NCT05298215

A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria

A Phase II, Double-blind, Randomized, Parallel Group, Placebo-controlled Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: United BioPharma · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, double-blind, randomized, parallel group, placebo-controlled study to evaluate the pharmacodynamics, pharmacokinetics, efficacy, and safety of 2-dose UB-221 IV infusion as an add-on therapy in patients with chronic spontaneous urticaria. The study will be conducted at multiple study centers in Taiwan. Approximate 25 eligible subjects will be randomized into two UB-221 (5 \&10 mg/kg) and one placebo (saline) cohorts in a ratio of 2:2:1. The study consists of a pre-screening period (Day -42 to -29), a screening period (Day -28 to -1), a dose 1 period (Day 0 to 83), and a dose 2 period (Day 84 to 196).

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	UB-221	UB-221 is a recombinant humanized IgG1 monoclonal antibody with neutralizing capability against soluble human IgE and CD23-bound IgE for the treatment of allergic diseases. The activity of UB-221 is directly through the high-affinity binding with soluble and membrane bound IgE. The neutralization of soluble IgE will desensitize the activation of mast cells and basophils by inhibiting IgE cross-linking and down-regulation of FcεRI (high affinity IgE receptor) expression on those cells. The binding to CD23-bound IgE may inhibit IgE synthesis by stabilization of membrane-bound CD23 on B lymphocytes.
OTHER	sterile saline solution	sterile saline solution (0.9% NaCl) for intravenous (IV) infusion

Timeline

• Start date: 2022-10-05
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-03-28
• Last updated: 2022-10-07

Locations

1 site across 1 country: Taiwan