Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)

Browse trials for

• Urticaria 237
• Chronic Urticaria 214

Urticaria

237 studies on the registry are indexed under Urticaria; 26 are open to participants now.

This study's planned enrollment of 252 is above the median of 61 across 174 interventional studies indexed under Urticaria.

Lead sponsor

Hangzhou Grand Biologic Pharmaceutical, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Study arms

• Experimental
  Treatment

  Treatment arm will receive a dose of Histamine Human Immunoglobulin 12mg (2ml) s.c. which consists of one injection of Histamine Human Immunoglobulin 12mg(2ml) vial every week for 4 times. Treatment arm will also receive a dose of loratadine p.o. which consists of one pill of loratadine 10mg every day for 4 weeks.

  Biological: human histaglobulin · Drug: Loratadine 10 Mg

• Placebo comparator
  Placebo

  Placebo arm will receive placebo which consists of one injection of placebo 12mg(2ml) vial every week for 4 times. Placebo arm will also receive a dose of loratadine p.o. which consists of one pill of loratadine 10mg every day for 4 weeks.

  Biological: placebo · Drug: Loratadine 10 Mg

Interventions

• Biologicalhuman histaglobulin

  once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;

• Biologicalplacebo

  once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;

• DrugLoratadine 10 Mg

  orally, 10mg once a day for 4 weeks

Primary outcomes

1. Disease control rate during the last week of treatment (i.e., proportion of patients with urticaria activity score for 7d（UAS7，range 0-42) < 7 for 7 consecutive days after the last injection)

   The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) . The daily UAS is calculated as the average of the morning and evening scores. The urticaria activity score for 7d (UAS7) is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. If UAS7 score is less than 7, it indicates disease control. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The primary outcome measure was disease control rate in the last week of treatment. Chi-square test was used for comparison between groups. Based on the analysis for the main full analysis set (FAS), based on the analysis of the per protocol set（PPS) for supporting analysis.

   Time frame: through study completion, an average of 1 year

Secondary outcomes

1. Time when UAS7 (range 0-42) <7 for the first time

   The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) . The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.If UAS7 score is less than 7, it indicates disease control.

   Time frame: up to 5 weeks

2. Changes in UAS7 scores(range 0-42) after each dose compared with baseline

   The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) . The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.If UAS7 score is less than 7, it indicates disease control.

   Time frame: up to 5 weeks

3. Proportion of patients who responded to treatment as assessed by UCT score

   The urticaria control test (UCT) is a recently validated tool for disease control assessment in patients with CSU.Disease control over the past 4 weeks was evaluated retrospectively. The assessment included: ①the occurrence of urticaria symptoms (such as itching, wheals, etc.); ②the impact of quality of life; ③the frequency of symptoms was not sufficiently controlled by the treatment; ④overall disease control status. The score of each item ranged from 0 to 4, and the total score was the sum of the scores of the four questions.A score of 0 indicates that the disease is not under control at all, and a score of 16 indicates that it is under complete control. A total score ≥12 indicated well-controlled urticaria, and a score \< 12 indicated poorly controlled urticaria.When UCT increased by ≥ 3 points, the current treatment regimen was effective.

   Time frame: up to 5 weeks

4. Proportion of patients with well-controlled disease as assessed by UCT score

   The urticaria control test (UCT) is a recently validated tool for disease control assessment in patients with CSU.Disease control over the past 4 weeks was evaluated retrospectively. The assessment included: ① the occurrence of urticaria symptoms (such as itching, wheals, etc.); ② the impact of quality of life; ③ the frequency of symptoms was not sufficiently controlled by the treatment; ④ overall disease control status. The score of each item ranged from 0 to 4, and the total score was the sum of the scores of the four questions.A score of 0 indicates that the disease is not under control at all, and a score of 16 indicates that it is under complete control. A total score ≥12 indicated well-controlled urticaria, and a score \< 12 indicated poorly controlled urticaria.When UCT increased by ≥ 3 points, the current treatment regimen was effective.

   Time frame: up to 5 weeks

5. Change in chronic urticaria quality of life questionnaire (CU-Q2oL) score from baseline

   The Chronic Urticaria Quality of Life Questionnaire(CU-Q2oL) contains 23 items to assess the impairment of health-related quality of life (HR-QOL) in the past 2 weeks from pruritus, swelling, effect on daily activities, sleep problems, limitation and appearance. The scores of 23 items were added and linearly transformed to a total score of 0-100 CU⁃Q2oL can not only use the total score of the questionnaire to represent the overall damage of HR⁃QoL, but also use the score of one aspect (dimension) to represent the damage of specific HR⁃QoL. The higher the score, the more severe the impact of CSU on the patient.

   Time frame: up to 5 weeks

6. Proportion of patients who developed respiratory infections

   Assess the proportion of patients who developed respiratory infections during the study

   Time frame: up to 10 weeks

Other outcomes

1. Dosage of loratadine tablets and ebastine tablets

   Assess the dosage of loratadine tablets and ebastine tablets

   Time frame: up to 10 weeks

2. The Amount of Histamine, autoantibodies and FcepsilonRI receptors

   Assess the Histamine, autoantibodies, and immunoglobulin E binds to the high-affinity Fcepsilon receptor I (FcepsilonRI) receptors

   Time frame: up to 10 weeks

Individual participant data

Plan to share: No