A Long-term Safety and Efficacy Study Evaluating CM512 in Atopic Dermatitis.

Keymed Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis (AD)

Treatments: Biological: CM512

Study type: Interventional

Funder types: Industry

Identifiers

NCT07230483

CM512-101103

Details and patient eligibility

About

This is an Open-label ,Multicenter Study to evaluate Long-Term Safety and Efficacy of CM512 in patients with Atopic Dermatitis who have completed treatment in parent CM512 Study.

Enrollment: 246 estimated patients

Sex: All

Ages: 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).
• Subjects who have completed the week 18 evaluation in the parent study CM512-101102 or the End of Study(EOS) visit in the parent study CM512-100001.

Exclusion criteria

• Not enough washing-out period for previous therapy.
• Any other condition assessed by the investigator that makes participants unsuitable for participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 4 patient groups

Group 1

Experimental group

Treatment:

Biological: CM512

Group 2

Experimental group

Treatment:

Biological: CM512

Group 3

Experimental group

Treatment:

Biological: CM512

Group 4

Experimental group

Treatment:

Biological: CM512