Clinical trial NCT06931405: Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
Official title: A Phase 2 Study to Evaluate the Safety, Tolerability, and Clinical Activity of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Inducible Urticaria
Chronic Spontaneous Urticaria
Keywords: Chronic Inducible Urticaria
Chronic Spontaneous Urticaria
BLU-808
CIndU
CSU
Chronic Urticaria
CU
Cold Urticaria
ColdU
Symptomatic Dermographism
SD
Lead sponsor: Blueprint Medicines Corporation
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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 ≥6 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 A: History of cold-induced anaphylaxis.
* 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.

Primary outcomes:
measure: Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 through Week 16
Secondary outcomes:
measure: Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12
timeFrame: Baseline, Week 12
measure: Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12
timeFrame: Baseline, Week 12
measure: Part A and Part B: Complete Response Rate
timeFrame: Week 12
measure: Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12
timeFrame: Baseline, Week 12
measure: Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12
timeFrame: Baseline, Week 12
measure: Part A and Part B: Area Under the Curve (AUC) of BLU-808
timeFrame: Day 1 to Day 57
measure: Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808
timeFrame: Day 1 to Day 57
measure: Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808
timeFrame: Day 1 to Day 57
measure: Part A and Part B: Apparent Clearance (CL/F) of BLU-808
timeFrame: Day 1 to Day 57
measure: Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808
timeFrame: Day 1 to Day 57
measure: Part A and Part B: Terminal Half-life (t½) of BLU-808
timeFrame: Day 1 to Day 57
measure: Part B: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Modena Allergy & Asthma Clinical Research - La Jolla
state: California
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Bowling Green
country: United States
facility: Equity Medical - Bowling Green
state: Kentucky
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: New York
country: United States
facility: Equity Medical (at Cameron Dermatology) - New York
state: New York
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immunology Associates
state: Pennsylvania
Study officials:
References: