Clinical Trials Logo
  1. Home
  2. Atopic Dermatitis
  3. NCT05715320
  4. Details
NCT05715320 Clinical Trial

Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05715320
Other study ID # CM310-101109
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 10, 2023
Est. completion date March 30, 2024

Study information
Verified date January 2023
Source Keymed Biosciences Co.Ltd
Contact Qian Jia
Phone 028-88610620
Email qianjia@keymedbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

This study includes screening, treatment and follow-up periods. 160 subjects will be enrolled to receive CM310.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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 combined skin diseases that may affect the evaluation of the study. - Confronting IL-4R a Monoclonal antibody or CM310/placebo drug or ingredient allergy.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• CM310
IL-4Ra monoclonal antibody

Locations
Country Name City State
China Hangzhou First People's Hospital Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects achieving EASI-75 Proportion of subjects achieving EASI-75 (=75% reduction from baseline in Eczema Area and Severity Index score). up to week 12
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2