Chronic Spontaneous UriticariaPhase 2/3ESIT-CSUNCT06924762
Interleukin-2 for Refractory Chronic Spontaneous Urticaria
A Phase 2/3 study testing Human interleukin-2 (I) intramuscular injection in people with Chronic Spontaneous Uriticaria, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Chronic Spontaneous Uriticaria
- What is being tested?
- Human interleukin-2 (I) intramuscular injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 31 May 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Prof. Zhuo Li, M.D., 86+85292097, xy2gcphyb@163.com
About this study
Official title: Efficacy and Safety of Interleukin-2 Treatment in Moderate to Severe Chronic Spontaneous Urticaria With Poor Control by Antihistamines: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Read more
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.
Read the detailed description
Background:
Urticaria is a common disorder characterized by localized edema due to dilation and increased permeability of small blood vessels in the skin and mucous membranes. The primary clinical manifestations include wheals and pruritus.
Chronic spontaneous urticaria (CSU) is defined as recurrent, transient (<24 hours), pruritic wheals on the skin and mucosa lasting for more than 6 weeks, with or without angioedema, excluding chronic inducible urticaria. Among patients with chronic urticaria, about 2/3 have CSU. Although the pathogenesis of CSU remains unclear, increasing evidence suggests an autoimmune feature of this disorder. Oral antihistamines are the primary treatment for CSU, yet some patients continue to experience symptoms despite treatment with standard or double doses. Recent studies have shown that human IL-2 (Interleukin-2) can be effective in a proportion of CSU patients refractory to antihistamine treatment, without significant side effects. Therefore, in this clinical trial we aim to evaluate the therapeutic effect and safety of this new therapeutic method.
Study Design:
This is a randomized, placebo-controlled, multi-center clinical trial to evaluate the safety and efficacy of IL-2 treatment in CSU patients who remain symptomatic despite oral antihistamine treatment.
Methods:
CSU patients who meet the inclusion criteria will receive IL-2 or placebo intramuscular injections in combination with their current antihistamine regimen (either a single antihistamine or a combination of two to three antihistamines at a dose of at least the standard dosage). Endpoints include clinical response, quality of life, and safety profiles.
- Conditions
- Chronic Spontaneous Uriticaria
- Being tested
- Placebo intramuscular injection, Human interleukin-2 (I) intramuscular injection
- Keywords
- Interleukin-2, Chronic spontaneous uriticaria, urticaria control test, poor response to second-generation antihistamines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo intramuscular injectionDrug
On the basis of background treatment, intramuscular injection of placebo was added.
Human interleukin-2 (I) intramuscular injectionDrug
On the basis of background treatment, intramuscular injection of human interleukin-2 (I) will be added.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo intramuscular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks.
Secondary outcomes (11)
Proportion of patients who achieve the treatment target at 2, 4, 8, 12 and 24 weeks, respectively
According to the Expert Consensus on Treat⁃To⁃Target in Chronic Spontaneous Urticaria (2023), published in Chinese Journal of Dermatology, we count the proportion of CSU patients who achieve treatment targets at 2, 4, 8, 12 and 24 weeks post IL-2 or placebo intervention. As stated in Table 1 in the Expert Consensus mentioned above, a CSU patient achieves the treatment target when he meets the following criteria: (1) at 2 weeks post-intervention: UAS7 ≤6, or UAS7 decreased by ≥11 from baseline, or chronic urticaria quality of life questionnaire (CU-Q2oL) score increased by ≥8 from baseline; (2) at 4 weeks or 8 weeks: urticaria control test (UCT) score ≥12, or UAS7 ≤6, or UAS7 decreased by ≥11 from baseline, or CU-Q2oL increased by ≥8 from baseline; (3) at 12 weeks: UCT ≥12, or UAS7 ≤6, or CU-Q2oL increased by ≥19 from baseline; (4) at 24 weeks: UCT =16, or UAS7 =0, or CU-Q2oL increased by ≥19 from baseline.
Measured: 2, 4, 8, 12 and 24 weeks post-intervention
The change from baseline in UAS7 at 2 weeks and 24 weeks, respectively
This rating requires patients to record the number of wheals and the severity of itching once a day. The sum of the wheal score (range 0-3 points; 0 points refer to no wheals in the day, 1 point refers to ≤ 20 wheals, 2 points refer to 20-50 wheals, and 3 points refer to ≥ 50 wheals in the day) and itching score (range 0-3 points; 0 points=none, 1 point=mild itching, 2 points=moderate itching, 3 points=severe itching) is the UAS score for the day. The sum of scores for seven consecutive days is UAS7.
Measured: Baseline, 2 weeks, and 24 weeks
Change from baseline in HSS7 score at 2, 12 and 24 weeks, respectively
This rating requires patients to record the number of wheals once daily. The sum of each day's wheal score (range 0-3 points; 0 points refer to no wheals in the day, 1 point refers to ≤ 20 wheals, 2 points refer to 20-50 wheals, and 3 points refer to ≥ 50 wheals in the day) in the past seven consecutive days is HSS7.
Measured: Baseline, 2 weeks, 12 weeks and 24 weeks
Change from baseline in ISS7 score at 2, 12 and 24 weeks, respectively
This rating requires patients to record the severity of itching once a day. The sum of the itching scores (range 0-3 points; 0 points=none, 1 point=mild itching, 2 points=moderate itching, 3 points=severe itching) in the past seven consecutive days is ISS7.
Measured: Baseline, 2, 12 and 24 weeks
Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at 2, 12 and 24 weeks, respectively
DLQI has a total of 10 questions, covering symptoms and feelings, daily activities, leisure and entertainment, work and study, interpersonal relationships, and treatment. The score range for each item is 0-3 points. Those who answer no or irrelevant questions will receive 0 points, while those who answer a lot will receive 3 points. The sum of the scores for each question is the total score (ranging from 0 to 30).
Measured: Baseline, 2, 12 and 24 weeks
Proportion of CSU patients with no disease activity (UAS7=0) and those with low disease activity (UAS7 ≤6) at 2, 12 and 24 weeks, respectively
At each time point (2, 12 and 24 weeks post-intervention), the proportion of CSU patients with UAS7 =0 and the proportion of CSU patients with UAS7 ≤6 are counted, respectively.
Measured: Baseline, 2, 12 and 24 weeks
Proportion of well-controlled CSU patients (UCT ≥12) and completely controlled CSU patients (UCT=16) at 2, 12 and 24 weeks, respectively
At each time point (2, 12 and 24 weeks post-intervention), the proportion of CSU patients with UCT ≥12 and the proportion of CSU patients with UCT =16 are counted, respectively.
Measured: Baseline, 2, 12 and 24 weeks
Total number of second-generation antihistamines taken per week at 2, 12 and 24 weeks, respectively
Record the number of second-generation antihistamines tablets/capsules taken by the patient on a daily basis, and add up the number of pills taken each day in the past seven consecutive days to obtain the total number of second-generation antihistamines taken in the previous week.
Measured: Baseline, 2, 12 and 24 weeks
Proportion of CSU patients receiving systemic corticosteroid treatment and the total duration of systemic corticosteroid treatment during the study
Record the initiation date and cease date of systemic corticosteroid treatment for each subject since their enrollment in interleukin-2/placebo intervention and calculate the duration (dates). The number of subjects who received systemic corticosteroid treatment during the study was calculated, and the total duration (dates) of systemic corticosteroid treatment was summed up in each group.
Measured: 24 weeks post-intervention or the date of patient withdrawal from the group
Incidence of Adverse Events
Any adverse event is recorded for each subject during the study. Incidence of adverse events, either in total or in separate types of adverse events, is calculated for each treatment group.
Measured: 12 and 24 weeks
Incidence of Severe Adverse Events
The ratio of the number of cases with severe adverse events to the total number of cases in each treatment group is calculated.
Measured: 2, 12 and 24 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start19 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UriticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, West China Hospital, First Affiliated Hospital of Guangxi Medical University, Fujian Medical University Union Hospital, Second Affiliated Hospital of Guangzhou Medical University, The First People's Hospital of Changde City, The Third People's Hospital of Hangzhou
- Responsible party
- Principal investigator, Hai Long, Second Xiangya Hospital of Central South University
- Investigators
- Hai Long, MD, PhD, Principal investigator, Second Xiangya Hospital of Central South UniversityQianjin Lu, MD, PhD, Study director, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924762
- Sponsor's protocol ID
- LYG20240044
- Other IDs
- MR-43-25-003708
- Acronym
- ESIT-CSU
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We would agree to share all IPD collected throughout the trial, but we have not made a decision on this, because we are not sure how to share or by which website we can share this information.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Interleukin-2 Treatment in Moderate to Severe Chronic Spontaneous Urticaria With Poor Control by Antihistamines: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06924762
- Acronym / sponsor ID
- ESIT-CSU / LYG20240044
- Conditions
- Chronic Spontaneous Uriticaria
- Keywords
- Interleukin-2, Chronic spontaneous uriticaria, urticaria control test, poor response to second-generation antihistamines
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, West China Hospital, First Affiliated Hospital of Guangxi Medical University, Fujian Medical University Union Hospital, Second Affiliated Hospital of Guangzhou Medical University, The First People's Hospital of Changde City, The Third People's Hospital of Hangzhou
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Urticaria is a common disorder characterized by localized edema due to dilation and increased permeability of small blood vessels in the skin and mucous membranes. The primary clinical manifestations include wheals and pruritus.
Chronic spontaneous urticaria (CSU) is defined as recurrent, transient (<24 hours), pruritic wheals on the skin and mucosa lasting for more than 6 weeks, with or without angioedema, excluding chronic inducible urticaria. Among patients with chronic urticaria, about 2/3 have CSU. Although the pathogenesis of CSU remains unclear, increasing evidence suggests an autoimmune feature of this disorder. Oral antihistamines are the primary treatment for CSU, yet some patients continue to experience symptoms despite treatment with standard or double doses. Recent studies have shown that human IL-2 (Interleukin-2) can be effective in a proportion of CSU patients refractory to antihistamine treatment, without significant side effects. Therefore, in this clinical trial we aim to evaluate the therapeutic effect and safety of this new therapeutic method.
Study Design:
This is a randomized, placebo-controlled, multi-center clinical trial to evaluate the safety and efficacy of IL-2 treatment in CSU patients who remain symptomatic despite oral antihistamine treatment.
Methods:
CSU patients who meet the inclusion criteria will receive IL-2 or placebo intramuscular injections in combination with their current antihistamine regimen (either a single antihistamine or a combination of two to three antihistamines at a dose of at least the standard dosage). Endpoints include clinical response, quality of life, and safety profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Interleukin-2 treatment group | Experimental | Drug: Human interleukin-2 (I) intramuscular injectionThe 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. |
| Placebo group | Placebo comparator | Drug: Placebo intramuscular injectionThe 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo intramuscular injectionOn the basis of background treatment, intramuscular injection of placebo was added. | Drug | Placebo group |
| Human interleukin-2 (I) intramuscular injectionOn the basis of background treatment, intramuscular injection of human interleukin-2 (I) will be added. | Drug | Interleukin-2 treatment group |
Primary outcome
Change from Baseline in the Urticaria Activity Score of 7 Days（UAS7）at 12 Weeks
Time frame: Baseline and 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.
11 secondary outcomes
Proportion of patients who achieve the treatment target at 2, 4, 8, 12 and 24 weeks, respectively
Time frame: 2, 4, 8, 12 and 24 weeks post-intervention
The change from baseline in UAS7 at 2 weeks and 24 weeks, respectively
Time frame: Baseline, 2 weeks, and 24 weeks
Change from baseline in HSS7 score at 2, 12 and 24 weeks, respectively
Time frame: Baseline, 2 weeks, 12 weeks and 24 weeks
Change from baseline in ISS7 score at 2, 12 and 24 weeks, respectively
Time frame: Baseline, 2, 12 and 24 weeks
Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at 2, 12 and 24 weeks, respectively
Time frame: Baseline, 2, 12 and 24 weeks
Proportion of CSU patients with no disease activity (UAS7=0) and those with low disease activity (UAS7 ≤6) at 2, 12 and 24 weeks, respectively
Time frame: Baseline, 2, 12 and 24 weeks
Proportion of well-controlled CSU patients (UCT ≥12) and completely controlled CSU patients (UCT=16) at 2, 12 and 24 weeks, respectively
Time frame: Baseline, 2, 12 and 24 weeks
Total number of second-generation antihistamines taken per week at 2, 12 and 24 weeks, respectively
Time frame: Baseline, 2, 12 and 24 weeks
Proportion of CSU patients receiving systemic corticosteroid treatment and the total duration of systemic corticosteroid treatment during the study
Time frame: 24 weeks post-intervention or the date of patient withdrawal from the group
Incidence of Adverse Events
Time frame: 12 and 24 weeks
Incidence of Severe Adverse Events
Time frame: 2, 12 and 24 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Undecided. We would agree to share all IPD collected throughout the trial, but we have not made a decision on this, because we are not sure how to share or by which website we can share this information.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hai Long, MD, PhD principal investigator
Second Xiangya Hospital of Central South University
Qianjin Lu, MD, PhD study director
Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Human interleukin-2 (I) intramuscular injection in people with Chronic Spontaneous Uriticaria, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hai Long, M.D. Ph.D. (86+18229743206 ext. 86+73185292097, Dr.hailong@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Urticaria Activity Score of 7 Days（UAS7）at 12 Weeks (time frame: Baseline and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.