A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis

Browse trials for

• Dermatitis, Atopic 1,419
• Dermatitis 1,435
• Eczema 1,084

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 500 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Lead sponsor

Keymed Biosciences Co.Ltd is the lead sponsor of 63 studies on the registry; 31 are open to participants now.

Study arms

• Experimental
  CM310

  CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)

  Drug: CM310

• Placebo comparator
  Placebo

  Double blind treatment period : Placebo Maintenance treatment period : CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)

  Drug: CM310 · Other: Placebo

Interventions

• DrugCM310

  IL-4Rα monoclonal antibody

• OtherPlacebo

  Placebo

Primary outcomes

1. Proportion of subjects achieving EASI-75 at week 16

   Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score) at week 16. The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).

   Time frame: 16 weeks

2. Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16

   Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).

   Time frame: 16 weeks

Secondary outcomes

1. Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

   Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

   Time frame: 64 weeks

2. Percent change of EASI score from baseline

   The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).

   Time frame: 52 weeks

3. Percent change of NRS score from baseline

   The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)

   Time frame: 52 weeks

4. Body surface area (BSA) of involvement of atopic dermatitis

   Change from baseline in percent of BSA

   Time frame: 52 weeks

5. Changes from baseline in Dermatology Life Quality Index (DLQI)

   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. It is a 10-question questionnaire with a score of 0 (not at all) to 3 (very much) for each question. A high score is indicative of a poor quality of life.

   Time frame: 52 weeks

6. Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)

   anti-drug antibody (ADA) and neutralizing antibody (Nab)

   Time frame: 64 weeks