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Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria

ConditionChronic Spontaneous Urticaria (CSU)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Men and women aged 18 to 75 years.

2. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines.

3. CSU duration for ≥ 6 months prior to randomization.

4. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form.

Disqualifiers

1. Having the other medical conditions related to CSU or other skin diseases/conditions.

2. Potential medical conditions or issues.

3. Pregnant female subjects or lactating female subjects.

4. The investigator determines that the subject is unsuitable for participating in this study for any reason.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ICP-332 Tablets

    Drug

    ICP-332 will be administered as tablet for 12 weeks

  • ICP-332 placebo Tablets

    Drug

    ICP-332 placebo will be administered as tablet for 12 weeks

  • ICP-332 Tablets

    Drug

    ICP-332 will be administered as tablet for 24 weeks

Treatment groups

344 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ICP-332 dose A（Phase2）Experimental treatment 1 intervention
Group B: ICP-332 dose B（Phase2）Experimental treatment 1 intervention
Group C: ICP-332 dose C（Phase2）Experimental treatment 1 intervention
Group D: Placebo（Phase2）Placebo comparator 1 intervention
Group E: ICP-332 dose A or dose B or dose C（Phase3）Experimental treatment 1 intervention
Group F: Placebo（Phase3）Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.

The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0.

Time frame
4 weeks
2

Phase 3: Change from baseline in UAS7 at Week 12.

The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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