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New treatment option for Chronic Spontaneous Urticaria (CSU)
Official title Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
ClinicalTrials.gov ID: NCT07166211
What this study is testing
What is CM512 injection?
CM512 injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic spontaneous urticaria (csu).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily sign the Informed Consent Form.
- Age ≥ 18 years old and ≤ 75 years old.
- Patients with a diagnosis of CSU before screening visit, and the duration was ≥6 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...
You likely can't join if
- 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, people 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.
See the full eligibility criteria
- Voluntarily sign the Informed Consent Form.
- Age ≥ 18 years old and ≤ 75 years old.
- Patients with a diagnosis of CSU before screening visit, and the duration was ≥6 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...
- Within 7 days before randomization, UAS7≥16 and ISS7 ≥8.
- 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, people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.