Prurigo Nodularis
Conditions
Interventions
Group of QX005N:QX005N injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participation in a prior clinical trial of QX005N for PN(parent study: QX005NE-01) and met one of the criteria below, a.Received study treatment according to the protocol and adequately completed the last visit assessments of the parent study as defined. b.Treatment discontinuation due to a poor compliance event or a AE that was deemed not related to QX005N, and complete the early withdrawal visit, according to the judgement of the investigator and the sponsor, the factor that led to the patient's early termination of treatment has disappeared/no longer affect the subject's participation in this study. 2. No birth plan and willing to use adequate birth control from the start of this study to 6 months after the last dose. 3. With ability to understand contents of informed consent form (ICF), and willing to sign and comply with terms in ICF. 4. Willing and able to comply with the planned clinic visits.
Exclusion criteria
Exclusion criteria: 1. Participation in a prior clinical trial of QX005N for PN (parent study: QX005NE-01 ) and meet one of the criteria below, a.Developed a SAE that was deemed related to QX005N, and in the opinion of the investigator, the factors that led to the patient's early termination of treatment may present an unreasonable risk for the patient. b.Developed a AE that was deemed related to QX005N, and in the opinion of the investigator, the factors that led to the patient's early termination of treatment may present an unreasonable risk for the patient. c.Developed other conditions that lead to early termination of treatment, and in the opinion of the investigator, the factors that led to the patient's early termination of treatment may present an unreasonable risk for the patient. 2. Allergic to any ingredients or excipients of the study drugs. 3. Pregnant or breast-feeding women, or women who plans to pregnant or breast-feeding during the whole study. 4.Treatment with an investigational drug or an investigational medical device within 3 months before the screening visit. 5.With history of or presence of diseases as below at the screening visit, a.History of chronic or acute infection requiring with systematic treatment with antibodies, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the screening visit, or superficial skin infection within 1 weeks before the screening visit. (the patient may be re-screened after infection subside with just for 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. Any other active inflammatory skin diseases that, in the opinion of the investigator, might interfere with the evaluation in this study at the screening visit. d. Any other medical or psychological history that, in the opinion of the investigator, may present an unreasonable risk to the study patients a result of his/her participation in this clinical trial may make patient’s participation unreliable, or may interfere with study assessments, such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, hematological system diseases, immune system diseases, mental diseases, etc. 6. Infectious disease test results meet the following criteria at the screening visit, a.History of tuberculosis, or active or latent TB infection at the time of screening (according to T-spot.TB or QuantiFERON-TB Gold test results and chest imageologic examination result). b.Positive hepatitis B surface antigen (or negative HBsAg plus positive HBcAb plus positive HBV-DNA). c.Positive hepatitis C antibody(with positive HCV-RNA if necessary). 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 IL-4Ra target medicines(except for QX005N in QX005NE-01). b.Treatment with one of the therapies below within 1 weeks before the baseline visit, a)Medium-to-superpotent TCS. b)TCI on areas other than face, neck, genital, etc. c)Topical capsaicin. d)Topical coal tar remedies. e)Topical salicylic acid. f)Topical retinoids, or topical calcipotriol. g)Topical lidocaine. h)Topical PDE-4 inhibitors (for example, Crisaborole O
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| SAEs;Percentage of participants with an improvement (reduction) in WI-NRS by =4 from baseline;Proportion of participants with IGA PN-S 0 or 1 score;Change from baseline in WI-NRS 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;Percent change from baseline in WI-NRS score; | — |
Countries
China
Contacts
Public ContactZhang Jianzhong
Peking University People's Hospital
Outcome results
None listed