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

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: CM512; Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT06947980

CM512-101102

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of moderate-to-severe 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Group 1

Placebo Comparator group

Treatment:

Drug: Placebo Comparator

Group 2

Experimental group

Treatment:

Biological: CM512

Group 3

Experimental group

Treatment:

Biological: CM512