Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07276620

Treatment of Moderate-to-Severe Atopic Dermatitis With Ivarmacitinib 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Ivarmacitinib Sulfate Tablets

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to achieve a ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS).

    Time frame: Baseline and Day 7

    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).

  2. 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 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.

  3. 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

  4. 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

    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.

  5. 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 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.

  6. The recurrence of atopic dermatitis.

    Time frame: Week 16、52

  7. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Xiang Xiang Chen

CONTACT

[email protected]

073189753406

Su Juan Juan Su

CONTACT

[email protected]

073189753406

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

A Study on the Efficacy and Safety of Ivarmacitinib in the Treatment of Moderate to Severe Atopic Dermatitis in Adolescents and Adults

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.