prurigo nodularis
Conditions
Interventions
Treatment group:Oral Ivarmacitinib
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, regardless of gender; 2.Clinically diagnosed with prurigo nodularis (PN) by a dermatologist, with a disease duration of at least 6 months; 3.At screening and baseline, based on the investigator's assessment, the severity of PN pruritus and nodules concurrently meets the following criteria: a) At the screening visit, the Worst Itch Numeric Rating Scale (WI-NRS) score over the past 24 hours is >= 7. At the baseline visit, the average WI-NRS score over the past week is >= 7 (out of 7 days, scores from at least 4 days are required to calculate the baseline average. If the patient reports fewer than 4 days in the 7 days prior to the planned baseline date, the baseline visit should be postponed until the requirement is met, but not exceeding the maximum screening period of 28 days); b) At the screening and baseline visits, nodules are distributed in at least 2 different anatomical areas, with a total of at least 20 nodules present; c) According to the investigator's judgment, the subject has an inadequate response to topical treatments such as medium-to-high potency topical corticosteroids (TCS) [treated with TCS for >= 14 days or the maximum duration recommended in the product prescribing information (whichever is shorter), but failed to achieve and maintain remission, and failed to reach a low disease activity state, equivalent to an IGA PN-S score <= 2 (i.e., <= 19 nodules)]; or the subject is not suitable for TCS treatment (evidence of prior TCS intolerance indicating significant side effects or safety risks); Note: In addition to meeting the above clinical features of PN, if necessary, a skin pathological examination should be performed for differential diagnosis to further confirm the clinical diagnosis of PN; 4.Women of childbearing potential (WOCBP) and male subjects who have not undergone a vasectomy must agree to use highly effective contraceptive methods [abstinence, prior ligation, oral contraceptives, and/or barrier methods (condoms, vaginal diaphragms, cervical caps, etc.)] during the trial, including up to 6 months after the end of the study or drug discontinuation; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) pregnancy test at the screening visit; male subjects must not donate sperm during the trial and for 6 months after the end of the study or drug discontinuation. Note: WOCBP subjects are defined as female subjects who are post-menarcheal, have not reached a postmenopausal state (continuous amenorrhea for at least 12 months with no other obvious cause except menopause), and are not permanently infertile due to surgery (i.e., bilateral oophorectomy and/or bilateral salpingectomy and/or hysterectomy) or other reasons determined by the investigator (e.g., Mullerian agenesis); 5.Subjects must have the capacity to understand the study requirements and procedures, voluntarily participate in the clinical trial, sign the informed consent form, and be willing and able to comply with study visits and related procedures.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, or subjects planning to become pregnant or lactate during the study period; 2.History of severe allergic reactions to drugs or food, and/or known allergy to the investigational drug or any of its components; 3.History of alcohol abuse (defined as > 2 units/day or > 14 units/week, where 1 unit equals 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) or drug abuse within 6 months prior to screening; 4.Prior receipt of any of the following treatments: a) Systemic glucocorticoids, systemic immunosuppressive/immunomodulatory therapies [e.g., cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, interferon-gamma (IFN-gamma) targeted drugs, thalidomide, hydroxychloroquine, JAK inhibitors, and neurokinin-1 (NK-1) receptor antagonists (such as aprepitant)] within 4 weeks prior to screening; or use of other immunomodulatory biologics (rituximab, omalizumab, etc.) within 3 months or 5 half-lives of the drug (if known) (whichever is longer) prior to screening; b) Participation in other drug clinical trials within 3 months or at least 5 half-lives (whichever is longer) prior to screening, or participation in a medical device clinical trial within 3 months prior to screening; 5.Presence of other skin comorbidities (except PN and mild atopic dermatitis [AD]) at screening and baseline that might interfere with study assessments (e.g., scabies, insect bites, lichen simplex chronicus, psoriasis, acne, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis and bullous diseases, sporotrichosis. Note: Patients with mild active AD can account for a maximum of 10% of the PN study population); 6.Presence of other diseases at screening and baseline that might interfere with efficacy assessments or cause pruritus, such as uncontrolled diabetes or thyroid disease, cholestatic liver disease, end-stage renal disease, iron deficiency anemia, etc; 7.Severe medical history as determined by the investigator at screening, including but not limited to unstable cardiac conditions (such as II-III degree atrioventricular block, severe heart disease classified as New York Heart Association [NYHA] class III/IV, etc.), pulmonary, renal, or gastrointestinal diseases; 8.History of malignancy at screening (except for squamous cell carcinoma of the skin, basal cell carcinoma, or carcinoma in situ of the cervix that has been successfully treated with no evidence of recurrence for over 5 years); 9.Possible active tuberculosis infection at screening, or a history of active tuberculosis; 10.At screening, presence of Hepatitis B [Hepatitis B virus surface antigen (HBsAg) positive, or HBsAg negative but Hepatitis B virus core antibody (HBcAb) positive with a quantitative HBV DNA result higher than the upper limit of normal (ULN)]; or Hepatitis C [Hepatitis C virus (HCV) antibody positive with a quantitative HCV-RNA result higher than ULN]; or positive syphilis screening [a positive specific antibody test indicates a positive syphilis screen (except for those with a positive specific antibody test and a negative non-specific antibody test, confirmed by clinical judgment as a previously cured syphilis infection)]; or a history of human immunodeficiency virus (HIV) infection, or positive HIV antibodies, or suspected HIV infection; or active tuberculosis or latent tuberculosis [IGRA positive]. Note: Inclusion is not recommended if screening results are indeterminate; 11.Presence of any of the foll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a >= 4-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a >= 4-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS) score;Absolute and percentage changes from baseline in the Worst Itch Numeric Rating Scale (WI-NRS) score;The proportion of subjects with an overall assessment score of "0" or "1" in the Investigator's Global Assessment for Prurigo Nodularis Stage (IGA PN-S);Changes in the IGA PN-S staging score compared to the baseline;Proportion of subjects with an Investigator's Global Assessment for Prurigo Nodularis Activity (IGA PN-A) score of 0 or 1;Changes in the IGA PN-A staging score compared to the baseline;Change from baseline in Prurigo Activity Score (PAS);Change from baseline in Sleep Disturbance Numeric Rating Scale (SD-NRS) score;Change from baseline in Dermatology Life Quality Index (DLQI) score;Change from baseline in Prurigo Control Test (PCT) score;Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs);Change from baseline in Hospital Anxiety and Depression Scale (HADS) score; | — |
Countries
China
Contacts
Public ContactFang Wang
Dematology Hospital of Southern Medical University
Outcome results
None listed