Back to resultsEfficacy of Low-dose Interleukin-2 Treatment in Chronic Spontaneous Urticaria
Primary Purpose
Chronic Spontaneous Urticaria
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Recombinant human interleukin-2 (rhIL-2)
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring chronic urticaria, interleukin-2
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The Second Xiangya Hospital of Central South University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Low-dose interleukin-2 treatment group
Control group
Arm Description
Use Interleukin-2 to treat CSU during day1-day28.
Use Interleukin-2 to treat CSU during day15-day28.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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.
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.
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.
The drug adverse reactions throughout the entire study process.
The adverse reactions of rhIL-2 including fever, myalgia, nausea, emesis, rash.
Full Information
NCT ID
NCT04893980
First Posted
January 31, 2021
Last Updated
May 15, 2021
Sponsor
Second Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04893980
Brief Title
Efficacy of Low-dose Interleukin-2 Treatment in Chronic Spontaneous Urticaria
Official Title
Short-term Efficacy of Low-dose Interleukin-2 Treatment in Chrornic Spontaneous Urticaria: a Randomized, Controlled, Single-center Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2021 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
Keywords
chronic urticaria, interleukin-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-dose interleukin-2 treatment group
Arm Type
Experimental
Arm Description
Use Interleukin-2 to treat CSU during day1-day28.
Arm Title
Control group
Arm Type
Other
Arm Description
Use Interleukin-2 to treat CSU during day15-day28.
Intervention Type
Drug
Intervention Name(s)
Recombinant human interleukin-2 (rhIL-2)
Other Intervention Name(s)
Recombinant Human Interleukin-2 (I)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Control group
Other Intervention Name(s)
No injections during Day 0-14
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of Urticaria Activity Score of 7 Days（UAS7）from baseline (Day 0) to Day 14.
Description
UAS7 score on Day 14 - UAS7 score on Day 0
Time Frame
from baseline to Day 14
Secondary Outcome Measure Information:
Title
The change of UAS7 from baseline (Day 0) to Day 28 and Day 56, respectively.
Description
UAS7 score on Day 28 (or Day 56) - UAS7 score on Day 0
Time Frame
from baseline to Day 28 and Day 56, respectively
Title
The change of chronic urticaria quality of life questionnaire (CU-Q2oL) score after a 14-, 28- and 56-day treatment, respectively.
Description
CU-Q2oL score on Day 0 - CU-Q2oL score on Day N
Time Frame
from baseline to 14, 28 and 56 days, respectively
Title
The change of urticaria control test (UCT) after a 14-, 28- and 56-day treatment, respectively.
Description
UCT score on Day 0 - UCT score on Day N
Time Frame
from baseline to 14, 28 and 56 days, respectively
Title
For patients with angioedema, the change of Angioedema Activity Score of 7days（AAS7）after a 14-, 28- and 56-day treatment, respectively.
Description
AAS7 on Day 0 - AAS7 on Day N
Time Frame
from baseline to 14, 28 and 56 days, respectively
Title
For patients with angioedema, the change of Angioedema quality of life questionnaire(AE-QoL) after a 28- and 56-day treatment, respectively.
Description
AE-QoL on Day 0 - AE-QoL on Day N
Time Frame
from baseline to 28 and 56 days, respectively
Title
The change of sera autoantibodies titer after a 14- and 28-day treatment, respectively.
Description
The autoantibodies including IgG-anti-FcεRⅠand IgG-anti-IgE antibodies titer are detected by Elisa.
Time Frame
from baseline to 14 and 28 days, respectively
Title
The change of accumulative dose of antihistamines in the past 7 days on Day 28 and Day 56, respectively, compared to baseline.
Description
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.
Time Frame
from baseline to 28 and 56 days, respectively
Title
Percentage of patients with UAS7 less than 6 on Day 14 and Day 28, respectively.
Description
The percentage of patients with UAS7 less than 6 were calculated on Day 14 and Day 28, respectively.
Time Frame
from baseline to 28 and 56 days, respectively
Title
The drug adverse reactions throughout the entire study process.
Description
The adverse reactions of rhIL-2 including fever, myalgia, nausea, emesis, rash.
Time Frame
through study completion, an average of 56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianjin Lu
Phone
13787097676
Email
qianlu5860@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hai Long
Phone
18229743206
Email
dr.hailong@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qianjin Lu, MD, PhD
Organizational Affiliation
The Second Xiangya Hospital, Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhuo Li
Phone
+86-731-84896038
Email
xiangyagcp@126.com
First Name & Middle Initial & Last Name & Degree
Hai Long
Phone
18229743206
Email
dr.hailong@csu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Low-dose Interleukin-2 Treatment in Chronic Spontaneous Urticaria
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