Atopic Dermatitis (AD)NCT07276620
Treatment of Moderate-to-Severe Atopic Dermatitis With Ivarmacitinib in Adolescents and Adults
A study testing Ivarmacitinib Sulfate Tablets in people with Atopic Dermatitis (AD), run by Xiangya Hospital of Central South University.
Trial summary
Atopic dermatitis (AD) is a skin condition characterized by a rash and itching, resulting from skin inflammation. Ivarmacitinib is an approved medication for treating AD. This study aims to evaluate the effectiveness and safety of Ivarmacitinib in the treatment of moderate-to-severe atopic dermatitis under real-world… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Ivarmacitinib Sulfate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged between 12 and 75 years;
- Diagnosed with moderate-to-severe atopic dermatitis (AD) ;
- Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.
Who cannot join
- Subject has any of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary:
- Absolute lymphocyte count of <0.50 x 10^9 /L (<500/mm3);
- Absolute Neutrophil Count (ANC) of <1 X 10^9/L (<1000/mm3);
- Hemoglobin level < 80 g/L.
- Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- Subject with a prior history of thromboembolic events, including deep vein thromboses (DVT), pulmonary embolism, cerebrovascular accidents and those with known inherited conditions that predispose to hypercoagulability.
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- Presence of an active severe acute or chronic bacterial, fungal, or viral infection requiring systemic therapy.
- Subjects with active tuberculosis or known active hepatitis B and/or hepatitis C infection.
- Subjects with clinically significant diseases of the heart, liver, kidney, or other major organ systems.
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Efficacy and Safety of Ivarmacitinib in the Treatment of Moderate to Severe Atopic Dermatitis in Adolescents and Adults
Atopic dermatitis (AD) is a skin condition characterized by a rash and itching, resulting from skin inflammation. Ivarmacitinib is an approved medication for treating AD.
This study aims to evaluate the effectiveness and safety of Ivarmacitinib in the treatment of moderate-to-severe atopic dermatitis under real-world conditions. It will assess the time to pruritus improvement and skin lesion clearance, collect large-sample safety data, analyze disease improvement across patient subgroups with different baseline characteristics, and explore the impact of various maintenance treatment regimens on disease recurrence.
It is expected that there will be no additional burden for participants in this trial.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Ivarmacitinib Sulfate Tablets
- Keywords
- Atopic Dermatitis, Ivarmacitinib
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivarmacitinib Sulfate TabletsDrug
Patients with moderate to severe atopic dermatitis are initially treated with 4 mg of ivarmacitinib once daily for 16 weeks. Subsequently, those who respond adequately may transition to an individualized maintenance regimen until week 52.If a suboptimal response is observed with the 4 mg once-daily dose, an increase to 8 mg once daily may be considered. Treatment should be discontinued if an adequate response is not achieved following dose escalation to 8 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Moderate-to-Severe Atopic Dermatitis with Ivarmacitinib in Adolescents and Adults | Experimental | Not described Receives: Drug: Ivarmacitinib Sulfate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic dermatitis based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness , thickness, scratching, and lichenification.
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Baseline and Week 16
Secondary outcomes (7)
Time to achieve a ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS).
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Measured: Baseline and Day 7
The proportion of patients achieving an Investigator's Global Assessment (IGA) response at each scheduled visit, defined as an IGA score of 0 or 1 with at least a 2-point reduction from baseline.
The IGA is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
0 - Clear: No inflammatory signs of AD;
- - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification, no oozing or crusting;
- - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification, no oozing or crusting;
- - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;
- - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.
Measured: Baseline and Week 1、2、4、8、12、16、24、32、40、52
The proportion of subjects achieving EASI 75 at each scheduled visit.
Measured: Baseline and Week 1、2、4、8、12、24、32、40、52
Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults.
Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.
Measured: Baseline and Week 1、2、4、8、12、16、24、32、40、52
Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
Measured: Baseline and Week 1、2、4、8、12、16、24、32、40、52
The recurrence of atopic dermatitis.
Measured: Week 16、52
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From Baseline to 30 days following last dose of study drug (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276620
- Sponsor's protocol ID
- MA-DER-RWS-101
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Ivarmacitinib in the Treatment of Moderate to Severe Atopic Dermatitis in Adolescents and Adults
- ClinicalTrials.gov ID
- NCT07276620
- Acronym / sponsor ID
- MA-DER-RWS-101
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis, Ivarmacitinib
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 11 Dec 2025 (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.
Atopic dermatitis (AD) is a skin condition characterized by a rash and itching, resulting from skin inflammation. Ivarmacitinib is an approved medication for treating AD.
This study aims to evaluate the effectiveness and safety of Ivarmacitinib in the treatment of moderate-to-severe atopic dermatitis under real-world conditions. It will assess the time to pruritus improvement and skin lesion clearance, collect large-sample safety data, analyze disease improvement across patient subgroups with different baseline characteristics, and explore the impact of various maintenance treatment regimens on disease recurrence.
It is expected that there will be no additional burden for participants in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of Moderate-to-Severe Atopic Dermatitis with Ivarmacitinib in Adolescents and Adults | Experimental | Drug: Ivarmacitinib Sulfate Tablets |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 12 and 75 years;
- Diagnosed with moderate-to-severe atopic dermatitis (AD) ;
- Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.
Key exclusion criteria (10 listed)
- Subject has any of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary:
- Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- Subject with a prior history of thromboembolic events, including deep vein thromboses (DVT), pulmonary embolism, cerebrovascular accidents and those with known inherited conditions that predispose to hypercoagulability.
- Presence of an active severe acute or chronic bacterial, fungal, or viral infection requiring systemic therapy.
- Subjects with active tuberculosis or known active hepatitis B and/or hepatitis C infection.
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 |
|---|---|---|
| Ivarmacitinib Sulfate TabletsPatients with moderate to severe atopic dermatitis are initially treated with 4 mg of ivarmacitinib once daily for 16 weeks. Subsequently, those who respond adequately may transition to an individualized maintenance regimen until week 52.If a suboptimal response is observed with the 4 mg once-daily dose, an increase to 8 mg once daily may be considered. Treatment should be discontinued if an adequate response is not achieved following dose escalation to 8 mg once daily. | Drug | Treatment of Moderate-to-Severe Atopic Dermatitis with Ivarmacitinib in Adolescents and Adults |
Primary outcome
Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
Time frame: Baseline and Week 16
EASI is a tool used to measure the extent (area) and severity of atopic dermatitis based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness , thickness, scratching, and lichenification. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
7 secondary outcomes
Time to achieve a ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS).
Time frame: Baseline and Day 7
The proportion of patients achieving an Investigator's Global Assessment (IGA) response at each scheduled visit, defined as an IGA score of 0 or 1 with at least a 2-point reduction from baseline.
Time frame: Baseline and Week 1、2、4、8、12、16、24、32、40、52
The proportion of subjects achieving EASI 75 at each scheduled visit.
Time frame: Baseline and Week 1、2、4、8、12、24、32、40、52
Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
Time frame: Baseline and Week 1、2、4、8、12、16、24、32、40、52
Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline and Week 1、2、4、8、12、16、24、32、40、52
The recurrence of atopic dermatitis.
Time frame: Week 16、52
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From Baseline to 30 days following last dose of study drug (Week 52)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ivarmacitinib Sulfate Tablets in people with Atopic Dermatitis (AD), run by Xiangya Hospital of Central South University.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Xiang Xiang Chen (073189753406, chenxiangck@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 (time frame: Baseline and Week 16). 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 11 Dec 2025.