Treatment of Moderate-to-Severe Atopic Dermatitis With Ivarmacitinib in Adolescents and Adults

Official title

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

Overview

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.

Interventions

• Drug Ivarmacitinib Sulfate Tablets
  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 outcome measures

• 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]

Secondary outcome measures (7)

• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07276620 · MA-DER-RWS-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗