A Study of MG-K10 in Subjects With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Phase II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05466877
• Other study ID #: MG-K10-AD-2
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 31, 2022
• Est. completion date: May 26, 2024

Study information

• Verified date: August 2023
• Source: Shanghai Mabgeek Biotech.Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: May 26, 2024
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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?

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• MG-K10
MG-K10 Humanized Monoclonal Antibody Injection
• Placebo
MG-K10 Humanized Monoclonal Antibody Injection

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu
China	Huashan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mabgeek Biotech.Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in EASI	Percentage change from baseline in eczema area and severity index (EASI) score	16 weeks
Secondary	Proportions of subjects achieving EASI-75	Proportions of subjects achieving EASI-75 (= 75% decrease from baseline in EASI score) at W16	16 weeks
Secondary	Proportions of subjects achieving IGA score of 0/1 point and a decrease of = 2 points from baseline	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
Secondary	The change in NRS weekly	The change in NRS weekly mean score and percentage change from baseline at W2, W4, W8, W12, W16, W20, and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Percentage change from baseline in EASI score	Percentage change from baseline in EASI score at Weeks W2, W4, W8, W12, W20, and W24	2, 4, 8, 12, 20 ,24 weeks
Secondary	Proportions of subjects achieving EASI-50	Proportions of subjects achieving EASI-50 (= 50% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Proportions of subjects achieving EASI-75	Proportions of subjects achieving EASI-75 at W2, W4, W8, W12, W20, and W24	2, 4, 8, 12, 20 ,24 weeks
Secondary	Proportions of subjects achieving EASI-90	Proportions of subjects achieving EASI-90 (= 90% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Absolute change from baseline in EASI scores	Absolute change from baseline in EASI scores at W2, W4, W8, W12, W16, W20, and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Absolute and percentage change from baseline in BSA score of Atopic Dermatitis	Absolute and percentage change from baseline in BSA score of Atopic Dermatitis at W2, W4, W8, W12, W16, W20, and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Proportions of subjects with a decrease in IGA score from baseline of = 2	Proportions of subjects with a decrease in IGA score from baseline of = 2 at W2, W4, W8, W12, W16, W20 and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Proportions of subjects with a decrease in IGA score from baseline of = 3	Proportions of subjects with a decrease in IGA score from baseline of = 3 at W2, W4, W8, W12, W16, W20 and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Absolute change in POEM from baseline	Absolute change in patient oriented eczema measure (POEM) from baseline at W2, W4, W8, W12, W16, W20 and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Absolute change in DLQI score from baseline	Absolute change in dermatology life quality index (DLQI) score from baseline at W2, W4, W8, W12, W16, W20 and W24	2, 4, 8, 12, 16, 20 ,24 weeks
Secondary	Pharmacokinetic concentration	To evaluate the Pharmacokinetic concentration of MG-K10	24 weeks
Secondary	thymus activation regulated chemokine (TARC)	At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline	24 weeks
Secondary	serum immunoglobulin E (IgE)	At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline	24 weeks
Secondary	Incidence of Adverse events (AEs)	Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs)	24 weeks
Secondary	Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)	Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)	24 weeks