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

Sponsor

Innovaderm Research Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT05602207

Collaborator

(none)

Enrollment

Locations

Arm

10.2

Anticipated Duration (Months)

6.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Abrocitinib	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 25, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Abrocitinib 100 mg tablet (marketed drug)

Drug: Abrocitinib

100 mg Abrocitinib once daily (QD) for 12 weeks

Other Names:

CIBINQO

Outcome Measures

Primary Outcome Measures

Change from baseline of Eczema Area and Severity Index (EASI) [at Week 12]
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) [at Week 12]
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) [at Week 12]
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) [over 12 weeks]
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) [at Week 12]
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) [at Week 12]
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 [at Week 12]
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 [at Week 12]
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 [at Week 12]
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 [at Week 12]
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 [at Week 12]
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 [at Week 12]
The molecular effects of abrocitinib will be evaluated by measuring changes from baseline in S100A9 skin biomarker levels lesional and nonlesional skin samples.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inno-6050 Site 13	Fountain Valley	California	United States	92708
2	Inno-6050 Site 19	Saint Petersburg	Florida	United States	33709
3	Inno-6050 Site 16	Quincy	Massachusetts	United States	02169
4	Inno-6050 Site 17	Auburn Hills	Michigan	United States	48326
5	Inno-6050 Site 15	Winnipeg	Manitoba	Canada	R3C 0N2
6	Inno-6050 Site 18	Newmarket	Ontario	Canada	L3Y 5G8
7	Inno-6050 Site 11	Toronto	Ontario	Canada	M4W 2N4
8	Inno-6050 Site 10	Montreal	Quebec	Canada	H2X 2V1
9	Inno-6050 Site 14	Québec	Quebec	Canada	G1V 4X7