Efficacy of Low-dose Interleukin-2 Treatment in Chronic Spontaneous Urticaria

May 15, 2021 updated by: Qianjin Lu, MD, PhD, Second Xiangya Hospital of Central South University

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: between 18- and 75-years old;
  2. 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.
  3. 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;
  4. Written informed consent was obtained, and the patient volunteers to participate in the project and complete the project as required.

Exclusion Criteria:

  1. Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;
  2. Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);
  3. Patients have a clear history of allergy to rhIL-2;
  4. Patients receiving Interleukin-2 treatment in the last 3 months by subcutaneous or intramuscular injection；
  5. Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;
  6. Pregnant women, lactating women or women who are willing to conceive within 3 months;
  7. 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；
  8. Patients who have participated in other clinical trials within 3 months before the screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose interleukin-2 treatment group
Use Interleukin-2 to treat CSU during day1-day28.
Drug: Recombinant human interleukin-2 (rhIL-2)
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.
Other Names:
  • Recombinant Human Interleukin-2 (I)
Other: Control group
Use Interleukin-2 to treat CSU during day15-day28.
Drug: Control group
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.
Other Names:
  • No injections during Day 0-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
UAS7 score on Day 28 (or Day 56) - UAS7 score on Day 0
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
CU-Q2oL score on Day 0 - CU-Q2oL score on Day N
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
UCT score on Day 0 - UCT score on Day N
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
AAS7 on Day 0 - AAS7 on Day N
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
AE-QoL on Day 0 - AE-QoL on Day N
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 autoantibodies including IgG-anti-FcεRⅠand IgG-anti-IgE antibodies titer are detected by Elisa.
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
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.
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 percentage of patients with UAS7 less than 6 were calculated on Day 14 and Day 28, respectively.
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
The adverse reactions of rhIL-2 including fever, myalgia, nausea, emesis, rash.
through study completion, an average of 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Qianjin Lu, MD, PhD, The Second Xiangya Hospital, Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 16, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

May 15, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSU202009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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