The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for Chronic Spontaneous Urticaria.
Participants must be between 18 and 70 years of age, inclusive, at the time of signing the Informed Consent Form (ICF), with no restriction on gender.
Participants must have a history of chronic spontaneous urticaria (CSU) with a disease duration of at least 6 months prior to screening.
Participants must be diagnosed with H1-antihistamine-inadequately-controlled CSU at screening, defined as: having had persistent symptoms of pruritus and wheals for ≥6 weeks prior to screening, despite regular use of second-generation H1-antihistamines during that period.
At randomization, the UAS7 score must be ≥16 (range: 0-42) and the HSS7 score ≥ 8 (range: 0-21).
Any skin disease that could interfere with study assessment (e.g., chronic inducible urticaria, urticarial vasculitis, atopic dermatitis, psoriasis).
Use of systemic or topical medications with therapeutic or immunomodulatory effects on the study disease during the relevant washout period prior to screening.
Use of investigational drugs or medical devices within 8 weeks or 5 half-lives (if known), whichever is longer, or within 30 days (for small molecules) prior to screening.
Vaccination or exposure to live or attenuated vaccines within 3 months prior to screening or participation in a vaccine-related clinical trial within 3 months prior to randomization.
Parallel
HRS-3095 Tablet
DrugHRS-3095 tablet.
HRS-3095 Tablet Placebo
DrugHRS-3095 tablet placebo.
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 4.
The concentration of HRS-3095 in serum (Cmax)
The time of metabolism of the drug in the serum
The concentration of HRS-3095 in plasma will be determined.
The concentration of HRS-3095 in serum (AUC)
The concentration of HRS-3095 in plasma will be determined.
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2
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This trial is not recruiting at the moment. You can still explore other options:
