Prurigo nodosum
Conditions
Interventions
Experimental group:Ruxolitinib gel(HDM3010)
Control group:Vehicle for ruxolitinib gel (HDM3010)
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) At the time of signing the informed consent, the age of the subjects was 18-65 years old (including the cut-off value), and the gender was not limited; 2) Clinical diagnosis of PN by a dermatologist = 3 months at the time of screening and the following criteria must be met at the same time: a) Pruritic nodules present in at least two body surface regions (e.g., left lower extremity and right lower extremity) during the screening period and at baseline, and there must be symmetrically distributed nodules in all four limbs (upper and/or lower extremities); b) IGA PN-S >=2 at screening period and baseline; c) The weekly mean of PN-related WI-NRS in the past week at baseline >=7 (out of 7 days, at least 4 days of scoring are required to be used for the calculation of the baseline mean score.) If the number of reported days 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 beyond the maximum screening period of 28 days); Note: In addition to meeting the above clinical features of PN, dermatopathological examination is performed for differential diagnosis if necessary to further clarify the clinical diagnosis of PN. 3) Body surface area (BSA) involved at screening and baseline (except scalp): Cohorts 1 and 2 should be =25%; 4) Female subjects of childbearing potential (WOCBP) have a negative serum pregnancy test at the screening period and a negative urine pregnancy test at the baseline visit. WOCBP subjects and male subjects not undergoing vasectomy must agree to use at least one reliable contraceptive measure throughout the study, including: oral/implantable/injectable/percutaneous contraceptives, intrauterine device, bilateral tubal ligation or bilateral tubal occlusion, vasectomy, etc. If barrier contraception (eg, male condom, female condom) is used, at least one should be chosen and used correctly throughout sexual intercourse. If the subject is abstinent in his or her usual life, then the subject may use this form of contraception, but when he is no longer abstinent, he or she will need to choose one of the reliable contraceptive methods mentioned above. Male subjects who cannot donate sperm from the first dose to 3 months after the last dose of study drug; Note: WOCBP subjects are defined as female subjects who, after menarche, have not reached a postmenopausal state (continuous amenorrhea for at least 12 months with no other clear cause other than menopause) and are not surgically surgically (i.e., bilateral oophorectomy and/or bilateral salpingectomy and/or hysterectomy) or other cause of permanent sterility as determined by the investigator (such as Müllerian duct hypoplasia); 5) After fully understanding the content of the trial and possible adverse reactions, the subjects voluntarily participated in the trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other diseases that may interfere with the evaluation of efficacy or cause itching at screening and baseline, such as uncontrolled diabetes or thyroid disease, cholestatic liver disease, end-stage renal disease, iron deficiency anemia, etc.; or PN caused by drugs (e.g., opioids, angiotensin-converting enzyme inhibitors [ACEIs]) or secondary to neuropathy or psychiatric disorders; 2. Active atopic dermatitis (AD) lesions within the screening period or within 3 months prior to baseline or other skin comorbidities other than PN that may interfere with the study evaluation (such as dermatomycosis, psoriasis, scabies, chronic lichen simplex, chronic actinic dermatitis, dermatitis herpetiformis and contact dermatitis, etc.); 3) Receiving any of the following treatments prior to randomization: (1) Prior treatment with a systemic JAK inhibitor or any topical JAK inhibitor in the 3 months prior to randomization; (2) Received topical capsaicin, tar drugs, topical salicylic acid, topical retinoids, topical vitamin D3 analogues, compound lidocaine cream, topical phosphodiesterase-4 (PDE-4) inhibitors (such as cliborol), topical antihistamines, topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), emollients containing clear and effective antipruritic ingredients, topical Chinese patent medicines or herbal treatments, etc.; (3) Received systemic glucocorticoids, systemic immunosuppressive therapy/immunomodulatory therapy (e.g., cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, PDE-4 inhibitors, interferon ? [IFN-?] target drugs), thalidomide, hydroxychloroquine, and neurokinin-l (NK-1) receptor antagonists (e.g., aprepitant), opioid receptor antagonists, and other drugs that may affect the evaluation of PN efficacy (e.g., antidepressants, etc.); (4) Received oral antihistamines within 2 weeks before randomization ? Received gabapentin, pregabalin, systemic Chinese patent medicines (such as compound glycyrrhizin tablets, tripterygium wilfordii polyglycoside tablets) within 4 weeks before randomization; (5) use of immunomodulatory biologics (e.g., dupilevue) within 12 weeks or 5 drug half-lives (if known) (whichever is longer) prior to randomization; (6) Received intralesional corticosteroid injection, cryotherapy, and phototherapy within 4 weeks before randomization; (7) Have received any live vaccine, live attenuated vaccine within 4 weeks prior to randomization, or plan to receive a live vaccine, live attenuated vaccine during the study period; (8) Received a systemic potent cytochrome P450 3A4 inhibitor or a dual inhibitor of CYP2C9/3A4 (such as fluconazole) within 2 weeks or 5 half-lives (whichever is longer) prior to randomization; 4. Previous human immunodeficiency virus (HIV) infection or suspected infection or positive HIV antibody at screening; or hepatitis B positive (hepatitis B virus surface antigen [HBsAg] positive or HBsAg negative but hepatitis B virus core antibody [HBcAb] positive, HBV-DNA quantification is required, and the result is higher than the upper limit of normal value); or hepatitis C (hepatitis C virus [HCV] antibody positive and HCVRNA quantification above the upper limit of normal); or positive syphilis screening (positive for specific antibodies, except for those with negative non-specific antibody tests and confirmed as inactive infection based on clinical judgment); 5. There may be active tuberculosis infection at the time of screening, or a history of active tuberculosis, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy end Points;PK index; | — |
Countries
China
Contacts
Public ContactHongzhong Jin
Peking Union Medical College Hospital
Outcome results
None listed