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New treatment option for Psoriatic Arthritis
Official title A Clinical Trial of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
ClinicalTrials.gov ID: NCT07406035
What this study is testing
What is TQH3906 Capsule?
TQH3906 Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for psoriatic arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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）;
You likely can't join if
- 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;
See the full eligibility 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）;
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bozhou, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Jiangmen, Guangdong, China
- Shenzhen, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Baoding, Hebei, China
- Cangzhou, Hebei, China
- Kaifeng, Henan, China
- Luoyang, Henan, China
- Puyang, Henan, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Shaoyang, Hunan, China
- Zhuzhou, Hunan, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bozhou, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Dongguan, Guangdong, China; Guangzhou, Guangdong, China; Jiangmen, Guangdong, China and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.