This is a multicenter, randomized, double-blind, vehicle-controlled phase III study of MH004 Ointment with a 44-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with mild to moderate atopic dermatitis.
This phase III trial of MH004 Ointment comprises two periods: a vehicle control period and an open-label long-term safety extension period. Participants will be randomly aligned to the 1.0% MH004 Ointment BID or Vehicle BID arm and treated for up to 8 weeks, followed by a 44-week open-label LTS treatment period with 1.0% MH004 Ointment BID. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with mild to moderate atopic dermatitis (AD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
375
MH004 1% ointment applied topically to the affected area as a thin film twice daily.
Matching vehicle ointment applied topically to the affected area as a thin film twice daily.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Proportion of participants achieving Investigator's Global Assessment treatment success (IGA-TS) at Week 4.
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Time frame: Baseline to week 4.
Proportion of participants achieving EASI-75 at Week 4.
EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
Time frame: Baseline to week 4.
Key Secondary Endpoints: Proportion of participants achieving IGA-TS at Week 8.
The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.
Time frame: Baseline to week 8.
Key Secondary Endpoints: Proportion of participants achieving EASI-75 at Week 8.
An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
Time frame: Baseline to week 8.
Key Secondary Endpoints: Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (INRS) from baseline to Week 4.
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The Itch NRS is a daily patient-reported measure (24-hour recall) of the worst level of itch intensity. Participants will be asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.
Time frame: From pre-dose to 4 weeks after the first dose.
Key Secondary Endpoints: Proportion of participants with a clinically meaningful (≥ 6-point) improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form-Sleep Disturbance (8b - 24-hour recall) score at Week 4
This assessment is self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS Short Form - Sleep-Related Impairment (8a) collected in the evening before sleeping; PROMIS Short Form - Sleep Disturbance (8b) collected in the morning after the participant wakes up.
Time frame: From pre-dose to 4 weeks after the first dose.
Key Secondary Endpoints: Proportion of participants with a clinically meaningful (≥ 6-point) improvement in the PROMIS Short Form - Sleep - Related Impairment (8a - 24-hour recall) score at Week 4.
This assessment is self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS Short Form - Sleep-Related Impairment (8a) collected in the evening before sleeping; PROMIS Short Form - Sleep Disturbance (8b) collected in the morning after the participant wakes up.
Time frame: From pre-dose to 4 weeks after the first dose.
Incidence, Frequency, Duration and Severity of Treatment-Emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Time frame: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52)
Incidence of Treatment-Emergent Serious Adverse Event (SAE) and Incidence of AEs resulting discontinue medication
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Time frame: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52)
Characterization of Pharmacokinetics (Ctrough) of MH004 Ointment in Participants With Mild to Moderate Atopic Dermatitis at Week 2.4.8 during the VC period and Week 12, 24, 36, 52 during the LTS period.
Trough drug concentration (Ctrough)
Time frame: Baseline, Week 2, 4, 8, 12, 24, 36, 52
Change From Baseline in DLQI/CDLQI at Week 2, 4, 8, 12, 24, 52
The DLQI/CDLQI (Dermatology Life Quality Index/Children Dermatology Life Quality Index) is a standardized tool for assessing the impact of skin diseases on patients' quality of life. It consists of 10 questions covering multiple dimensions such as symptom perception, daily activities, and social psychology. The total score ranges from 0 to 30, with a higher score indicating a more severe impact of the disease on life.
Time frame: Baseline, Week 2, 4, 8, 12, 24, 52