prurigo nodularis
Conditions
Interventions
Group A (1.5% ruxolitinib gel):1.5% ruxolitinib gel, QD, BID
Group B (1.5% ruxolitinib gel):1.5% ruxolitinib gel
Group C (Excipient ?1.5% ruxolitinib gel QD):Excipient ?1.5% ruxolitinib gel QD
Group D (Excipient ?1.5% ruxolitinib gel BID):Excipient ?1.5% ruxolitinib gel BID
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.When signing the ICF, the age of the subjects should be between 18 and 75 years old (including the threshold), and there is no gender restriction. 2. At the time of screening, the clinical diagnosis by a dermatologist with PN=3 months must simultaneously meet the following criteria: a) At least two surface areas (such as the left lower extremity and the right lower extremity) at the screening period and baseline have pruritus nodules distributed in both lower extremities and/or both upper extremities and/or both sides of the trunk; b) During the screening period and at baseline, the IGA PN-S was 2 or 3 (the number of palpable pruritus nodules was =6 and =100, except for the scalp, face and palm); c) The weekly average of WI-NRS related to PN in the past week at baseline is =7 (among the 7 days, it is required that at least 4 days' scores be used for the calculation of the baseline average score. If the number of days reported by the patient in the 7 days prior to the originally planned randomization date is less than 4 days, randomization should be postponed until the requirements are met, but not exceeding the maximum screening period of 28 days. Note: In addition to meeting the above clinical features of PN, if necessary, a skin pathological examination should be conducted for differential diagnosis to further confirm the clinical diagnosis of PN. 3. For at least 4 consecutive days prior to randomization, apply a stable dose (fixed frequency) of emollient (uniformly provided by the sponsor) to the affected area of pruritus once a day. If the above requirements are not met within 7 days prior to the originally planned randomization date, randomization should be postponed until the requirements are met, but not beyond the maximum screening period of 28 days. 4. During the screening period and at baseline, itchy rash lesions (including papular type, nodular type, plaque type, umbilical depression type and linear type) involving BSA (excluding scalp) were less than 20%. 5. During the screening period, female subjects of childbearing potential (WOCBP) must have a negative serum pregnancy test and a negative urine pregnancy test at the baseline visit. Both WOCBP subjects and male subjects who have not undergone vasectomy are required to agree to employ at least one reliable form of contraception from the time of signing the ICF until three months after the last dose of the investigational medicinal product (IMP). Acceptable contraceptive methods include: oral/implantable/injectable/transdermal contraceptives, intrauterine devices, bilateral tubal ligation or bilateral tubal occlusion, vasectomy, etc. If barrier methods (e.g., male condom, female condom) are used, at least one method must be selected and consistently and correctly applied throughout the entire duration of sexual activity. Subjects who practice habitual abstinence may rely on this method for contraception; however, in the event that they cease to abstain, one of the aforementioned reliable contraceptive methods must be adopted. Male subjects are prohibited from donating sperm from the first administration of IMP until three months after the last dose. Note: A WOCBP subject is defined as a female who has experienced menarche, has not reached a postmenopausal state (defined as =12 consecutive months of amenorrhea without an alternative identified cause), and has no surgical (i.e., bilateral oophorectomy and/or bilateral salpingectomy and/or hysterectomy) or other conditi
Exclusion criteria
Exclusion criteria: 1.During the screening and baseline assessment, there may be other diseases that could interfere with the validity assessment or cause itching, such as cholestatic liver disease, iron deficiency anemia, uncontrolled diabetes or thyroid disorders; or PN caused by drugs (such as opioids, angiotensin-converting enzyme inhibitors) or secondary to neuropathy or mental disorders. 2. Active AD lesions (active AD refers to AD with symptoms or signs other than dry skin) were present during the screening period or within 3 months before baseline. Or during the screening period and/or at baseline, the researcher determined that the subjects had other skin comorbidities other than PN that might interfere with the study evaluation (such as cutaneous mycosis, psoriasis, scabies, chronic lichen monophylsis, chronic photochemical dermatitis, herpedermatitis and contact dermatitis, etc.). 3. Before randomization, receive any of the following treatments: ? Have received systemic JAK inhibitors before or have received any topical JAK inhibitors within the previous 3 months; ? Have received topical capsaicin, tar-based drugs, topical salicylic acid drugs, topical retinoid acid drugs, topical vitamin D3 analogues, compound lidocaine cream, topical PDE-4 inhibitors (such as cliborlo), topical antihistamines, TCS, TCI, moisturizers containing clearly effective anti-itch ingredients, topical Chinese medicine or herbal treatments within the previous 2 weeks; ? Have received systemic glucocorticoids, systemic immunosuppressive therapies/immunomodulatory therapies (such as cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, PDE-4 inhibitors, IFN-? target drugs), thalidomide, hydroxychloroquine, and neurokinin-l (NK-1) receptor antagonists (such as aprepitant), opioid receptor antagonists, and other drugs that may affect the efficacy assessment of PN (such as antidepressants, etc.); ? Have received oral antihistamines within the previous 2 weeks; ? Have received gabapentin, pregabalin, systemic Chinese medicine (such as compound glycyrrhizin tablets, rehmannia polysaccharide tablets); ? Have used immunomodulatory biological agents within 12 weeks or within 5 half-lives (whichever is longer) (if known); (Note: Half-life refers to the time it takes for a drug to reduce its concentration by half in the body); ? Have received intralesional corticosteroid injections and cryotherapy, phototherapy within the previous 4 weeks; ? Have received any live vaccine or attenuated live vaccine before randomization, or plan to receive live vaccine or attenuated live vaccine during the study; ? Have received systemic strong and potent CYP3A4 inhibitors or CYP2C9/3A4 dual inhibitors (such as fluconazole) within 2 weeks or 5 half-lives (whichever is longer). 4. Previous HIV infection or suspected infection, or HIV antibody positive at the time of screening; Or hepatitis B virus (HBV) infection (positive for hepatitis B virus surface antigen [HBsAg] or negative for HBsAg but positive for hepatitis B virus core antibody [HBcAb], HBV-DNA quantification needs to be detected, and the result is higher than the upper limit of the normal detection value [ULN]); Or hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA quantification result higher than ULN); Or syphilis screening is positive (except for positive specific antibody test, negative non-specific antibody test and confirmed as inactive infection in combination with clinical judgment). 5. There may be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects whose weekly average WI-NRS score decreased by >= 4 points compared to the baseline at the 16th week; | — |
Secondary
| Measure | Time frame |
|---|---|
| security analysis;The proportion of subjects with an IGA PN-S score of "0" or "1" in the 16th week and a decrease of >=2 points from the baseline; | — |
Countries
China
Contacts
Public ContactWu Liming
Hangzhou First People's Hospital
Outcome results
None listed