Treatment of Moderate to Severe Plaque Psoriasis

Last updated: October 9, 2024
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Rash

Skin Wounds

Warts

Treatment

Placebo of TQH3906 capsules

TQH3906 capsules

Clinical Study ID

NCT06542614
TQH3906-II-01
  • Ages 18-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 orsignificant 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 thesPGA ≥ 3 points ;

  • Have a full understanding of this study, voluntarily participate in the trial, andhave signed a written informed consent form;

  • Subjects (including partners) are willing to voluntarily use appropriate andeffective contraceptive measures from screening to 3 months after the last dose ofstudy drug.

Exclusion

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 hepatitisB core antibody (HBcA positive and Hepatitis B virus (HBV) DNA positive, orHepatitis C virus (HCV) antibody positive and HCV-RNA positive;

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

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

  • Have a history of active tuberculosis during the screening period or before, or havelatent tuberculosis infection found at screening (refers to T-SPOT positive withoutclinical manifestations). (Note: Patients with latent tuberculosis infection can bere-screened 1 month after starting prophylaxis according to the guidelines, and inorder to continue to participate in the study, patients must agree to continue tocomplete the prophylactic regimen during the study, but rifampicin treatment shouldbe avoided.) ;

  • Has a history of severe herpes zoster or herpes simplex infection, including but notlimited to herpetic encephalitis, disseminated herpes simplex, generalized herpeszoster;

  • History of severe bacterial, fungal or viral infection within 2 months prior torandomization, requiring hospitalization for intravenous antibiotics or antiviraldrug treatment;

  • Live vaccine within 4 weeks prior to randomization or planned live vaccine duringthe study;

  • Clinically significant infection, including but not limited to upper respiratorytract infection, lower respiratory tract infection, herpes simplex, herpes zoster,during the screening period, and requiring antibiotic or antiviral medicationtreatment;

  • 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 theinvestigator to be unsuitable for participation in this study.

  • Abnormal laboratory tests during the screening period:

  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 timesupper 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 theinvestigator, the subject is not suitable for participation in this study.

  • History of malignant tumors (including carcinoma in situ) and lymphoproliferativedisorders within 5 years prior to randomization;

  • Those who have received anti-IL-12, IL-17, Interleukin 23 (IL-23) monoclonalantibody therapy (such as ustekinumab, secukinumab, Ixekizumab, guselkumab,adalimumab, etc.) within 6 months prior to randomization, or those who have receivedat least 12 consecutive times of the above drugs in the past but have poor clinicalresponse (defined as not achieving PASI 50 during treatment);

  • Receipt of any other marketed or investigational biologic agent within 3 months or 5half-lives (whichever is longer) prior to randomization;

  • Receipt of any other investigational drug in 1 month or 5 half-lives (whichever islonger) prior to randomization;

  • Those who have undergone surgical surgery within 4 weeks prior to randomization, orwho plan to undergo surgical procedures during the study;

  • Those who have lost blood or donated more than 400 mL of blood within 4 weeks priorto randomization;

  • Receipt of immunoglobulin or blood products within 4 weeks prior to randomization;

  • Systemic treatment drugs or immunosuppressants for psoriasis within 4 weeks prior torandomization, 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 psoriasiswithin 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: Mildemollients (without active substances such as urea, salicylic acid, α, or β hydroxyacids) are allowed to be used at all sites, but should not be used within 24 hoursprior to each study visit);

  • Potential difficulty in blood collection, with a history of fainting needle andblood sickness;

  • Allergy to any of the known ingredients of the TQH3906, or any previous history ofsevere drug allergies.

  • Those with a history of substance abuse or a positive urine drug screen;

  • Has any other reasonable medical, psychiatric, or social reason that, in the opinionof the investigator, precludes participation in this study.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo of TQH3906 capsules
Phase: 2
Study Start date:
August 27, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241000
    China

    Site Not Available

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing 100730
    China

    Site Not Available

  • The first affiliated hospital of chongqing medical university

    Chongqing, Chongqing 400042
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510091
    China

    Site Not Available

  • Liuzhou People'S Hospital

    Liuzhou, Guangxi 545006
    China

    Site Not Available

  • Shijiazhuang Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei 50000
    China

    Site Not Available

  • The Second Hospital of HeBei Medical University

    Shijiazhuang, Hebei 50000
    China

    Site Not Available

  • The Second Affiliated Hospital Of Xingtai Medical Colledge

    Xingtai, Hebei 054002
    China

    Site Not Available

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang 150036
    China

    Site Not Available

  • The Second Affiliated Hospital of Henan University of Science and Technology

    LuoYang, Henan 471000
    China

    Site Not Available

  • Nanyang First People'S Hospital

    Nanyang, Henan 473010
    China

    Site Not Available

  • Shiyan Renmin Hospital

    Shiyan, Hubei 442000
    China

    Site Not Available

  • Wuhan First Hospital

    Wuhan, Hubei 430033
    China

    Site Not Available

  • The First People's Hospital of Changde

    Changde, Hunan 415100
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Site Not Available

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia 014000
    China

    Site Not Available

  • Hospital of Dermatology, Chinese Academy of Medical Sciences

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Yancheng First People's Hospital

    Yancheng, Jiangsu 224006
    China

    Site Not Available

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin 130031
    China

    Site Not Available

  • Meihekou Central Hospital

    Meihekou, Jilin 135000
    China

    Site Not Available

  • Genertec Liaoyou Gem Flower Hospital

    Panjin, Liaoning 124000
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • The first hospital of china medical university

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710000
    China

    Site Not Available

  • Shandong First Medical University Affiliated Dermatology Hospital

    Jinan, Shandong 250022
    China

    Site Not Available

  • Shandong University Qilu Hospital

    Jinan, Shandong 250063
    China

    Site Not Available

  • Qingdao Municipal hospital (group)

    Qingdao, Shandong 266011
    China

    Site Not Available

  • Qingdao Traditional Chinese Medicine Hospital

    Qingdao, Shandong 266033
    China

    Active - Recruiting

  • Shanghai JiaoTong University of medicine Ruijin Hospital

    Shanghai, Shanghai 20025
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi 030012
    China

    Site Not Available

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin 300120
    China

    Site Not Available

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang 830001
    China

    Site Not Available

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

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

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