Atopic DermatitisPhase 4NCT05602207
Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab
A Phase 4 study testing Abrocitinib in people with Atopic Dermatitis, run by Innovaderm Research Inc. at 12 sites in 2 countries.
Trial summary
This is a single-arm, open-label study that will examine the effect of abrocitinib in subjects with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Abrocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 25 Nov 2022to 9 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States6 sites
Inno-6050 Site 17
Auburn Hills, Michigan, 48326
Inno-6050 Site 22
Birmingham, Alabama, 35244
Inno-6050 Site 13
Fountain Valley, California, 92708
Inno-6050 Site 21
Miami Lakes, Florida, 33014
Inno-6050 Site 16
Quincy, Massachusetts, 02169
Inno-6050 Site 19
St. Petersburg, Florida, 33709
Canada6 sites
Inno-6050 Site 10
Montreal, Quebec, H2X 2V1
Inno-6050 Site 18
Newmarket, Ontario, L3Y 5G8
Inno-6050 Site 14
Québec, Quebec, G1V 4X7
Inno-6050 Site 20
Québec, Quebec, G1W 4R4
Inno-6050 Site 11
Toronto, Ontario, M4W 2N4
Inno-6050 Site 15
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Abrocitinib
- Keywords
- eczema, dupilumab, abrocitinib
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
Also called CIBINQO
100 mg Abrocitinib once daily (QD) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Abrocitinib 100 mg tablet (marketed drug) | Experimental | Not described Receives: Drug: Abrocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Week 12
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start25 Nov 2022
- Primary completion3 Dec 2024
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602207
- Sponsor's protocol ID
- Inno-6050
- Status last verified
- Mar 2025
- First submitted
- 15 Jul 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response or Facial Erythema After Treatment With Dupilumab
- ClinicalTrials.gov ID
- NCT05602207
- Acronym / sponsor ID
- Inno-6050
- Conditions
- Atopic Dermatitis
- Keywords
- eczema, dupilumab, abrocitinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abrocitinib 100 mg tablet (marketed drug) | Experimental | Drug: Abrocitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbrocitinibAlso: CIBINQO100 mg Abrocitinib once daily (QD) for 12 weeks | Drug | Abrocitinib 100 mg tablet (marketed drug) |
Primary outcome
Change from baseline of Eczema Area and Severity Index (EASI)
Time frame: 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.
11 secondary outcomes
Change from baseline of Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)
Time frame: at Week 12
Change from baseline of Body Surface Area (BSA)
Time frame: at Week 12
Change from baseline of Peak pruritus Numerical Rating Scale (NRS)
Time frame: over 12 weeks
Change from baseline of Facial Eczema Area and Severity Index (EASI)
Time frame: at Week 12
Change from baseline of Modified validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)
Time frame: at Week 12
Change from baseline of the CCL18 Skin Biomarker Level
Time frame: at Week 12
Change from baseline of the MMP12 Skin Biomarker Level
Time frame: at Week 12
Change from baseline of the Keratin 16 Skin Biomarker Level
Time frame: at Week 12
Change from baseline of the S100A7 Skin Biomarker Level
Time frame: at Week 12
Change from baseline of the S100A8 Skin Biomarker Level
Time frame: at Week 12
Change from baseline of the S100A9 Skin Biomarker Level
Time frame: at Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD principal investigator
Innovaderm Research Inc.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abrocitinib in people with Atopic Dermatitis, run by Innovaderm Research Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Eczema Area and Severity Index (EASI) (time frame: at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.