A Study of MG-K10 in Subjects With Atopic Dermatitis

Shanghai Mabgeek Biotech

Status and phase: Active, not recruiting; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: MG-K10

Study type: Interventional

Funder types: Other

Identifiers

NCT05466877

MG-K10-AD-2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 163 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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。

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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163 participants in 4 patient groups, including a placebo group

MG-K10 Regimen 1

Experimental group

Description:

subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)

Treatment:

Drug: MG-K10

MG-K10 Regimen 2

Experimental group

Description:

subcutaneous injection every 2 weeks

Treatment:

Drug: MG-K10

MG-K10 Regimen 3

Experimental group

Description:

subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)

Treatment:

Drug: MG-K10

Placebo

Placebo Comparator group

Description:

subcutaneous injection every 2 weeks

Treatment:

Drug: Placebo