NCT05715320CompletedPhase 2
Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double Blind, Parallel-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate-to-severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
This study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 27 Jan 2023
- Start date
- 10 Mar 2023
- Primary completion date
- 18 Jul 2024
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05715320
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 160
- From 10 Mar 2023 to the primary completion date, 18 Jul 2024
- 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
- Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization.
- He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization.
- Major surgery is planned during the study period.
- Previous history of atopic keratoconjunctivitis and corneal involvement.
Other illness
- Other combined skin diseases that may affect the evaluation of the study.
- Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.
Who the study is looking for
- Have the ability to understand the study and voluntarily sign a written ICF.
- Age ≥ 18 and ≤ 75 years old, male or female.
- The fertile subjects agreed to take effective contraceptive measures throughout the study period.
- The subjects can communicate well with the investigators and complete the follow-up according to the protocol.
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 |
|---|---|---|---|
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.