Abrocitinib for Eczema

Recruiting at 11 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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests abrocitinib, a medication taken regularly, on people with atopic dermatitis who didn't respond well to another treatment or have facial redness. It works by reducing inflammation. Abrocitinib is approved in Europe, the United States, and other countries for the treatment of atopic dermatitis in adults whose disease is not controlled with other treatments.

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 data supports the idea that Abrocitinib for Eczema is an effective drug?

The available research shows that Abrocitinib is effective in treating moderate-to-severe eczema. Studies have shown that taking Abrocitinib once a day leads to significant improvements in the symptoms of eczema. It has been tested in controlled studies and found to be effective and well-tolerated by patients. Additionally, it has been approved for use in several countries, including the UK and Japan, which supports its effectiveness as a treatment option for eczema. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Abrocitinib for eczema?

Research shows that Abrocitinib, taken once daily, significantly improves the symptoms of moderate-to-severe eczema (atopic dermatitis) in both adults and adolescents. It has been approved in several countries for this use, indicating its effectiveness and safety. ^{1 2 3 4 5}

What safety data is available for Abrocitinib in treating eczema?

Abrocitinib, also known as Cibinqo or PF-04965842, has been evaluated for safety in several studies. It was found to be well tolerated in a phase 3 monotherapy trial for patients with moderate-to-severe atopic dermatitis. The drug has been approved in the UK and Japan, and has received a positive opinion in the EU, indicating a favorable safety profile. Additional studies have shown meaningful improvements in symptoms, suggesting a balance of efficacy and safety. ^{1 2 3 4 5}

Is Abrocitinib safe for humans?

Abrocitinib has been shown to be well tolerated in clinical trials for moderate-to-severe atopic dermatitis, meaning it generally did not cause serious side effects in those studies. ^{1 2 3 4 5}

Is the drug Abrocitinib a promising treatment for eczema?

Yes, Abrocitinib is a promising drug for treating eczema. It has been approved in several countries for moderate-to-severe cases and has shown effectiveness in clinical trials. It works quickly to relieve itching and has been compared favorably to other treatments. ^{1 5 6 7 8}

What makes the drug Abrocitinib unique for treating eczema?

Abrocitinib is unique because it is an oral medication that specifically targets Janus kinase 1 (JAK1), which helps reduce inflammation in moderate-to-severe eczema. It has shown a faster effect in relieving itch compared to some other treatments, like dupilumab. ^{1 5 6 7 8}

Research Team

Robert Bissonnette, MD

Principal Investigator

Innovaderm Research Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Abrocitinib: First Approval. [2022]

2. England 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. [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. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. [2021]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of JAK1 Inhibitor Abrocitinib in Atopic Dermatitis. [2023]

8. 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]