Chronic Idiopathic UrticariaPhase 4NCT03183024
Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody
A Phase 4 study testing benralizumab in people with Chronic Idiopathic Urticaria, run by Jonathan A. Bernstein, MD at 1 site in United States.
Trial summary
Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- benralizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 6 Nov 2018
- Phase
- Phase 4
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines
Who cannot join
- hives due to known reasons history of cancer pregnant or nursing History of HIV or Hepatitis recent parasitic infection currently or have received treatment with a monoclonal antibody
Trial locations and contacts
1 site in 1 country.
United States1 site
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
About this study
Official title: Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monocloncal Antibody
Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment
Read the detailed description
Subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. Subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. The study also involved blood draws and a punch biopsy of a hive
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- benralizumab, placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benralizumabBiological
open-label treatment
placeboBiological
sterile water to mimic benralizumab
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo for benralizumab sc given during run-in phase Receives: Biological: placebo |
| benralizumab | Experimental | benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase Receives: Biological: benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in urticarial activity score averaged over 7 days- no units
subject completed form
Measured: through study completion, up to 7 months
Secondary outcomes (7)
change in blood anti-FCER1 level (kU/l)
specific lab test
Measured: through study completion, up to 7 months
change in blood anti-TPO level (IU/L)
specific blood test
Measured: through study completion, up to 7 months
change in Blood ECP level (ug/L)
specific blood test
Measured: through study completion, up to 7 months
change in blood eotaxin level (pg/ml)
specific blood test
Measured: through study completion, up to 7 months
change in RNA testing
gene expression profile using RNA-sequencing in skin biopsy samples (lesional vs non-lesional skin) (log 2 fold-change)
Measured: through study completion, up to 7 months
change in skin biopsy inflammatory cell counts
inflammatory cell count in skin biopsy (number of cells/sq mm)
Measured: through study completion, up to 7 months
change in cytokine quantification in skin biopsy (units/mL)
skin biopsy
Measured: through study completion, up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start12 Sep 2017
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan A. Bernstein, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan A. Bernstein, MD, Bernstein Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183024
- Sponsor's protocol ID
- SAIRB-17-0036
- Status last verified
- Jul 2019
- First submitted
- 25 May 2017
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monocloncal Antibody
- ClinicalTrials.gov ID
- NCT03183024
- Acronym / sponsor ID
- SAIRB-17-0036
- Conditions
- Chronic Idiopathic Urticaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jonathan A. Bernstein, MDUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 9 Jun 2017 (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.
Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment
Detailed description
Subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. Subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. The study also involved blood draws and a punch biopsy of a hive
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Biological: placeboplacebo for benralizumab sc given during run-in phase |
| benralizumab | Experimental | Biological: benralizumabbenralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines
Key exclusion criteria (1 listed)
- hives due to known reasons history of cancer pregnant or nursing History of HIV or Hepatitis recent parasitic infection currently or have received treatment with a monoclonal antibody
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 |
|---|---|---|
| benralizumabopen-label treatment | Biological | benralizumab |
| placebosterile water to mimic benralizumab | Biological | placebo |
Primary outcome
change in urticarial activity score averaged over 7 days- no units
Time frame: through study completion, up to 7 months
subject completed form
7 secondary outcomes
change in blood anti-FCER1 level (kU/l)
Time frame: through study completion, up to 7 months
change in blood anti-TPO level (IU/L)
Time frame: through study completion, up to 7 months
change in Blood ECP level (ug/L)
Time frame: through study completion, up to 7 months
change in blood eotaxin level (pg/ml)
Time frame: through study completion, up to 7 months
change in RNA testing
Time frame: through study completion, up to 7 months
change in skin biopsy inflammatory cell counts
Time frame: through study completion, up to 7 months
change in cytokine quantification in skin biopsy (units/mL)
Time frame: through study completion, up to 7 months
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 10 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing benralizumab in people with Chronic Idiopathic Urticaria, run by Jonathan A. Bernstein, MD at 1 site in United States.
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 1 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 10 Jul 2019. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
change in urticarial activity score averaged over 7 days- no units (time frame: through study completion, up to 7 months). 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 10 Jul 2019.