Treatment of Moderate to Severe Plaque Psoriasis

NCT ID: NCT06542614

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-27
• Study Completion Date: 2025-12-06

Brief Summary

To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TQH3906 capsules

TQH3906 capsules are administered orally at the same time (±2 hours) on an empty stomach every day for 12 weeks starting from Day 1.

Group Type: EXPERIMENTAL

TQH3906 capsules

Intervention Type: DRUG

To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis.

Placebo of TQH3906 capsules

TQH3906 capsules placebo: TQH3906 capsules placebo administered orally once daily for 12 weeks at the same time (±2 hours) on an empty stomach starting from Day 1.

Group Type: PLACEBO_COMPARATOR

Placebo of TQH3906 capsules

Intervention Type: DRUG

Placebo without drug substance.

Interventions

TQH3906 capsules

To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis.

Intervention Type: DRUG

Placebo of TQH3906 capsules

Placebo without drug substance.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Be 18-70 years old (both 18 and 70 years old), regardless of gender；
• Clinically diagnosed with stable moderate to severe plaque psoriasis with a history ≥ 6 months (from randomization), and no morphological changes in skin lesions or significant disease outbreaks as assessed by the investigator;
• Appropriate for systemic therapy or phototherapy as judged by the investigator;
• At screening and baseline, the PASI score was ≥ 12 points, the BSA ≥ 10%, and the sPGA ≥ 3 points ;
• Have a full understanding of this study, voluntarily participate in the trial, and have signed a written informed consent form;
• Subjects (including partners) are willing to voluntarily use appropriate and effective contraceptive measures from screening to 3 months after the last dose of study drug.

Exclusion Criteria

• Pregnant and lactating females;
• Have other forms of psoriasis other than plaque psoriasis (e.g., guttate psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, arthropathic psoriasis);
• Presence of serovirological abnormalities during the screening period:

1. Active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcA positive and Hepatitis B virus (HBV) DNA positive, or Hepatitis C virus (HCV) antibody positive and HCV-RNA positive;

2. Positive for HIV antibody during the screening period, or have a history of HIV infection in the past;

3. Positive Treponema pallidum antibody and positive non-Treponema pallidum serum test (RPR or TRUST) during the screening period;

• Have a history of active tuberculosis during the screening period or before, or have latent tuberculosis infection found at screening (refers to T-SPOT positive without clinical manifestations). (Note: Patients with latent tuberculosis infection can be re-screened 1 month after starting prophylaxis according to the guidelines, and in order to continue to participate in the study, patients must agree to continue to complete the prophylactic regimen during the study, but rifampicin treatment should be avoided.) ;
• Has a history of severe herpes zoster or herpes simplex infection, including but not limited to herpetic encephalitis, disseminated herpes simplex, generalized herpes zoster;
• History of severe bacterial, fungal or viral infection within 2 months prior to randomization, requiring hospitalization for intravenous antibiotics or antiviral drug treatment;
• Live vaccine within 4 weeks prior to randomization or planned live vaccine during the study;
• Clinically significant infection, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, during the screening period, and requiring antibiotic or antiviral medication treatment;
• Has any significant illness or unstable clinical condition (such as renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurological, immune, or locally active infectious/infectious disease) that is judged by the investigator to be unsuitable for participation in this study.
• Abnormal laboratory tests during the screening period:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times upper limit of normal (ULN);

2. Hemoglobin <90g/L;

3. White blood cell count< 3.0×109/L;

4. Neutrophil count<1.0×109/L;

5. Lymphocyte count<0.5×109/L;

6. Platelet count < 100×109/L;

7. Total bilirubin >2 times ULN;

8. Other significant laboratory test abnormalities that, in the opinion of the investigator, the subject is not suitable for participation in this study.

• History of malignant tumors (including carcinoma in situ) and lymphoproliferative disorders within 5 years prior to randomization;
• Those who have received at least 6 consecutive months of anti-IL-12, IL-17, IL23 monoclonal antibody drugs (such as ustekin, secukziu, ichizzo, gusechiu, etc.) at the approved dose but have poor clinical response (defined as not achieving PASI 50 during treatment)；
• Receipt of any other marketed or investigational biologic agent within 3 months or 5 half-lives (whichever is longer) prior to randomization;
• Receipt of any other investigational drug in 1 month or 5 half-lives (whichever is longer) prior to randomization;
• Those who have undergone surgical surgery within 4 weeks prior to randomization, or who plan to undergo surgical procedures during the study;
• Those who have lost blood or donated more than 400 mL of blood within 4 weeks prior to randomization;
• Receipt of immunoglobulin or blood products within 4 weeks prior to randomization;
• Systemic treatment drugs or immunosuppressants for psoriasis within 4 weeks prior to randomization, including but not limited to retinoids, glucocorticoids, methotrexate, cyclosporine, azathioprine, Janus kinase (JAK) inhibitors, etc;
• Use of strong CYP450 inducers (such as rifampicin, phenobarbital, carbamazepine, phenytoin, etc.) within 4 weeks prior to randomization;
• Received topical or systemic phototherapy within 4 weeks prior to randomization, including but not limited to Narrow-band ultraviolet B (NB-UVB), photochemotherapy (PUVA), 308nm excimer light;
• Use of topical drugs that may affect the severity of skin lesions in psoriasis within 2 weeks prior to randomization, including but not limited to glucocorticoids, urea, >3% salicylic acid, α or β hydroxy acids, retinoids, vitamin D3 analogues, calcineurin inhibitors, Phosphodiesterase-4 (PDE-4) inhibitors, etc. (Note: Mild emollients (without active substances such as urea, salicylic acid, α, or β hydroxy acids) are allowed to be used at all sites, but should not be used within 24 hours prior to each study visit);
• Potential difficulty in blood collection, with a history of fainting needle and blood sickness;
• Allergy to any of the known ingredients of the TQH3906, or any previous history of severe drug allergies.
• Those with a history of substance abuse;
• Has any other reasonable medical, psychiatric, or social reason that, in the opinion of the investigator, precludes participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The first affiliated hospital of chongqing medical university

Chongqing, Chongqing Municipality, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Liuzhou People'S Hospital

Liuchow, Guangxi, China

Shijiazhuang Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

The Second Affiliated Hospital Of Xingtai Medical Colledge

Xingtai, Hebei, China

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Nanyang First People'S Hospital

Nanyang, Henan, China

Shiyan Renmin Hospital

Shiyan, Hubei, China

Wuhan First Hospital

Wuhan, Hubei, China

The First People's Hospital of Changde

Changde, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Hospital of Dermatology, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Yancheng First People's Hospital

Yancheng, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Meihekou Central Hospital

Meihekou, Jilin, China

Genertec Liaoyou Gem Flower Hospital

Panjin, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The first hospital of china medical university

Shenyang, Liaoning, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong First Medical University Affiliated Dermatology Hospital

Jinan, Shandong, China

Shandong University Qilu Hospital

Jinan, Shandong, China

Qingdao Municipal hospital (group)

Qingdao, Shandong, China

Qingdao Traditional Chinese Medicine Hospital

Qingdao, Shandong, China

Shanghai JiaoTong University of medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, China

Xinjiang Uygur Autonomous Region People's Hospital

Ürümqi, Xinjiang, China

Affiliated Hangzhou First People'S Hospital,School of Medicine, Westlake University

Hangzhou, Zhejiang, China

The Second Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

TQH3906-II-01

Identifier Type: -

Identifier Source: org_study_id