CLINICAL TRIALS PROFILE FOR ABROCITINIB

All Clinical Trials for abrocitinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03422822 ↗	Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis	Enrolling by invitation	Pfizer	Phase 3	2018-03-08	B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country
NCT03627767 ↗	Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects	Completed	Pfizer	Phase 3	2018-06-11	B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
NCT03915496 ↗	Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis	Active, not recruiting	Pfizer	Phase 2	2020-06-18	B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.
NCT04345367 ↗	Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy	Completed	Pfizer	Phase 3	2020-06-11	This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.
NCT04903093 ↗	A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.	Completed	Pfizer	Phase 1	2021-06-04	This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of abrocitinib and its metabolites will also be evaluated by administering abrocitinib 200 mg commercial tablet with or without famotidine 40 mg, as an acid-reducing agent. Part B is to assess the taste and palatability of six different abrocitinib oral suspension formulations. Additionally, the safety and tolerability of abrocitinib tablet (in Part A) and abrocitinib oral suspension formulations (in Part B) will be assessed when given with or without famotidine 40 mg once daily.
NCT05038982 ↗	Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin	Recruiting	Duke University	Phase 2	2021-09-09	The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus.

Clinical Trial Conditions for abrocitinib

Condition Name

Condition Name for abrocitinib
Intervention	Trials
Atopic Dermatitis	4
Dermatitis, Atopic	2
Skin Diseases	2
Healthy Participants	1

Condition MeSH

Condition MeSH for abrocitinib
Intervention	Trials
Dermatitis	6
Eczema	6
Dermatitis, Atopic	6
Hypersensitivity	2

Clinical Trial Locations for abrocitinib

Trials by Country

Trials by Country for abrocitinib
Location	Trials
United States	88
China	26
Canada	26
Mexico	11
Italy	10

Trials by US State

Trials by US State for abrocitinib
Location	Trials
Florida	6
Indiana	4
California	4
Texas	4
New York	4

Clinical Trial Progress for abrocitinib

Clinical Trial Phase

Clinical Trial Phase for abrocitinib
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2	5

Clinical Trial Status

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

Clinical Trial Sponsors for abrocitinib

Sponsor Name

Sponsor Name for abrocitinib
Sponsor	Trials
Pfizer	11
Yale University	2
Duke University	1

Sponsor Type

Sponsor Type for abrocitinib
Sponsor	Trials
Industry	11
Other	8
NIH	1

Abrocitinib Market Analysis and Financial Projection

Abrocitinib: Clinical Trials, Market Analysis, and Projections

Introduction to Abrocitinib

Abrocitinib, marketed as Cibinqo, is a Janus kinase (JAK) inhibitor developed by Pfizer for the treatment of moderate to severe atopic dermatitis (AD), also known as eczema. This medication has shown significant promise in addressing the cytokine signaling pathways that disrupt the immune response in AD patients.

Clinical Trials Update

Efficacy and Safety in Phase 3 Studies

Abrocitinib has demonstrated robust efficacy and a manageable safety profile in several phase 3 clinical trials. The JADE MONO-1, JADE MONO-2, and JADE COMPARE studies showed that abrocitinib significantly improved the signs and symptoms of AD at 12 or 16 weeks. Patients who received abrocitinib (200 mg or 100 mg once daily) achieved high response rates, including skin clearance (IGA 0/1) and itch response (PP-NRS severity ≥4-point improvement)[1].

Long-Term Efficacy and Safety

The JADE EXTEND study, a long-term extension of the previous trials, evaluated the efficacy and safety of abrocitinib up to 48 weeks. As of the data cut-off, approximately 70% and 45% of patients received abrocitinib for at least 36 and 48 weeks, respectively. The results showed that abrocitinib maintained clinically meaningful skin and pruritus improvement over the long term. The safety profile was consistent with previous reports, with nasopharyngitis, atopic dermatitis, nausea, and upper respiratory tract infections being the most frequent treatment-emergent adverse events (TEAEs)[1].

Adolescent and Pediatric Populations

The JADE TEEN trial specifically evaluated the efficacy of abrocitinib in adolescents aged 12 to 17 years with moderate to severe AD. This trial supported the efficacy of abrocitinib in this younger population, aligning with the positive outcomes seen in adult trials[4].

Market Analysis

Market Size and Growth

The global market for atopic dermatitis treatment is anticipated to grow significantly, driven in part by the launch of innovative therapies like abrocitinib. The market is expected to reach $31.7 billion by 2031, expanding at a double-digit CAGR of 14.1% over the forecast period. Abrocitinib, with its novel mechanism as a JAK inhibitor, is poised to capture a substantial share of this growing market[5].

Market Drivers

Several factors are driving the growth of the abrocitinib market:

• Increasing Incidence of Atopic Dermatitis: The rising prevalence of AD among both adults and children is a key driver.
• Advancements in Drug Development: The innovation in JAK inhibitors and their efficacy in treating AD are significant market drivers.
• Growing Awareness: Increasing awareness among healthcare providers and patients about the benefits of JAK inhibitors is boosting market growth[2].

Market Opportunities

• Geographical Expansions: Emerging markets with rising healthcare expenditures offer significant opportunities for growth.
• Digital Marketing and Educational Initiatives: Targeted digital marketing and educational programs can increase prescription rates and patient engagement.
• Innovation in Formulation: Reducing side effects and enhancing patient compliance through innovative formulations is a promising area of research[2].

Market Challenges

Despite the positive outlook, the market faces several challenges:

• Stringent Reimbursement Policies: Affordability and accessibility are affected by stringent reimbursement policies.
• Supply Chain Disruptions: Manufacturing bottlenecks and supply chain issues can impact the availability of abrocitinib.
• Regulatory Hurdles: Navigating regulatory approvals in global markets remains a challenge[2].

Market Projections

Forecasted Sales

The abrocitinib market is projected to see remarkable growth through 2032. The market forecast indicates that abrocitinib will be a key player in the atopic dermatitis treatment market, particularly in the seven major markets (the United States, EU4, the United Kingdom, and Japan). The sales forecasts are categorized across these regions, providing a detailed analysis of the market's potential[3].

Competitive Landscape

Abrocitinib competes with other emerging therapies, including biologics like dupilumab. However, abrocitinib has shown numerically better outcomes in some clinical trials, particularly in achieving clinically meaningful patient-reported outcomes and faster response times compared to dupilumab[4].

Key Takeaways

• Clinical Efficacy: Abrocitinib has demonstrated significant efficacy in treating moderate to severe atopic dermatitis in both short-term and long-term studies.
• Safety Profile: The safety profile of abrocitinib is manageable, with common adverse events being nasopharyngitis, atopic dermatitis, nausea, and upper respiratory tract infections.
• Market Growth: The market for abrocitinib is expected to grow substantially, driven by increasing incidence of AD, advancements in drug development, and growing awareness of JAK inhibitors.
• Challenges and Opportunities: Despite challenges like reimbursement policies and supply chain disruptions, opportunities in emerging markets, digital marketing, and innovative formulations present avenues for growth.

Frequently Asked Questions (FAQs)

1. What is Abrocitinib Used For?

Abrocitinib is used for the treatment of moderate to severe atopic dermatitis (eczema) in adults and adolescents.

2. How Does Abrocitinib Work?

Abrocitinib works by inhibiting the Janus kinase (JAK) pathways, which are involved in the immune response and cytokine signaling that disrupts the skin in AD patients.

3. What Are the Common Side Effects of Abrocitinib?

Common side effects include nasopharyngitis, atopic dermatitis, nausea, and upper respiratory tract infections.

4. How Effective is Abrocitinib in Long-Term Treatment?

Abrocitinib has shown clinically meaningful skin and pruritus improvement over long-term treatment, with response rates maintained up to 48 weeks.

5. What Are the Market Projections for Abrocitinib?

The market for abrocitinib is projected to grow significantly through 2032, driven by increasing incidence of AD and advancements in drug development, with forecasted sales categorized across major markets.

Sources:

1. Journal of the European Academy of Dermatology and Venereology: "Abrocitinib efficacy and safety in patients with moderate-to-severe atopic dermatitis: long-term extension of phase 3 studies."
2. 360iResearch: "Abrocitinib Tablets Market Size & Share 2025-2030."
3. OpenPR: "Abrocitinib Poised for Remarkable Market Expansion of Atopic Dermatitis by 2032."
4. VA.gov: "Abrocitinib (CIBINQO) in Atopic Dermatitis National Drug Monograph."
5. iHealthcareAnalyst: "Global Atopic Dermatitis Treatment Market $31.7 Billion by 2031."