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Atopic DermatitisPhase 2NCT05466877

A Study of MG-K10 in Subjects With Atopic Dermatitis

A Phase 2 study testing MG-K10 in people with Atopic Dermatitis, run by Shanghai Mabgeek Biotech.Co.Ltd at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
MG-K10
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
2 sitesChina
Study dates
31 Aug 2022to 26 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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。

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Huashan Hospital Affiliated to Fudan University

    Shanghai

Other trials in China

About this study

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

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.

Read the 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).

Being tested
MG-K10, Placebo
Keywords
Atopic dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MG-K10Drug

    MG-K10 Humanized Monoclonal Antibody Injection

  • PlaceboDrug

    MG-K10 Humanized Monoclonal Antibody Injection

Study groups in NCT05466877
Study groupRoleWhat they receive
MG-K10 Regimen 1Experimentalsubcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)
Receives: Drug: MG-K10
MG-K10 Regimen 2Experimentalsubcutaneous injection every 2 weeks
Receives: Drug: MG-K10
MG-K10 Regimen 3Experimentalsubcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)
Receives: Drug: MG-K10
PlaceboPlacebo comparatorsubcutaneous injection every 2 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change from baseline in EASI

    Percentage change from baseline in eczema area and severity index (EASI) score

    Measured: 16 weeks

Secondary outcomes (18)

  1. Proportions of subjects achieving EASI-75

    Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI score) at W16

    Measured: 16 weeks

  2. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  3. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  4. Percentage change from baseline in EASI score

    Percentage change from baseline in EASI score at Weeks W2, W4, W8, W12, W20, and W24

    Measured: 2, 4, 8, 12, 20 ,24 weeks

  5. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  6. Proportions of subjects achieving EASI-75

    Proportions of subjects achieving EASI-75 at W2, W4, W8, W12, W20, and W24

    Measured: 2, 4, 8, 12, 20 ,24 weeks

  7. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  8. Absolute change from baseline in EASI scores

    Absolute change from baseline in EASI scores at W2, W4, W8, W12, W16, W20, and W24

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  9. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  10. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  11. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  12. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  13. 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

    Measured: 2, 4, 8, 12, 16, 20 ,24 weeks

  14. Pharmacokinetic concentration

    To evaluate the Pharmacokinetic concentration of MG-K10

    Measured: 24 weeks

  15. thymus activation regulated chemokine (TARC)

    At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline

    Measured: 24 weeks

  16. serum immunoglobulin E (IgE)

    At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline

    Measured: 24 weeks

  17. Incidence of Adverse events (AEs)

    Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs)

    Measured: 24 weeks

  18. Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)

    Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study start31 Aug 2022
  3. Primary completion22 Sep 2023
  4. Study completion26 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
163 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05466877
Sponsor's protocol ID
MG-K10-AD-2
Status last verified
Aug 2023
First submitted
13 Jul 2022
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MG-K10 in people with Atopic Dermatitis, run by Shanghai Mabgeek Biotech.Co.Ltd at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change from baseline in EASI (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05466877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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