This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
105
Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Week 16
Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12
CTT is the temperature at which CIndU symptoms appear.
Time frame: Baseline, Week 12
Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12
TFS is a measure of CIndU trigger thresholds and disease activity.
Time frame: Baseline, Week 12
Part A and Part B: Complete Response Rate
Time frame: Week 12
Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12
Time frame: Baseline, Week 12
Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12
Time frame: Baseline, Week 12
Part A and Part B: Area Under the Curve (AUC) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Apparent Clearance (CL/F) of BLU-808
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Allervie Clinical Research
Birmingham, Alabama, United States
Acuro Research, Inc.
Little Rock, Arkansas, United States
Modena Allergy & Asthma Clinical Research - La Jolla
La Jolla, California, United States
Allergy & Asthma Associates of Southern California
Laguna Niguel, California, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, United States
Allergy Affiliates Inc.
Bradenton, Florida, United States
University of South Florida
Tampa, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Endeavor Health
Northbrook, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
...and 37 more locations
Time frame: Day 1 to Day 57
Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Terminal Half-life (t½) of BLU-808
Time frame: Day 1 to Day 57
Part B: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 12
UAS7 is a patient-reported outcome used to assess symptoms in participants with CSU.
Time frame: Baseline, Week 12