A Study of MG-K10 in Subjects With Atopic Dermatitis
- Registration Number
- NCT05466877
- Lead Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Brief Summary
This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.
- Detailed Description
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It is planned to enroll approximately 160 adult patients with moderate-to-severe AD uncontrolled by topical therapy, who will receive multiple subcutaneous injections. The study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 163
-
Aged 18 - 70 years (inclusive), male or female;
-
Patients diagnosed with AD according to American Academy of Dermatology Consensus Criteria (2014) for at least 6 months prior to screening and meet the following criteria:
- EASI score ≥ 16 at the screening and baseline visits;
- IGA score ≥ 3 at the screening and baseline visits;
- AD affected body surface area (BSA) percent ≥10% at the screening and baseline visits;
- Documented recent history (within 6 months before the screening) of inadequate response to treatment with potent topical corticosteroids for at least 4 weeks or super-potent topical corticosteroids for at least 2 weeks, or topical calcineurin inhibitors for 4 weeks, or prior systemic use of corticosteroids or immunosuppressive agents for more than 2 weeks;
Key
- Subjects currently diagnosed with other active skin disorders (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation;
- Subjects with concomitant diseases that may require systemic hormone therapy or other interventions or require active and frequent monitoring;
- Subjects with unstable or not well controlled apparent cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychological diseases that is considered by the investigator to be clinically significant；
- Patients with ocular diseases that are not suitable for enrollment by the investigator；
- Use of biological agents within 12 weeks prior to randomization or within 5 half-lives (whichever is longer)；
- Use of topical corticosteroids, topical calcineurin inhibitors, antibiotic compound cream and other topical products for AD treatment within 1 week prior to randomization;
- chest X-ray or CT examination within 3 months prior to screening/during the screening period suggests the presence of active tuberculosis infection；
- History of parasitic infection or travel to endemic areas (South America and Africa) half a year prior to screening。
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo subcutaneous injection every 2 weeks MG-K10 Regimen 2 MG-K10 subcutaneous injection every 2 weeks MG-K10 Regimen 3 MG-K10 subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness) MG-K10 Regimen 1 MG-K10 subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)
- Primary Outcome Measures
Name Time Method Percentage change from baseline in EASI 16 weeks Percentage change from baseline in eczema area and severity index (EASI) score
- Secondary Outcome Measures
Name Time Method The change in NRS weekly 2, 4, 8, 12, 16, 20 ,24 weeks The change in NRS weekly mean score and percentage change from baseline at W2, W4, W8, W12, W16, W20, and W24
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline 2, 4, 8, 12, 16, 20 ,24 weeks Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
Absolute and percentage change from baseline in BSA score of Atopic Dermatitis 2, 4, 8, 12, 16, 20 ,24 weeks Absolute and percentage change from baseline in BSA score of Atopic Dermatitis at W2, W4, W8, W12, W16, W20, and W24
Pharmacokinetic concentration 24 weeks To evaluate the Pharmacokinetic concentration of MG-K10
Proportions of subjects achieving EASI-50 2, 4, 8, 12, 16, 20 ,24 weeks Proportions of subjects achieving EASI-50 (≥ 50% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24
Proportions of subjects achieving EASI-75 2, 4, 8, 12, 20 ,24 weeks Proportions of subjects achieving EASI-75 at W2, W4, W8, W12, W20, and W24
Percentage change from baseline in EASI score 2, 4, 8, 12, 20 ,24 weeks Percentage change from baseline in EASI score at Weeks W2, W4, W8, W12, W20, and W24
Proportions of subjects achieving EASI-90 2, 4, 8, 12, 16, 20 ,24 weeks Proportions of subjects achieving EASI-90 (≥ 90% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24
Proportions of subjects with a decrease in IGA score from baseline of ≥ 2 2, 4, 8, 12, 16, 20 ,24 weeks Proportions of subjects with a decrease in IGA score from baseline of ≥ 2 at W2, W4, W8, W12, W16, W20 and W24
Proportions of subjects with a decrease in IGA score from baseline of ≥ 3 2, 4, 8, 12, 16, 20 ,24 weeks Proportions of subjects with a decrease in IGA score from baseline of ≥ 3 at W2, W4, W8, W12, W16, W20 and W24
Absolute change in POEM from baseline 2, 4, 8, 12, 16, 20 ,24 weeks Absolute change in patient oriented eczema measure (POEM) from baseline at W2, W4, W8, W12, W16, W20 and W24
Absolute change in DLQI score from baseline 2, 4, 8, 12, 16, 20 ,24 weeks Absolute change in dermatology life quality index (DLQI) score from baseline at W2, W4, W8, W12, W16, W20 and W24
thymus activation regulated chemokine (TARC) 24 weeks At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline
serum immunoglobulin E (IgE) 24 weeks At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline
Incidence of Adverse events (AEs) 24 weeks Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs)
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) 24 weeks Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)
Absolute change from baseline in EASI scores 2, 4, 8, 12, 16, 20 ,24 weeks Absolute change from baseline in EASI scores at W2, W4, W8, W12, W16, W20, and W24
Trial Locations
- Locations (2)
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China