Abrocitinib for Eczema

Recruiting at 1 trial location

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

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

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