BLU-808 for Chronic Inducible and Spontaneous Urticaria
BLU-808
+ Placebo
Chronic Urticaria+11
+ Chronic Inducible Urticaria
+ Cold Urticaria
Treatment Study
Summary
Study start date: May 28, 2025
Actual date on which the first participant was enrolled.This clinical trial aims to explore the effectiveness and safety of a new medication called BLU-808 for people suffering from two types of chronic hives: Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU). Hives are itchy, raised welts on the skin, often triggered by allergens or other factors, and can be very uncomfortable. For those with chronic forms, hives can persist for six weeks or more, making treatment challenging. This study is important, as it could lead to a new treatment option that helps manage symptoms more effectively, improving the quality of life for those affected. Participants in this study will receive the medication BLU-808, which is taken orally. The study is divided into two parts, with each part focusing on one of the two types of chronic urticaria. Researchers will closely monitor participants to assess how well the medication works, its safety, and how the body processes it. By evaluating these aspects, the study seeks to ensure that BLU-808 is both effective and safe for long-term use in managing chronic hives.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.105 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Key Inclusion Criteria: * Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines. * Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines. Key Exclusion Criteria: * Part A: Any active urticaria that may interfere with study assessments. * Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria. * Part A and Part B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions. * Part A and Part B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results. * Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation. * Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 46 locations
Acuro Research, Inc.
Little Rock, United StatesModena Allergy & Asthma Clinical Research - La Jolla
La Jolla, United StatesAllergy & Asthma Associates of Southern California
Laguna Niguel, United States