A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis
- Summary
- This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.
- Short title
- A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis
- Official title
- An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-11-26
- First posted
- 2023-11-03
- Registry last updated
- 2026-08-20
- Primary completion date
- 2025-11-26
- Start date
- 2023-12-21
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06116565
- ClinicalTrials.gov ID
- NCT06116565
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Adverse events (AEs)
Timeframe: up to Week 60
Incidence of adverse events (AEs).
Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit
Timeframe: up to Week 60
Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit
Timeframe: up to Week 60
Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit
Timeframe: up to Week 60
Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit
Timeframe: up to Week 60
Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Timeframe: up to Week 60
Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Timeframe: up to Week 60
Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Timeframe: up to Week 60
Percentage of subjects achieving a ≥4-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Timeframe: up to Week 60
Percentage of subjects achieving a ≥3-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Timeframe: up to Week 60
Change and percentage change from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Timeframe: up to Week 60
Change and percentage change from baseline in the body surface area (BSA) affected by atopic dermatitis (AD) at each scheduled assessment visit
Timeframe: up to Week 60
Change from baseline in Dermatology Life Quality Index (DLQI) score at each scheduled assessment visit
Timeframe: up to Week 60
Trough concentration (Ctrough) of CM310
Timeframe: up to Week 60
Incidence of treatment-emergent anti-drug antibodies (ADA)
Timeframe: up to Week 60
Incidence of neutralizing antibodies (NAb)
Timeframe: up to Week 60
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Age ≥ 18 and ≤ 75 years old.
- With Atopic Dermatitis.
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Major surgeries are planned during the study period.
- Peking University People's HospitalBeijing, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Atopic eczema Primary condition