Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

Blueprint Medicines

Status and phase: Enrolling; Phase 2

Conditions: Chronic Inducible Urticaria; Chronic Spontaneous Urticaria

Treatments: Drug: Placebo; Drug: BLU-808

Study type: Interventional

Funder types: Industry

Identifiers

NCT06931405

2024-520031-33-00 (Other Identifier)

BLU-808-1201

Details and patient eligibility

About

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).

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups

Arm A1 (Part A): BLU-808

Experimental group

Description:

BLU-808 will be administered orally.

Treatment:

Drug: BLU-808

Arm A3 (Part A): BLU-808

Experimental group

Description:

BLU-808 will be administered orally.

Treatment:

Drug: BLU-808

Arm B (Part B): BLU-808/Placebo

Experimental group

Description:

BLU-808 or matching placebo will be administered orally.

Treatment:

Drug: BLU-808

Drug: Placebo