Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

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

Study Snapshot

  • Program: BLU-808
  • Study ID(s): NCT06931405
  • Phase: Phase 2
  • Indication: Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
  • Status: Recruiting
  • Sponsor: Blueprint Medicines Corporation

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: TRIPLE
  • Primary purpose: TREATMENT
  • Enrollment: 105 (ESTIMATED)

Population

  • Conditions: Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to None
  • Healthy volunteers: False
  • 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).

Operational design summary

  • Arms represented in current CT.gov export: 3
  • Active dose regimens represented in current local source layer: 1
  • Total study enrollment in CT.gov: 105 (ESTIMATED)
  • Per-arm sample size summary: 105 total across 3 listed arms; exact arm-specific counts are not explicitly stated in the current local source text.
  • Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arms

Arm Type Dose Frequency Route Description N Evidence status
Arm A1 (Part A): BLU-808 EXPERIMENTAL NR NR Oral BLU-808 will be administered orally. NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Arm A3 (Part A): BLU-808 EXPERIMENTAL NR NR Oral BLU-808 will be administered orally. NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Arm B (Part B): BLU-808/Placebo EXPERIMENTAL NR NR Oral BLU-808 or matching placebo will be administered orally. NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer

Endpoints

  • Primary outcomes:
  • Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 through Week 16)

Clinical Pharmacology Findings

  • PK: ClinicalTrials.gov summary text indicates pharmacokinetics were part of the study objectives or assessments.
  • PD: ClinicalTrials.gov summary text indicates pharmacodynamics were part of the study objectives or assessments.
  • Linked manuscripts: No trial-level primary publication is explicitly linked in the current registry.

Safety Findings

  • Safety detail is not strongly enriched beyond the current CT.gov/source-registry layer.

Linked Evidence

  • CT.gov page: https://clinicaltrials.gov/study/NCT06931405
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT06931405.md

Interpretation

  • Verified facts: this page reflects the current local registry and CT.gov inventory export without inferring unsupported arm sizes or endpoint results.
  • Interpretation: this trial is currently represented mainly by CT.gov and any linked sponsor-source artifacts; manual enrichment is still needed for a richer narrative page.
  • Open questions:
  • Some studies still lack exact arm-specific N in the current promoted evidence layer even when allocation schema or total enrollment is visible.
  • No explicit trial-level primary manuscript is currently linked in the registry.
  • No sponsor artifact is explicitly linked to this trial by identifier in the current registry.

Provenance

  • Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
  • Primary source(s):
  • NCT06931405
  • ../raw/clinicaltrials/markdown/NCT06931405.md
  • ../inventories/source_registry.json
  • Supporting source(s):
  • ../inventories/ctgov_priority_trials.json
  • Last verified: 2026-04-08
  • Verification status: Partial

Change Log

  • 2026-04-08: Generated or refreshed this study page from the v2 source registry and CT.gov inventory.