Prurigo Nodularis
Conditions
Interventions
Parallel arm 1:QX005N Injection
Parallel arm 2:QX005N Injection
Parallel arm 3:QX005N Injection
Parallel arm 4:Placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.18-75 years old(including 18 and 75)male or female. 2.Diagnosed as PN for at least 3 months before the screening visit, and meet the criteria below at the same time, a. With a minimum of 20 PN lesions in total on both arms, and/or both legs, and/or trunk at both screening visit and baseline visit. b. With a worse itch score(WI-NRS) of >=7 in the past 24 hours before the screening visit, and an average worse itch score(WI-NRS) of >=7 in the 7 days prior to D1(baseline visit). 3.History of inadequately controlled with a 2-week course of medium-to-supertotent TCS before the screening visit, or medium-to-supertotent TCS are not medically advisable. 4.With no birth plan and willing to use adequate birth control during screening and treatment period until 6 months after the last dose of the investigational medicinal product(IMP). 5.With ability to understand contents of informed consent form (ICF), and willing to sign and comply with terms in ICF. 6.Willing and able to comply with all the planned clinic visits, and complete a daily assessment scale as required for the duration of the study.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breast-feeding women. 2.Allergic to ingredients or excipients of the study drugs. 3.Treatment with an investigational drug or a medical device within 3 weeks before the screening visit. 4.PN diagnosed as below, a.PN secondary to medications. b.PN secondary to medical conditions such as neuropathy or psychiatric disease. 5.Presence of any medical condition at the screening visit or in a certain period before the screening visit as below, a.Systematic chronic or acute infection requiring with treatment with antibodies, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the screening visit, or herpes simplex infection within 2 weeks before the screening visit, or superficial skin infection within 1 weeks before the screening visit. (If have an infection, the patient can be re-screened after infection has subsided for only once). b.History of or suspected immunosuppressive disorders, including invasive occasional infectious diseases (eg. histoplasmosis, listeriosis, coccidiodomycosis, pneumocystosis, and aspergillosis), even if the infection has subsided, or there are unusually frequent, recurrent or long-term infections,the patient should be ruled out. c.History of VKC or AKC within 6 months before the screening visit. d.History of malignancy within 5 years before the screening visit (except patients with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin). e.Presence of active skin morbidities that may need urgent treatment. f.Any other medical or psychological history which may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patients participation unreliable, or may interfere with study assessments , in the opinion of the investigator, such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, hematological system diseases, immune system diseases, mental diseases, etc. 6.History of or presence of infectious diseases at screening visit as below : a.History of a tuberculosis(TB) infection, or an active TB infection at the time of screening(in the investigators judgement, according to T-spot.TB or QuantiFERON-TB Gold test result, and chest CT result) b.Positive hepatitis B surface antigen (or negative HBsAg plus positive HBcAb plus positive HBV-DNA) c.Positive hepatitis C antibody plus positive HCV-RNA. d.Positive treponema pallidum antibody plus positive RPR test. e.History of HIV infection, or positive HIV antibody. 7.Prior/concomitant therapy a.Treatment with Dupilumab or other same-target(IL-4Ra) drugs before the screening visit. b.Treatment with topical drugs or some small molecules within 1 weeks before the baseline visit, such as TCS, TCI, intralesional corticosteroids, capsaicin, tar, topical salicylates, topical tretinoin, topical Vitamin D3 and analogues, lidocaine cream, cryotherapy, topical PDE-4 inhibitor, oral leukotriene receptor, antagonists, oral pregabalin, etc. c.Treatment with systemic traditional Chinese medicine therapies within 2 weeks, or treatment with topical traditional Chinese medicine therapies within 1 weeks before the baseline visit.(Treatment with systemic tripterygium wilfordii within 4 weeks, or treatment with topical tripterygium wilfordii within 2 weeks before the baseline visit) d.Treatment with systematic corticosteroids, or systema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with an improvement (reduction) in WI-NRS by =4 from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first onset of effect on pruritus;Change from baseline in WI-NRS scores;Percent change from baseline in WI-NRS scores;Percentage of participants with =4 Points improvement (reduction) from baseline in WI-NRS scores;Onset of action in change from baseline in WI-NRS;Proportion of participants with IGA PN-S 0 or 1 score;Change from baseline in IGA PN-S score;Proportion of participants with IGA PN-A 0 or 1 score;Change from baseline in Dermatology Life Quality Index (DLQI) score;Safety and tolerability(TEAEs,SAEs,Physical examination,Vital signs,12-lead ECG, Laboratory Test);PK;Incidence of antidrug antibodies (ADA) against QX005N;PD; | — |
Countries
China
Contacts
Public ContactZhang Jianzhong
Peking University People's Hospital
Outcome results
None listed