Urticaria ChronicPhase 1NCT03632291
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
A Phase 1 study testing UB-221 in people with Urticaria Chronic, run by United BioPharma at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Urticaria Chronic
- What is being tested?
- UB-221
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesTaiwan
- Study dates
- 9 Apr 2019to 19 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
National Taiwan University Hospital
Taipei, 100
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study 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
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.
Read the detailed description
This is a phase I, open-label, dose-escalation study 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.
- Conditions
- Urticaria Chronic
- Being tested
- UB-221
- Keywords
- UB-221, anti-IgE monoclonal antibody, chronic spontaneous urticaria (CSU)
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-221Biological
UB-221 (75 mg/ml)
| Study group | Role | What they receive |
|---|---|---|
| UB-221 (0.2 mg/kg) | Experimental | Intravenous infusion Receives: Biological: UB-221 |
| UB-221 (0.6 mg/kg) | Experimental | Intravenous infusion Receives: Biological: UB-221 |
| UB-221 (2 mg/kg) | Experimental | Intravenous infusion Receives: Biological: UB-221 |
| UB-221 (6 mg/kg) | Experimental | Intravenous infusion Receives: Biological: UB-221 |
| UB-221 (10 mg/kg) | Experimental | Intravenous infusion Receives: Biological: UB-221 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event incidence
from the baseline to day 15 after IP infusion
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start9 Apr 2019
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urticaria ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- United BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632291
- Sponsor's protocol ID
- UBP-A107-IgE
- Status last verified
- May 2022
- First submitted
- 13 Aug 2018
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study 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
- ClinicalTrials.gov ID
- NCT03632291
- Acronym / sponsor ID
- UBP-A107-IgE
- Conditions
- Urticaria Chronic
- Keywords
- UB-221, anti-IgE monoclonal antibody, chronic spontaneous urticaria (CSU)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase I, open-label, dose-escalation study 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| UB-221 (0.2 mg/kg) | Experimental | Biological: UB-221Intravenous infusion |
| UB-221 (0.6 mg/kg) | Experimental | Biological: UB-221Intravenous infusion |
| UB-221 (2 mg/kg) | Experimental | Biological: UB-221Intravenous infusion |
| UB-221 (6 mg/kg) | Experimental | Biological: UB-221Intravenous infusion |
| UB-221 (10 mg/kg) | Experimental | Biological: UB-221Intravenous infusion |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-221UB-221 (75 mg/ml) | Biological | 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) |
Primary outcome
Adverse event incidence
Time frame: 15 days
from the baseline to day 15 after IP infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-221 in people with Urticaria Chronic, run by United BioPharma at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event incidence (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.