This trial is planned to investigate the efficacy and safety of Stapokibart (an IL-4 receptor antagonist) in patients with PCA.
Males or females aged 18 to 75 years, with a diagnosis of PCA confirmed by skin biopsy, and an IGA score of ≥3, a AASI score of ≥5, and a BSA involvement of ≥5%.
Subjects who have received at least 4 weeks of mid-to-high potency or at least 2 weeks of very high potency topical corticosteroids (TCS) or an adequate course of systemic corticosteroids within the 6 months prior to screening, but with an inadequate response; or subjects who are unable to receive the above treatments due to adverse reactions or potential risks.
Prior to the first dose, subjects must have used a moisturizer continuously for at least 1 week, once daily, and must continue to use it throughout the study period.
Able to understand and complete study-related questionnaires.
Use of any of the following treatments within 4 weeks prior to randomization: a. Immunosuppressants or immunomodulators, such as systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma (IFN-γ), azathioprine, methotrexate, and Janus kinase (JAK) inhibitors; b. UV phototherapy; c. Systemic traditional Chinese medicine (TCM) treatment.
Use of topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), TCM, or phosphodiesterase 4 (PDE-4) inhibitors within 2 weeks prior to randomization.
Receipt of anti-IL-4R monoclonal antibodies, anti-IgE monoclonal antibodies, or other biologics within 12 weeks or 5 half-lives (whichever is longer) prior to randomization.
Receipt of live attenuated vaccines within 12 weeks prior to randomization or planned vaccination during the study period.
Parallel
Stapokibart
Biological/VaccineA humanized monoclonal antibody that targets the interleukin (IL)-4 receptor subunit alpha
Placebo drug
Other interventionPlacebo drugs without Stapokibart
The percentage of subjects achieving AASI-75 at Week 16 of treatment
AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations. AASI-75: A 75% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome.
The percentage of subjects with a weekly average reduction of≥4 points in PP-NRS score at Week 16 of treatment compared to baseline
PP-NRS: Peak Pruritus Numerical Rating Scale. The minimum and maximum values: 0-10. Higher scores mean more serious situations.
The percentage of subjects with an IGA score of 0 or 1 and a reduction of≥2 points compared to baseline.
IGA: Investigator Global Assessment. The minimum and maximum values: 0-4. Higher scores mean more serious situations.
The percentage of subjects achieving AASI-50 compared to baseline.
AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations. AASI-50: A 50% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome.
The percentage of subjects with a weekly average reduction of≥3 points in PP-NRS score compared to baseline
PP-NRS: Peak Pruritus Numerical Rating Scale. The minimum and maximum values: 0-10. Higher scores mean more serious situations.
Safety Endpoints:Including the occurrence of AEs(Adverse Events),and abnormalities in laboratory tests,physical examinations,and vital signs.
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This trial is not recruiting at the moment. You can still explore other options:
