Treatment of Moderate to Severe Plaque Psoriasis

NCT06542614 | Completed Phase 2

• 1 other identifier: TQH3906-II-01
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 35

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 at week 12

  Achieve a PASI 75 ratio

  Up to week 12

Secondary Outcomes (17)

• Proportion of patients achieving Static Physician's Global Assessment (sPGA) 0/1 at week 12

  Up to week 12

• Proportion of patients achieving PASI 50 at week 12

  Up to week 12

• Proportion of patients achieving PASI 90 at week 12

  Up to week 12

• Proportion of patients achieving PASI 100 at week 12

  Up to week 12

• Body Surface Area (BSA) score

  Up to week 12

Study Arms (2)

TQH3906 capsules

EXPERIMENTAL

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

Drug: TQH3906 capsules

Placebo of TQH3906 capsules

PLACEBO COMPARATOR

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.

Drug: Placebo of TQH3906 capsules

Interventions

TQH3906 capsules DRUG

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

TQH3906 capsules

Placebo of TQH3906 capsules DRUG

Placebo without drug substance.

Placebo of TQH3906 capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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;
• Positive for HIV antibody during the screening period, or have a history of HIV infection in the past;
• 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:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times upper limit of normal (ULN);
• Hemoglobin \<90g/L;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (35)

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

The first affiliated hospital of chongqing medical university

Chongqing, Chongqing Municipality, 400042, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

Liuzhou People'S Hospital

Liuchow, Guangxi, 545006, China

Location

Shijiazhuang Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, 50000, China

Location

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, 50000, China

Location

The Second Affiliated Hospital Of Xingtai Medical Colledge

Xingtai, Hebei, 054002, China

Location

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, 150036, China

Location

The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471000, China

Location

Nanyang First People'S Hospital

Nanyang, Henan, 473010, China

Location

Shiyan Renmin Hospital

Shiyan, Hubei, 442000, China

Location

Wuhan First Hospital

Wuhan, Hubei, 430033, China

Location

The First People's Hospital of Changde

Changde, Hunan, 415100, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, 014000, China

Location

Hospital of Dermatology, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210000, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Yancheng First People's Hospital

Yancheng, Jiangsu, 224006, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130031, China

Location

Meihekou Central Hospital

Meihekou, Jilin, 135000, China

Location

Genertec Liaoyou Gem Flower Hospital

Panjin, Liaoning, 124000, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

The first hospital of china medical university

Shenyang, Liaoning, 110001, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

Shandong First Medical University Affiliated Dermatology Hospital

Jinan, Shandong, 250022, China

Location

Shandong University Qilu Hospital

Jinan, Shandong, 250063, China

Location

Qingdao Municipal hospital (group)

Qingdao, Shandong, 266011, China

Location

Qingdao Traditional Chinese Medicine Hospital

Qingdao, Shandong, 266033, China

Location

Shanghai JiaoTong University of medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 20025, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

Location

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, 300120, China

Location

Xinjiang Uygur Autonomous Region People's Hospital

Ürümqi, Xinjiang, 830001, China

Location

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

Hangzhou, Zhejiang, 310003, China

Location

The Second Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start: August 27, 2024
• Primary Completion: November 3, 2025
• Study Completion: December 6, 2025
• Last Updated: January 30, 2026

Record last verified: 2025-12

Locations

CN (35)