CLINICAL TRIALS PROFILE FOR EUCRISA

All Clinical Trials for Eucrisa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03250663 ↗	Eucrisa for Atopic Dermatitis	Active, not recruiting	Wake Forest University Health Sciences	Phase 1	2017-10-01	Patients with mild to moderate atopic dermatitis will be asked to participate in helping the study team determine how well the medication works for atopic dermatitis. Participants will not be told that adherence will be monitored. Patients will be dispensed topical crisaborole 2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System (MEMS) cap if they agree to participate. This cap records dates and times the bottle is opened and this data can be downloaded and tabulated with the associated software. Investigators and subjects will be blinded to the adherence data until the final treatment (12 month) session. The study subjects will be randomized to two groups. After baseline visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12 months. The intervention group will also be asked to complete an online treatment response survey designed to improve adherence at weekly intervals for 6 weeks, then monthly thereafter. The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to apply the medication twice daily (morning and evening) to all of their AD lesions. They will be instructed to apply the smallest amount of study medication possible that is sufficient to cover all lesions. These instructions are standard-of-care for patients with AD. Subjects will be asked to bring their medication tubes with them at each visit. At each visit, the study coordinator will weigh the medication tube and download the MEMS cap data. Disclosure of the adherence monitoring will occur at the 12 month visit (or end of treatment), at which time the results of the subject's adherence behavior will be used to supply individualized treatment options for each subject (feedback session). At each visit, drug tubes will be measured for weight to determine the amount of study medication used. This data will be correlated with the extent of BSA involved and the response of the disease. The MEMS caps will be downloaded at each visit.
NCT03351114 ↗	Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea	Completed	Pfizer	Phase 2	2018-09-01	This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
NCT03351114 ↗	Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea	Completed	Duke University	Phase 2	2018-09-01	This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
NCT03356977 ↗	A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis	Completed	Pfizer	Phase 4	2018-01-16	This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
NCT03539601 ↗	A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD	Terminated	Pfizer	Phase 4	2018-04-27	This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to <18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.
NCT03567980 ↗	A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis	Completed	University of Alabama at Birmingham	Phase 4	2018-09-01	Seborrheic dermatitis is a common and recurrent dermatosis that characteristically involves the scalp, nasolabial folds, eyebrows, glabella, and upper eye lids. It presents as an erythematous, thin scaly patch with a greasy sandpaper texture that varies depending on disease severity. While seborrheic dermatitis most frequently occurs on the face, it can involve other areas of the body especially the chest, abdomen, and axilla. Overall incidence is thought to be between 2-5% of the general population, though this is likely an underestimation. Pruritus is variable, though the signs and symptoms of this disorder are certainly worsened by certain external conditions especially weather, personal perspiration, stress, and poor hygiene. Patients often complain about the red, scaly patches on the face. Antifungal agents are frequently used as monotherapy or in combination regimens in the treatment of seborrheic dermatitis. Topical corticosteroids are often used for their anti-inflammatory effects. Long term use of topical steroids on the face is not a preferred treatment modality due to the risk of striae development and other textural changes that occur over time. Therefore, topical crisaborole may be an alternative given its non-corticosteroid anti-inflammatory action. Crisaborole is a phosphodiesterase-4 (PDE-4) inhibitor that increases intracellular cyclic AMP (cAMP) levels to exert its anti-inflammatory effects. While it has not previously been investigated for its effects in seborrheic dermatitis, further studies evaluating its role in this disease are warranted. Therefore, the investigators propose a proof of concept study using topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
NCT03645057 ↗	ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis	Completed	University of Rochester	Phase 3	2019-02-20	This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate atopic dermatitis over a 12 week period of time. The goal of this study is to detect changes in PROs and caregiver burden during treatment for atopic dermatitis of moderate or less severity. The study design will allow us to correlate PROs and caregiver burden with treatment response and disease improvement in children.

Clinical Trial Conditions for Eucrisa

Condition Name

Condition Name for Eucrisa
Intervention	Trials
Atopic Dermatitis	8
Eczema	2
Morphea	1
Seborrheic Dermatitis	1

Condition MeSH

Condition MeSH for Eucrisa
Intervention	Trials
Dermatitis	13
Eczema	11
Dermatitis, Atopic	11
Vitiligo	1

Clinical Trial Locations for Eucrisa

Trials by Country

Trials by Country for Eucrisa
Location	Trials
United States	34
Germany	5
Italy	4
Canada	3
Australia	3

Trials by US State

Trials by US State for Eucrisa
Location	Trials
California	4
Kentucky	3
North Carolina	3
Utah	2
Texas	2

Clinical Trial Progress for Eucrisa

Clinical Trial Phase

Clinical Trial Phase for Eucrisa
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Eucrisa
Clinical Trial Phase	Trials
Completed	6
Recruiting	5
Not yet recruiting	3

Clinical Trial Sponsors for Eucrisa

Sponsor Name

Sponsor Name for Eucrisa
Sponsor	Trials
Pfizer	9
Ann & Robert H Lurie Children's Hospital of Chicago	1
University of Sheffield	1

Sponsor Type

Sponsor Type for Eucrisa
Sponsor	Trials
Other	13
Industry	10

EUCRISA: Clinical Trials, Market Analysis, and Projections

Introduction to EUCRISA

EUCRISA (crisaborole) is a topical phosphodiesterase 4 (PDE4) inhibitor used for the treatment of mild to moderate atopic dermatitis (AD) in patients as young as 3 months of age. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

The efficacy and safety of EUCRISA were evaluated in several clinical trials.

Trial Design and Participants

Two pivotal Phase III multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (Trials 1 and 2) were conducted. These trials involved a total of 1522 subjects aged 2 to 79 years, with 86.3% of the subjects being between 2 and 17 years old. Participants had mild to moderate atopic dermatitis, with 38.5% having an Investigator's Static Global Assessment (ISGA) score of mild (2) and 61.5% having an ISGA score of moderate (3)[1][3][4].

Treatment and Efficacy Endpoints

In both trials, participants were randomized 2:1 to receive either EUCRISA or a vehicle applied twice daily for 28 days. The primary efficacy endpoint was the proportion of subjects at Day 29 who achieved success, defined as an ISGA grade of clear (0) or almost clear (1) with a 2-grade or greater improvement from baseline[1][3][4].

Efficacy Results

The results showed that patients treated with EUCRISA had a statistically significant higher rate of success in ISGA at Day 29 compared to those treated with the vehicle. Specifically, the success rates were 32.8% and 31.4% for EUCRISA-treated patients versus 25.4% and 18.0% for vehicle-treated patients in Trials 1 and 2, respectively[1][3][4].

Long-Term Efficacy and Safety

An additional trial (Trial 3) assessed the efficacy and safety of EUCRISA once daily over 52 weeks in pediatric and adult subjects who had achieved success on EUCRISA twice daily during an open-label treatment period of up to 8 weeks. This trial demonstrated that a significant percentage of subjects maintained an ISGA of clear or almost clear through Week 52[1].

Market Analysis

Current Market Size and Growth Potential

The EUCRISA market is expected to grow at a strong Compound Annual Growth Rate (CAGR) of around 6.5% during the forecast period from 2023 to 2030. The market was valued at USD XX Billion in 2022 and is anticipated to expand due to increasing cases of atopic eczema globally, particularly affecting 1 in 5 children and 1 in 10 adults in the UK[2].

Driving Factors

Several factors are driving the growth of the EUCRISA market:

• Increasing Product Launches: Pharmaceutical companies are actively launching new products to address the growing need for effective treatments for atopic dermatitis.
• Research and Development: Ongoing research and development activities are crucial in finding new and better treatments for eczema.
• Government Initiatives: Various government initiatives are aimed at improving the management and treatment of atopic dermatitis[2].

Distribution Channels and Regional Analysis

The market can be segmented by distribution channels (online and offline) and regions (Asia Pacific, Europe, North America, and the Rest of the World). The report highlights that exhaustive secondary research and primary interviews with industry experts were conducted to estimate the current market size and forecast future growth[2].

Market Projections

Future Market Trends

The global EUCRISA market is expected to continue growing due to the increasing prevalence of atopic dermatitis and the ongoing efforts by pharmaceutical companies to develop and launch new treatments. Here are some key projections:

• Market Size: The market is expected to grow significantly, driven by the increasing demand for effective treatments for atopic dermatitis.
• Competitive Landscape: The launch of late-stage emerging therapies in the near future will significantly impact the market, providing tough competition to EUCRISA[5].

Regulatory and Developmental Activities

The regulatory milestones and developmental activities for EUCRISA are closely monitored. The detailed analysis of forecasted sales data from 2023 to 2032 will help clients in decision-making regarding their therapeutic portfolios[5].

Key Takeaways

• Clinical Efficacy: EUCRISA has demonstrated significant efficacy in treating mild to moderate atopic dermatitis in clinical trials.
• Market Growth: The EUCRISA market is projected to grow at a CAGR of 6.5% from 2023 to 2030.
• Driving Factors: Increasing product launches, research and development, and government initiatives are key drivers of market growth.
• Future Trends: The market will be influenced by the launch of new therapies and ongoing research activities.

FAQs

Q1: What is the primary efficacy endpoint in EUCRISA clinical trials?

The primary efficacy endpoint is the proportion of patients at Day 29 who achieve an ISGA grade of clear (0) or almost clear (1) with a 2-grade or greater improvement from baseline[1][3][4].

Q2: What is the expected CAGR of the EUCRISA market from 2023 to 2030?

The EUCRISA market is expected to grow at a CAGR of around 6.5% during the forecast period from 2023 to 2030[2].

Q3: What are the main factors driving the growth of the EUCRISA market?

The main factors include increasing product launches by pharmaceutical companies, ongoing research and development activities, and government initiatives to address atopic dermatitis[2].

Q4: How does EUCRISA perform in long-term treatment?

EUCRISA has shown that a significant percentage of subjects can maintain an ISGA of clear or almost clear through Week 52 when treated once daily[1].

Q5: What is the impact of emerging therapies on the EUCRISA market?

The launch of late-stage emerging therapies is expected to provide significant competition to EUCRISA, impacting the market dynamics in the future[5].

Sources

1. Pfizer Medical Information: EUCRISA (crisaborole) Clinical Studies.
2. UnivDatos: EUCRISA Market: Current Analysis and Forecast (2023-2030).
3. Health Canada: Summary Basis of Decision for Eucrisa.
4. FDA: Drug Trials Snapshot: EUCRISA.
5. ResearchAndMarkets: EUCRISA Market Drug Insight and Market Forecast - 2032.