Abrocitinib for Eczema

Recruiting at 7 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 research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to \<12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.

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