Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab

NCT05602207 | Completed Phase 4 FDA Drug

• 1 other identifier: Inno-6050
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 12

Brief Summary

This is a single-arm, open-label study that will examine the effect of abrocitinib in subjects with atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

eczema; dupilumab; abrocitinib

Outcome Measures

Primary Outcomes (1)

• Change from baseline of Eczema Area and Severity Index (EASI)

  The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of body surface area (BSA) involved for each body region and for the proportion of the body region to the whole body. The primary endpoint is the change from baseline in EASI at Week 12.

  at Week 12

Secondary Outcomes (11)

• Change from baseline of Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)

  at Week 12

• Change from baseline of Body Surface Area (BSA)

  at Week 12

• Change from baseline of Peak pruritus Numerical Rating Scale (NRS)

  over 12 weeks

• Change from baseline of Facial Eczema Area and Severity Index (EASI)

  at Week 12

• Change from baseline of Modified validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)

  at Week 12

Study Arms (1)

Abrocitinib 100 mg tablet (marketed drug)

EXPERIMENTAL

Drug: Abrocitinib

Interventions

Abrocitinib DRUG

100 mg Abrocitinib once daily (QD) for 12 weeks

Also known as: CIBINQO

Abrocitinib 100 mg tablet (marketed drug)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject 18 years of age or older, at the time of consent.
• Subject has clinically confirmed diagnosis of active atopic dermatitis (AD), according to Hanifin and Rajka criteria.
• Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before screening.
• Subjects who had moderate to severe AD before initiating dupilumab treatment.
• Subject currently has an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab, defined as follows:
• A global vIGA-AD ≥ 2, at least 1% BSA with facial erythema, and a modified vIGA-AD for the face ≥2 at screening and Day 1 OR
• A global vIGA-AD ≥ 2, at least 3% BSA affected by AD on the trunk and/or limbs, and a modified vIGA-AD for the trunk/limbs ≥ 2 at screening and Day 1.

You may not qualify if:

• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has clinically infected AD.
• Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
• Subject has a history of cancer within 5 years prior to Day 1.
• Subject has a history of lymphoproliferative disorder, lymphoma, or leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
• Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
• Subject is known to have immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
• Subject has a current or recent clinically serious infection.
• Subject has used abrocitinib prior to Day 1.
• Subject has a known hypersensitivity to abrocitinib or its excipients.
• Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (12)

Inno-6050 Site 22

Birmingham, Alabama, 35244, United States

Location

Inno-6050 Site 13

Fountain Valley, California, 92708, United States

Location

Inno-6050 Site 21

Miami Lakes, Florida, 33014, United States

Location

Inno-6050 Site 19

St. Petersburg, Florida, 33709, United States

Location

Inno-6050 Site 16

Quincy, Massachusetts, 02169, United States

Location

Inno-6050 Site 17

Auburn Hills, Michigan, 48326, United States

Location

Inno-6050 Site 15

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Inno-6050 Site 18

Newmarket, Ontario, L3Y 5G8, Canada

Location

Inno-6050 Site 11

Toronto, Ontario, M4W 2N4, Canada

Location

Inno-6050 Site 10

Montreal, Quebec, H2X 2V1, Canada

Location

Inno-6050 Site 14

Québec, Quebec, G1V 4X7, Canada

Location

Inno-6050 Site 20

Québec, Quebec, G1W 4R4, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: November 2, 2022
• Study Start: November 25, 2022
• Primary Completion: December 3, 2024
• Study Completion: January 9, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CA (6)