Chronic Spontaneous UrticariaPhase 2/3NCT04893980
Efficacy of Low-dose Interleukin-2 Treatment in Chronic Spontaneous Urticaria
A Phase 2/3 study testing Recombinant human interleukin-2 (rhIL-2) in people with Chronic Spontaneous Urticaria, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study is a randomized, controlled, single-center clinical study to evaluate the short-term efficacy of low-dose Interleukin-2 injection as an add-on therapy for the treatment of patients aged 18-75 who have been diagnosed with CSU and remain symptomatic despite oral antihistamine treatment . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Recombinant human interleukin-2 (rhIL-2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2021to 1 Dec 2022
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: between 18- and 75-years old;
- Patients definitely diagnosed with chronic spontaneous urticaria according to 'Guideline for diagnosis and treatment of urticaria in China (2018) '; or chronic spontaneous urticaria has been diagnosed in the past.
- Patients taking antihistamines daily ( one kind or two to three kinds in combination, with a standard- or doubled-dose of each kind of antihistamines) for at least one week and remain symptomatic with a UAS7 score of not less than 16;
- Written informed consent was obtained, and the patient volunteers to participate in the project and complete the project as required.
Who cannot join
- Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;
- Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);
- Patients have a clear history of allergy to rhIL-2;
- Patients receiving Interleukin-2 treatment in the last 3 months by subcutaneous or intramuscular injection；
- Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;
- Pregnant women, lactating women or women who are willing to conceive within 3 months;
- Patients receiving glucocorticoid treatment in the last 4 weeks; Patients receiving cyclosporin treatment in the last 90 days；Patients receiving tripterygium wilfordii polyglycoside treatment in the last 6 months；Patients receiving Omalizumab treatment in the last 1 year；Other drugs used previously should be identified whether they are in the washout period one by one, and patients who have taken drugs that may have an impact on the study should be excluded during the washout period or screened again for enrollment after the washout period；
- Patients who have participated in other clinical trials within 3 months before the screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
zhuo Li, +86-731-84896038, xiangyagcp@126.com
Hai Long, 18229743206, dr.hailong@csu.edu.cn
About this study
Official title: Short-term Efficacy of Low-dose Interleukin-2 Treatment in Chrornic Spontaneous Urticaria: a Randomized, Controlled, Single-center Clinical Trial
This study is a randomized, controlled, single-center clinical study to evaluate the short-term efficacy of low-dose Interleukin-2 injection as an add-on therapy for the treatment of patients aged 18-75 who have been diagnosed with CSU and remain symptomatic despite oral antihistamine treatment .
Read the detailed description
Backgrounds:
Urticaria is a common disorder that present with localized edema reaction caused by dilatation and increased permeability of small blood vessels in skin and mucosa. The main clinical manifestations are wheal and erythema reaction.
Chronic spontaneous urticaria (CSU) is defined as the recurrent, transient (<24h), pruritic wheals of the skin and mucosa lasting for more than 6 weeks ,with or without angioedema, excluding chronic inducible urticaria and urticarial vasculitis. Among all patients with chronic urticaria, CSU patients accounts for about 80%. Although the pathogenesis of CSU is still unclear, increasing evidence has shown an autoimmune feature of this chronic disease. Oral antihistamines are the mainstay of treatment for patients with CSU. However, a proportion of patients with CSU remain symptomatic despite treatment with standard- or doubled-dose of antihistamines. In recent years, studies have shown that low-dose recombinant human IL-2 (rhIL-2) treatment has good therapeutic effect in a variety of autoimmune diseases, such as systemic lupus erythematosus, type 1 diabetes, without serious side reactions. Therefore, we propose low-dose rhIL-2 as an add-on treatment for patient with CSU that are recalcitrant to treatment with antihistamines. Here we designed this clinical trial to explore its therapeutic effect as well as therapeutic mechanisms.
Design of Study:
This is a randomized, controlled, single-center clinical trial to assess the short-term efficacy of rhIL-2 treatment for patients with CSU.
Methods:
RhIL-2 injection combined with the current dose of antihistamine (Use one kind or two to three kinds in combination, and use one or two doses of each kind of antihistamine，keeping doses before enrollment) will be applied to CSU patients meeting the inclusion criteria. The end points include clinical response and immunological changes, as well as safety.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Recombinant human interleukin-2 (rhIL-2), Control group
- Keywords
- chronic urticaria, interleukin-2
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human interleukin-2 (rhIL-2)Drug
Also called Recombinant Human Interleukin-2 (I)
During Day 0-14, patients in this group will receive treatment with antihistamines at the same dosage as pre-recruitment, together with a low-dose recombinant human Interleukin-2 (rhIL-2) at a dosage of 1 million international units every other day by intramuscular injection (rhIL-2, 1 MIU, im, Qod). During Day 15-28, the injections of rhIL-2 will be continued at the same dosage and the dose of antihistamines may be adjusted according to the control of symptoms.
Control groupDrug
Also called No injections during Day 0-14
During Day 0-14, patients in the control group receive treatment with only antihistamines at the same dosage as pre-recruitment, but no injection of rhIL-2. During Day 15-28, treatment with low dose recombinant human Interleukin-2 (rhIL-2), i.e., 1 million international units every other day by subcutaneous or intramuscular injection (rhIL-2, 1MIU, im, Qod), will be added.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose interleukin-2 treatment group | Experimental | Use Interleukin-2 to treat CSU during day1-day28. Receives: Drug: Recombinant human interleukin-2 (rhIL-2) |
| Control group | Other | Use Interleukin-2 to treat CSU during day15-day28. Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Urticaria Activity Score of 7 Days（UAS7）from baseline (Day 0) to Day 14.
UAS7 score on Day 14 - UAS7 score on Day 0
Measured: from baseline to Day 14
Secondary outcomes (9)
The change of UAS7 from baseline (Day 0) to Day 28 and Day 56, respectively.
UAS7 score on Day 28 (or Day 56) - UAS7 score on Day 0
Measured: from baseline to Day 28 and Day 56, respectively
The change of chronic urticaria quality of life questionnaire (CU-Q2oL) score after a 14-, 28- and 56-day treatment, respectively.
CU-Q2oL score on Day 0 - CU-Q2oL score on Day N
Measured: from baseline to 14, 28 and 56 days, respectively
The change of urticaria control test (UCT) after a 14-, 28- and 56-day treatment, respectively.
UCT score on Day 0 - UCT score on Day N
Measured: from baseline to 14, 28 and 56 days, respectively
For patients with angioedema, the change of Angioedema Activity Score of 7days（AAS7）after a 14-, 28- and 56-day treatment, respectively.
AAS7 on Day 0 - AAS7 on Day N
Measured: from baseline to 14, 28 and 56 days, respectively
For patients with angioedema, the change of Angioedema quality of life questionnaire(AE-QoL) after a 28- and 56-day treatment, respectively.
AE-QoL on Day 0 - AE-QoL on Day N
Measured: from baseline to 28 and 56 days, respectively
The change of sera autoantibodies titer after a 14- and 28-day treatment, respectively.
The autoantibodies including IgG-anti-FcεRⅠand IgG-anti-IgE antibodies titer are detected by Elisa.
Measured: from baseline to 14 and 28 days, respectively
The change of accumulative dose of antihistamines in the past 7 days on Day 28 and Day 56, respectively, compared to baseline.
The accumulative dose of antihistamines in the past 7 days will be calculated on Day 28 and Day 56, respectively, and compared to that of baseline.
Measured: from baseline to 28 and 56 days, respectively
Percentage of patients with UAS7 less than 6 on Day 14 and Day 28, respectively.
The percentage of patients with UAS7 less than 6 were calculated on Day 14 and Day 28, respectively.
Measured: from baseline to 28 and 56 days, respectively
The drug adverse reactions throughout the entire study process.
The adverse reactions of rhIL-2 including fever, myalgia, nausea, emesis, rash.
Measured: through study completion, an average of 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start16 Jun 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (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.
- More trials run by Second Xiangya Hospital of Central South UniversityThe 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qianjin Lu, MD, PhD, Second Xiangya Hospital of Central South University
- Investigators
- Qianjin Lu, MD, PhD, Principal investigator, The Second Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893980
- Sponsor's protocol ID
- CSU202009
- Status last verified
- May 2021
- First submitted
- 31 Jan 2021
- Last updated
- 20 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy of Low-dose Interleukin-2 Treatment in Chrornic Spontaneous Urticaria: a Randomized, Controlled, Single-center Clinical Trial
- ClinicalTrials.gov ID
- NCT04893980
- Acronym / sponsor ID
- CSU202009
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- chronic urticaria, interleukin-2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 May 2021 (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 study is a randomized, controlled, single-center clinical study to evaluate the short-term efficacy of low-dose Interleukin-2 injection as an add-on therapy for the treatment of patients aged 18-75 who have been diagnosed with CSU and remain symptomatic despite oral antihistamine treatment .
Detailed description
Backgrounds:
Urticaria is a common disorder that present with localized edema reaction caused by dilatation and increased permeability of small blood vessels in skin and mucosa. The main clinical manifestations are wheal and erythema reaction.
Chronic spontaneous urticaria (CSU) is defined as the recurrent, transient (<24h), pruritic wheals of the skin and mucosa lasting for more than 6 weeks ,with or without angioedema, excluding chronic inducible urticaria and urticarial vasculitis. Among all patients with chronic urticaria, CSU patients accounts for about 80%. Although the pathogenesis of CSU is still unclear, increasing evidence has shown an autoimmune feature of this chronic disease. Oral antihistamines are the mainstay of treatment for patients with CSU. However, a proportion of patients with CSU remain symptomatic despite treatment with standard- or doubled-dose of antihistamines. In recent years, studies have shown that low-dose recombinant human IL-2 (rhIL-2) treatment has good therapeutic effect in a variety of autoimmune diseases, such as systemic lupus erythematosus, type 1 diabetes, without serious side reactions. Therefore, we propose low-dose rhIL-2 as an add-on treatment for patient with CSU that are recalcitrant to treatment with antihistamines. Here we designed this clinical trial to explore its therapeutic effect as well as therapeutic mechanisms.
Design of Study:
This is a randomized, controlled, single-center clinical trial to assess the short-term efficacy of rhIL-2 treatment for patients with CSU.
Methods:
RhIL-2 injection combined with the current dose of antihistamine (Use one kind or two to three kinds in combination, and use one or two doses of each kind of antihistamine，keeping doses before enrollment) will be applied to CSU patients meeting the inclusion criteria. The end points include clinical response and immunological changes, as well as safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose interleukin-2 treatment group | Experimental | Drug: Recombinant human interleukin-2 (rhIL-2)Use Interleukin-2 to treat CSU during day1-day28. |
| Control group | Other | Drug: Control groupUse Interleukin-2 to treat CSU during day15-day28. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: between 18- and 75-years old;
- Patients definitely diagnosed with chronic spontaneous urticaria according to 'Guideline for diagnosis and treatment of urticaria in China (2018) '; or chronic spontaneous urticaria has been diagnosed in the past.
- Patients taking antihistamines daily ( one kind or two to three kinds in combination, with a standard- or doubled-dose of each kind of antihistamines) for at least one week and remain symptomatic with a UAS7 score of not less than 16;
- Written informed consent was obtained, and the patient volunteers to participate in the project and complete the project as required.
Key exclusion criteria (8 listed)
- Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;
- Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);
- Patients have a clear history of allergy to rhIL-2;
- Patients receiving Interleukin-2 treatment in the last 3 months by subcutaneous or intramuscular injection；
- Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;
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 |
|---|---|---|
| Recombinant human interleukin-2 (rhIL-2)Also: Recombinant Human Interleukin-2 (I)During Day 0-14, patients in this group will receive treatment with antihistamines at the same dosage as pre-recruitment, together with a low-dose recombinant human Interleukin-2 (rhIL-2) at a dosage of 1 million international units every other day by intramuscular injection (rhIL-2, 1 MIU, im, Qod). During Day 15-28, the injections of rhIL-2 will be continued at the same dosage and the dose of antihistamines may be adjusted according to the control of symptoms. | Drug | Low-dose interleukin-2 treatment group |
| Control groupAlso: No injections during Day 0-14During Day 0-14, patients in the control group receive treatment with only antihistamines at the same dosage as pre-recruitment, but no injection of rhIL-2. During Day 15-28, treatment with low dose recombinant human Interleukin-2 (rhIL-2), i.e., 1 million international units every other day by subcutaneous or intramuscular injection (rhIL-2, 1MIU, im, Qod), will be added. | Drug | Control group |
Primary outcome
The change of Urticaria Activity Score of 7 Days（UAS7）from baseline (Day 0) to Day 14.
Time frame: from baseline to Day 14
UAS7 score on Day 14 - UAS7 score on Day 0
9 secondary outcomes
The change of UAS7 from baseline (Day 0) to Day 28 and Day 56, respectively.
Time frame: from baseline to Day 28 and Day 56, respectively
The change of chronic urticaria quality of life questionnaire (CU-Q2oL) score after a 14-, 28- and 56-day treatment, respectively.
Time frame: from baseline to 14, 28 and 56 days, respectively
The change of urticaria control test (UCT) after a 14-, 28- and 56-day treatment, respectively.
Time frame: from baseline to 14, 28 and 56 days, respectively
For patients with angioedema, the change of Angioedema Activity Score of 7days（AAS7）after a 14-, 28- and 56-day treatment, respectively.
Time frame: from baseline to 14, 28 and 56 days, respectively
For patients with angioedema, the change of Angioedema quality of life questionnaire(AE-QoL) after a 28- and 56-day treatment, respectively.
Time frame: from baseline to 28 and 56 days, respectively
The change of sera autoantibodies titer after a 14- and 28-day treatment, respectively.
Time frame: from baseline to 14 and 28 days, respectively
The change of accumulative dose of antihistamines in the past 7 days on Day 28 and Day 56, respectively, compared to baseline.
Time frame: from baseline to 28 and 56 days, respectively
Percentage of patients with UAS7 less than 6 on Day 14 and Day 28, respectively.
Time frame: from baseline to 28 and 56 days, respectively
The drug adverse reactions throughout the entire study process.
Time frame: through study completion, an average of 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
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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.
Qianjin Lu, MD, PhD principal investigator
The Second Xiangya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Recombinant human interleukin-2 (rhIL-2) in people with Chronic Spontaneous Urticaria, run by Second Xiangya Hospital of Central South University at 1 site in China.
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 8 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 20 May 2021. 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 China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Qianjin Lu (13787097676, qianlu5860@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Urticaria Activity Score of 7 Days（UAS7）from baseline (Day 0) to Day 14. (time frame: from baseline to Day 14). 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 20 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.