Psoriatic Arthritis Clinical Trials

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A Randomized, Placebo- and Active Drug-Controlled, Double-Blind, Multicenter, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis

Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a marketing-oriented clinical trial of TQH3906 Capsules. A total of 156 participants are planned to be enrolled, aiming to evaluate the dose-effect relationship of TQH3906 versus placebo in the treatment of active Psoriatic Arthritis (PsA) at Week 12, with the proportion of participants achieving an American College of Rheumatology 20% (ACR20) Improvement Criteria (ACR20) response at Week 12 as the primary endpoint.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Sign a written Informed Consent Form, which must meet the following requirements

‣ Be willing to participate in the study and able to sign the informed consent form;

⁃ Be willing and able to complete all study-specific procedures and visits;

• PsA trial participant disease characteristics

‣ Aged 18 to 70 years(inclusive);

⁃ ii.diagnosed with PsA for at least 3 months prior to screening, and meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening;

⁃ Active arthritis at screening and at baseline (Day 1);

⁃ Has failed or was intolerant to at least one prior therapy;

⁃ If receiving a conventional synthetic Disease-Modifying Antirheumatic Drug (csDMARD), trial participants must be on only one DMARD, which must have been administered for at least 3 months prior to screening, with a stable dose for at least 28 days prior to the first dose;

⁃ If using NSAIDs, the dose must have been stable for at least 14 days before the first dose;

⁃ If using oral corticosteroids, the dose must have been stable for at least 14 days before the first dose;

⁃ Topical treatments for plaque psoriasis must have remained stable for at least 14 days before the first dose;

• Female participants of child-bearing potential shall agree to use effective contraception during the study and for 30 days following the last dose, and pregnancy tests at the screening and baseline visits shall be negative; male participants shall agree to use effective contraception during the study and for 30 days following the last dose.

Locations
Other Locations
China
Bao Ding NO.1 Central
RECRUITING
Baoding
Peking Union Medical College Hospital
RECRUITING
Beijing
Bozhou People's Hospital
RECRUITING
Bozhou
Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine
RECRUITING
Cangzhou
Jilin Provincial People's Hospital
RECRUITING
Changchun
The First Hospital of Jilin University
RECRUITING
Changchun
Xiangya Hospital of Central South University
RECRUITING
Changsha
Southwest Hospital, Third Military Medical University (Army Medical University)
RECRUITING
Chongqing
The second hospital of dalian medical university
WITHDRAWN
Dalian
Deyang People's Hospital
RECRUITING
Deyang
Dongguan People's Hospital
RECRUITING
Dongguan
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
RECRUITING
Guangzhou
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
WITHDRAWN
Guiyang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Jiangmen Central Hospital
RECRUITING
Jiangmen
Shandong Provincial Hospital
RECRUITING
Jinan
Kaifeng People's Hospital
RECRUITING
Kaifeng
Linfen Central Hospital
RECRUITING
Linfen
Luoyang Orthopedic-Traumatological Hospital Of Henan Province(Henan Provincial Orthopedic Hospital)
RECRUITING
Luoyang
The First Affiliated Hospital of Henan University of science and Technology
NOT_YET_RECRUITING
Luoyang
Affiliated Hospital of Southwest Medical University
RECRUITING
Luzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Hospital of North Sichuan Medical College
RECRUITING
Nanchong
Jiangsu Peopince Hospital
RECRUITING
Nanjing
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
The Second Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Ningbo Medical Center Li HuiLi Hospital
RECRUITING
Ningbo
Pingxiang People's Hospital
NOT_YET_RECRUITING
Pingxiang
Puyang Oilfield General Hospital
RECRUITING
Puyang
Shanghai Tenth People's Hospital
RECRUITING
Shanghai
The Central Hospital of Shaoyang
WITHDRAWN
Shaoyang
The First Hospital of China Medical University
RECRUITING
Shenyang
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
RECRUITING
Tianjin
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
RECRUITING
Tianjin
Xinjiang Uygur Autonomous Region People's Hospital
WITHDRAWN
Ürümqi
Weifang People'S Hospital
RECRUITING
Weifang
Yancheng No.1 People's Hospital
RECRUITING
Yancheng
The First Affiliated Hospital of Henan University of CM
WITHDRAWN
Zhengzhou
Zhuzhou Central Hospital
RECRUITING
Zhuzhou
Contact Information
Primary
Xiaofeng Zeng, Doctor
xiaofeng.zeng@cstar.org.cn
13501069845
Time Frame
Start Date: 2026-07-16
Estimated Completion Date: 2027-11
Participants
Target number of participants: 156
Treatments
Experimental: TQH3906 Capsule 24 mg
Oral administration daily from Day 1 (D1) to Day 169 (D169) Morning Fasting: 3 Capsules of 8 mg TQH3906
Experimental: TQH3906 Capsule 16 mg
Oral administration daily from Day 1 (D1) to Day 169 (D169) Morning fasting: 2 capsules of 8 mg TQH3906
Placebo_comparator: TQH3906 Capsule 0 mg
Oral administration daily from Day 1 (D1) to Day 85 (D85): Morning fasting: 3 placebo capsules of TQH3906;~Oral administration daily from Day 86(D86) to Day 169 (D169):~Morning fasting: 2 capsules of 8 mg TQH3906 or 3capsules of 8 mg TQH3906.
Active_comparator: Tofacitinib Citrate Tablet 5 mg
Oral administration daily from Day 1 (D1) to Day 169 (D169):~Morning fasting: 1 tablet of tofacitinib citrate; Administer 1 tablet of Tofacitinib Citrate at bedtime.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov