Health Trials

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

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

Treatments tested in this trial

  • ICP-332 Tablets
  • ICP-332 placebo Tablets
  • ICP-332 Tablets

Treatment groups

344 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

30
Bengbu Medical University First Affiliated Hospital233004, BengbuAnhui, China
The Second Affiliated Hospital of Wannan Medical College241000, WuhuAnhui, China
Beijing Tongren Hospital, Capital Medical University100730, BeijingBeijing Municipality, China
Peking University People's Hospital100044, BeijingBeijing Municipality, China

Sponsors and collaborators

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov