CLINICAL TRIALS PROFILE FOR SORIATANE

All Clinical Trials for SORIATANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03529955 ↗	Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis	Completed	Tulane University	Phase 2	2018-06-12	With limited treatment options available for dermatomyositis, the investigators hypothesize that apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, is a safe and efficacious add-on treatment in patients with refractory cutaneous dermatomyositis. The study will investigate the efficacy, safety and toxicity of apremilast given at 30 mg twice daily to patients with refractory cutaneous dermatomyositis. Clinical response will be assessed at 1 and 3 months. Patients will also be evaluated for durability of their response for up to 6 months. Treatment will be monitored with frequent clinical visits (0, 1, 3 and 6 months) and blood tests (CBC, CMP, creatine kinase, aldolase). Treatment will be discontinued at disease progression or unacceptable adverse events. Disease progression is defined as 4 points increase in the cutaneous dermatomyositis disease area and severity index (CDASI) score, worsening of muscle disease by manual muscle testing (MMT-8) score and 5 points increase in dermatomyositis life quality index (DLQI). 5 mm skin biopsies from lesional skin will be performed before treatment with apremilast and after 3 months of treatment for gene expression profiling and confirmatory immunohistochemical stains.
NCT02113904 ↗	Clinical Trial Using Humira in Netherton Syndrome	Completed	Assistance Publique - Hôpitaux de Paris	Phase 2	2014-01-27	The main objective of this studies therapeutic : to determine the effect of Adalimumab (HumiraR) on clinical inflammatory manifestations of patients with Netherton syndrome after 3 months of treatment , with a post treatment period follow-up of 3 months. Second objectives are To evaluate the safety of Adalimumab in the context of NS To evaluate the improvement of the quality of life at 3 months To evaluate the improvement of pruritus and pain in the patients To study markers of inflammatory and allergy in NS prior and after treatment Benefit of the study An improvement by at least 20% of the cutaneous signs in these patients who suffer from a genetic incurable, chronic, painful and very afflicting disease would be of a great help for these patients. NS is a major source of social exclusion. Risks They are inherent to the risks of biotherapies, especially for an anti-TNF therapy, they comprise a risk of infection. Cutaneous infections occur mainly during infancy, and we have therefore chosen to treat patients over 4 years of age in this study. A close clinical surveillance will be set up (initially every week during the first month of treatment, then every month). This will represents a large number of visits but will provide a high level of security. Benefits/risks ratio In the absence of curative treatment for these patients with a severe genetic skin disease, the benefits/risks ration clearly appears to be in favour of an expected benefit.
NCT02050321 ↗	A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma	Terminated	University of Arizona	Phase 2	2013-12-01	We propose to conduct a phase 2 study to assess whether the addition of acitretin to vemurafenib therapy is able to decrease the rate of cutaneous squamous cell carcinoma (cSCC) development, a known side effect of vemurafenib therapy, in patients with advanced melanoma. Further, we seek a preliminary assessment as to whether the addition of acitretin to vemurafenib enhances the clinical efficacy of this anti-melanoma agent.
NCT01545284 ↗	Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis	Completed	Tribute Pharmaceuticals	Phase 2/Phase 3	2012-03-01	This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate the efficacy and safety of acitretin in patients with severe chronic hand dermatitis .
NCT01545284 ↗	Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis	Completed	Innovaderm Research Inc.	Phase 2/Phase 3	2012-03-01	This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate the efficacy and safety of acitretin in patients with severe chronic hand dermatitis .
NCT00156247 ↗	Acitretin and Etanercept in Psoriasis	Completed	Connetics Corp.	Phase 2	2005-09-01	To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.
NCT00156247 ↗	Acitretin and Etanercept in Psoriasis	Completed	University of Medicine and Dentistry of New Jersey	Phase 2	2005-09-01	To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.

Clinical Trial Conditions for SORIATANE

Condition Name

Condition Name for SORIATANE
Intervention	Trials
Malignant Melanoma	1
Netherton Syndrome	1
Psoriasis	1
Chronic Hand Dermatitis	1

Condition MeSH

Condition MeSH for SORIATANE
Intervention	Trials
Dermatitis	1
Psoriasis	1
Dermatomyositis	1
Syndrome	1

Clinical Trial Locations for SORIATANE

Trials by Country

+

−

Trials by Country for SORIATANE
Location	Trials
Canada	2
United States	2
France	1

Trials by US State

+

−

Trials by US State for SORIATANE
Location	Trials
Louisiana	1
Arizona	1

Clinical Trial Progress for SORIATANE

Clinical Trial Phase

Clinical Trial Phase for SORIATANE
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for SORIATANE
Clinical Trial Phase	Trials
Completed	4
Terminated	1

Clinical Trial Sponsors for SORIATANE

Sponsor Name

Sponsor Name for SORIATANE
Sponsor	Trials
Connetics Corp.	1
University of Medicine and Dentistry of New Jersey	1
Tribute Pharmaceuticals	1

Sponsor Type

Sponsor Type for SORIATANE
Sponsor	Trials
Other	6
Industry	1

SORIATANE: Clinical Trials, Market Analysis, and Projections

Introduction

SORIATANE, also known as acitretin, is a second-generation retinoid used primarily for the treatment of severe psoriasis. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy in Psoriasis Treatment

Clinical trials have demonstrated the efficacy of SORIATANE in treating severe psoriasis. In two double-blind, placebo-controlled trials, subjects with severe psoriasis (covering at least 10% to 20% of the body surface area) were treated with SORIATANE once daily. At 8 weeks, significant improvements were observed in the physician’s global evaluation and in the mean ratings of severity of psoriasis, including scaling, thickness, and erythema. Specifically, subjects treated with 50 mg of SORIATANE per day showed significant improvements relative to baseline and placebo[1][4].

Safety and Adverse Effects

While SORIATANE has shown efficacy, it also comes with potential adverse effects. In clinical trials, treatment was discontinued in 3.8% of subjects due to elevated liver function test results. Hepatotoxicity is a significant concern, and monitoring of liver function is recommended during treatment[1][4].

Contraception and Pregnancy Precautions

Given the teratogenic potential of SORIATANE, stringent contraception and pregnancy testing protocols are in place. Patients must have a negative pregnancy test before starting treatment and must use two effective forms of contraception simultaneously. Pregnancy tests must be repeated every month during treatment and every three months for at least three years after discontinuing therapy[1][4].

Market Analysis

Current Market Trends

The global acitretin market is driven by several key factors, including the increasing number of patients with psoriasis and the development of pipeline drugs. The market is also influenced by advancements in diagnosis and treatment, as well as increased healthcare expenditure and R&D activities[2].

Market Size and Growth Projections

The psoriasis drugs market, which includes SORIATANE, is projected to grow significantly. By 2025, the global psoriasis drugs market is expected to grow by $10.8 billion, driven by a compounded growth rate of 9%. This growth is partly due to the increasing prevalence of psoriasis and the demand for effective treatments[5].

Key Market Players

The acitretin market includes several key players such as SGPharma Pvt Ltd., Sionc Pharmaceuticals Pvt Ltd., Chongqing Huapont Pharmaceutical Co., Ltd., Merck KGaA, Sun Pharma Industries Limited, and others. These companies are involved in the production, distribution, and research of acitretin and other psoriasis treatments[2].

Challenges and Restraints

Adverse Effects and Safety Concerns

Despite its efficacy, SORIATANE faces challenges due to its adverse effects, such as hepatotoxicity and teratogenicity. These safety concerns can limit its use and impact market growth[1][4].

Supply Chain Issues

Supply chain disruptions and the availability of alternative treatments can also hamper the growth of the acitretin market. The presence of other effective psoriasis treatments, such as biologics and newer oral agents like deucravacitinib (Sotyktu), can compete with SORIATANE for market share[2][3].

Future Projections and Opportunities

New Drug Launches and Innovations

The market is expected to benefit from new drug launches and innovative delivery methods. For example, unique preparations and delivery methods for acitretin, such as those for neonatal harlequin ichthyosis, can expand its therapeutic applications and attract new patients[2].

Pipeline Drugs and R&D Activities

The ongoing R&D activities and the presence of pipeline drugs are expected to fuel the growth of the acitretin market. These developments can lead to improved treatment options and increased market demand[2].

Increasing Demand for Organ Transplantation

Interestingly, the increase in demand for organ transplantation can also fuel the growth of the acitretin market, as patients undergoing transplantation may require treatments like SORIATANE for various skin conditions[2].

Competitive Landscape

Comparison with Other Treatments

SORIATANE competes with other psoriasis treatments, including biologics and newer oral agents. For instance, deucravacitinib (Sotyktu) has shown durable response rates and consistent safety profiles in long-term extension trials, posing a competitive challenge to SORIATANE[3].

Key Takeaways

• Efficacy in Psoriasis: SORIATANE has demonstrated significant improvements in treating severe psoriasis in clinical trials.
• Safety Concerns: The drug is associated with hepatotoxicity and teratogenicity, requiring careful monitoring and stringent contraception protocols.
• Market Growth: The global acitretin market is projected to grow due to increasing psoriasis prevalence, R&D activities, and healthcare expenditure.
• Challenges: Adverse effects, supply chain issues, and competition from other treatments are key challenges.
• Future Opportunities: New drug launches, innovative delivery methods, and ongoing R&D activities are expected to drive market growth.

FAQs

What are the primary uses of SORIATANE?

SORIATANE is primarily used for the treatment of severe psoriasis, covering at least 10% to 20% of the body surface area.

What are the significant adverse effects of SORIATANE?

The significant adverse effects include hepatotoxicity and teratogenicity, necessitating careful monitoring of liver function and stringent contraception protocols.

How does SORIATANE compare to other psoriasis treatments?

SORIATANE competes with other treatments like biologics and newer oral agents such as deucravacitinib (Sotyktu), which have shown durable response rates and consistent safety profiles.

What are the market growth projections for SORIATANE?

The global acitretin market is projected to grow significantly, driven by increasing psoriasis prevalence, R&D activities, and healthcare expenditure.

What are the key challenges facing the SORIATANE market?

Key challenges include adverse effects, supply chain issues, and competition from other effective psoriasis treatments.

Who are the key players in the acitretin market?

Key players include SGPharma Pvt Ltd., Sionc Pharmaceuticals Pvt Ltd., Chongqing Huapont Pharmaceutical Co., Ltd., Merck KGaA, Sun Pharma Industries Limited, and others.

Sources

1. SORIATANE - GSKPro for Healthcare Professionals. GSKPro.
2. Acitretin Market Size, Share, Industry Report, 2027. Allied Market Research.
3. New Four-Year Sotyktu (deucravacitinib) Data Demonstrate Durable Response Rates and Consistent Safety in Moderate-to-Severe Plaque Psoriasis. Bristol Myers Squibb.
4. SORIATANE (acitretin) Capsules. FDA.
5. Psoriasis Drugs Market Analysis, Trends, and Forecasts, 2025. ResearchAndMarkets.com.