Abrocitinib for Atopic Dermatitis/Eczema
(JADE EXTEND Trial)

Recruiting in Palo Alto (17 mi)

+589 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a pill called Abrocitinib to help people aged 12 and older with severe eczema. It aims to see if the pill can reduce inflammation and itching by blocking certain body chemicals. The study includes patients who have already participated in a related study.

Eligibility Criteria

This trial is for people aged 12+ with moderate to severe atopic dermatitis who've finished a related study. They must not plan to get pregnant, be currently pregnant or breastfeeding, and agree to use contraception if applicable. Participants should avoid sun exposure and certain medications.

Inclusion Criteria

I am 12 years or older and meet the weight requirement from a previous study.

I am not pregnant, breastfeeding, or planning to become pregnant and agree to use effective birth control.

Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.

+2 more

Exclusion Criteria

I do not have other skin conditions that could affect the study.

Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Ongoing adverse event in the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.

+2 more

Participant Groups

The trial tests two doses of Abrocitinib (100 mg & 200 mg) taken daily by mouth against a placebo in patients with atopic dermatitis over an initial period of 92 weeks, followed by open-label treatment until the drug's commercial availability or study end.

2Treatment groups

Experimental Treatment

Group I: Abrocitinib 200 mgExperimental Treatment2 Interventions

Abrocitinib 200 mg QD PO

Group II: Abrocitinib 100 mgExperimental Treatment2 Interventions

Abrocitinib 100 mg QD PO