Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

Study Overview
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Brief Summary
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A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.

Detailed Description
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The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Biological: Adalimumab
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of psoriasis for at least 6 months. Must have stable plaque psoriasis for at least 2 months before screening and baseline visits. Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit. Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit. Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit. Exclusion Criteria: Diagnosis of other active skin diseases or skin infections. Participant has known hypersensitivity to adalimumab or it excipients. Participant has chronic recurring infections or active tuberculosis. Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease. Participant is known to have immune deficiency or is immunocompromised.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab<br>Adalimumab 40 mg every other week (eow) | Biological: Adalimumab<br>* adalimumab eow<br>* Other names: Humira;|
| Placebo Comparator: Placebo<br>placebo | Biological: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12 | The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A] | The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement. | Weeks 3 and 7 | 
| Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B] | The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement. | Weeks 16, 19, and 24 | 
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A] | Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement. | Baseline to Week 12 | 
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B] | PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement. | Baseline to Week 24 | 
| Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A] | The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement. | Weeks 3, 7, and 12 | 
| Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B] | The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement. | Weeks 16, 19, and 24 | 
| Percentage of Participants With a Physician's Global Assessment (PGA) of Clear [Period A] | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.' | Baseline and Weeks 3, 7, and 12 | 
| Percentage of Participants With a Physician's Global Assessment (PGA) of Clear [Period B] | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.' | Weeks 16, 19, and 24 | 
| Percentage of Participants With a Physician's Global Assessment (PGA) of Clear or Minimal [Period A] | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.' | Baseline and Weeks 3, 7, and 12 | 
| Percentage of Participants With a Physician's Global Assessment (PGA) of Clear or Minimal [Period B] | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.' | Weeks 16, 19, and 24 | 
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period A] | The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement. | Baseline, Week 3, and Week 12 | 
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period B] | The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement. | Week 16 and Week 24 | 
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period A] | The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement. | Baseline, Week 3, and Week 12 | 
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period B] | The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement. | Week 16 and Week 24 | 
| Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A] | Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated. | Baseline to Week 12 | 
| Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B] | Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated. | Baseline to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Plaque Psoriasis, Placebo Controlled, Skin Disease, Double Blind