A Phase 2/3 interventional study of Recombinant human interleukin-2 (rhIL-2) and Control group in Chronic Spontaneous Urticaria, sponsored by Second Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Second Xiangya Hospital of Central South University · Phase 2/3, Interventional, and Treatment
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 .
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.
237 studies on the registry are indexed under Urticaria; 26 are open to participants now.
This study's planned enrollment of 56 is close to the median of 61 across 174 interventional studies indexed under Urticaria.
Browse Urticaria studies →Second Xiangya Hospital of Central South University is the lead sponsor of 82 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use Interleukin-2 to treat CSU during day1-day28.
Drug: Recombinant human interleukin-2 (rhIL-2)
Use Interleukin-2 to treat CSU during day15-day28.
Drug: Control group
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)
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
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
Time frame: from baseline to Day 14
The change of UAS7 from baseline (Day 0) to Day 28 and Day 56, respectively.
UAS7 score on Day 28 (or Day 56) - UAS7 score on Day 0
Time frame: 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.
CU-Q2oL score on Day 0 - CU-Q2oL score on Day N
Time frame: 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.
UCT score on Day 0 - UCT score on Day N
Time frame: 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.
AAS7 on Day 0 - AAS7 on Day N
Time frame: 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.
AE-QoL on Day 0 - AE-QoL on Day N
Time frame: from baseline to 28 and 56 days, respectively
The change of sera autoantibodies titer after a 14- and 28-day treatment, respectively.
The autoantibodies including IgG-anti-FcεRⅠand IgG-anti-IgE antibodies titer are detected by Elisa.
Time frame: 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.
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.
Time frame: from baseline to 28 and 56 days, respectively
Percentage of patients with UAS7 less than 6 on Day 14 and Day 28, respectively.
The percentage of patients with UAS7 less than 6 were calculated on Day 14 and Day 28, respectively.
Time frame: from baseline to 28 and 56 days, respectively
The drug adverse reactions throughout the entire study process.
The adverse reactions of rhIL-2 including fever, myalgia, nausea, emesis, rash.
Time frame: through study completion, an average of 56 days
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Xiangya Hospital of Central South University