Abrocitinib for Eczema

Not yet recruiting at 7 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: JAK inhibitors, CYP2C19 inhibitors

Disqualifiers: Infections, Immunodeficiency, Malignancy, 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

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of a new liquid medicine, abrocitinib, for children with moderate-to-severe eczema, a condition causing itchy, inflamed skin. The research will assess how well this treatment works over a long period, either alone or with creams and ointments. It is open to children who have participated in other studies with this medicine and those who have not. Suitable candidates for this trial are children aged 6 to under 12 who have had eczema for at least six months and have not found relief with topical treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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

The trial does not specify if you must stop taking your current medications, but it does prohibit the use of certain treatments, like strong inhibitors and inducers of specific enzymes. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that abrocitinib is likely to be safe for humans?

Studies have shown that abrocitinib is generally safe for long-term use in treating moderate-to-severe atopic dermatitis, a more serious type of eczema. While some side effects occur, they are usually mild and manageable. Teenagers and adults tolerate the treatment well. Research indicates that younger patients tend to experience fewer side effects than those aged 65 and older. However, some individuals might be more prone to side effects. Prospective trial participants can use this information to understand what to expect regarding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Abrocitinib is unique because it targets eczema in a novel way. While most treatments for eczema, like topical corticosteroids and calcineurin inhibitors, primarily focus on reducing inflammation on the skin's surface, abrocitinib works from the inside out. It specifically inhibits Janus kinase 1 (JAK1), an enzyme that plays a crucial role in the inflammatory process. Researchers are excited about abrocitinib because this targeted approach could offer faster relief from symptoms and potentially help those who haven't responded well to traditional treatments.

What evidence suggests that abrocitinib might be an effective treatment for eczema?

Studies have shown that abrocitinib effectively treats atopic dermatitis, commonly known as eczema. Research indicates that many patients experience significant improvement, with some seeing up to a 75% reduction in eczema severity within 12 weeks. One study found that 20.5% to 36.1% of patients achieved skin that was clear or almost clear. Additionally, real-world evidence suggests it works well even for those unresponsive to other treatments. This makes abrocitinib a promising option for managing moderate-to-severe eczema. ^{3 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for children aged 2 years and older with moderate to severe eczema who haven't responded well to topical treatments. They must have a confirmed diagnosis of atopic dermatitis, meet specific severity criteria, and weigh at least 15 kg. Girls able to have children must not be pregnant or breastfeeding and agree to avoid pregnancy during the study.

Inclusion Criteria

Body weight ≥15 kg

I have finished the treatment phase of a previous study and am between 2 and 12 years old.

I am not pregnant or breastfeeding and will use effective birth control during and after the study.

Exclusion Criteria

Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members

Participants living outside the US

I have a history of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive liquid abrocitinib oral suspension with or without topical medications

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue receiving the study drug until commercial availability

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Abrocitinib

Trial Overview The study tests long-term safety and effectiveness of an oral liquid medicine called Abrocitinib for kids with eczema. It includes those new to Abrocitinib as well as those who've been part of previous related studies, assessing its use alone or with other skin treatments over two years.

How Is the Trial Designed?

Group I: Extension Experimental Treatment 1 Intervention

Patients who have completed other abrocitinib studies

Group II: De novo Experimental Treatment 1 Intervention

Patients who have not participated other abrocitinib studies

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

Citations

1. 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, ...

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

63262 Treatment patterns and effectiveness of Abrocitinib ... 11.9% of patients who discontinued Abrocitinib experienced AD flare-ups during their follow-up. 20.5%, 27.0%, and 36.1% of patients achieved IGA success at ...

3. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02873-0

The impact of abrocitinib treatment on lesion area and pruritus ... All five studies reported the percentage of patients achieving a 75% improvement in the Eczema Area and Severity Index at week 12, providing a ...

4. medicaljournalssweden.se medicaljournalssweden.se/actadv/article/view/19454

Real-world Experience of Abrocitinib Treatment in Patients ... Abrocitinib is an effective treatment for atopic dermatitis and can be effective for patients with previous inadequate response to dupilumab or upadacitinib.

5. tandfonline.com tandfonline.com/doi/full/10.1080/09546634.2024.2411855

Short-term effectiveness and safety of abrocitinib in adults ... Conclusion: Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40081761/

Long-Term Safety of Abrocitinib in Moderate-to-Severe ... Conclusions: Abrocitinib has a manageable long-term safety profile. TEAEs of special interest were lower in adolescents and higher in the 65- ...

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

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 ...

8. 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 ...

9. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2766772

Efficacy and Safety of Abrocitinib in Patients With Moderate ... Abrocitinib was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis.