Interleukin-2 for Refractory Chronic Spontaneous Urticaria

Summary

The goal of this clinical trial is to learn if human interleukin-2 (IL-2) works to treat moderate to severe chronic spontaneous urticaria in adults who remain symptomatic despite oral antihistamine treatment (refractory CSU). It will also learn about the safety of IL-2. The main questions it aims to answer are:

Does IL-2 alleviate the symptoms of urticaria in patients? What medical problems do participants have when given IL-2? Researchers will compare IL-2 to a placebo (a look-alike and smell-like substance that contains no IL-2) to see if IL-2 works to treat refractory, moderate to severe CSU.

Participants will:

Receive IL-2 or a placebo intramuscular injections for 3 rounds at Week 0, 4 and 8, in which each round includes one injection daily for seven consecutive days.

Visit the clinic for checkups and tests at Week 2, 4, 8, 12 and 24. Keep a diary of their symptoms and the number of tablets of oral antihistamines.

Conditions

• Chronic Spontaneous Uriticaria

Interventions

DRUG

Placebo intramuscular injection

On the basis of background treatment, intramuscular injection of placebo was added.

DRUG

Human interleukin-2 (I) intramuscular injection

On the basis of background treatment, intramuscular injection of human interleukin-2 (I) will be added.

Sponsors & Collaborators

• Xiangya Hospital of Central South University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• The First People's Hospital of Changde City

  collaborator OTHER

• The Third People's Hospital of Hangzhou

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  lead OTHER

Principal Investigators

• Hai Long, MD, PhD · Second Xiangya Hospital of Central South University

• Qianjin Lu, MD, PhD · Second Xiangya Hospital of Central South University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-19

Primary Completion

2025-12-31

Completion

2026-05-31

Countries

• China

Study Locations