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

Clinical and Molecular Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response or Facial Erythema After Treatment With Dupilumab

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

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Abrocitinib

Detailed Description

This study is being conducted to evaluate the efficacy, safety, and molecular effects of abrocitinib in subjects with an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab. Approximately 60 subjects with atopic dermatitis will receive abrocitinib once daily for 12 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dominique Dufour Bergeron; Phone Number: 397 1-866-575-3111; Email: ddbergeron@innovaderm.com

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Recruiting
      • Inno-6050 Site 15
      • Contact: Tiffany Toews
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Recruiting
      • Inno-6050 Site 18
      • Contact: Monaliben Patel
    • Toronto, Ontario, Canada, M4W 2N4
      • Recruiting
      • Inno-6050 Site 11
      • Contact: Megan Balakas
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Recruiting
      • Inno-6050 Site 10
      • Contact: Lydia Edjekouane
    • Québec, Quebec, Canada, G1V 4X7
      • Recruiting
      • Inno-6050 Site 14
      • Contact: Marie Martin de Mereuil
    • Québec, Quebec, Canada, G1W 4R4
      • Recruiting
      • Inno-6050 Site 20
      • Contact: Pascale Laberge
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Recruiting
      • Inno-6050 Site 22
      • Contact: Ashlee Rawlins; Email: arawlins@cahabaderm.com
  • California
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • Inno-6050 Site 13
      • Contact: Vanessa Montanez
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Recruiting
      • Inno-6050 Site 21
      • Contact: Luis Sanchez
    • Saint Petersburg, Florida, United States, 33709
      • Recruiting
      • Inno-6050 Site 19
      • Contact: Ingrid Rodriguez
  • Massachusetts
    • Quincy, Massachusetts, United States, 02169
      • Recruiting
      • Inno-6050 Site 16
      • Contact: Ada Zhu
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Recruiting
      • Inno-6050 Site 17
      • Contact: Elise Shammami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subject 18 years of age or older, at the time of consent.
2. Subject has clinically confirmed diagnosis of active atopic dermatitis (AD), according to Hanifin and Rajka criteria.
3. Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before screening.
4. Subjects who had moderate to severe AD before initiating dupilumab treatment.

5. Subject currently has an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab, defined as follows:

   1. 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
   2. 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.

Exclusion Criteria:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
2. Subject has clinically infected AD.
3. Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
4. Subject has a history of cancer within 5 years prior to Day 1.
5. Subject has a history of lymphoproliferative disorder, lymphoma, or leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
6. 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.
7. Subject is known to have immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
8. Subject has a current or recent clinically serious infection.
9. Subject has used abrocitinib prior to Day 1.
10. Subject has a known hypersensitivity to abrocitinib or its excipients.
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abrocitinib 100 mg tablet (marketed drug)	Drug: Abrocitinib; 100 mg Abrocitinib once daily (QD) for 12 weeks; Other Names: CIBINQO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)	The vIGA-AD is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity.	at Week 12
Change from baseline of Body Surface Area (BSA)	The overall BSA affected by disease will be evaluated (from 0% to 100%). The palmar surface of one hand (using the patient's hand and including the fingers) represents 1% of the total BSA.	at Week 12
Change from baseline of Peak pruritus Numerical Rating Scale (NRS)	The intensity of pruritus will be evaluated using a NRS by asking subjects to assign a numerical score representing of the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst imaginable symptoms.	over 12 weeks
Change from baseline of Facial Eczema Area and Severity Index (EASI)	The facial 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 six facial regions, with adjustment for the percentage of facial surface area involved for each facial region, using the "rule of fours".	at Week 12
Change from baseline of Modified validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)	The modified vIGA-AD will be used to assess the severity of lesions on the face for subjects with facial erythema at baseline and on the trunk and/or limbs for subjects with atopic dermatitis (AD) on those body parts at baseline.	at Week 12
Change from baseline of the CCL18 Skin Biomarker Level	The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in CCL18 skin biomarker levels in lesional and nonlesional skin samples.	at Week 12
Change from baseline of the MMP12 Skin Biomarker Level	The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in MMP12 skin biomarker levels lesional and nonlesional skin samples.	at Week 12
Change from baseline of the Keratin 16 Skin Biomarker Level	The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in Keratine 16 skin biomarker levels lesional and nonlesional skin samples.	at Week 12
Change from baseline of the S100A7 Skin Biomarker Level	The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A7 skin biomarker levels lesional and nonlesional skin samples.	at Week 12
Change from baseline of the S100A8 Skin Biomarker Level	The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A8 skin biomarker levels lesional and nonlesional skin samples.	at Week 12
Change from baseline of the S100A9 Skin Biomarker Level	The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A9 skin biomarker levels lesional and nonlesional skin samples.	at Week 12

Collaborators and Investigators

• Sponsor: Innovaderm Research Inc.
• Investigators: Principal Investigator: Robert Bissonnette, MD, Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: eczema; dupilumab; abrocitinib
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abrocitinib
• Other Study ID Numbers: Inno-6050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No