This is a multi-regional, randomized, double-blind, placebo-controlled, clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SHR-1314 in adults with moderate-to-severe plaque psoriasis.
This study is a multiple dose escalating design to evaluate the safety, PK, and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-1314. There are two parts in this study. The safety, PK, and PD will be evaluated in Part A, the dose escalation part. The efficacy and safety on different doses will be assessed in parallel-groups in Part B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
211
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Revival Research
Doral, Florida, United States
Number of Participants With Clinically Significant Events (Part A)
Clinically significant events were defined as abnormal laboratory values and/or adverse events that are related to treatment
Time frame: From baseline through 24 weeks
Pharmacokinetics (PK) of SHR-1314 (Part A)
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Time frame: From baseline through 24 weeks
Pharmacokinetics (PK) of SHR-1314 (Part A)
Observed Maximum Serum Concentration Following Drug Administration (Cmax)
Time frame: From baseline through 24 weeks
Percentage of Participants With Anti-SHR-1314 Antibodies (Part A)
Percentage of participants with treatment-emergent positive anti-SHR-1314 antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-SHR-1314 antibodies / number of evaluable participants \* 100%.
Time frame: From baseline through 24 weeks
Percentage of subjects who achieve Psoriasis Area Severity Index (PASI) score 75 (Part B)
Percentage of subjects who achieve at least 75% improvement in the PASI (PASI 75)
Time frame: From baseline through 12 weeks
Psoriasis Area Severity Index (PASI) score
PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as:sum of severity parameters for each region\*area score\*weighing factor (head\[0.1\],upper limbs\[0.2\],trunk\[0.3\],lower limbs \[0.4\]).Overall scores range from 0(no psoriasis) to 72(most severe disease). Percent change from baseline in PASI score over time will be evaluated.
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Indago Research and Health Center - Emergency Medicine
Hialeah, Florida, United States
Great Lakes Clinical Trials LLC
Chicago, Illinois, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
St George Dermatology and Skin Cancer Centre - Dermatology
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
...and 3 more locations
Time frame: From baseline through 24 weeks (Part A) or 36 weeks (Part B)
Physician's Global Assessment (PGA) of 0 or 1 achievement
The PGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 \[clear\] to 5 \[severe\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=moderate to severe; 5 = severe). Proportion of subjects achieving PGA response of 0 or 1 over time will be evaluated. PGA response of 0 or 1 is defined as a PGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points on the PGA scale from baseline.
Time frame: From baseline through 24 weeks (Part A) or 36 weeks (Part B)
Change of dermatology life quality index (DLQI) score
Change from baseline in DLQI over time. This DLQI is a 10-question patient administered questionnaire that covers six quality of life domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, with total scores ranging from 0-30 (less to more impairment)
Time frame: From baseline up to 12 weeks (Part A) or 36 weeks (Part B)
Change from baseline in Body Surface Area (BSA)
Change from baseline in the BSA affected by psoriasis over time.
Time frame: From baseline through 12 weeks (Part A) or (Part B)