Psoriatic Arthritis
Conditions
Brief 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.
Interventions
DRUGTQH3906 Capsule
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
DRUGTQH3906 Placebo Capsule
Placebo without drug substance.
DRUGTofacitinib Citrate Tablet 5 mg
Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Presence of conditions other than PsA: * Presence of non-plaque psoriasis (i.e., guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) at screening or first dose; * Presence of any other autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, etc.; * Presence of active (i.e., currently symptomatic) fibromyalgia; * Other Medical Conditions and Medical History: * Trial participants who are pregnant or breastfeeding; * Evidence of a serious illness/condition or unstable clinical condition, or localized active infection/infectious disease; * Any major surgery performed within 30 days prior to the first dose of study treatment, or any planned surgery during the study; * Cancer or a history of cancer or lymphoproliferative disease within the past 5 years; * New York Heart Association (NYHA) Class III or IV congestive heart failure, or any recent episode of heart failure resulting in NYHA Class III/IV symptoms; or a history of clinically significant ventricular arrhythmia or arrhythmia requiring continuous antiarrhythmic drug therapy; * Uncontrolled hypertension at screening or randomization; * History of thrombotic disease within 24 weeks prior to screening; viii. History of acute coronary syndrome and/or any major cerebrovascular disease within 24 weeks prior to screening; * Current or recent (within 3 months prior to randomization) gastrointestinal disease that may affect absorption of study treatment, including gastrointestinal surgery; * Severe blood loss (\> 500 mL) or blood transfusion within 4 weeks prior to randomization; * Inability to take oral medication; * Inability to undergo venipuncture and/or tolerate venous access; * History of substance abuse with inability to abstain or presence of a psychiatric disorder; * Any other medical, psychiatric, and/or social reason as determined by medical judgment; * Prior and concomitant medications: If the trial participant has a history of biologic use, the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 20% Improvement Criteria | Day 1, 15, 29, 57, 85, 113, 141, 169 | The proportion of trial participants achieving an ACR20 response at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR20 in the subgroup of trial participants | Day 1, 15, 29, 57, 85, 113, 141, 169 | The proportion of biologic-naive trial participants in the subgroup who achieved ACR20 response. |
| American College of Rheumatology 50 (ACR50) | Day 1, 15, 29, 57, 85, 113, 141, 169 | ACR50 response rate |
| American College of Rheumatology 70 (ACR70) | Day 1, 15, 29, 57, 85, 113, 141, 169 | ACR70 response rate |
| Psoriasis Area and Severity Index (PASI) 75 | Day 1, 15, 29, 57, 85, 113, 141, 169 | PASI 75 response rate |
| Psoriasis Area and Severity Index 90 | Day 1, 15, 29, 57, 85 | PASI 90 response rate |
| 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) | From the time trial participants sign the informed consent form to 28 days after the last dose | 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 to Peak Concentration (Tmax) | Up to day 169 | Evaluation of the Time to Peak Concentration (Tmax) of TQH3906 in participants with Psoriatic Arthritis after oral administration. |
| Peak Concentration (Cmax) | Up to day 169 | Evaluation of the Peak Concentration (Cmax) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration |
| Plasma Clearance (CL/F) | Up to day 169 | Evaluation of the Plasma Clearance (CL/F) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration. |
| Plasma Elimination Half-Life (t₁/₂) | Up to day 169 | Evaluation of the Plasma Elimination Half-Life (t₁/₂) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration. |
| Trough Concentration at Steady State (Cmin, ss) | Up to day 169 | Evaluation of the Trough Concentration at Steady State (Cmin, ss) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration. |
| Degree of Fluctuation (DF) | Up to day 169 | Evaluation of the Degree of Fluctuation (DF) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration. |
| Evaluation of Interleukin (IL) Levels in Participants with Psoriatic Arthritis Treated with TQH3906 | Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24. | Evaluation of Interleukin (IL) Levels in Participants with Psoriatic Arthritis Treated with TQH3906 |
| Evaluation of Defensin Levels in Participants with Psoriatic Arthritis Treated with TQH3906 | 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 |
Countries
China
Contacts
CONTACTXiaofeng Zeng, Doctor
Outcome results
None listed