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A Study of MG-K10 in Subjects With Atopic Dermatitis

S

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

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

Trial contacts and locations

2

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Central trial contact

xiaofeng Cai, bachelor

Data sourced from clinicaltrials.gov

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