Abrocitinib for Atopic Dermatitis/Eczema

(JADE EXTEND Trial)

Recruiting at 589 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Disqualifiers: Other skin diseases, Psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

3164 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a pill called Abrocitinib to help people aged 12 and older with severe eczema. It aims to see if the pill can reduce inflammation and itching by blocking certain body chemicals. The study includes patients who have already participated in a related study.

Do I need to stop my current medications to join the trial?

The trial requires participants to avoid using prohibited medications during the study, but it does not specify which medications are prohibited. It's best to discuss your current medications with the study team to determine if any need to be stopped.

What data supports the effectiveness of the drug Abrocitinib for treating atopic dermatitis?

Research shows that Abrocitinib, especially at 200 mg, is effective in reducing the severity of atopic dermatitis and provides quick relief from itching. It has been found to work as well as or better than another treatment called dupilumab, with many patients experiencing long-term benefits without serious side effects. ^{1 2 3 4 5}

Is Abrocitinib safe for humans?

Abrocitinib, used for treating atopic dermatitis, has shown a favorable safety profile in clinical trials. Common side effects are generally not serious, and while there is a dose-related decrease in platelet counts (cells that help blood clot), it does not have clinical consequences. ^{1 4 6 7 8}

How is the drug abrocitinib different from other treatments for atopic dermatitis?

Abrocitinib is unique because it is an oral medication that selectively inhibits Janus kinase 1 (JAK1), which helps control the inflammation in atopic dermatitis. It provides faster itch relief compared to some other treatments and has shown high efficacy with a favorable safety profile. ^{1 4 5 6 9}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for people aged 12+ with moderate to severe atopic dermatitis who've finished a related study. They must not plan to get pregnant, be currently pregnant or breastfeeding, and agree to use contraception if applicable. Participants should avoid sun exposure and certain medications.

Inclusion Criteria

I am 12 years or older and meet the weight requirement from a previous study.

I am not pregnant, breastfeeding, or planning to become pregnant and agree to use effective birth control.

Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.

Exclusion Criteria

I do not have other skin conditions that could affect the study.

Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Ongoing adverse event in the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Initial Treatment

Participants receive Abrocitinib 100 mg or 200 mg orally once daily for 92 weeks

92 weeks

Secondary Treatment

Participants continue treatment with open-label Abrocitinib until commercial product availability or study termination

Variable length

Follow-up

Participants are monitored for safety and effectiveness after treatment

Estimated maximum of 8 years

Sub-study

Sub-study evaluating potential effects on adolescent bone with annual MRI until subjects are 18 years old

Estimated maximum of 4 years

Treatment Details

Interventions

• Abrocitinib 100 mg
• Abrocitinib 200 mg
• Placebo

Trial Overview The trial tests two doses of Abrocitinib (100 mg & 200 mg) taken daily by mouth against a placebo in patients with atopic dermatitis over an initial period of 92 weeks, followed by open-label treatment until the drug's commercial availability or study end.

Participant Groups

Group I: Abrocitinib 200 mg Experimental Treatment 2 Interventions

Abrocitinib 200 mg QD PO

Group II: Abrocitinib 100 mg Experimental Treatment 2 Interventions

Abrocitinib 100 mg QD PO

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

In the JADE COMPARE trial, abrocitinib significantly improved patient-reported outcomes for atopic dermatitis (AD) compared to placebo, with 21.3% of patients on 200 mg achieving a POEM score of less than 3, indicating meaningful symptom relief.

Abrocitinib 200 mg showed greater efficacy than dupilumab in improving itch severity and quality of life, with 64.3% of patients experiencing a significant reduction in nighttime itch compared to 54.0% for dupilumab, highlighting its potential as a more effective treatment option for moderate-to-severe AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis. Thyssen, JP., Yosipovitch, G., Paul, C., et al.[2022]

In a phase 3 study, abrocitinib demonstrated high efficacy in treating moderate-to-severe atopic dermatitis, achieving over 75% improvement in skin severity for 93.5% of prior dupilumab responders and 80.0% of nonresponders after 12 weeks.

The safety profile of abrocitinib was favorable, with fewer cases of conjunctivitis compared to prior dupilumab treatment, although common side effects included nasopharyngitis and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). Shi, VY., Bhutani, T., Fonacier, L., et al.[2022]

Abrocitinib, an oral medication that selectively inhibits JAK1, showed comparable efficacy to dupilumab and superior results to placebo in treating atopic dermatitis, with a faster response and itch relief observed from week 2 to 26.

The treatment with abrocitinib 200 mg was the most effective, and an induction-maintenance approach led to over 55% of patients remaining flare-free for 40 weeks, while common side effects were nonserious and included a dose-related decrease in platelet counts without clinical consequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abrocitinib for the treatment of atopic dermatitis. Lé, AM., Gooderham, M., Torres, T.[2023]

Abrocitinib, an oral JAK 1 inhibitor, has shown significant efficacy in treating moderate-to-severe atopic dermatitis, with 47.5% of patients on 200 mg achieving a favorable treatment response at 12 weeks, compared to 32.0% on 100 mg.

In clinical trials, abrocitinib demonstrated better disease severity and itch response compared to dupilumab, and most adverse events were mild and self-limiting, making it a promising alternative for patients preferring oral treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abrocitinib: A New FDA-Approved Drug for Moderate-to-Severe Atopic Dermatitis. Perche, PO., Cook, MK., Feldman, SR.[2023]

In a study of 41 patients with difficult-to-treat moderate-to-severe atopic dermatitis (AD), abrocitinib significantly reduced disease severity over a median follow-up of 25 weeks, with EASI scores improving from 14.7 to 4.0 (p < 0.001).

Despite its effectiveness, 39% of patients discontinued abrocitinib due to ineffectiveness or adverse events, with common side effects including gastrointestinal symptoms (27.6%) and acne (20.7%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. Olydam, JI., Schlösser, AR., Custurone, P., et al.[2023]

In a study of 942 patients with moderate-to-severe atopic dermatitis, abrocitinib was found to be effective in improving skin condition and quality of life, regardless of the presence of allergic comorbidities like asthma or food allergies.

The treatment was associated with a higher percentage of patients achieving significant improvements in key measures of atopic dermatitis compared to placebo, and most treatment-emergent adverse events were mild or moderate, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. Schmid-Grendelmeier, P., Gooderham, MJ., Hartmann, K., et al.[2023]

In a phase 2b study involving 267 adults with moderate-to-severe atopic dermatitis, abrocitinib (200 mg and 100 mg) showed significant improvements in symptoms and quality of life compared to placebo, with effects observed as early as 2 days after starting treatment.

Patients reported rapid and lasting relief from itching and other symptoms, with notable improvements in various patient-reported outcome measures, indicating that abrocitinib could be an effective treatment option for those inadequately controlled by current therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. Simpson, EL., Wollenberg, A., Bissonnette, R., et al.[2022]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Abrocitinib 100 mg versus 200 mg for atopic dermatitis: a meta-analysis of randomized controlled trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Abrocitinib for the treatment of atopic dermatitis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Abrocitinib: A New FDA-Approved Drug for Moderate-to-Severe Atopic Dermatitis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. [2023]

7. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. [2022]