NCT03632291

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2021

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

August 13, 2018

Last Update Submit

May 12, 2022

Conditions

Urticaria Chronic

Keywords

UB-221anti-IgE monoclonal antibodychronic spontaneous urticaria (CSU)

Outcome Measures

Primary Outcomes (1)

  • Adverse event incidence

    from the baseline to day 15 after IP infusion

    15 days

Study Arms (5)

UB-221 (0.2 mg/kg)

EXPERIMENTAL

Intravenous infusion

Biological: UB-221

UB-221 (0.6 mg/kg)

EXPERIMENTAL

Intravenous infusion

Biological: UB-221

UB-221 (2 mg/kg)

EXPERIMENTAL

Intravenous infusion

Biological: UB-221

UB-221 (6 mg/kg)

EXPERIMENTAL

Intravenous infusion

Biological: UB-221

UB-221 (10 mg/kg)

EXPERIMENTAL

Intravenous infusion

Biological: UB-221

Interventions

UB-221BIOLOGICAL

UB-221 (75 mg/ml)

UB-221 (0.2 mg/kg)UB-221 (0.6 mg/kg)UB-221 (10 mg/kg)UB-221 (2 mg/kg)UB-221 (6 mg/kg)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with age between 20 to 65 years old (inclusive).
  • Subjects who are able and willing to provide the informed consent.
  • Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above.
  • Subjects diagnosed with chronic spontaneous urticaria (CSU).

You may not qualify if:

  • History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject is not suitable to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

April 9, 2019

Primary Completion

January 19, 2021

Study Completion

January 19, 2021

Last Updated

May 13, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)