Interleukin-2 for Refractory Chronic Spontaneous Urticaria

NCT06924762 | Recruiting Phase 2 DMC

• 2 other identifiers: LYG20240044MR-43-25-003708
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Interleukin-2; Chronic spontaneous uriticaria; urticaria control test; poor response to second-generation antihistamines

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Urticaria Activity Score of 7 Days（UAS7）at 12 Weeks

  This rating requires patients to record the number of wheals and the severity of itching once a day. The sum of each day's UAS score in the past seven consecutive days is UAS7.

  Baseline and 12 weeks.

Secondary Outcomes (11)

• Proportion of patients who achieve the treatment target at 2, 4, 8, 12 and 24 weeks, respectively

  2, 4, 8, 12 and 24 weeks post-intervention

• The change from baseline in UAS7 at 2 weeks and 24 weeks, respectively

  Baseline, 2 weeks, and 24 weeks

• Change from baseline in HSS7 score at 2, 12 and 24 weeks, respectively

  Baseline, 2 weeks, 12 weeks and 24 weeks

• Change from baseline in ISS7 score at 2, 12 and 24 weeks, respectively

  Baseline, 2, 12 and 24 weeks

• Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at 2, 12 and 24 weeks, respectively

  Baseline, 2, 12 and 24 weeks

Study Arms (2)

Interleukin-2 treatment group

EXPERIMENTAL

The enrolled subjects will receive three cycles of interleukin-2 treatment in the first 12 weeks upon initiation of the intervention, while continuing with the same oral regimen of second-generation antihistamines as they have been receiving before initiation of the trial. In each cycle of interleukin-2 treatment, the enrolled subjects will receive an intramuscular injection of interleukin-2 at a dosage of 1 million international units, dissolved in 1.0 mL of sterile water for injection, once daily for 7 consecutive days. The three cycles of interleukin-2 treatment will be administered on Day 0\~6, Day 28\~34 and Day 56\~62, respectively.

Drug: Human interleukin-2 (I) intramuscular injection

Placebo group

PLACEBO COMPARATOR

The enrolled subjects will receive three cycles of placebo injections in the first 12 weeks upon initiation of the intervention, while continuing with the same oral regimen of second-generation antihistamines as they have been receiving before initiation of the trial. In each cycle of placebo injections, the enrolled subjects will receive an intramuscular injection of placebo at a same specification as in the IL-2 treatment group, dissolved in 1.0 mL of sterile water for injection, once daily for 7 consecutive days. The three cycles of placebo injections will be administered on Day 0\~6, Day 28\~34 and Day 56\~62, respectively.

Drug: Placebo intramuscular injection

Interventions

Placebo intramuscular injection DRUG

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

Placebo group

Human interleukin-2 (I) intramuscular injection DRUG

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

Interleukin-2 treatment group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: Not limited; Age: at least 18 years old and less than 75 years old;
• Diagnosed with chronic spontaneous urticaria (CSU) (including patients overlapped with chronic inducible urticaria) according to the 2021 EAACI/GA²LEN/EDF/AAAAI guidelines;
• Disease course of CSU for at least 12 weeks;
• The patient has been treated with second-generation antihistamines (one or more types, up to 4 tablets per day) every day for 2 weeks or more but still experiences significant symptoms of wheals and/or itching, with a UAS7 score ≥16 or a UCT score \<12;
• UAS7 ≥16 on the date prior to randomization (according to complete daily symptom log data recorded in the past 7 days before randomization);
• Willing and able to complete daily symptom logs throughout the entire study period;
• The patient voluntarily consents to participate in this research project and has signed the informed consent.

You may not qualify if:

• Pregnant or breastfeeding women, or women planning to conceive within 6 months;
• Has used corticosteroids, immunosuppressants, leukotriene receptor antagonists, H2 receptor antagonists, intravenous immunoglobulin (IVIG) therapy, and/or undergone plasma exchange in the past 4 weeks;
• Has received omalizumab or other biologic treatments in the past 12 weeks;
• Has previously undergone interleukin-2 treatment;
• Has a history of anaphylactic shock;
• Plans or anticipates the use of any prohibited drugs or treatments during the screening and/or treatment periods;
• Currently has active or recurrent severe infections, such as active tuberculosis;
• Has a congenital or acquired immunodeficiency disorder;
• Has a history of drug or alcohol abuse, mental disorders, or poor compliance, making them unable to adhere to treatment;
• Currently enrolled in another clinical trial;
• Is an employee of the clinical research facility or directly involved in the study, or is an immediate family member of such an individual;
• Any other reason that makes participation in this trial inappropriate.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead
• Xiangya Hospital of Central South University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Tongji Hospital: collaborator
• West China Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• The First People's Hospital of Changde City: collaborator
• The Third People's Hospital of Hangzhou: collaborator

Study Sites (1)

the Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Interventions

Injections, Intramuscular

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hai Long, MD, PhD

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Qianjin Lu, MD, PhD

  Second Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Hai Long, M.D. Ph.D.

CONTACT

86+18229743206; Dr.hailong@csu.edu.cn

Guishao Tang, M.D.

CONTACT

86+15200900288; tang140503@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D. & Vice President, The Second Xiangya Hospital of Central South University

Model Details: A multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: April 11, 2025
• Study Start: March 19, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2024-11

Locations

CN (1)