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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
Placebo without drug substance.
Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.
Bozhou People's Hospital
Bozhou, Anhui, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGSouthwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, China
RECRUITINGDongguan People's Hospital
Dongguan, Guangdong, China
American College of Rheumatology 20% Improvement Criteria
The proportion of trial participants achieving an ACR20 response at Week 12.
Time frame: Day 1, 15, 29, 57, 85, 113, 141, 169
ACR20 in the subgroup of trial participants
The proportion of biologic-naive trial participants in the subgroup who achieved ACR20 response.
Time frame: Day 1, 15, 29, 57, 85, 113, 141, 169
American College of Rheumatology 50 (ACR50)
ACR50 response rate
Time frame: Day 1, 15, 29, 57, 85, 113, 141, 169
American College of Rheumatology 70 (ACR70)
ACR70 response rate
Time frame: Day 1, 15, 29, 57, 85, 113, 141, 169
Psoriasis Area and Severity Index (PASI) 75
PASI 75 response rate
Time frame: Day 1, 15, 29, 57, 85, 113, 141, 169
Psoriasis Area and Severity Index 90
PASI 90 response rate
Time frame: Day 1, 15, 29, 57, 85
Numbers of subjects with incidence and Severity Level of adverse Event (AE), serious Adverse Event (SAE), adverse event leading to study discontinuation, adverse event of special interest (AESI)
Numbers of subjects with incidence rates and Severity Level of Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events Leading to Study Discontinuation, and Adverse Events of Special Interest (AESIs)
Time frame: From the time trial participants sign the informed consent form to 28 days after the last dose
Time to Peak Concentration (Tmax)
Evaluation of the Time to Peak Concentration (Tmax) of TQH3906 in participants with Psoriatic Arthritis after oral administration.
Time frame: Up to day 169
Peak Concentration (Cmax)
Evaluation of the Peak Concentration (Cmax) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration
Time frame: Up to day 169
Plasma Clearance (CL/F)
Evaluation of the Plasma Clearance (CL/F) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Time frame: Up to day 169
Plasma Elimination Half-Life (t₁/₂)
Evaluation of the Plasma Elimination Half-Life (t₁/₂) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Time frame: Up to day 169
Trough Concentration at Steady State (Cmin, ss)
Evaluation of the Trough Concentration at Steady State (Cmin, ss) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Time frame: Up to day 169
Degree of Fluctuation (DF)
Evaluation of the Degree of Fluctuation (DF) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Time frame: Up to day 169
Evaluation of Interleukin (IL) Levels in Participants with Psoriatic Arthritis Treated with TQH3906
Evaluation of Interleukin (IL) Levels in Participants with Psoriatic Arthritis Treated with TQH3906
Time frame: Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24.
Evaluation of Defensin Levels in Participants with Psoriatic Arthritis Treated with TQH3906
Evaluation of Defensin Levels in Participants with Psoriatic Arthritis Treated with TQH3906
Time frame: Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24.
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The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGThe Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGJiangmen Central Hospital
Jiangmen, Guangdong, China
RECRUITINGShenzhen Second People's Hospital
Shenzhen, Guangdong, China
RECRUITINGThe Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGThe Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
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