Abrocitinib for Eczema

No longer recruiting at 12 trial locations

Overseen By Dominique Dufour Bergeron

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Innovaderm Research Inc.

Must be taking: Dupilumab

Disqualifiers: Pregnancy, Cancer, Immunodeficiency, others

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called abrocitinib to evaluate its effectiveness for people with atopic dermatitis, also known as eczema. The goal is to determine if abrocitinib can help those who haven't responded well to another treatment, dupilumab, particularly if they experience troublesome facial redness. Individuals who have dealt with moderate to severe eczema for at least a year and continue to have issues despite previous treatment may be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how abrocitinib can benefit more patients with eczema.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it seems that participants are expected to have been on dupilumab treatment before joining the study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it seems that participants are already on dupilumab treatment, so you may need to continue that medication. Please consult with the study team for specific guidance.

What is the safety track record for Abrocitinib?

Research has shown that abrocitinib is generally safe for people with moderate-to-severe eczema. Studies involving over 7,000 patient-years of data indicate it has a manageable safety profile. While some people might experience side effects, these are usually not serious.

Abrocitinib is approved for use in individuals aged 12 and older with eczema, confirming the treatment's safety for this age group. Always consult a doctor to understand personal risks and benefits. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Abrocitinib is unique because it targets specific proteins in the body's immune system called Janus kinases (JAKs). Unlike standard treatments for eczema, which often include topical steroids or calcineurin inhibitors, Abrocitinib is an oral medication that offers a different approach by directly blocking pathways that lead to inflammation. Researchers are excited about Abrocitinib because it can potentially offer faster relief from symptoms like itching and redness, with the convenience of a daily tablet. This new mechanism of action could improve the lives of many eczema patients, particularly those who have not responded well to traditional treatments.

What is the effectiveness track record for Abrocitinib in treating eczema?

Research has shown that abrocitinib effectively treats atopic dermatitis, also known as eczema. Studies have found that it can quickly lead to clearer skin and reduce itching. Evidence suggests that patients can experience significant improvements, with measures like EASI 75, EASI 90, and EASI 100, which track skin clarity, showing strong results. Abrocitinib has proven effective in both clinical trials and real-world use. This treatment is already approved, underscoring its success in managing eczema. ^{5 6 7 8 9}

Who Is on the Research Team?

Robert Bissonnette, MD

Principal Investigator

Innovaderm Research Inc.

Are You a Good Fit for This Trial?

This trial is for adults with atopic dermatitis (eczema) who haven't responded well to dupilumab treatment. Participants must have a history of moderate to severe eczema, no significant flare-ups in the last month, and meet specific criteria regarding skin condition severity. Excluded are those with certain immune disorders, cancer within the past 5 years, serious infections or conditions that could affect results.

Inclusion Criteria

A global vIGA-AD ≥ 2, at least 3% BSA affected by AD on the trunk and/or limbs, and a modified vIGA-AD for the trunk/limbs ≥ 2 at screening and Day 1

Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before screening.

A global vIGA-AD ≥ 2, at least 1% BSA with facial erythema, and a modified vIGA-AD for the face ≥2 at screening and Day 1 OR A global vIGA-AD ≥ 2, at least 3% BSA affected by AD on the trunk and/or limbs, and a modified vIGA-AD for the trunk/limbs ≥ 2 at screening and Day 1.

Exclusion Criteria

Subject has a history of lymphoproliferative disorder, lymphoma, or leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease

Subject is known to have immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency

Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abrocitinib once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abrocitinib

Trial Overview The study is testing Abrocitinib's effectiveness on individuals with atopic dermatitis who didn't see improvement after using Dupilumab. It's an open-label trial where all participants know they're receiving Abrocitinib without being compared to a placebo or other drug.

How Is the Trial Designed?

Group I: Abrocitinib 100 mg tablet (marketed drug) Experimental Treatment 1 Intervention

Abrocitinib is already approved in European Union, United States for the following indications:

Approved in European Union as Cibinqo for:

• Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy

Approved in United States as Cibinqo for:

• Refractory, moderate-to-severe atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable

Who Is Running the Clinical Trial?

Innovaderm Research Inc.

Lead Sponsor

Trials

49

Recruited

3,200+

Published Research Related to This Trial

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]

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]

Abrocitinib, a selective JAK1 inhibitor approved for moderate-to-severe atopic dermatitis, shows a higher expected EASI-75 response rate at week 12 compared to lower doses, with 62.9% for 200 mg and 43.0% for 100 mg, indicating its efficacy in treating this condition.

While abrocitinib has demonstrated faster relief of itch compared to dupilumab, it requires careful patient screening for latent tuberculosis and caution in elderly patients or those at risk for blood clots, highlighting the importance of monitoring safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of JAK1 Inhibitor Abrocitinib in Atopic Dermatitis. Iznardo, H., Roé, E., Serra-Baldrich, E., 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]

In a pooled analysis of 942 patients from three clinical trials, abrocitinib treatment significantly improved signs and symptoms of moderate-to-severe atopic dermatitis compared to placebo, with many patients achieving higher threshold efficacy responses.

Patients who met these higher efficacy thresholds reported greater quality-of-life benefits, indicating that abrocitinib not only alleviates symptoms but also enhances overall well-being in a meaningful way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. Ständer, S., Bhatia, N., Gooderham, MJ., et al.[2022]

Abrocitinib, an oral JAK1 inhibitor developed by Pfizer, has been approved in the UK and Japan for treating moderate-to-severe atopic dermatitis in adults and adolescents aged 12 and older.

The drug has also received a positive opinion from the European Medicines Agency and is under review in several other countries, indicating its potential as a new systemic therapy option for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abrocitinib: First Approval. Deeks, ED., Duggan, S.[2022]

In a phase 3 trial involving 391 patients with moderate-to-severe atopic dermatitis, abrocitinib demonstrated significant efficacy, with 38.1% of patients on the 200 mg dose achieving clear or almost clear skin compared to only 9.1% in the placebo group.

Abrocitinib was well tolerated, with serious adverse events occurring in only a small percentage of patients, indicating it is a safe treatment option for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. Silverberg, JI., Simpson, EL., Thyssen, JP., et al.[2021]

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]

Citations

1. cibinqo.com cibinqo.com/study-results

Study Results for CIBINQO® (abrocitinib) | Safety Info Clinical studies showed that with CIBINQO, clearer skin and fast itch relief could be achieved. Take a look at the results below.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40363984/

Real-World Effectiveness and Safety of Upadacitinib ... Our study showed comparable or even higher effectiveness outcomes in terms of EASI 75, EASI 90, and EASI 100 at week 52 compared to phase-3 clinical trials, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03720470

NCT03720470 | Study Evaluating Efficacy and Safety of PF ... A Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy.

4. jaad.org jaad.org/article/S0190-9622(25)02055-9/fulltext

63262 Treatment patterns and effectiveness of Abrocitinib ... Data were collected at routine clinical visits, including demographics, Abrocitinib treatment patterns, and clinical outcomes. Clinical outcomes included AD ...

5. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198%2825%2900213-2/fulltext

Long-Term Safety of Abrocitinib in Moderate-to-Severe ... Results of that analysis suggested that the efficacy of abrocitinib after 12 or 16 weeks of treatment was dose-dependent across age groups and was comparable ...

6. cibinqo.pfizerpro.com cibinqo.pfizerpro.com/safety

Safety Integrated safety analysis of abrocitinib in 3848 patients with moderate-to-severe atopic dermatitis: data from more than 7000 patient-years with up to ~4.5 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/213871s001lbl.pdf

CIBINQO (abrocitinib) - accessdata.fda.gov The safety and effectiveness of CIBINQO in pediatric patients 12 years of age and older weighing 25 kg or more with atopic dermatitis has been established. In ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38888681/

Integrated Safety Update of Abrocitinib in 3802 Patients ... ... abrocitinib has a manageable long-term safety profile in patients with moderate-to-severe atopic dermatitis. Risk of specific adverse events ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825002132

Long-Term Safety of Abrocitinib in Moderate-to-Severe ... Abrocitinib has a manageable long-term safety profile for patients with moderate-to-severe atopic dermatitis. Identifying populations at higher risk of adverse ...