Chronic Spontaneous UrticariaPhase 2NCT05298215
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 2 study testing UB-221 and sterile saline solution in people with Chronic Spontaneous Urticaria, run by United BioPharma at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- UB-221 and sterile saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Oct 2022to 31 Dec 2023
- Phase
- Phase 2
- 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 75 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 with body weight of 45 kilogram (kg) or above.
- Subjects with moderate-to-severe chronic spontaneous urticaria (CSU) (with or without urticaria dermographism when testing for dermographism) refractory to H1-antihistamine (H1-AH) at approved dose or increased dose alone or in combination with H2-antihistamine (H2-AH) and/or leukotriene receptor antagonist (LTRA) at the time of randomization (Day 0), as defined by All of the following:
- CSU diagnosis for ≥ 6 months.
- The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to enrollment despite current use of non-sedating H1-AH (up to 4-fold of the approved dosage) or in combination with H2-AH, and/or LTRA treatment during this time period.
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- UAS7 score ≥ 16 and HSS7 ≥ 8 during 7 days prior to randomization (Day 0).
- In-clinic UAS ≥ 4 on at least one of the screening visit days or Day 0.
- Patients must have been on H1-AH at approved or increased doses (up to 4-fold) alone or in combination with H2-AH and/or LTRA for treatment of CSU for at least 3 consecutive days immediately prior to the screening visit and must have documented current use on the initial screening visit day.
- Both male and female subjects of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study with their partners (excluding women who are not of childbearing potential and men who have been sterilized).
- Female subjects who had bilateral insertion of Essure® implants (or analogous) for at least 6 months prior to the screening visit; bilateral tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal status with amenorrhea (no menstruation) for at least 2 years prior to the screening visit, are considered as non-childbearing potential by the investigator's judgment.
- Females must have a negative serum pregnancy test at the screening visit and negative urine pregnancy test prior to each study drug administration.
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.
- History of anaphylaxis to food, medications, or other causes.
- History of severe eosinophilia (eosinophil counts > 5000 /uL).
- History of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, stevens-Johnson syndrome (SJS), or toxic epidermal necrolysis (TEN).
- History of serious cardiovascular or cerebrovascular diseases by the investigator's judgment within 1 year prior to the screening visit.
- Subject who is taking beta-blocker at time of screening or is suggested to take beta-blocker during the study period.
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- Any other skin disease associated with chronic itching that might confound the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
- Having clearly defined underlying etiology for chronic urticaria other than CSU. This includes the following:
- Patients have inducible urticaria forms impacting their daily symptoms in a relevant way, such as but not limited to urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria.
- Diseases with possible symptoms of urticaria or angioedema such as urticaria vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
- Use of any of the following medications: a) systemic corticosteroids (such as prednisolone), b) immunomodulators (including but not limited to azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, tacrolimus, cyclosporine). Subjects can be enrolled when they discontinued these medications for at least 4 weeks prior to the screening visit.
- Use of doxepin (oral) within 14 days prior to the screening visit.
- Treatment with any investigational agent (except investigational anti-IgE mAb) within 60 days or 5 half-lives (whichever is longer) prior to the screening visit.
- Prior experience with other investigational anti-IgE Ab drug such as QGE031 (ligelizumab) or FB825.
- Previous exposure to Xolair® (omalizumab) or UB-221 within 26 weeks prior to the screening visit.
- History of allergic or anaphylactic reaction to any component of the investigational product formulation (e.g., histidine and trehalose) or other drug that in the opinion of the investigator or medical monitor, contraindicates the subject's participation.
- Subject has a history of drug abuse or heavy drinking. Heavy drinking is defined as drinking 5 glasses of alcoholic drinks or more (e.g., ≥ 60 ounces/1700 mL of regular beer; 25 ounces/700 mL of wine; 7.5 ounces/213 mL of distilled spirits) in the same occasion for 5 or more days within 30 days prior to the screening visit.
- Subjects with confirmed abnormal liver function test values (aspartate transaminase [AST] and alanine transaminase [ALT]) during the screening period that are ≥ 1.5 times the upper limit of normal (ULN).
- Electrocardiogram (ECG) abnormalities of clinical significance as judged by the investigators.
- IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to the screening visit.
- Contraindications to or hypersensitivity to antihistamines (such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or epinephrine, or any of the ingredients.
- Patients with a stool examination positive for ova or parasites at screening visit; re-screening may be considered if a repeat stool examination is negative following parasite treatment.
- Known history of prior infusion-related reaction to mAb administration.
- Women who are pregnant, breastfeeding, or lactating.
- Subject had blood donation over 250 mL within 90 days prior to the screening visit; subjects who plan to donate blood or plan to continue blood donation during the study period.
- Subjects who receive live attenuated vaccination or COVID-19 vaccine (either 1st or 2nd dose) within 30 days prior to the screening visit.
- Subjects who receive inactive vaccination within 48 hours prior to the first study drug administration.
- A positive HIV or Hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody test result at screening visit.
- History or presence of renal disease and/or serum creatinine value > 1.5 times the upper limit of normal (ULN) at screening visit.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yu Tung Chiang, +886 2 2312 3456, ting82082002@hotmail.com
About this study
Official title: 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
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
- Being tested
- UB-221, sterile saline solution
- 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
Also called recombinant humanized IgG1 monoclonal antibody
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.
sterile saline solutionOther
sterile saline solution (0.9% NaCl) for intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| 5 mg/kg UB-221 | Experimental | Total of 2 doses on Day 0 (week 1) and 84 (Week 12), respectively, by intravenous (IV) infusion. Receives: Biological: UB-221 |
| 10 mg/kg UB-221 | Experimental | Total of 2 doses on Day 0 (week 1) and 84 (Week 12), respectively, by intravenous (IV) infusion. Receives: Biological: UB-221 |
| Placebo | Placebo comparator | sterile saline solution (0.9% NaCl) for intravenous (IV) infusion Receives: Other: sterile saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum free IgE level from baseline over time
To evaluate the extent of reduction and duration of suppression of serum free IgE level upon q12w (once-every-12-weeks) treatment with UB-221
Measured: Day 0 to 83
Secondary outcomes (1)
Time to complete response (UAS7=0) after the 1st dose of UB-221 administration.
To evaluate efficacy with respect to time to complete response and time to first relapse after the 1st dose of UB-221 administration.
Measured: Day 84 to 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start5 Oct 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia Yu Chu, MD, Principal investigator, Dermatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298215
- Sponsor's protocol ID
- UBP-A236-IgE
- Status last verified
- Oct 2022
- First submitted
- 17 Mar 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05298215
- Acronym / sponsor ID
- UBP-A236-IgE
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Mar 2022 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 mg/kg UB-221 | Experimental | Biological: UB-221Total of 2 doses on Day 0 (week 1) and 84 (Week 12), respectively, by intravenous (IV) infusion. |
| 10 mg/kg UB-221 | Experimental | Biological: UB-221Total of 2 doses on Day 0 (week 1) and 84 (Week 12), respectively, by intravenous (IV) infusion. |
| Placebo | Placebo comparator | Other: sterile saline solutionsterile saline solution (0.9% NaCl) for intravenous (IV) infusion |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects with age between 20 to 75 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 with body weight of 45 kilogram (kg) or above.
- Subjects with moderate-to-severe chronic spontaneous urticaria (CSU) (with or without urticaria dermographism when testing for dermographism) refractory to H1-antihistamine (H1-AH) at approved dose or increased dose alone or in combination with H2-antihistamine (H2-AH) and/or leukotriene receptor antagonist (LTRA) at the time of randomization (Day 0), as defined by All of the following:
- Both male and female subjects of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study with their partners (excluding women who are not of childbearing potential and men who have been sterilized).
Key exclusion criteria (29 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.
- History of anaphylaxis to food, medications, or other causes.
- History of severe eosinophilia (eosinophil counts > 5000 /uL).
- History of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, stevens-Johnson syndrome (SJS), or toxic epidermal necrolysis (TEN).
- History of serious cardiovascular or cerebrovascular diseases by the investigator's judgment within 1 year prior to the screening visit.
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-221Also: recombinant humanized IgG1 monoclonal antibodyUB-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. | Biological | 10 mg/kg UB-221, 5 mg/kg UB-221 |
| sterile saline solutionsterile saline solution (0.9% NaCl) for intravenous (IV) infusion | Other | Placebo |
Primary outcome
Change in serum free IgE level from baseline over time
Time frame: Day 0 to 83
To evaluate the extent of reduction and duration of suppression of serum free IgE level upon q12w (once-every-12-weeks) treatment with UB-221
1 secondary outcome
Time to complete response (UAS7=0) after the 1st dose of UB-221 administration.
Time frame: Day 84 to 196
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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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.
Chia Yu Chu, MD principal investigator
Dermatologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UB-221 and sterile saline solution in people with Chronic Spontaneous Urticaria, run by United BioPharma at 1 site 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 12 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Shih (+886-3-6684800 ext. 3641, linda.shih@unitedbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum free IgE level from baseline over time (time frame: Day 0 to 83). 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 7 Oct 2022.