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NCT Number: NCT04893707

The Study of CM310 in Patients With Atopic Dermatitis

This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).

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Key information

Conditions

Moderate-to-severe Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's hospital

Beijing, China

About this study

The secondary objective of the study is to assess the immunogenicity of CM310 in patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:
  • Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit.
  • Participation in CM310AD002 and met one of the following：i: Received study treatment and adequately completed the assessments and completed the EOS(V12) visit. ii:Treatment termination due to other reasons other than poor compliance or AE related to CM310 , completed the EOS visit .
  • Provide signed informed consent

Exclusion criteria

  • Patients who, during their participation in a previous CM310 clinical trial, developed a SAE/AE deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with CM310.
  • Not enough washing-out period for previous therapy.
  • Pregnancy.
  • Other

Treatment and study plan

CM310

Biological

adults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC.

teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.

Other names: IL-4Rα monoclonal antibody

Primary outcomes

  1. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 2 Years

    The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs

Secondary outcomes

  1. Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)

    Time frame: Up to 2 Years

    Incidence and rate (events per patient-year) of SAEs and AESIs

  2. Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline of the parent study) at each visit

    Time frame: Up to 2 Years

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD

  3. Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit

    Time frame: Up to 2 Years

    Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale [(a 6-point scale ranging from 0 (clear) to 5 (very severe)]

  4. Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline of the parent study) at each visit

    Time frame: Up to 2 Years

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD

  5. Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline of the parent study) at each visit

    Time frame: Up to 2 Years

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD

  6. Change from baseline in EASI score at each visit

    Time frame: Up to 2 Years

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD

  7. Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit

    Time frame: Up to 2 Years

    IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)

  8. Proportion of patients with IGA reduction from baseline of ≥2 points at each visit

    Time frame: Up to 2 Years

    IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)

  9. Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline

    Time frame: Up to 2 Years

    Proportion of subjects with improvement (reduction) of pruritus NRS of ≥4 points from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch)

  10. Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline

    Time frame: Up to 2 Years

    The range of NRS is from 0 (no itch)-10 (worst imaginable itch)

  11. Percent change from baseline in NRS

    Time frame: Up to 2 Years

    The range of NRS is from 0 (no itch)-10 (worst imaginable itch)

  12. Body Surface Area (BSA)

    Time frame: Up to 2 Years

    Change from baseline in percent of BSA

  13. Time to first remission (achieving IGA = 0 or 1)

    Time frame: Up to 2 Years

  14. Time to first relapse (eg, IGA >2) after remission or to not achieving remission

    Time frame: Up to 2 Years

  15. Time to first EASI-50/75/90

    Time frame: Up to 2 Years

  16. Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment

    Time frame: Up to 2 Years

  17. Number of days on topical medication (per patient-year)

    Time frame: Up to 2 Years

  18. Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI)

    Time frame: Up to 2 Years

    The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) (Badia 1999). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL

  19. immunogenicity

    Time frame: Up to 2 Years

    Detection of anti-drug antibody (ADA)

  20. Pharmacokinetics parameters

    Time frame: Up to 2 Years

    trough concentration of CM310

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 19, 2021
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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