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
Phase 4	9
Phase 3	19
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for STELARA
Clinical Trial Phase	Trials
Recruiting	19
Completed	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
Alvotech Swiss AG	2

Sponsor Type

Sponsor Type for STELARA
Sponsor	Trials
Industry	44
Other	29
NIH	2

STELARA (Ustekinumab): Clinical Trials, Market Analysis, and Projections

Introduction to STELARA

STELARA, also known as ustekinumab, is a prescription medicine approved for the treatment of various autoimmune diseases, including moderately to severely active Crohn's disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. Since its introduction in 2009, it has been a cornerstone in the treatment of these inflammatory conditions.

Clinical Trials and Safety Profile

Clinical Trials Overview

STELARA has undergone extensive clinical trials to assess its efficacy and safety. For instance, in the treatment of Crohn's disease (CD) and ulcerative colitis (UC), STELARA was evaluated in several phase 2 and 3 studies. These studies included randomized, double-blind, placebo-controlled trials such as the UNITI-1 and UNITI-2 induction studies, followed by the IM-UNITI maintenance study and its long-term extension[1].

Safety Profile

The safety of STELARA has been closely monitored, particularly regarding the occurrence of malignancies. Data from clinical trials and observational studies, such as the PSOLAR registry, indicate that the incidence of all malignancies, including nonmelanoma skin cancer (NMSC), is within a manageable range. For example, in psoriasis indications, the incidence of all malignancies was 1.27 per 100 patient-years (95% CI: 1.06-1.51)[1].

Long-Term Safety

Long-term safety analyses, such as the 2011 Safety Analysis and subsequent reports, have shown that the safety profile of STELARA remains stable over time. Studies like those conducted by Hanauer et al. and Sandborn et al. have evaluated the long-term efficacy and safety of STELARA up to 5 years, confirming its consistent safety profile[1].

Market Analysis

Current Market Position

STELARA is one of Johnson & Johnson's most successful drugs, with sales reaching $9.7 billion in 2022. It is a critical treatment for various inflammatory conditions and holds a significant position in the market for autoimmune disease treatments[2].

Impact of Biosimilars

The landscape for STELARA is set to change significantly with the introduction of biosimilars. As of late 2024, six biosimilars have been approved by the FDA, with several more pending approval. The first biosimilar, Wezlana, is expected to launch in January 2025, followed by others in the second half of 2025[4][5].

Market Projections

Analysts predict that the launch of biosimilars will impact STELARA's sales. Despite this, Johnson & Johnson is expected to maintain significant revenue from STELARA. Sales are projected to decrease from $9.9 billion in 2023 to around $7.5 billion in 2024 and $5.4 billion in 2025. However, the company's overall drug sales are still forecasted to reach $57 billion by 2025, thanks in part to the delayed entry of biosimilars due to legal agreements[2].

Competitive Landscape

The market for Crohn's disease and other autoimmune conditions is evolving, with several emerging therapies expected to compete with STELARA. Companies are developing novel approaches to treat these diseases, which may challenge STELARA's dominance in the future. The launch of late-stage emerging therapies will significantly impact the market dynamics[3].

Strategic Implications for Healthcare Payers

Pharmacy Benefit Management

The introduction of STELARA biosimilars presents a valuable opportunity for healthcare payers to optimize drug spend. Strategies such as offering interchangeable biosimilars at significantly lower prices (e.g., more than 80% off the list price) can help reduce costs while maintaining patient care. For example, Evernorth has announced plans to offer an interchangeable biosimilar with a $0 copay for members[5].

Patient Care and Access

The availability of biosimilars is expected to improve patient access to treatment by reducing costs. This shift can also encourage more patients to adhere to their treatment plans, potentially improving health outcomes.

Regulatory Milestones and Developmental Activities

Current Regulatory Status

STELARA has been approved for various indications, and its regulatory milestones have been closely tracked. The approval of biosimilars marks a new phase in the regulatory landscape, with several biosimilars receiving FDA approval in recent months[4].

Future Development

The market forecast for STELARA from 2022 to 2032 indicates ongoing research and development activities. These include clinical trials, regulatory submissions, and the development of new therapeutic approaches. The extensive research and incremental healthcare spending globally are expected to expand the market size, allowing drug manufacturers to penetrate deeper into the market[3].

Key Takeaways

• Clinical Trials and Safety: STELARA has a well-established safety profile based on extensive clinical trials and long-term observational studies.
• Market Impact of Biosimilars: The introduction of biosimilars will significantly impact STELARA's sales, but Johnson & Johnson is expected to maintain substantial revenue.
• Market Projections: Sales of STELARA are projected to decrease but remain significant, contributing to Johnson & Johnson's overall revenue projections.
• Competitive Landscape: Emerging therapies and biosimilars will challenge STELARA's market position, necessitating strategic planning by healthcare payers and manufacturers.
• Strategic Implications: The launch of biosimilars offers opportunities for cost savings and improved patient access to treatment.

FAQs

What is STELARA used for?

STELARA (ustekinumab) is used for the treatment of moderately to severely active Crohn's disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis.

How safe is STELARA?

STELARA has a manageable safety profile, with a stable incidence of malignancies and other adverse events as observed in clinical trials and long-term studies.

What is the impact of biosimilars on STELARA sales?

The introduction of biosimilars is expected to reduce STELARA sales, but Johnson & Johnson is still projected to generate significant revenue from the drug.

When are STELARA biosimilars expected to launch?

The first STELARA biosimilar, Wezlana, is expected to launch in January 2025, followed by others in the second half of 2025.

How will the launch of biosimilars affect patient care?

The launch of biosimilars is expected to improve patient access to treatment by reducing costs and potentially improving health outcomes through better adherence to treatment plans.

Sources

1. Janssen Science: STELARA - Occurrence of Malignancies.
2. Reuters: Stelara Patent Agreement Revives J&J's Revenue Projection of $57 Billion by 2025.
3. BusinessWire: STELARA (Ustekinumab) Research Report 2022: A Treatment for Adults with Moderately to Severe Active Crohn's Disease and Ulcerative Colitis.
4. AJMC: FDA Approves Sixth Ustekinumab Biosimilar, Yesintek.
5. PSG Consults: Stelara Biosimilars: Preparing for the Upcoming Market Shift.

Last updated: 2025-01-01