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

NCT04893980 | Unknown Phase 2

• 1 other identifier: CSU202009
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chronic Spontaneous Urticaria

Keywords

chronic urticaria; interleukin-2

Outcome Measures

Primary Outcomes (1)

• 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

  from baseline to Day 14

Secondary Outcomes (9)

• The change of UAS7 from baseline (Day 0) to Day 28 and Day 56, respectively.

  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.

  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.

  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.

  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.

  from baseline to 28 and 56 days, respectively

Study Arms (2)

Low-dose interleukin-2 treatment group

EXPERIMENTAL

Use Interleukin-2 to treat CSU during day1-day28.

Drug: Recombinant human interleukin-2 (rhIL-2)

Control group

OTHER

Use Interleukin-2 to treat CSU during day15-day28.

Drug: Control group

Interventions

Recombinant human interleukin-2 (rhIL-2) DRUG

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.

Also known as: Recombinant Human Interleukin-2 (I)

Low-dose interleukin-2 treatment group

Control group DRUG

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.

Also known as: No injections during Day 0-14

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

aldesleukin; Control Groups

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Qianjin Lu, MD, PhD

  The Second Xiangya Hospital, Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianjin Lu

CONTACT

13787097676; qianlu5860@gmail.com

Hai Long

CONTACT

18229743206; dr.hailong@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Institute of Dermatology, Central South University

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: May 20, 2021
• Study Start: June 16, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 20, 2021

Record last verified: 2021-05

Locations

CN (1)