AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)

RecruitingPhase 2Ages 18 Years - 75 YearsAllKeymed Biosciences Co.Ltd
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Voluntarily sign the Informed Consent Form. * Age โ‰ฅ 18 years old and โ‰ค 75 years old. * Patients with a diagnosis of CSU before screening visit, and the duration was โ‰ฅ6 months. * Pruritus and wheals existed for more than 6 weeks before screening, despite regular H1-Antihistamines(AH) treatment during this period. * A stable dose of the second-generation H1-Antihistamines(AH) has been continuously used for at least 7 days before randomization, and the individual is willing to continue to use it stably as stipulated in the protocol during the study period. * Within 7 days before randomization, UAS7โ‰ฅ16 and ISS7 โ‰ฅ8. Exclusion Criteria: * Not enough washing-out period for previous therapy. * Planned major surgical procedure during the patient's participation in this study. * Has ever experienced a systemic allergic reaction or immediate allergic reaction to any biological product (including any excipients). * CM512 has been used before. * Women who are pregnant or breastfeeding. During the study period, subjects who had plans to have children, or did not agree to contraception. * With any medical or non-medical conditions that are not suitable for participation in this study by investigators.
๐Ÿ’Š

What it tests

  • CM512 injection
  • placebo
๐Ÿ“

Where

1 site
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy