Plaque psoriasis
Conditions
Interventions
HS-10374 12 mg QD:HS-10374 tablet
placebo:HS-10374 tablets of simulator
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 999 Years
Inclusion criteria
Inclusion criteria: Signed informed consent 1) The subject can communicate well with the investigator, understand and comply with the requirements of this study, have a full understanding of the content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form. Target Population 2) Has had a diagnosis of plaque psoriasis for at least 6 months prior to randomization. 3) Judged by the investigator to be in line with the indications for phototherapy or systemic therapy. 4) Psoriasis plaque BSA = 10%. 5) PASI = 12 with sPGA score = 3. General condition and maternity status 6) Male or female, not less than 18 years of age. 7) Female subjects are not in pregnancy or lactation from the screening period to 40 days after the last dose of the investigational drug. 8) Subject has no fertility plan, no sperm or egg donation plan for the following time periods, and voluntarily takes effective contraceptive measures as required by the protocol: WOCBP is from the screening period to 40 days after the last dose of the investigational drug, and from the screening period to 10 days after the last dose of the investigational drug for male subjects with a WOCBP partner.
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with psoriasis other than plaque psoriasis at screening or baseline, such as guttate psoriasis, reverse psoriasis Psoriasis, pustular psoriasis and erythrodermic psoriasis; 2) Patients with drug-induced psoriasis were diagnosed at screening or baseline; 3) People who have had or currently have an active infection and/or febrile illness within 7 days prior to the first dosing; 4) Those who have had a severe bacterial, fungal, or viral infection within 60 days prior to the first dose and need to be hospitalized and treated with intravenous anti-infective drugs. 5) Patients with chronic bacterial infections during the screening period or baseline period, such as chronic pyelonephritis, chronic osteomyelitis, chronic bronchitis, etc. 6) Those who have replaced artificial joints, those who have had artificial joint infection in the past or have received antimicrobial treatment for suspected artificial joint infection, and the artificial joint has not been removed or replaced. 7) Those with herpes zoster in the screening period or baseline period; Those with a history of severe herpes zoster or severe herpes simplex (including but not limited to disseminated herpes simplex, generalized herpes zoster (involving 2 or more ganglia at the same time, with lesions in contralateral or ipsilateral multiple dermatomes), herpes virus encephalitis, ocular herpes, recurrent herpes zoster (at least 2 episodes within two years). 8) HBsAg positive; Those who have a positive HBV DNA PCR test; HbcAb-positive and HBsAb-negative. 9) HCV RNA PCR test is required for HCV-Ab positive patients, and those with positive HCV PCR test results are excluded. 10) Those who have any known or suspected history of congenital or acquired immunodeficiency that may impair the subject's immune function, such as splenectomy, opportunistic infections (such as Pneumocystis pneumonia, histoplasmosis, coccidioidomycosis, etc.), primary immunodeficiency, AIDS, etc.; or those who test positive for HIV-Ab. 11) Those with a history of tuberculosis or tuberculosis infection: (1) Those who have a history of active tuberculosis, or who currently have symptoms, signs, imaging or laboratory evidence of active tuberculosis; (2) Patients with inactive tuberculosis indicated by medical history, physical examination, laboratory examination or imaging examination; (3) LTBI, i.e., the body is infected with Mycobacterium tuberculosis, but no clinical tuberculosis occurs, and there is no evidence of active tuberculosis in clinical bacteriology or imaging. A positive IGRA may indicate infection with Mycobacterium tuberculosis. Concentrate: a) For patients who do not develop clinical tuberculosis, if the IGRA test report is "inconclusive" or synonymous, the test can be repeated 1 time. Those who are still inconclusive on the retest are excluded, those who are positive on the retest and are considered LTBI, and those who are negative on the retest and meet other screening requirements can be included. b) On the premise that LTBI subjects have no active manifestations of tuberculosis, if there is medical documentation that the subject has received normative prophylactic anti-tuberculosis therapy within 5 years prior to screening, or the subject has started or agrees to start normative prophylactic anti-tuberculosis treatment and treatment for at least 4 weeks, it may be included if other screening requirements are met, and the latter agrees to complete standardized treatment during
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI 75 response rate;sPGA 0/1 response rate; | — |
Countries
China
Contacts
Public ContactJinhua Xu
Huashan Hospital, Fudan University
Outcome results
None listed