Prurigo Nodularis
Conditions
Interventions
Prurigo nodularis (atopic ):Dupilumab
Prurigo nodularis (non-atopic ):Dupilumab
Non-prurigo atopic dermatitis:Dupilumab
Sponsors
Peking Uinversity First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for prurigo nodularis (PN): 1. PN diagnosed by a dermatologist, aged >= 18 years, with a disease duration of at least 3 months; 2. The worst itch numeric rating scale (WI-NRS) >= 7 in the 7 days prior to treatment; 3. A total of at least 20 PN lesions on the legs and/or arms, and/or trunk, before treatment, the investigator's global assessment-PN score >= 3; 4. Poor response or intolerance to at least one topical drug (such as TCS, TCI, PDE4 inhibitor) in the last 2 weeks; 5. Volunteer to participate in the study, sign informed consent, and agree to conduct the experiment according to the doctor's guidance throughout the study period. Inclusion criteria for Non-prurigo atopic dermatitis (AD): 1. AD was diagnosed according to the Williams diagnostic criteria for atopic dermatitis without PN-like lesions; 2. Patients aged >= 18 years old and diagnosed with AD >= 3 months; 3. The investigator global assessment-AD (IGA-AD) score >= 3; 4. Poor response or intolerance to at least one topical drug (such as TCS, TCI, PDE4 inhibitor) in the last 2 weeks; 5. Volunteer to participate in the study, sign informed consent, and agree to conduct the experiment according to the doctor's guidance throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Use of other study drugs at the time of screening; 2. Those suffering from serious diseases of the heart, liver, kidney and other visceral systems, active infections, tumors or mental disorders; 3. Pregnant or nursing women; 4. Subjects deemed unsuitable for the study by the researcher for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WI-NRS response rate (WI-NRS improvement >= 4 is defined as response); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of IGA 0/1;Change of DLQI from baseline;WI-NRS response rate (WI-NRS improvement >= 4 is defined as response); | — |
Countries
China
Contacts
Public ContactZhao Zuotao
Peking Uinversity First Hospital
Outcome results
None listed