Psoriatic Arthritis study: TQH3906 Capsule vs Tofacitinib Citrate Tablet
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?
an investigational oral capsule being studied as a potential treatment for psoriatic arthritis is designed to inhibit tyrosine kinase activity in the body
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 testing whether TQH3906 works better than a pretend treatment. It looks at how well it helps joints at week 12.
- Who it's for
- You may be able to join if you have active psoriatic arthritis.
- What's involved
- You would take TQH3906 capsules or a pretend pill. You would be picked by chance, like a coin toss.
- Time commitment
- The study lasts 12 weeks with check-ins to see how you are doing.
- 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 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;
- 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;
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）;
- 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...
- 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...
- 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;
- 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
- 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;
- 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;
- 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 is enrolling
- 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
- Baoding, Hebei, China
- Cangzhou, Hebei, China
- Kaifeng, Henan, China
- Luoyang, Henan, China
- Puyang, Henan, China
- Changsha, Hunan, China
- Zhuzhou, Hunan, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Yancheng, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
+ 11 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, but 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?
This study is enrolling now at Bozhou, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Dongguan, Guangdong, China; Guangzhou, Guangdong, China; Jiangmen, Guangdong, China and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.