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This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of CM326 in moderate-severe AD subjects.
The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week randomized Treatment Period and a 12-week Safety Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM326 55 mg, once every two weeks (Q2W) | Experimental | 55mg for 6 doses, every 2 weeks, subcutaneous (SC) |
|
| CM326 110 mg, once every two weeks (Q2W) | Experimental | 110mg for 6 doses, every 2 weeks, subcutaneous (SC) |
|
| CM326 110 mg, once every four weeks (Q4W) | Experimental | 110mg for 3 doses, every 4 weeks, subcutaneous (SC) |
|
| CM326 220 mg, once every two weeks (Q2W) | Experimental | 220mg for 6 doses, every 2 weeks, subcutaneous (SC) |
|
| CM326 220 mg, once every four weeks (Q4W) | Experimental | 220mg for 3 doses, every 4 weeks, subcutaneous (SC) |
|
| Placebo | Placebo Comparator | Placebo for 6 doses, every 2 weeks, subcutaneous (SC) and placebo for 3 doses, every 4 weeks, subcutaneous (SC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM326 | Biological | CM326 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AE) | Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | Up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax) | Time to reach peak concentration (Tmax) | Up to Week 24 |
| Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | +862888610620 | qianjia@keymedbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Placebo | Other | Placebo |
|
Peak Plasma concentration (Cmax)
| Up to Week 24 |
| Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC) | Area under the plasma concentration-time curve (AUC) | Up to Week 24 |
| Pharmacokinetics (PK) parameter : Clearance rate (CL/F) | Clearance rate (CL/F) | Up to Week 24 |
| Pharmacokinetics (PK) parameter : Elimination half life (T1/2z) | Elimination half life (T1/2z) | Up to Week 24 |
| Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration | Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration | Up to Week 24 |
| Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration | Changes from baseline in eosinophil count after CM326 administration | Up to Week 24 |
| Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration | Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration | Up to Week 24 |
| Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration | Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration | Up to Week 24 |
| Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration | Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration | Up to Week 24 |
| Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration | Changes from baseline in serum periostin concentration after CM326 administration | Up to Week 24 |
| Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab) | Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab) | Up to Week 24 |
| Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit | IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) | Up to Week 24 |
| Proportion of patients with IGA reduction from baseline of ≥2 points at each visit | IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) | Up to Week 24 |
| Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) at each visit | 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 | Up to Week 24 |
| Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit | 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 | Up to Week 24 |
| Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit | 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 | Up to Week 24 |
| Change from baseline in Eczema Area and Severity Index (EASI) score at each visit | 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 | Up to Week 24 |
| Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline | The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Up to Week 24 |
| Percent change from baseline in Numerical Rating Scale (NRS) | The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Up to Week 24 |
| Body surface area (BSA) of involvement of atopic dermatitis | Change from baseline in percent of BSA | Up to Week 24 |
| Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit | 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 | Up to Week 24 |