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Recruiting

NCT Number: NCT06947980

Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's hospital

Beijing, China

Location status: Recruiting

Location contact

Jianzhong Zhang

CONTACT

[email protected]

15545433012

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of AD for at least 1 year according to the American Academy of Dermatology's consensus criteria prior to the screening visit meeting all of the following criteria:
  • EASI≥16 at Screening and Baseline visits;
  • Investigator's Global Assessment (IGA) score of≥3 at Screening and Baseline visits;
  • 10% Body Surface Area (BSA) of AD involvement at Screening and Baseline visits;
  • Mean of weekly Pruritus Numeric Rating Scale (NRS) severity score≥4 at Baseline;

Exclusion criteria

  • Not enough washing-out period for previous therapy.
  • Concurrent disease/status which may potentially affect the efficacy/safety judgement.
  • Organ dysfunction.
  • Pregnancy.
  • Other.

Treatment and study plan

placebo comparator

Drug

Placebo subcutaneous injection

CM512

Biological

CM512 subcutaneous injection

Primary outcomes

  1. Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 24

    Time frame: Baseline, Week 24

    The EASI score is used to measure the severity and extent of AD and measured erythema, edema/papulation, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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