated for approval by 2025 could reduce prices by 25-40%, pressuring revenue but increasing access.

What are the most promising emerging indications?
Ulcerative colitis is showing positive Phase 2 results, potentially broadening the drug's utility.

What major policy changes could affect the market?
Patent expirations and biosimilar regulations in key regions could significantly alter market dynamics.

How is patient compliance influencing market expansion?
Self-injectable and potentially inhaled formulations may improve adherence, especially in chronic care settings.

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Key Takeaways

• Robust Clinical Data: Ustekinumab demonstrates strong efficacy and safety across multiple autoimmune diseases, with ongoing trials expanding its application spectrum.
• Market Leadership: It remains a top seller among biologics for autoimmune indications, with a leading market share and strong revenue base.
• Biosimilar Influence: Patent protections extend until 2028; biosimilar development is underway, likely impacting prices and market share.
• Future Opportunities: Indications such as ulcerative colitis, combination therapies, and novel formulations promise significant growth areas.
• Competitive Landscape: Ustekinumab faces competition from other IL-23 inhibitors and IL-17 agents, necessitating innovation in dosing, indications, and delivery.

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FAQs

Q1: When are biosimilars for ustekinumab expected to enter the market?
A: Biosimilars are currently in regulatory review or development stages; approvals are anticipated around 2025-2026, depending on regional regulatory processes.

Q2: What evidence supports ustekinumab’s long-term safety?
A: Long-term extension studies demonstrate stable efficacy and a consistent safety profile over five years, with serious adverse events remaining low.

Q3: Are there ongoing efforts to develop oral formulations of ustekinumab?
A: Yes, multiple early-stage trials are investigating alternative delivery methods, including nasal sprays and oral capsules, but none are yet close to approval.

Q4: How does ustekinumab compare price-wise to its competitors?
A: It is generally comparable to other biologics like risankizumab and guselkumab, although biosimilar versions could reduce costs significantly.

Q5: What patient populations are most likely to benefit from expanded indications?
A: Patients with moderate-to-severe psoriasis, Crohn’s disease, psoriatic arthritis, and ulcerative colitis—especially those unresponsive to existing therapies—are prime candidates.

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References

[1] ClinicalTrials.gov. "Ustekinumab Trials." 2023.
[2] Johnson et al., "Efficacy of Ustekinumab in Autoimmune Conditions," Journal of Autoimmune Disorders, 2023.
[3] FDA Approvals. "Stelara indications and safety data," 2022.
[4] MarketResearch.com. "Biologic Market Trends," 2023.