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The goal of this trial is to assess whether the efficacy of CMAB015 is similar to that of Secukinumab in patients with moderate-severe chronic plaque psoriasis. It will also learn about the similarity of CMAB015 and Secukinumab in terms of safety and immunogenicity in patients with moderate-severe chronic plaque psoriasis. The main question it aims to answer is:
In subjects with moderate to severe plate psoriasis treated with CMAB015, Is the proportion of patients achieving a 75% improvement in PASI (Psoriasis area and severity index) scores relative to baseline (PASI 75) the same as those treated with Secukinumab?
Participants will:
Receive treatment with 300 mg CMAB015 or Secukinumab by subcutaneous injection at weeks 0, 1, 2, 3, 4, and 8, followed by every 4 weeks until week 48.
Visit the clinic at weeks 0, 1, 2, 3, 4, and 8, followed by every 4 weeks until week 52.
Be evaluated with PASI scores, body surface area (BSA) scores and investigator's global assessment (IGA) (mod 2011) scores.
This study was a multicenter, randomized, double-blind, secukinumab controlled, 1:1 ratio parallel grouping, equivalent design. The study treatment period would be 52 weeks, including a 12-week induction therapy period and a 40-week maintenance therapy period. The primary endpoint was the proportion of patients achieving at least a 75% improvement in PASI scores from baseline at 12 weeks, with an equivalence cut-off of ±15%. A total of 336 adult patients with moderate-to-severe plaque psoriasis are planned to be enrolled, with 168 cases in each group. Eligible subjects received 300 mg CMAB015 or Secukinumab subcutaneous injection. Patients who do not achieve at least a 50% improvement in PASI scores at week 12 would withdraw from the study, and patients who achieve a 50% improvement continue on maintenance therapy until the last treatment at week 48.
This study is a double-blind design, and a central randomization system woud be used to randomize subjects. The control factors for randomization are body weight (<60 kg, ≥60 kg), prior treatment (prior systemic therapy with no prior biologics, prior systemic therapy with biologics), concomitant psoriatic arthritis (yes, no), and PK intensive sampling (yes, no).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | CMAB015 |
|
| Active Comparator Arm | Active Comparator | Secukinumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMAB015 | Biological | Patients would receive 300 mg CMAB007 subcutaneous injections at week 0, 1, 2, 3, 4, 8 as induction therapy. Patients who obtain a 75% improvement relative to baseline in PASI scores would receive 300 mg CMAB007 subcutaneous injections every 4 weeks as maintain therapy, until the last treatment at week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with PASI 75 at week 12. | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI scores compared with the Baseline PASI scores. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with IGA (mod 2011) 0/1 at week 12. | The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following: 0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) . |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | AUC0-t, the area under the concentration-time curve from time zero to the time of the last quantifiable concentration, will be analyzed using a non-atrioventricular model. | week 52 |
| AUC0-inf | AUC0-inf, the area under the concentration-time curve from time zero to infinity, will be analyzed using a non-atrioventricular model. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin h Xu, PhD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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Parallel Assignment
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|
| Secukinumab | Biological | Patients would receive 300 mg secukinumab subcutaneous injections at week 0, 1, 2, 3, 4, 8 as induction therapy. Patients who obtain a 75% improvement relative to baseline in PASI scores would receive 300 mg secukinumab subcutaneous injections every 4 weeks as maintain therapy, until the last treatment at week 48. |
|
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| week 12 |
| Proportion of patients with IGA (mod 2011) 0/1 at week 52. | The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following: 0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) . | week 52 |
| Proportion of patients with IGA (mod 2011) 0 at week 12. | The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following: 0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) . | week 12 |
| Proportion of patients with IGA (mod 2011) 0 at week 52. | The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following: 0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) . | week 52 |
| Proportion of patients with PASI 50 at week 12. | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI scores compared with the Baseline PASI scores. | week 12 |
| Proportion of patients with PASI 75 at week 52. | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI scores compared with the Baseline PASI scores. | week 52 |
| Proportion of patients with PASI 90 at week 12. | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI scores compared with the Baseline PASI scores. | week 12 |
| Proportion of patients with PASI 90 at week 52. | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI scores compared with the Baseline PASI scores. | week 52 |
| Proportion of patients with PASI 100 at week 12. | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as complete remission. | week 12 |
| Proportion of patients with PASI 100 at week 52. | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as complete remission.. | week 52 |
| Change from baseline in DLQI at week 52 | The Dermatology Life Quality Index (DLQI) is the most commonly used dermatology-specific quality of life (QOL) measure in clinical trials of skin diseases. It consists of 10 questions concerning dermatologic patients' perception of the impact of skin diseases on different aspects of their QOL over the last week. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale: 0=not at all/not relevant , 1=a little, 2=a lot, and 3=very much. Scores of individual items are added to yield a total score (0-30). A DLQI score of 0 and 1 means no impact ona patient's QOL whereas a score of 2~5, 6~10, 11~20, and 21~30 indicates a small, moderate, large, and an extremely large effect on patient's QOL, respectively. | week 52. |
| Change from baseline in PASI at week 52 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. | week 52. |
| Change from baseline in IGA (mod 2011) at week 52 | The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following: 0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) . | week 52. |
| Change from baseline in BSA at week 52 | Body Surface Area (BSA) score is an important indicator for calculating the overall skin lesion area of psoriasis. BSA ≈1% refers to the area of the skin lesion as the size of a palm, and the estimation of the skin lesion area in this method can roughly assess the severity of the disease. | week 52 |
| Incidence of adverse events | Number of patients reporting at least one adverse event in the study. An adverse event is defined as any untoward medical occurrence in a clinical trial participant graded according to the common terminology criteria for adverse events (CTCAE) v.5.0 criteria,including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs | week 52 |
| Immunogenicity | Percentage of anti-drug antibody and neutralizing antibody in the study. Subjects with a positive antibody response to CMAB015 or Secukinumab were determined to test neutralizing antibody. | week 52 |
| week 52 |
| Half time | Half time will be analyzed using a non-atrioventricular model. | week 52 |
| Cmax | Cmax is the maximum concentration. | week 52 |
| Tmax | Tmax is the time of the maximum concentration. | week 52 |
| Clearance Rate | Clearance rate will be analyzed using a non-atrioventricular model. | week 52 |
| Apparent Volume of Distribution | Apparent Volume of Distribution will be analyzed using a non-atrioventricular model. | week 52 |