CLINICAL TRIALS PROFILE FOR STERANE

All Clinical Trials for Sterane

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00900445 ↗	Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia	Withdrawn	National Cancer Institute (NCI)		2008-03-24	This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT00900445 ↗	Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia	Withdrawn	Children's Oncology Group		2008-03-24	This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT02828358 ↗	Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2017-03-27	This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.
NCT03007147 ↗	Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia	Recruiting	EsPhALL network I-BFM Study Group	Phase 3	2017-07-28	This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
NCT03007147 ↗	Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 3	2017-07-28	This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

Clinical Trial Conditions for Sterane

Condition Name

Condition Name for Sterane
Intervention	Trials
B Acute Lymphoblastic Leukemia	5
Mixed Phenotype Acute Leukemia	3
B Lymphoblastic Lymphoma	2
Refractory Mixed Phenotype Acute Leukemia	2

Condition MeSH

Condition MeSH for Sterane
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	8
Leukemia, Lymphoid	8
Leukemia	8
Acute Disease	4

Clinical Trial Locations for Sterane

Trials by Country

Trials by Country for Sterane
Location	Trials
United States	233
Canada	30
Australia	15
New Zealand	6
Puerto Rico	4

Trials by US State

Trials by US State for Sterane
Location	Trials
Texas	6
Tennessee	6
South Carolina	6
Pennsylvania	6
Oklahoma	6

Clinical Trial Progress for Sterane

Clinical Trial Phase

Clinical Trial Phase for Sterane
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Sterane
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	4
Withdrawn	1

Clinical Trial Sponsors for Sterane

Sponsor Name

Sponsor Name for Sterane
Sponsor	Trials
National Cancer Institute (NCI)	9
Children's Oncology Group	5
EsPhALL network I-BFM Study Group	1

Sponsor Type

Sponsor Type for Sterane
Sponsor	Trials
NIH	9
Other	6

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

Introduction to STELARA (Ustekinumab)

STELARA (ustekinumab) is a human monoclonal antibody that has been approved for the treatment of various immune-mediated diseases, including moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe Crohn’s disease. Here, we will delve into the clinical trials, market analysis, and future projections for STELARA.

Clinical Trials Overview

Phase 3 UNITI-2 Study

The Phase 3 UNITI-2 study, sponsored by Janssen Research & Development, LLC, was a pivotal trial that evaluated the efficacy and safety of STELARA in patients with moderate to severe Crohn’s disease. This multicenter, randomized, double-blind, placebo-controlled study demonstrated that STELARA induced significant clinical response and remission in patients who had previously failed conventional therapies, including steroids and immunosuppressive agents, but were naïve to anti-tumor necrosis factor (TNF)-alpha therapy[1].

Key findings from the UNITI-2 study include:

• Clinical response rates at week 6 were significantly higher in the STELARA treatment groups compared to the placebo group.
• Clinical remission rates at week 8 were also higher in the STELARA groups, with 31% and 40% of patients achieving remission in the 130 mg and ~6 mg/kg doses, respectively, versus 20% in the placebo group[1].

Long-Term Extension Study (IM-UNITI)

The IM-UNITI study, a long-term extension of the Phase 3 trials, provided valuable insights into the long-term efficacy and safety of STELARA in patients with moderate to severe Crohn’s disease. The study showed that patients maintained clinical response and remission through five years of treatment with STELARA. The adverse event profile remained consistent with earlier findings, with no new safety signals observed[4].

Mechanism of Action

STELARA works by targeting interleukin (IL)-12 and IL-23 cytokines, which are believed to play a crucial role in immune-mediated diseases such as Crohn’s disease. By inhibiting these cytokines, STELARA reduces inflammation and helps in achieving clinical response and remission[1].

Market Analysis

Current Market Share

STELARA has established a significant presence in the Crohn’s disease market. According to a GlobalData report, in 2022, STELARA accounted for approximately $1.5 billion of the $7.4 billion total US Crohn’s disease drug sales, capturing about 20% of the market share. This places it second only to Humira, which held a 33.5% market share[2].

Market Trends and Projections

The Crohn’s disease market is undergoing significant changes with the launch of biosimilars and updates to treatment guidelines. The introduction of adalimumab biosimilars in 2023 and the expected launch of ustekinumab biosimilars in 2025 are likely to impact the market dynamics. New treatment guidelines are expected to shift first-line treatment modalities away from older anti-TNF therapies towards newer treatments like STELARA[2].

Global Sales and Growth

The global sales of STELARA have shown robust growth. Between 2020 and 2023, the sales of STELARA recorded a compound annual growth rate (CAGR) of 12%, reaching $11.309 billion in 2023. However, GlobalData projects a decline in sales at a certain CAGR in the coming years, though this is subject to various market and regulatory factors[5].

Safety and Efficacy

Short-Term Efficacy

The UNITI-2 study highlighted the short-term efficacy of STELARA, with significant improvements in clinical response and remission rates, as well as in health-related quality of life measures and markers of inflammation[1].

Long-Term Safety and Efficacy

The long-term extension study (IM-UNITI) demonstrated that STELARA maintained its efficacy over five years without significant increases in adverse events, serious adverse events, or serious infections. This long-term data is crucial for managing chronic conditions like Crohn’s disease[4].

Future Outlook

Market Competition

The Crohn’s disease market is highly competitive, with several drugs vying for market share. The upcoming launch of biosimilars and the potential shift in treatment guidelines towards newer therapies like STELARA could further intensify competition. However, STELARA’s established efficacy and safety profile position it well in the market[2].

Regulatory and Clinical Developments

Janssen is committed to the continued development of STELARA for immune-mediated diseases. The company has filed applications seeking approval for STELARA in the treatment of moderate to severe Crohn’s disease and is presenting ongoing research at major medical conferences[1].

Key Takeaways

• Clinical Efficacy: STELARA has demonstrated significant clinical response and remission in patients with moderate to severe Crohn’s disease in both short-term and long-term studies.
• Market Share: STELARA holds a substantial market share in the US Crohn’s disease market, second only to Humira.
• Market Trends: The market is expected to evolve with the introduction of biosimilars and updates to treatment guidelines, potentially favoring newer therapies like STELARA.
• Long-Term Safety: The drug has shown a favorable safety profile over five years of treatment.
• Future Outlook: STELARA is well-positioned in the market due to its efficacy, safety, and ongoing clinical and regulatory developments.

FAQs

What is STELARA used for?

STELARA (ustekinumab) is used for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe Crohn’s disease.

How does STELARA work?

STELARA works by targeting and inhibiting interleukin (IL)-12 and IL-23 cytokines, which are involved in immune-mediated diseases.

What were the key findings of the UNITI-2 study?

The UNITI-2 study showed that STELARA induced significant clinical response and remission in patients with moderate to severe Crohn’s disease who had previously failed conventional therapies.

What are the long-term outcomes of STELARA treatment?

The IM-UNITI study demonstrated that patients maintained clinical response and remission over five years of treatment with STELARA, with a favorable safety profile.

How is the market for Crohn’s disease treatments evolving?

The market is evolving with the introduction of biosimilars and updates to treatment guidelines, which may shift first-line treatment modalities towards newer therapies like STELARA.

Sources

1. Phase 3 Data Show STELARA® Induced Clinical Response And Remission In The Treatment Of Patients With Moderate To Severe Crohn’s Disease. Janssen.
2. Finding the Crohn's disease leader is underway with anti-interleukin-23s. Clinical Trials Arena.
3. Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]. Fortune Business Insights.
4. STELARA® (ustekinumab) Five-Year Results Presented from Long-Term Extension Study of Clinical Response and Remission in Patients with Moderate to Severe Crohn’s Disease. PR Newswire.
5. The Global Drug sales of Stelara (2020 - 2026, USD Millions). GlobalData.