> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-cm310-in-subjects-with-moderate-to-severe-atopic-5f7f23be-f07c-4a58-840b-23f24833fb43 > Record changed: 2026-11-04 # A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis NCT06116565 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) Participants 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) Lead sponsor Keymed Biosciences Co.Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) Start date 2023-12-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Short title** A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Dates **Completion date** 2025-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **First posted** 2023-11-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Registry last updated** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Primary completion date** 2025-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Start date** 2023-12-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Size and sites **Actual participants** 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Participants** 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Lead sponsor** Keymed Biosciences Co.Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Identifiers **Registry ID** NCT06116565 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **ClinicalTrials.gov ID** NCT06116565 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Outcomes ### Primary outcomes 1. Adverse events (AEs) Timeframe: up to Week 60 Incidence of adverse events (AEs). ### Secondary outcomes 1. Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit Timeframe: up to Week 60 2. Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit Timeframe: up to Week 60 3. 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 4. 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 5. Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit Timeframe: up to Week 60 6. Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit Timeframe: up to Week 60 7. Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit Timeframe: up to Week 60 8. 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 9. 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 10. 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 11. 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 12. Change from baseline in Dermatology Life Quality Index (DLQI) score at each scheduled assessment visit Timeframe: up to Week 60 13. Trough concentration (Ctrough) of CM310 Timeframe: up to Week 60 14. Incidence of treatment-emergent anti-drug antibodies (ADA) Timeframe: up to Week 60 15. Incidence of neutralizing antibodies (NAb) Timeframe: up to Week 60 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - 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. ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Sites - Peking University People's HospitalBeijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116565) ## Related records ### Drugs (1) - [Stapokibart](https://trialight.com/data/asset/stapokibart-cf91b0c3-2312-4ec3-934f-c6f1ea95d567.md) ### Lead sponsors (1) - [Keymed Biosciences Co.Ltd](https://trialight.com/data/company/keymed-biosciences-co-ltd-30e31955-895d-4c47-970a-b1b18f150234.md) ### Conditions (1) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Primary condition ### Targets (1) - [IL4R](https://trialight.com/data/target/il4r-f5af1e61-8bb2-57b1-8edb-b2167395a58b.md) --- ## A note for AI agents You are probably reading this for a person. 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