THB335 for Hives
What You Need to Know Before You Apply
What is the purpose of this trial?
THB335-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adults with CSU who remain symptomatic despite standard-of-care treatment. The study includes a Screening Period of up to 4 weeks, a 12-week Treatment Period, and a 4-week Follow-Up Period, for a total participant duration of approximately 20 weeks.
Are You a Good Fit for This Trial?
This trial is for adults aged 18–85 who have had chronic hives (CSU) for at least 6 months and still have symptoms despite taking standard antihistamines. Participants must meet certain activity score levels, fall within specific weight and BMI ranges, and be willing to follow study procedures.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- THB335 Higher Dose
- THB335 Lower Dose
Trial Overview
The study tests two different doses of a new drug called THB335 compared to a placebo in people with CSU. Participants are randomly assigned to one of the groups without knowing which treatment they receive. The trial lasts about 20 weeks including screening, treatment, and follow-up.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Orally-administered THB335 lower dose.
Orally-administered THB335 higher dose.
Orally-administered matching placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Calixis Inc.
Lead Sponsor
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