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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

NCT05298215 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-10-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • United BioPharma

    lead INDUSTRY

Principal Investigators

  • Chia Yu Chu, MD · Dermatologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05298215 on ClinicalTrials.gov