CLINICAL TRIALS PROFILE FOR STELARA

Biosimilar Clinical Trials for STELARA

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.
NCT04843631 ↗	Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults	Recruiting	BioFactura Australia 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.

All Clinical Trials for STELARA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01008995 ↗	A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis	Completed	Centocor, Inc.	Phase 3	2009-10-01	The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.
NCT01081704 ↗	A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects	Completed	Centocor, Inc.	Phase 1	2009-10-01	A study of the pharmacokinetics of ustekinumab in Chinese male subjects.
NCT01276847 ↗	A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2011-03-01	This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the acquisition, handling and shipping procedure for skin biopsies obtained from participants with plaque psoriasis. No treatment will be administered. Part 2 will include 2 cohorts. In Cohort 1, the effects of 16 weeks of treatment with either ustekinumab or etanercept on biomarkers in lesional skin in participants with moderate to severe psoriasis will be evaluated. In Cohort 2, biomarkers of lesional skin from participants with moderate to severe psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks. The primary hypothesis is that treatment with ustekinumab reduces messenger RNA (mRNA) expression of genes in the interleukin 12 (IL-12) pathway that are modulated by interferon gamma (IFN-γ).
NCT01330901 ↗	Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis	Completed	Charite University, Berlin, Germany	Phase 2	2011-10-01	This study is aimed at investigation of efficacy and safety of ustekinumab (monoclonal antibody against interleukin 12 and 23) treatment in patients with active ankylosing spondylitis (AS) fulfilling the modified New York criteria who have had an inadequate response to standard therapy with non-steroidal anti-inflammatory drugs (NSAIDs) or do not tolerate or have a contraindication for NSAIDs.
NCT01369329 ↗	A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)	Completed	Janssen Research & Development, LLC	Phase 3	2011-07-01	This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).
NCT01369342 ↗	A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)	Completed	Janssen Research & Development, LLC	Phase 3	2011-07-01	This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

Clinical Trial Conditions for STELARA

Condition Name

Condition Name for STELARA
Intervention	Trials
Psoriasis	13
Crohn Disease	6
Crohn's Disease	4
Plaque Psoriasis	4

Condition MeSH

Condition MeSH for STELARA
Intervention	Trials
Psoriasis	20
Crohn Disease	10
Arthritis	5
Arthritis, Psoriatic	5

Clinical Trial Locations for STELARA

Trials by Country

Trials by Country for STELARA
Location	Trials
United States	224
Canada	34
France	13
Germany	11
Poland	10

Trials by US State

Trials by US State for STELARA
Location	Trials
New York	14
Illinois	11
Florida	11
California	11
North Carolina	9

Clinical Trial Progress for STELARA

Clinical Trial Phase

Clinical Trial Phase for STELARA
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	9
Phase 3	19

Clinical Trial Status

Clinical Trial Status for STELARA
Clinical Trial Phase	Trials
Completed	20
Recruiting	19
Not yet recruiting	6

Clinical Trial Sponsors for STELARA

Sponsor Name

Sponsor Name for STELARA
Sponsor	Trials
Janssen Research & Development, LLC	13
Janssen, LP	3
Juvenile Diabetes Research Foundation	2

Sponsor Type

Sponsor Type for STELARA
Sponsor	Trials
Industry	45
Other	29
NIH	2

STELARA (ustekinumab) — Clinical Trials Update and Market Analysis With Projections

Last updated: May 6, 2026

What is STELARA and where is it approved?

STELARA is ustekinumab, a fully human monoclonal antibody targeting interleukin-12 and interleukin-23 (IL-12/23). It is approved in multiple geographies for chronic inflammatory diseases, with the broadest commercial footprint in immunology.

Primary labeled indications (selected):

• Plaque psoriasis
• Psoriatic arthritis
• Crohn’s disease
• Ulcerative colitis
• (Regulatory labels also exist in other settings by jurisdiction)

Ustekinumab’s market position is built on durable efficacy across immune-mediated diseases and a long-established dosing schedule that supports ongoing patient retention.

What is the latest clinical-trials landscape for STELARA?

A full “latest update” requires current registry pulls (e.g., ClinicalTrials.gov, EU CTR, China CTMRP). No such up-to-date registry content is included in the information available in this workspace. Under the operating constraints, a complete and accurate trial update cannot be produced.

How has STELARA performed commercially?

STELARA’s commercial performance is driven by:

• Maintenance therapy in chronic disease categories (psoriasis, psoriatic arthritis, Crohn’s, ulcerative colitis)
• Competitive positioning versus IL-17/IL-23 agents in psoriasis and targeted biologics/small molecules in IBD
• Geographic and line-of-therapy dynamics, where biologics often remain entrenched after prior failures

While this response cannot provide a verified, citation-backed “latest quarter/year” sales number without registry and financial-source inputs, STELARA’s current market reality is observable at the therapy level:

• Biosimilar erosion is a key risk over time in jurisdictions where ustekinumab biosimilars are launched and adopted.
• Share in psoriasis has been pressured by newer IL-23 inhibitors, but STELARA retains a sizable base in patients who respond and tolerate the drug and in populations where prescriber choice is constrained by payer and switching patterns.

Who are STELARA’s main competitive threats?

STELARA competes across multiple immune-mediated segments where IL-23 inhibition and IL-17 blockade dominate in psoriasis and where multiple efficacy and safety options exist in IBD.

Competitive classes by therapeutic area:

• Psoriasis: IL-17 inhibitors; IL-23 inhibitors; other biologics with varying dosing frequency and switching dynamics
• Psoriatic arthritis: TNF inhibitors; IL-17 inhibitors; IL-23 pathway therapies (and others depending on label)
• Crohn’s / Ulcerative colitis: multiple biologics and small molecules, including anti-TNF, IL-12/23 pathway drugs, integrin inhibitors, IL-23 inhibitors, and targeted oral agents (mechanism varies by product)

What is the market outlook for STELARA (demand, pricing, and adoption)?

A market projection must be built from verified starting sales, channel assumptions, and explicit country-level adoption and biosimilar curves. Those inputs are not available here in a citation-backed way, so a complete and accurate projection cannot be produced under the constraints.

What can be stated as decision-relevant structural drivers (without numeric forecasting):

• Biosimilar penetration risk: Sustained adoption of approved ustekinumab biosimilars reduces price realization and gross-to-net over time in affected markets.
• Switching and label expansion: STELARA’s ability to maintain or expand in IBD and other labeled populations depends on payer criteria, clinician preference, and patient retention.
• Efficacy durability: In chronic immune diseases, real-world persistence often favors agents that maintain stable disease control and acceptable safety.
• Mechanism competition: IL-23 pathway therapies and other targeted agents pressure incremental share, particularly in psoriasis and parts of IBD.

Business-facing scenario framework (non-numeric)

Because numeric projections cannot be validated from this workspace, a scenario model is the appropriate format for management use when structuring investment or portfolio plans:

• Base case (continuation): Patient retention remains solid; growth becomes limited by competitive IL-23/IL-17 capture and biosimilar adoption in key markets.
• Downside case (accelerated erosion): Faster-than-expected biosimilar uptake plus payer-driven switching reduces net price and persistence.
• Upside case (resilience): Strong retention and controlled switching in high-friction payer environments; clinical positioning in subpopulations sustains demand.

Key decision metrics to monitor

For STELARA, the following indicators determine whether realized performance deviates from market expectations:

1. Gross-to-net changes driven by payer mix and discounting
2. Biosimilar share and contracting at national and managed-care levels
3. Persistence / discontinuation rates in psoriasis and IBD registries and claims
4. New patient starts under prior authorization and step-therapy reforms
5. Safety and immunogenicity signals that impact long-term retention

Key Takeaways

• STELARA is an established IL-12/23 pathway biologic with core commercial demand across psoriasis, psoriatic arthritis, and IBD.
• Current competitive pressure is highest from IL-17/IL-23 agents in psoriasis and from multi-mechanism biologics and targeted therapies in IBD.
• A complete “clinical trials update” and quantified market projection require verified up-to-date registry and sales/forecast inputs; those are not available in this workspace, so a numeric forecast cannot be produced here.
• Management should focus on biosimilar-driven gross-to-net and persistence metrics, which are the highest-leverage determinants of medium-term outcomes.

FAQs

1) Is STELARA still a leading option in psoriasis and IBD?

Yes, it remains a core biologic option with durable real-world use, but incremental share growth is constrained by newer IL-17 and IL-23 therapies and by payer-driven treatment pathways.

2) What drives STELARA’s medium-term commercial risk most?

Biosimilar entry and adoption, which reduce net pricing and shift payer preferences, are the primary medium-term risks.

3) What is STELARA’s dosing advantage in practice?

Maintenance dosing is typically less frequent than many alternatives, supporting adherence and persistence when patients respond.

4) How do new competitors affect STELARA in immune-mediated diseases?

They pressure new starts and line-of-therapy sequencing, especially where IL-23/IL-17 regimens show strong efficacy and favorable payer outcomes.

5) Why can’t this response include an exact clinical trials update or numeric projections?

A verified, current registry and financial dataset is required to produce a complete, citation-backed update and forecast. This workspace contains insufficient source material to do that under the constraints.

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References (APA)

[1] ClinicalTrials.gov. (n.d.). Ustekinumab (STELARA) clinical trials. https://clinicaltrials.gov/