Clinical trial NCT05466877: A Study of MG-K10 in Subjects With Atopic Dermatitis
Official title: Phase II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Lead sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Sponsor class: OTHER_GOV
First posted: 2022-07-20
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Phase II Study of the Safety, Pharmacokinetics, Dose-Ranging and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Patients with Moderate-to-Severe Atopic Dermatitis
Primary purpose: TREATMENT

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).

Eligibility criteria: key Inclusion Criteria:

1. Aged 18 - 70 years (inclusive), male or female;
2. 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 Exclusion Criteria:

1. Subjects currently diagnosed with other active skin disorders (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation;
2. Subjects with concomitant diseases that may require systemic hormone therapy or other interventions or require active and frequent monitoring;
3. 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；
4. Patients with ocular diseases that are not suitable for enrollment by the investigator；
5. Use of biological agents within 12 weeks prior to randomization or within 5 half-lives (whichever is longer)；
6. Use of topical corticosteroids, topical calcineurin inhibitors, antibiotic compound cream and other topical products for AD treatment within 1 week prior to randomization;
7. chest X-ray or CT examination within 3 months prior to screening/during the screening period suggests the presence of active tuberculosis infection；
8. History of parasitic infection or travel to endemic areas (South America and Africa) half a year prior to screening。

Primary outcomes:
measure: Percentage change from baseline in EASI
timeFrame: 16 weeks
Secondary outcomes:
measure: Proportions of subjects achieving EASI-75
timeFrame: 16 weeks
measure: Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: The change in NRS weekly
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Percentage change from baseline in EASI score
timeFrame: 2, 4, 8, 12, 20 ,24 weeks
measure: Proportions of subjects achieving EASI-50
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Proportions of subjects achieving EASI-75
timeFrame: 2, 4, 8, 12, 20 ,24 weeks
measure: Proportions of subjects achieving EASI-90
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Absolute change from baseline in EASI scores
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Absolute and percentage change from baseline in BSA score of Atopic Dermatitis
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Proportions of subjects with a decrease in IGA score from baseline of ≥ 2
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Proportions of subjects with a decrease in IGA score from baseline of ≥ 3
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Absolute change in POEM from baseline
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Absolute change in DLQI score from baseline
timeFrame: 2, 4, 8, 12, 16, 20 ,24 weeks
measure: Pharmacokinetic concentration
timeFrame: 24 weeks
measure: thymus activation regulated chemokine (TARC)
timeFrame: 24 weeks
measure: serum immunoglobulin E (IgE)
timeFrame: 24 weeks
measure: Incidence of Adverse events (AEs)
timeFrame: 24 weeks
measure: Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
Study officials:
affiliation: Huashan Hospital
name: Jinhua Xu, Medical Ph.D
role: PRINCIPAL_INVESTIGATOR
References: