NCT05265923CompletedPhase 3
A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Patients With Moderate-to-severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
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 patients with moderate-to-severe atopic dermatitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (actual)
- First submitted
- 17 Feb 2022
- Start date
- 22 Apr 2022
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05265923
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 500
- From 22 Apr 2022 to the primary completion date, 31 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
Other
- Organ dysfunction.
- pregnancy.
- Other.
Who the study is looking for
- Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
- Efficacy and Safety of Stapokibart in Adults With Moderate-to-Severe Atopic Dermatitis With and Without Type 2 Comorbidities: A Post Hoc Analysis of a Phase 3 Trial.Clin Transl Allergy · 2025 · PMID 41257453
This page is information, not medical advice. Discuss any trial with your doctor.