A Clinical Trial of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis

Официальное название

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

Обзор

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.

Вмешательства

• Препарат TQH3906 Capsule
  TQH3906 is a small-molecule inhibitor of tyrosine kinase.
• Препарат TQH3906 Placebo Capsule
  Placebo without drug substance.
• Препарат Tofacitinib Citrate Tablet 5 mg
  Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.

Первичные конечные точки

• American College of Rheumatology 20% Improvement Criteria [Срок оценки: Day 1, 15, 29, 57, 85]

Вторичные конечные точки (12)

• ACR20 in the subgroup of trial participants [Срок оценки: Day 1, 15, 29, 57, 85]
• American College of Rheumatology 50 (ACR50) [Срок оценки: Day 1, 15, 29, 57, 85]
• American College of Rheumatology 70 (ACR70) [Срок оценки: Day 1, 15, 29, 57, 85]
• Psoriasis Area and Severity Index (PASI) 75 [Срок оценки: Day 1, 15, 29, 57, 85]
• Psoriasis Area and Severity Index 90 [Срок оценки: Day 1, 15, 29, 57, 85]
• Numbers of subjects with incidence of adverse Event (AE), serious Adverse Event (SAE), adverse event leading to study discontinuation, adverse event of special interest (AESI) [Срок оценки: From the time trial participants sign the informed consent form to 28 days after the last dose]
• Time to Peak Concentration (Tmax) [Срок оценки: Up to day 85]
• Peak Concentration (Cmax) [Срок оценки: Up to day 85]
• Plasma Clearance (CL/F) [Срок оценки: Up to day 85]
• Plasma Elimination Half-Life (t₁/₂) [Срок оценки: Up to day 85]
• Trough Concentration at Steady State (Cmin, ss) [Срок оценки: Up to day 85]
• Degree of Fluctuation (DF) [Срок оценки: Up to day 85]

Критерии участия

Критерии включения

• 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）;
• BMI ≥ 18 kg/m² at screening; 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;
• Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of the study; men must agree to use effective contraception during the study and for 6 months after the end of the study

Критерии исключения

• 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 exclusion criteria specified in the protocol will apply;
• Infection-related:

• Active tuberculosis identified by chest radiography within 6 months prior to screening; trial participants with a negative chest radiography within 3 months prior to screening are eligible if they meet the protocol requirements;
• Hepatitis C, hepatitis B, or human immunodeficiency virus (HIV) infection; or syphilis infection requiring treatment;
• Abnormal physical examination or laboratory findings;
• Other:

• History of any major drug allergy; known allergy to any excipient of the investigational product;
• Inability to comply with the trial protocol;
• History of substance abuse with inability to abstain or presence of a psychiatric disorder;
• Participation in another clinical trial and use of another investigational drug (other than for psoriatic arthritis) within 4 weeks prior to the first dose, based on the date of discontinuation from the previous trial;
• Planned or previous allogeneic bone marrow transplantation or solid organ transplantation;
• Any condition that, in the investigator's judgment, poses a serious risk to the safety of the trial participant or affects the participant's ability to complete the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 44 центра

• Bozhou People's Hospital — Бочжоу
• Peking Union Medical College Hospital — Пекин
• Southwest Hospital, Third Military Medical University (Army Medical University) — Чунцин
• Dongguan People's Hospital — Дунгуань
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine — Гуанчжоу
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• Jiangmen Central Hospital — Jiangmen
• Shenzhen Second People's Hospital — Шэньчжэнь
• … и ещё 36 центров

Идентификаторы

NCT: NCT07406035 · TQH3906-II-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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