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

ConditionsChronic Inducible UrticariaChronic Spontaneous Urticaria
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBlueprint Medicines Corporation

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BLU-808

    Drug

    Oral administration

  • Placebo

    Drug

    Oral administration

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Arm A1 (Part A): BLU-808Experimental treatment 1 intervention
Group B: Arm A3 (Part A): BLU-808Experimental treatment 1 intervention
Group C: Arm B (Part B): BLU-808/PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Time frame
Day 1 through Week 16

Secondary outcomes

1

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
2

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
3

Part A and Part B: Complete Response Rate

Time frame
Week 12
4

Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12

Time frame
Baseline, Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blueprint Medicines Corporation

Lead sponsor

Source ClinicalTrials.gov
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