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

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Abrocitinib
Sponsored by
Innovaderm Research Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, dupilumab, abrocitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Inno-6050 Site 13Recruiting
  • Inno-6050 Site 19Recruiting
  • Inno-6050 Site 16Recruiting
  • Inno-6050 Site 17Recruiting
  • Inno-6050 Site 15Recruiting
  • Inno-6050 Site 18Recruiting
  • Inno-6050 Site 11Recruiting
  • Inno-6050 Site 10Recruiting
  • Inno-6050 Site 14Recruiting
  • Inno-6050 Site 20Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abrocitinib 100 mg tablet (marketed drug)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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".
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 15, 2022
Last Updated
April 5, 2023
Sponsor
Innovaderm Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05602207
Brief Title
Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab
Official Title
Clinical and Molecular Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response or Facial Erythema After Treatment With Dupilumab
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovaderm Research Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema, dupilumab, abrocitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abrocitinib 100 mg tablet (marketed drug)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Abrocitinib
Other Intervention Name(s)
CIBINQO
Intervention Description
100 mg Abrocitinib once daily (QD) for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline of Eczema Area and Severity Index (EASI)
Description
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.
Time Frame
at Week 12
Secondary Outcome Measure Information:
Title
Change from baseline of Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)
Description
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.
Time Frame
at Week 12
Title
Change from baseline of Body Surface Area (BSA)
Description
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.
Time Frame
at Week 12
Title
Change from baseline of Peak pruritus Numerical Rating Scale (NRS)
Description
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.
Time Frame
over 12 weeks
Title
Change from baseline of Facial Eczema Area and Severity Index (EASI)
Description
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".
Time Frame
at Week 12
Title
Change from baseline of Modified validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)
Description
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.
Time Frame
at Week 12
Title
Change from baseline of the CCL18 Skin Biomarker Level
Description
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in CCL18 skin biomarker levels in lesional and nonlesional skin samples.
Time Frame
at Week 12
Title
Change from baseline of the MMP12 Skin Biomarker Level
Description
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in MMP12 skin biomarker levels lesional and nonlesional skin samples.
Time Frame
at Week 12
Title
Change from baseline of the Keratin 16 Skin Biomarker Level
Description
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in Keratine 16 skin biomarker levels lesional and nonlesional skin samples.
Time Frame
at Week 12
Title
Change from baseline of the S100A7 Skin Biomarker Level
Description
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A7 skin biomarker levels lesional and nonlesional skin samples.
Time Frame
at Week 12
Title
Change from baseline of the S100A8 Skin Biomarker Level
Description
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A8 skin biomarker levels lesional and nonlesional skin samples.
Time Frame
at Week 12
Title
Change from baseline of the S100A9 Skin Biomarker Level
Description
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A9 skin biomarker levels lesional and nonlesional skin samples.
Time Frame
at Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Dufour Bergeron
Phone
1-866-575-3111
Ext
397
Email
ddbergeron@innovaderm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD
Organizational Affiliation
Innovaderm Research Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inno-6050 Site 13
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Montanez
Facility Name
Inno-6050 Site 19
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Rodriguez
Facility Name
Inno-6050 Site 16
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ada Zhu
Facility Name
Inno-6050 Site 17
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Shammami
Facility Name
Inno-6050 Site 15
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Toews
Facility Name
Inno-6050 Site 18
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monaliben Patel
Facility Name
Inno-6050 Site 11
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Balakas
Facility Name
Inno-6050 Site 10
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydia Edjekouane
Facility Name
Inno-6050 Site 14
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Martin de Mereuil
Facility Name
Inno-6050 Site 20
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale Laberge

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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