Prurigo Nodularis
Conditions
Interventions
First Treatment Period(From week 0 to week 16) Arm A:QX005N injection, 450 mg, Q2W
First Treatment Period(From week 0 to week 16) Arm B:Matching placebo of QX005N injection, Q2W
Second Treatment Period(From week 16 to week 32) One Arm:QX005N injection, 450 mg, Q2W
Sponsors
Zhang Jianzhong
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, plus all the following criteria below: a)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(a minimum of 4 daily scores out of the 7 days before the baseline visit is required). b)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. c)History of inadequately controlled with medium-to-superpotent TCS before the screening visit(applied for at least 14 days, or for the maximum duration recommended by the product prescribing information), or medium-to-superpotent TCS are not medically advisable. d)IGA PN-S score of =7 at the baseline visit. 3)Apply emollient(moisturizer) twice daily for a minimum of 4 days out of 7 days immediately before randomization. 4)For male or female of child-bearing potential, willing to use a contraceptive method during the study until 6 months after the last dose of the investigation medicinal product(IMP), either donate or cryopreserve germ cells is not permitted during the period above. 5)With ability to understand requirements and study procedure. Willing and able to sign a contents of informed consent form (ICF), and comply with all the planned study visits requirements and visit procedures.
Exclusion criteria
Exclusion criteria: 1)Pregnant or breast-feeding women, or plan of pregnant during the whole study. 2)Presence of psychiatric illness at the screening visit or the baseline visit, or once hospitalization for mental illness(except patients suffering from a stable, mild anxiety or depression condition with Hospital Anxiety and Depression Scale(HADS) score=10,but don’t need a therapy, in the judgement of investigator). 3)History of severe allergic to drugs or food, or pharmaceutical ingredients of investigational medicinal product (IMP). 4)History of alcohol abuse (defined as>2 units per day, or >14 units per week, 1 unit alcohol equals to 360 mL beer or 45 mL 40% wine or 150 mL red wine) or drug abuse within 12 months before randomization. 5)Have used the following treatments a.Treatment with topical drugs or some small molecules within 2 weeks before randomization, eg, topical capsaicin, tar, topical salicylic acids drugs, topical tretinoin, topical Vitamin D3 and analogues, lidocaine cream, topical PDE-4 inhibitor(eg, Crisaborole Ointment). b.Treatment with IL-4Ra or IL-13 targeting antibodies. c.Initiation of treatment with TCS/TCI within 2 weeks before the screening visit, or treatment with high-potency or super-potent TCS/TCI. d.For patients who were on a stable regimen of TCS/TCI, application of TCS/TCI fewer than 6 days, or fail to maintain regimen the stable during the 7 days immediately before randomization. e.Treatment with naltrexone or other opioid antagonist, or gabapentin or pregabalin within 4 weeks before randomization. f.Treatment with cryotherapy, intralesional corticosteroids, or phototherapy (eg, NB-UVB, BB-UVB, UVA1, PUVA, tanning beds or any LED phototherapy) within 4 weeks before randomization. g.Treatment with systematic corticosteroids, or systematic immunosuppressive/immunomodulating medicine (eg, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, IFN-?target medicine, thalidomide, hydroxychloroquine, JAK inhibitor), orneurokinin-1(NK-1) receptor antagonists(such as aprepitant) within 4 weeks or <5 PK half-lives(whichever is longer) before randomization(except treatment with transnasal inhalation and spray corticosteroid) , or treatment with other immunomodulating biologic medicines within 3 months or <5 PK half-lives(whichever is longer) before randomization(eg, 6 months for rituximab, 5 months for omalizumab). h.Treatment with systemic traditional Chinese medicine(TCM) therapies within 4 weeks before randomization, or topical TCM e therapies within 1 weeks before randomization. (except that TCM therapies are used for other diseases which considered not interfere with for PN assessment, in the judgement of a investigator or specialist). i.Initiation of treatment with prescription moisturizers or moisturizers containing additives(eg, ceramide, hyaluronic acid, filaggrin degradation products) or anti-itch components(eg,menthol, multi-hydroxyl ethanol, pramoxine, lidocaine, procaine, capsaicin, naltrexone, N-dimethylethanolamine laurate)(basic moisturizer(emollient) provided by sponsor is permitted). j.Have used any of anti-depression therapies, such as paroxetine, fluvoxamine, or other SSRIs, or SNRIs, or amitriptyline or other tricyclic or tetracyclic antidepressants, ect., before the screening visit. k.History of treatment with an allergen immunotherapy within 6 months before the baseline visit. l.Exposure to any other investigative drugs within 3 months or <5 PK half-lives(whichever is longer) , or medical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with reduction in weekly average Worst-Itch Numeric Rating Scale(WI-NRS) by =4 points at week 16.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in weekly average WI-NRS from baseline to week 4,8,12,16,20,24,28,32.;Percent change in weekly average WI-NRS from baseline to week 4,8,12,16,20,24,28,32.;Percentage of participants with reduction in weekly average WI-NRS by =4 points at week 4,8,12,20,24,28,32.;Duration of response to itch from baseline to week 16.;First onset of response to itch from baseline to week 16.;Percentage of participants with Investigator’s Global Assessment PN-Stage(IGA PN-S) score of 0 or 1 at week 4,8,12,16,20,24,28,32.;Change in IGA PN-S score from baseline to week 4,8,12,16,20,24,28,32.;Percentage of participants with Investigator’s Global Assessment PN-Activity(IGA PN-A) score of 0 or 1 at week 4,8,12,16,20,24,28,32.;Change in IGA PN-A score from baseline to week 4,8,12,16,20,24,28,32.;Percentage of participants with reduction in weekly average WI-NRS by =4 points and IGA PN-S score of 0 or 1 at week 4,8,12,16,20,24,28,32.;Change in Dermatology Life Quality Index(DLQI) score from baseline to week 4,8,12,16,20,24,28,32.;Change in Hospital anxiety and depression scale(HADS) from baseline to week 4,8,12,16,20,24,28,32.;Frequency, severity and relationship with investigational medicine product of AE and SAE from baseline to week 36. ;Abnormal change in laboratory testing results, 12-ECG, vital sign, physical examination, and injection site reaction from baseline to week 36.;Change of QX005N serum concentrations during the study.;Change of total IgE and thymus and activation regulated chemokine(TARC) levels during the study.;Change of anti-drug antibody(ADA) and neutralizing antibody(NAb) levels during the study.; | — |
Countries
China
Contacts
Public ContactZhang Jianzhong
Peking University People's Hospital
Outcome results
None listed