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
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.
NCT04930042 ↗	Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis	Active, not recruiting	Alvotech Swiss AG	Phase 3	2021-06-03	Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

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.
NCT00508547 ↗	Psoriasis Longitudinal Assessment and Registry (PSOLAR)	Active, not recruiting	Janssen Scientific Affairs, LLC	Phase 4	2007-06-01	The purpose of this study is to further evaluate the safety of infliximab and ustekinumab in patients with plaque psoriasis, and other all forms of psoriasis (such as plaque psoriasis and psoriatic arthritis occurring together). The registry study will track the behavior of the disease in response to other therapies, such as other biologic drugs. The registry will also evaluate clinical outcomes; disease characteristics, including physician reported assessment of psoriatic arthritis (PsA); quality of life, and potential risks for patients who may receive standard therapies for psoriasis.
NCT00723528 ↗	An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis	Completed	Janssen Pharmaceutical K.K.	Phase 3	2008-03-01	The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type 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 Projection

Last updated: April 26, 2026

What is ustekinumab and where is it approved?

Ustekinumab (UST) is an IL-12/23 monoclonal antibody developed and marketed by Janssen (Johnson & Johnson). It is approved for multiple chronic inflammatory and autoimmune indications, with the largest commercial footprint tied to inflammatory bowel disease, psoriasis, and psoriatic arthritis. In the US, Janssen labels ustekinumab for:

• Crohn’s disease (adult and pediatric)
• Ulcerative colitis (adult and pediatric)
• Moderate-to-severe plaque psoriasis (adult and pediatric)
• Psoriatic arthritis
• Ankylosing spondylitis is not listed in US prescribing information for ustekinumab; separate IL-17/IL-23 or TNF agents cover that space depending on geography.

Ustekinumab’s clinical strategy has focused on expanding across IBD and maintaining durability through switching, treat-to-target pathways, and maintenance dosing.

Key product dosing (general clinical framing):

• Crohn’s disease/Ulcerative colitis: induction then maintenance dosing schedules depending on baseline weight and prior therapy.
• Psoriasis/Psoriatic arthritis: fixed dosing with periodic re-dosing; individualized adjustments are used in practice.

(Clinical trial landscape and endpoints below reflect the ongoing and post-approval evidence base; the market analysis reflects current commercial structure and pipeline dynamics.)

What do the latest clinical trials signal for ustekinumab?

A practical way to interpret the current clinical picture is by tracking (1) confirmatory and label-support studies in IBD and psoriasis, (2) head-to-head or comparative effectiveness narratives versus IL-23p19 competitors, and (3) long-term extension data that supports durability and safety continuation.

IBD: Crohn’s disease and ulcerative colitis

Ustekinumab’s IBD evidence base is anchored by the pivotal induction and maintenance trials that established its role as an effective option after anti-TNF exposure and as a later-line biologic in many treatment algorithms. The contemporary clinical update is less about new foundational efficacy claims and more about:

• Durability of response under maintenance (sustained clinical remission and endoscopic improvement over time)
• Safety continuity in extension cohorts
• Comparative positioning vs IL-23 inhibitors (ustekinumab is generally treated as a solid efficacy option with a different safety and onset profile compared with IL-23 agents)
• Real-world sequencing (switching from anti-TNF to IL-12/23 is common; subsequent switching after IL-23 failure is also common)

Psoriasis and psoriatic arthritis

In psoriasis, ustekinumab competes in a crowded biologics and small-molecule landscape. Clinical updates emphasize:

• Long-term persistence of response
• Safety and tolerability in chronic use
• Maintenance across dosing intervals and management of loss of response
• Skin and joint composite outcomes in psoriatic disease management

What endpoints matter for decision-making now?

For investors and pipeline teams, the decision criteria driving use and reimbursement are:

• Endoscopic response and remission in IBD, plus durability on maintenance
• sustained PASI responses in psoriasis and disease activity indices in psoriatic arthritis
• Safety continuity (infection profile, immunogenicity signals)
• Treatment sequencing outcomes (whether ustekinumab retains value after other biologics)

What is the active trial pattern for late-stage evidence?

The current clinical trial pattern for mature biologics typically falls into:

• Long-term extension and registry evidence rather than new Phase 3 registration-grade programs
• Comparative, pragmatic studies that inform place-in-therapy and payer acceptance
• Subpopulation analyses tied to prior biologic exposure and comorbid risk profiles

A current market-relevant conclusion is that ustekinumab’s clinical strategy is increasingly evidence-maintenance rather than label-expansion at the highest level of trial novelty.

Sources: Janssen product label and trial program context via FDA label and registrational study records [1,2].

How is the market for ustekinumab structured today?

Commercial positioning

Ustekinumab sits in the mid-to-high efficacy tier of biologic therapy with broad indication coverage. The market is shaped by:

• Inflammatory bowel disease: a large and expanding biologics class; treatment algorithms emphasize anti-TNF and IL-23 agents, with ustekinumab remaining an established option.
• Psoriasis and psoriatic arthritis: high volume, strong payer pressure, and rapid competitive switching due to expanding IL-23 and IL-17 options.
• Biologic channel dynamics: biosimilar penetration in some classes pressures net pricing; ustekinumab’s direct biosimilar exposure varies by region and timing.

Pricing and channel effects

Net pricing and unit volume growth hinge on:

• Patient selection (anti-TNF inadequate responders versus biologic-naïve selection depending on guideline and payer criteria)
• Switching velocity to newer IL-23 inhibitors
• Reimbursement restrictions tied to prior biologic exposure and objective disease criteria
• Biosimilar effects across the broader biologics category (even when ustekinumab is not biosimilar-exposed, biosimilar pressure can shift sequencing)

Competitive set (clinical class and practical switching behavior)

Ustekinumab competes directly and indirectly with:

• IL-23 inhibitors (strong efficacy and rapid adoption)
• IL-17 agents in psoriasis and psoriatic arthritis
• Anti-TNF bios and innovator biologics as first-line or early-line in many algorithms
• Small molecules (for psoriasis in some systems; IBD oral pipeline competition changes channel economics even when biologics dominate)

The key competitive mechanism is sequencing: when IL-23 agents are preferred for biologic-naïve or early-line use, ustekinumab tends to capture a larger share of later-line or biologic-experienced cohorts, depending on payer policy and real-world practice.

Sources: FDA label and program data supporting established efficacy across indications [1,2].

What are market assumptions that drive projection?

A robust projection model for ustekinumab is built on five measurable drivers:

1. Indication mix (IBD versus psoriasis versus psoriatic arthritis)
2. Share dynamics versus IL-23 (speed and depth of switching)
3. Biosimilar and class pricing pressure (affecting net price and payer restrictions)
4. Patient persistence (durability and discontinuation risk)
5. Pediatric penetration (where label and payer pathways support growth)

Base-case logic for growth

For mature biologics with stable safety and sustained efficacy:

• Unit growth is constrained by competitive switching and payer step edits.
• Revenue growth can continue if (a) persistence is strong, (b) sequencing retains a portion of later-line cohorts, and (c) price hold is maintained where biosimilar pressure is less direct.

Downside logic

• Faster adoption of IL-23 first-line in IBD and earlier-line psoriasis/psoriatic arthritis reduces incident and switching intake for ustekinumab.
• More restrictive payer policies tied to objective biomarkers (endoscopy, CALM measures, PASI response requirements) can reduce eligible volume.

Upside logic

• Demonstrated durable endoscopic remission and sustained PASI response in real-world cohorts can improve payer comfort and persistence.
• Clinical differentiation based on safety or patient-specific response patterns can stabilize share.

Sources: FDA label for clinical indications and dosing basis [1].

Revenue and unit projection for ustekinumab: base, bull, bear

Because the drug is commercial and widely sold, any projection must be framed as scenario-based and dependent on executable assumptions (market share, pricing, persistence). Below is a structured projection framework suitable for investment and R&D planning. It does not attempt to publish proprietary company revenue figures; it expresses market-level directional outcomes using industry-standard scenario mechanics.

Projection framework (directional, scenario-based)

Base case (most likely):

• Low single-digit CAGR in revenue over the projection window, driven by continued persistence in IBD and stable psoriasis share with gradual competitive erosion.

Bull case:

• Mid single-digit CAGR if ustekinumab maintains share in biologic-experienced IBD cohorts and holds psoriasis/psooriatic arthritis with better persistence and payer acceptance, offsetting some IL-23 substitution.

Bear case:

• Flat to negative CAGR if IL-23 continues rapid substitution and payer restrictions tighten eligibility for ustekinumab, accelerating loss of patients and compressing net price.

Key quantitative levers to monitor (quarterly)

• Net pricing changes driven by class competition and biosimilar environment
• Persistence and discontinuation rates by indication and line of therapy
• Share of switch initiations after IL-23 exposure or after anti-TNF failure
• Payer approvals and denial rates tied to objective disease metrics

What the clinical evidence implies for these levers

The FDA label establishes the drug’s indication breadth and clinical rationale; the market implication is that ustekinumab can retain usage when patients need a proven, durable biologic option across multiple chronic inflammatory disease settings [1]. Sustained maintenance dosing supports persistence as a commercial lever if real-world discontinuation stays low.

Sources: FDA prescribing information and supported clinical indication set [1].

What do investors watch in the clinical trial pipeline?

For a mature biologic like ustekinumab, the most decision-relevant “clinical trial update” signals come from:

• Long-term extension and real-world registry expansions that validate durability, safety, and persistence
• Subgroup analyses tied to prior biologic exposure and baseline severity
• Comparative effectiveness studies that inform switching and payer justification
• Any new label-support trials that would expand use into new patient segments or earlier lines

At present, the value signal is that ustekinumab retains a clinically established position across IBD and psoriasis, with ongoing evidence support through label and trial program publications rather than frequent high-impact new registration trials [1,2].

Key Takeaways

• Ustekinumab is a mature IL-12/23 biologic with an entrenched cross-indication presence, anchored in FDA-approved use for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis [1].
• The current clinical update is dominated by evidence durability, safety continuity, and real-world effectiveness rather than new broad Phase 3 breakthroughs.
• Market growth is likely to be scenario-dependent and constrained by IL-23 inhibitor substitution pressure, with the biggest swing factors being persistence, payer criteria, and sequencing dynamics across IBD and psoriasis.
• Base case expectations skew toward low single-digit revenue growth; bull outcomes require stable persistence and resilient payer access; bear outcomes follow accelerated switching to newer IL-23 therapies and tighter eligibility constraints.

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FAQs

1) Which approved indications drive ustekinumab’s largest addressable markets?

Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis, and psoriatic arthritis are the core approved indications supporting volume and revenue allocation [1].

2) What clinical endpoint set most strongly influences reimbursement for ustekinumab?

For IBD and psoriasis, payers typically focus on objective disease improvement over time: endoscopic response/remission for IBD and validated composite clinical response measures (such as PASI) for psoriasis, aligned with label-supported clinical outcomes [1,2].

3) How does ustekinumab generally compete versus IL-23 inhibitors?

Competition is primarily sequencing-based: IL-23 inhibitors often capture early-line or biologic-naïve growth, while ustekinumab retains share in biologic-experienced cohorts depending on payer policy and clinician preference anchored to durability and safety [1].

4) Does ustekinumab’s long-term safety profile influence its market resilience?

Yes. Mature biologics with label-backed long-term use often maintain persistence when safety signals remain stable, which supports continuing patient retention and payer acceptance [1].

5) What is the most important market metric to track next for projections?

Patient persistence and discontinuation by indication and line of therapy, because it controls whether unit share erosion translates into flat or declining revenues under competitive substitution [1].

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References

[1] U.S. Food and Drug Administration. (2024). Stelara (ustekinumab) prescribing information. FDA.
[2] PubMed. (n.d.). Registrational studies of ustekinumab in Crohn’s disease, ulcerative colitis, and psoriasis (trial publications and abstracts). National Library of Medicine.