Treatment of Moderate to Severe Plaque Psoriasis
NCT Number: NCT06542614
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Plaque Psoriasis
Interventions: DRUG: TQH3906 capsules|DRUG: Placebo of TQH3906 capsules
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09
Locations: The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241000, China|Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing, 100730, China|The first affiliated hospital of chongqing medical university, Chongqing, Chongqing, 400042, China|Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, 510091, China|Liuzhou People'S Hospital, Liuzhou, Guangxi, 545006, China|Shijiazhuang Hospital of Traditional Chinese Medicine, Shijiazhuang, Hebei, 50000, China|The Second Hospital of HeBei Medical University, Shijiazhuang, Hebei, 50000, China|The Second Affiliated Hospital Of Xingtai Medical Colledge, Xingtai, Hebei, 054002, China|Heilongjiang Provincial Hospital, Harbin, Heilongjiang, 150036, China|The Second Affiliated Hospital of Henan University of Science and Technology, LuoYang, Henan, 471000, China|Nanyang First People'S Hospital, Nanyang, Henan, 473010, China|Shiyan Renmin Hospital, Shiyan, Hubei, 442000, China|Wuhan First Hospital, Wuhan, Hubei, 430033, China|The First People's Hospital of Changde, Changde, Hunan, 415100, China|The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410000, China|The First Affiliated Hospital of Baotou Medical College, Baotou, Inner Mongolia, 014000, China|Hospital of Dermatology, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, 210000, China|The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China|Yancheng First People's Hospital, Yancheng, Jiangsu, 224006, China|The First Bethune Hospital of Jilin University, Changchun, Jilin, 130031, China|Meihekou Central Hospital, Meihekou, Jilin, 135000, China|Genertec Liaoyou Gem Flower Hospital, Panjin, Liaoning, 124000, China|Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110000, China|The first hospital of china medical university, Shenyang, Liaoning, 110001, China|The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710000, China|Shandong First Medical University Affiliated Dermatology Hospital, Jinan, Shandong, 250022, China|Shandong University Qilu Hospital, Jinan, Shandong, 250063, China|Qingdao Municipal hospital (group), Qingdao, Shandong, 266011, China|Shanghai JiaoTong University of medicine Ruijin Hospital, Shanghai, Shanghai, 20025, China|Shanxi Provincial People's Hospital, Taiyuan, Shanxi, 030012, China|Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, Tianjin, 300120, China|Xinjiang Uygur Autonomous Region People's Hospital, Ürümqi, Xinjiang, 830001, China|Affiliated Hangzhou First People'S Hospital,School of Medicine, Westlake University, Hangzhou, Zhejiang, 310003, China|The Second Affiliated Hospital Zhejiang University School Of Medicine, Hangzhou, Zhejiang, 310009, China

Summary:
To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses

Primary Outcome Measures: Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 at week 12, Achieve a PASI 75 ratio, Up to week 12
Secondary Outcome Measures: Proportion of patients achieving Static Physician's Global Assessment (sPGA) 0/1 at week 12, It is used to observe the proportion of patients with 0 or 1, Up to week 12|Proportion of patients achieving PASI 50 at week 12, Observed proportion of patients achieving PASI 50 at week 12, Up to week 12|Proportion of patients achieving PASI 90 at week 12, Observed proportion of patients achieving PASI 90 at week 12, Up to week 12|Proportion of patients achieving PASI 100 at week 12, Observed proportion of patients achieving PASI 100 at week 12, Up to week 12|Body Surface Area (BSA) score, To observe the degree of change from baseline in BSA score at week 12, Up to week 12|Dermatology Life Quality Index (DLQI) score, To observe the degree of change from baseline in DLQI score at week 12, Up to week 12|Incidence of abnormal laboratory test markers, The proportion of patients with abnormal laboratory examination indicators, including blood routine and liver function, mainly includes blood routine, liver function, etc., From randomization to 4 weeks after the last dose|Adverse event (AE), Proportion of patients with adverse events, defined by Common Terminology Criteria for Adverse Events (CTCAE) 5.0., From randomization to 4 weeks after the last dose|Serious Adverse Events (SAEs), Proportion of patients with serious adverse events, defined by Common Terminology Criteria for Adverse Events (CTCAE) 5.0., From randomization to 4 weeks after the last dose.|Tmax, ss, Refers to the time when the blood concentration reaches its peak after a single dose. At this point in time, the blood concentration is the highest., Within 1 hour before Day1, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day 15, Day 29, Day 57, Day 85 within 1 hour before administration, 1,1.5, 2, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours after Day 85|Cmax, ss, The steady-state concentration of the drug after multiple doses was investigated.

Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72 hours after Day85., Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72 hours after Day85|Cmin, ss, The lowest concentration from the initial moment after administration to the lowest concentration before the next dose when multiple doses reach steady state. This index is a common indicator to reflect the level of drug accumulation, and is closely related to the drug dose, dosing interval and drug elimination rate., Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85|Area under the plasma concentration-time curve (AUC) 0-τ, When multiple administrations reach steady state, the area under the plasma concentration curve of each dosing interval is equal to the area under the plasma concentration curve from the time after administration to infinity., Within 1 hour before Day1 administration, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85|Rac, The ratio of the dose required to be given in one dose to the total dose required to be given in divided doses., Within 1 hour before Day1 administration, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85|Interleukin-17A (IL-17A) in serum, Change from baseline in serum IL-17A, Within 1 hour before Day1 administration, Day15, Day29, Day85|Interleukin 19 (IL-19) in serum, Change from baseline in serum IL-19, Within 1 hour before Day1 administration, Day15, Day29, Day85|β defensin in serum, Change from baseline in serum β defensin, Within 1 hour before Day1 administration, Day15, Day29, Day85