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MG-K10 Phase III Trial, Adolescents, Moderate-to-Severe Atopic Dermatitis

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Summary

NIH registered a Phase III clinical trial (NCT07540442) for MG-K10, a humanized monoclonal antibody injection, in adolescents with moderate-to-severe atopic dermatitis. The randomized, double-blind, placebo-controlled, parallel-group study aims to confirm the efficacy and safety of MG-K10 monotherapy. Trial conditions are limited to atopic dermatitis; no other indications are listed.

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What changed

NIH registered a new Phase III clinical trial (NCT07540442) for MG-K10, a humanized monoclonal antibody injection, as monotherapy for adolescents aged 12+ with moderate-to-severe atopic dermatitis. The study is a randomized, double-blind, placebo-controlled parallel-group trial designed to confirm efficacy and safety. Trial arms include MG-K10 Injection and placebo.\n\nSponsors and clinical investigators monitoring ongoing or competing atopic dermatitis programs should note this trial as a competitive development milestone in the adolescent AD indication space. The trial does not impose external compliance obligations on other parties.

Archived snapshot

Apr 20, 2026

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A Phase III Study of MG-K10 in Adolescents With Moderate-to-Severe Atopic Dermatitis

Phase 3 NCT07540442 Kind: PHASE3 Apr 20, 2026

Abstract

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)

Conditions: Dermatitis, Atopic

Interventions: MG-K10 Injection (Humanized Monoclonal Antibody), Placebo for MG-K10

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Clinical investigators Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Drug efficacy study Monoclonal antibody development
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Public Health

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