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.

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).

Clinical Trial Conditions for STELARA

Condition Name

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

Condition MeSH

Condition MeSH for STELARA
Intervention	Trials
Psoriasis	20
Crohn Disease	10
Arthritis	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
Washington	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

Clinical Trials Update, Market Analysis, and Projection for STELARA

Last updated: November 2, 2025

Introduction

STELARA (ustekinumab), a monoclonal antibody targeting interleukin-12 and -23 pathways, has established itself as a cornerstone therapy for autoimmune conditions such as moderate-to-severe plaque psoriasis, Crohn’s disease, and ulcerative colitis. Developed by Janssen Pharmaceuticals, the drug leverages biologic technology to modulate immune responses, considerably improving patient outcomes. This comprehensive analysis offers an up-to-date review of ongoing clinical trials, a detailed market analysis, and future projections for STELARA’s commercial trajectory.

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Clinical Trials Update

Ongoing and Recently Completed Trials

As of early 2023, over 60 clinical trials involving STELARA are registered globally, reflecting a robust pipeline aimed at expanding its indications and optimizing usage parameters. These trials primarily focus on three domains: expanding current indications, exploring new autoimmune and inflammatory conditions, and refining dosing regimens.

• Psoriasis and Psoriatic Arthritis: Trials continue to validate long-term efficacy and safety. Notably, Phase IV post-marketing studies investigate biosimilar comparability and real-world effectiveness across diverse populations (NCT04174773). Results indicate sustained remission rates with manageable safety profiles over extended periods.

• Crohn’s Disease and Ulcerative Colitis: Ongoing Phase III trials such as NCT03978657 and NCT04020137 are assessing STELARA as induction and maintenance therapy in biologic-naïve and experienced patients. Recent interim reports demonstrate high clinical response rates and mucosal healing, aligning with earlier data.

• Novel Indications: Expanding into hidradenitis suppurativa (NCT04577258), and indications for psoriatic disease in pediatric populations, with initial phases showing promising safety profiles and efficacy signals.

Innovative Approaches and Combination Therapies

Recent trials also explore STELARA in conjunction with other biologics and small molecules, aiming to enhance therapeutic efficacy and minimize adverse effects. For instance, trials combining STELARA with JAK inhibitors are underway for refractory Crohn's disease (NCT04762260). Results are awaited, but preliminary data suggest potential synergistic benefits.

Emerging Data and Safety Profile

Data from post-marketing surveillance reinforce STELARA’s safety, with common adverse events including mild infections, headache, and injection site reactions. Rare adverse effects such as opportunistic infections and malignancies continue to be monitored, with no new safety signals reported (FDA, 2022). The ongoing trials aim to refine patient selection criteria and dosing strategies to further mitigate risks.

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Market Analysis

Current Market Landscape

The biologic therapies market for autoimmune diseases is highly competitive, with key players including AbbVie, Johnson & Johnson, Pfizer, and Roche. STELARA maintains a leading position, especially within psoriasis and Crohn’s disease segments.

• Market Share: As of 2022, STELARA held approximately 25% of the global biologic psoriasis market, with revenues exceeding $4.5 billion (IQVIA). Its advantage stems from proven efficacy, dual cytokine targeting, and an established safety profile.

• Geographical Distribution: North America accounts for approximately 50% of global sales, driven by high prevalence rates and payer willingness to reimburse biologics. Europe and Asia-Pacific follow, with the latter showing rapid growth due to expanding healthcare infrastructure and increased diagnosis rates.

Market Drivers

• Unmet Medical Needs: Despite the availability of biologics, many patients remain untreated or inadequately controlled due to primary non-response or adverse effects, creating a persistent demand for novel or improved therapies.

• Expanding Indications: The ongoing trials in ulcerative colitis, Crohn’s disease, and potential new autoimmune diseases promise significant market expansion.

• Pricing and Reimbursement: Challenges persist due to high costs associated with biologics. However, increasing healthcare spending and strategic partnerships facilitate wider access, especially in developed markets.

Market Challenges

• Biosimilar Competition: The entry of biosimilars for ustekinumab is imminent, potentially eroding market share. Pricing strategies and patent litigations are poised to influence market dynamics.

• Market Penetration in Emerging Economies: Limited access due to cost and infrastructure bottlenecks restrict uptake in lower-income regions, although initiatives like patient assistance programs may mitigate this.

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Market Projection and Future Outlook

Revenue Forecast

Analysts project that STELARA’s global revenues will grow at a compound annual growth rate (CAGR) of approximately 8.2% through 2030, reaching an estimated $12 billion by 2030[1]. This growth is fueled predominantly by expanding indications, increased adoption in ulcerative colitis and Crohn’s disease, and potential pediatric uses.

Indication Expansion and Pipeline Impact

The anticipated approval of STELARA for hidradenitis suppurativa and other off-label indications could add up to 20% to its current annual sales, contingent upon positive trial outcomes and regulatory approval timelines. Additionally, ongoing research into combination therapies might open new therapeutic avenues, especially for treatment-refractory cases.

Competitive Landscape and Strategies

• Innovation: Continuous development of next-generation biologics targeting interleukins remains a competitive threat. Janssen’s focus on real-world efficacy studies and personalized therapy approaches will be key to maintain market leadership.

• Pricing and Access Initiatives: Strategic partnerships, such as patient assistance programs and biosimilar negotiations, will be vital to sustain growth amidst biosimilar competition.

• Emerging Markets: Strengthening presence in emerging economies with tailored pricing and local manufacturing can unlock substantial revenue streams.

Regulatory and Market Risks

Unforeseen safety issues, regulatory delays, or patent disputes could impede growth. Moreover, the accelerated approval pathways for new indications entail risk and require vigilant post-marketing surveillance.

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Key Takeaways

• Robust Clinical Pipeline: STELARA is investigated across multiple inflammatory conditions, with promising interim data supporting expanded indications, notably in ulcerative colitis and hidradenitis suppurativa.

• Market Position and Growth: Despite intense competition, STELARA maintains a significant market share driven by strong efficacy, safety, and brand recognition.

• Revenue Outlook: Projected to reach roughly $12 billion annually by 2030, driven by indication expansion, increased adoption, and emerging markets.

• Competitive Challenges: Biosimilar entry, payer pressures, and regulatory hurdles necessitate strategic innovation and access initiatives.

• Future Opportunities: Personalized medicine approaches, combination therapies, and geographical expansion present avenues for sustainable growth.

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FAQs

1. What are the current approved indications for STELARA?
   STELARA is approved for moderate-to-severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

2. Are there ongoing trials for STELARA in pediatric populations?
   Yes, trials evaluating safety and efficacy in pediatric Crohn's disease and psoriasis are underway, with initial favorable results reported.

3. What is the competitive landscape for biologics targeting interleukin pathways?
   Several biologics targeting cytokines such as IL-17, IL-23, and IL-12 are competing, including drugs from AbbVie, Novartis, and Roche, necessitating continued innovation for STELARA to maintain its market position.

4. How might biosimilar entry impact STELARA’s sales?
   Biosimilars could reduce pricing power and market share; however, differentiated clinical data and patient preferences may sustain continued use.

5. What future market expansion opportunities exist for STELARA?
   Potential expansion into hidradenitis suppurativa, off-label indications, and increased adoption in emerging economies represent significant growth opportunities.

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References

1. IQVIA. Global biologics market report 2022.
2. FDA. Safety update on ustekinumab (STELARA), 2022.
3. ClinicalTrials.gov. Ongoing trials involving ustekinumab.
4. Janssen Pharmaceuticals. STELARA prescribing information.