This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. The study has 2 parts: first part (randomized double-blind) and second part (open).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
454
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
The percentage of subjects who achieved at least 75% reduction in Psoriasis Area Severity Index (PASI)score from baseline (PASI 75) and the percentage of subjects with sPGA 0/1 at week 16.
PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%),and severity is estimated by clinical signs, erythema, induration and desquamation: scale 0 (none) to 4 (maximum).Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3,legs: 0.4).PASI 50, PASI75 and PASI 90 were defined as participants achieving \>= 50%, \>= 75% or \>= 90% improvement from baseline, respectively.The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 =severe.
Time frame: at week 16
The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90).
Time frame: at week 16
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Nanyang First People's hospital national third class a hospital
Nanyang, Henan, China
Yichang central People's hospital
Yichang, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The affiliated hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Dermatology hospital of Jiangxi province
Nanchang, Jiangxi, China
Tianjin academy of traditional Chinese medicine affiliated hospital
Tianjin, Tianjin Municipality, China
Hangzhou First People's hospital
Hangzhou, Zhejiang, China
...and 1 more locations