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ClinPharm Vault

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria

Study Snapshot

  • Program: EP262
  • Study ID(s): NCT06077773
  • Phase: Phase 2
  • Indication: Chronic Spontaneous Urticaria
  • Status: Terminated
  • Sponsor: Escient Pharmaceuticals, Inc

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: DOUBLE
  • Primary purpose: TREATMENT
  • Enrollment: 113 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to 80 Years
  • Healthy volunteers: False
  • Summary: Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

Operational design summary

  • Arms represented in current CT.gov export: 4
  • Active dose regimens represented in current local source layer: 3
  • Total study enrollment in CT.gov: 113 (ACTUAL)
  • Design interpretation: Terminated phase 2 CSU study with placebo, EP262 50 mg, and EP262 150 mg enrolled in Part 1; CT.gov still lists a planned EP262 25 mg arm not carried into the posted results groups.
  • Per-arm sample size summary: ClinicalTrials.gov results-section denominators support placebo n=38, EP262 50 mg n=37, and EP262 150 mg n=38, totaling 113 participants. The posted results note that Part 2 was not enrolled, so the listed EP262 25 mg row remains unresolved in the current local layer.
  • Arm-size evidence source: ClinicalTrials.gov API v2 resultsSection participant flow and baseline-characteristics denominators.

Arms

Arm Type Dose Frequency Route Description N Evidence status
EP262 50 mg EXPERIMENTAL 50 mg NR Oral NR 37 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
EP262 150 mg EXPERIMENTAL 150 mg NR Oral NR 38 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Placebo PLACEBO_COMPARATOR NR NR NR NR 38 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
EP262 25 mg EXPERIMENTAL 25 mg NR Oral NR NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer

Key Efficacy and Safety Findings

  • Result status: Posted (CT.gov)

Efficacy

  • Primary endpoint not met: UAS7 change from baseline at week 6 showed no significant separation from placebo for either EP262 dose.
  • EP262 50 mg: LS mean UAS7 change -8.43 versus placebo -10.41; difference +1.99 (95% CI -1.96 to 5.94; P = 0.41).
  • EP262 150 mg: LS mean UAS7 change -11.95 versus placebo -10.41; difference -1.53 (95% CI -5.49 to 2.42; P = 0.52).
  • Study was terminated; Part 2 was not enrolled.

Safety

  • TEAEs: placebo 12/38 (31.6%), EP262 50 mg 15/37 (40.5%), EP262 150 mg 19/38 (50.0%).
  • Grade >= 3 TEAEs: placebo 1, EP262 50 mg 0, EP262 150 mg 1.

Result source(s)

  • ClinicalTrials.gov posted results (NCT06077773 resultsSection)

Endpoints

  • Primary outcomes:
  • Change From Baseline to Visit 4 (Week 6) in the Urticaria Activity Score Over a 7-day Period (UAS7) (time frame: Baseline; Week 6)

Clinical Pharmacology Findings

  • PK: Not clearly summarized in the currently linked local source snippets.
  • PD: Not clearly summarized in the currently linked local source snippets.
  • 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/NCT06077773
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT06077773.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):
  • NCT06077773
  • ../raw/clinicaltrials/markdown/NCT06077773.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.