Abrocitinib for Eczema

Recruiting at 21 trial locations

Overseen By Nancy A Sherman, BA

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: JAK inhibitors, CYP2C19 inhibitors

Disqualifiers: Infections, Immunodeficiency, Malignancy, others

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: 2

Duration: 16 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether abrocitinib, a JAK inhibitor, can safely and effectively improve eczema in children. Participants will receive either abrocitinib or a placebo, a non-active substance resembling the medicine, over 16 weeks. The trial seeks children aged 6 to under 12 years who have had moderate-to-severe eczema for at least a year and have not improved with standard creams or ointments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for eczema.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they are strong inhibitors or inducers of specific enzymes (CYP2C19, CYP2C9) or certain other drugs. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that abrocitinib is likely to be safe for children with eczema?

Research shows that abrocitinib is generally safe for people with moderate-to-severe eczema. Studies have found that it maintains a manageable safety profile over time. While some people experience side effects, they are usually not serious.

Abrocitinib has been approved for adults and teenagers with atopic dermatitis (another name for eczema), indicating that its safety has been thoroughly evaluated. Most reported side effects are mild, such as nausea or headaches. However, safety can vary from person to person. Always consult a healthcare provider to determine if it's a suitable option for you or your child. ^{1 2 3 4 5}

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

Unlike the standard treatments for eczema, such as topical steroids and calcineurin inhibitors, Abrocitinib works by specifically targeting and inhibiting Janus kinase 1 (JAK1). This mechanism of action potentially allows for more precise control of the inflammatory processes underlying eczema. Researchers are excited about Abrocitinib because it is administered as a liquid oral suspension, offering an alternative to topical treatments, which can be cumbersome and less effective for widespread or severe cases. Additionally, this oral option could lead to improved patient adherence and convenience.

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

Research has shown that abrocitinib, which participants in this trial may receive, effectively treats eczema. Studies indicate that many patients experience a 75% improvement in their eczema symptoms by week 12. Additionally, many people report less itching and smaller skin rashes after using abrocitinib. Real-world evidence supports its effectiveness, even for those who haven't succeeded with other treatments. These findings suggest that abrocitinib can be a promising option for managing moderate-to-severe eczema. ^{4 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 6 to less than 12 with moderate-to-severe eczema, diagnosed for at least a year. They must have tried topical treatments without success and weigh over 15 kg. Children who meet these criteria can participate.

Inclusion Criteria

My body weight is at least 15 kg.

I am a male participant and do not need to use contraception.

I am between 6 and 11 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either abrocitinib or placebo for 16 weeks

16 weeks

Regular clinic visits and phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Abrocitinib

Trial Overview The study tests if abrocitinib is effective and safe in treating children's eczema compared to a placebo. Participants are randomly assigned to receive either the actual medicine or a pretend version for 16 weeks, with the total study lasting about 24 weeks.

How Is the Trial Designed?

Group I: Abrocitinib Experimental Treatment 1 Intervention

Abrocitinib administered as liquid oral suspension.

Group II: Matching Placebo Placebo Group 1 Intervention

Placebo administered as liquid oral suspension.

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 ... Abrocitinib has a manageable long-term safety profile. TEAEs of special interest were lower in adolescents and higher in the 65-years-old or ...

7. 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 ...

8. link.springer.com link.springer.com/article/10.1007/s40257-024-00869-w

Integrated Safety Update of Abrocitinib in 3802 Patients ... Abrocitinib is an approved treatment for people with moderate or severe atopic dermatitis, also known as AD or atopic eczema. Abrocitinib is a ...

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.