Chronic Spontaneous UrticariaEarly Phase 1NCT03494881
Mepolizumab for the Treatment of Chronic Spontaneous Urticaria
A Early Phase 1 study testing Nucala in people with Chronic Spontaneous Urticaria, run by Mayo Clinic at 1 site in United States.
Trial summary
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Nucala
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 25 Feb 2025
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 years or older.
- Clinical and/or histopathological diagnosis of conventional CSU
- Unresponsive to oral antihistamine therapy
- Good general health as confirmed by medical history
- Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- Patients who read and sign an approved informed consent for this study
Who cannot join
- Vulnerable study population
- If you are female and pregnant
- Biopsy proven neutrophilic rich urticaria
- Known history of adverse reaction to mepolizumab (Nucala)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.
Read the detailed description
This is an open-label, single arm exploratory study of mepolizumab in the treatment of CSU. The primary endpoint will be the mean reduction in the seven day urticaria activity score (UAS7) before and after 10 weeks of treatment with mepolizumab. Secondary endpoints will be the mean reduction of the urticaria control test (UCT) score and the weekly itch severity score (ISS) before and after treatment. Enrollment examination will include a standardized history and examination, baseline UCT score, CBC with differential, serum IgE level, chronic urticaria index, IgE Fc receptor antibody functional assay, and a 4 mm punch biopsy of lesional skin to confirm the urticarial tissue reaction includes eosinophils and is not neutrophilic predominant. Patients will discontinue all anti-histamines and start cetirizine 10 mg PO BID which may be continued throughout the study duration. Patients will be provided with a log book to track daily urticaria signs and symptoms in a standardized manner for UAS scoring. At week 0 (enrollment visit +7 days), baseline UAS7 and ISS score will be assessed and skin biopsy results reviewed. Patients with a confirmatory skin biopsy will receive 200 mg SC of mepolizumab at week 0,2,4,6,and 8. UAS-7 and weekly ISS score will be calculated at week 0, 4, 8, and 10. UCT scoring will be calculated at week 0 and at week 10. Repeat CBC with differential, serum IgE level, and measures of basophil serum activation (chronic urticaria index, IgE FC Receptor antibody functional assay) will be assessed at week 10. Attached to this document is a protocol summary.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Nucala
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NucalaDrug
Also called Mepolizumab
All study participants will receive Nucala (2) 100mg SQ injections administered at two different anatomical sites at week zero, 2,4,6, and 8 for a total of 5 doses.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | This is an open-label pilot investigation and all study participants are assigned to active treatment. There is no placebo arm in this study. Receives: Drug: Nucala |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Urticaria Activity Score (UAS7)
Study participants documented their chronic spontaneous urticaria (CSU) symptoms using a diary, daily scoring for a) the number of wheals [none (=0 points), <10 (=1 point), 10-50 (=2 points), or >50 per day (=3 points)], and b) the intensity of pruritus [none (=0 points), mild (=1 point), moderate (=2 points), severe (=3 points)]. The daily UAS score is summed over a week to calculate the UAS7 score (range: 0-42). Participants were considered responders if they had ≥ 95% reduction in baseline UAS7 score and non-responders if they had <95% reduction in baseline UAS7 score.
Measured: Baseline to 10 Weeks
Secondary outcomes (3)
Change in Short Form Urticaria Control Test Score (S-UCT)
The short form urticaria control test (S-UCT) is a more recently developed and validated outcome instrument to retrospectively assess urticaria control. The S-UCT consists of 4 questions with each question having 5 answer options scored 0-4 with low points indicating high disease activity and low disease control. The minimum and maximum S-UCT scores are 0-16 with 16 points indicating complete disease control. Participants were considered responders if they had ≥ 95% reduction in baseline S-UCT score and non-responders if they had <95% reduction in baseline S-UCT score.
Measured: Baseline to 10 weeks
Change in Long Form Urticaria Control Test (L-UCT) Score
The long form urticaria control test (L-UCT) is a more recently developed and validated outcome instrument to retrospectively assess urticaria control. The L-UCT consists of 8 questions with each question having 5 answer options scored 0-4 with low points indicating high disease activity and low disease control. The minimum and maximum L-UCT scores are 0-32 with 32 points indicating complete disease control. Participants were considered responders if they had ≥ 95% reduction in baseline L-UCT score and non-responders if they had <95% reduction in baseline L-UCT score.
Measured: Baseline to 10 Weeks
Change in Itch Severity Score (ISS)
The weekly itch severity score measures the intensity and impact of itching (pruritus). It is calculated using the pruritus score of the daily Urticaria Activity Score (UAS) score summed over a week. Scores range from 0 to 21 with higher scores indicating worse itching. Participants were considered responders if they had ≥ 95% reduction in baseline ISS score and non-responders if they had <95% reduction in baseline ISS score.
Measured: Baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start30 Jul 2019
- Primary completion15 Nov 2023
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mepolizumab for the treatment of chronic spontaneous urticaria
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Jason Sluzevich MD, Mayo Clinic
- Investigators
- Jason C Sluzevich, M.D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494881
- Sponsor's protocol ID
- 17-009322
- Status last verified
- Aug 2025
- First submitted
- 4 Apr 2018
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study
- ClinicalTrials.gov ID
- NCT03494881
- Acronym / sponsor ID
- 17-009322
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.
Detailed description
This is an open-label, single arm exploratory study of mepolizumab in the treatment of CSU. The primary endpoint will be the mean reduction in the seven day urticaria activity score (UAS7) before and after 10 weeks of treatment with mepolizumab. Secondary endpoints will be the mean reduction of the urticaria control test (UCT) score and the weekly itch severity score (ISS) before and after treatment. Enrollment examination will include a standardized history and examination, baseline UCT score, CBC with differential, serum IgE level, chronic urticaria index, IgE Fc receptor antibody functional assay, and a 4 mm punch biopsy of lesional skin to confirm the urticarial tissue reaction includes eosinophils and is not neutrophilic predominant. Patients will discontinue all anti-histamines and start cetirizine 10 mg PO BID which may be continued throughout the study duration. Patients will be provided with a log book to track daily urticaria signs and symptoms in a standardized manner for UAS scoring. At week 0 (enrollment visit +7 days), baseline UAS7 and ISS score will be assessed and skin biopsy results reviewed. Patients with a confirmatory skin biopsy will receive 200 mg SC of mepolizumab at week 0,2,4,6,and 8. UAS-7 and weekly ISS score will be calculated at week 0, 4, 8, and 10. UCT scoring will be calculated at week 0 and at week 10. Repeat CBC with differential, serum IgE level, and measures of basophil serum activation (chronic urticaria index, IgE FC Receptor antibody functional assay) will be assessed at week 10. Attached to this document is a protocol summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mepolizumab for the treatment of chronic spontaneous urticaria
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: NucalaThis is an open-label pilot investigation and all study participants are assigned to active treatment. There is no placebo arm in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients 18 years or older.
- Clinical and/or histopathological diagnosis of conventional CSU
- Unresponsive to oral antihistamine therapy
- Good general health as confirmed by medical history
- Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
Key exclusion criteria (4 listed)
- Vulnerable study population
- If you are female and pregnant
- Biopsy proven neutrophilic rich urticaria
- Known history of adverse reaction to mepolizumab (Nucala)
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 |
|---|---|---|
| NucalaAlso: MepolizumabAll study participants will receive Nucala (2) 100mg SQ injections administered at two different anatomical sites at week zero, 2,4,6, and 8 for a total of 5 doses. | Drug | Treatment Arm |
Primary outcome
Reduction in Urticaria Activity Score (UAS7)
Time frame: Baseline to 10 Weeks
Study participants documented their chronic spontaneous urticaria (CSU) symptoms using a diary, daily scoring for a) the number of wheals [none (=0 points), <10 (=1 point), 10-50 (=2 points), or >50 per day (=3 points)], and b) the intensity of pruritus [none (=0 points), mild (=1 point), moderate (=2 points), severe (=3 points)]. The daily UAS score is summed over a week to calculate the UAS7 score (range: 0-42). Participants were considered responders if they had ≥ 95% reduction in baseline UAS7 score and non-responders if they had <95% reduction in baseline UAS7 score.
3 secondary outcomes
Change in Short Form Urticaria Control Test Score (S-UCT)
Time frame: Baseline to 10 weeks
Change in Long Form Urticaria Control Test (L-UCT) Score
Time frame: Baseline to 10 Weeks
Change in Itch Severity Score (ISS)
Time frame: Baseline to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jason C Sluzevich, M.D. principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nucala in people with Chronic Spontaneous Urticaria, run by Mayo Clinic 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 6 inclusion and 4 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 27 Aug 2025. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in Urticaria Activity Score (UAS7) (time frame: Baseline to 10 Weeks). 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 27 Aug 2025.