Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Biological: CM310; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06277765

CM310-101212

Details and patient eligibility

About

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

Enrollment: 180 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
• With Atopic Dermatitis.

Exclusion criteria

• Not enough washing-out period for previous therapies.
• Any major surgery planned during the research period.
• With intestinal parasitic infection within the 6 months before screening.
• With any circumstance that is not suitable to participate in this study.
• Major surgeries are planned during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

CM310 group

Experimental group

Treatment:

Biological: CM310

Placebo

Placebo Comparator group

Treatment:

Other: placebo