Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study

Study Snapshot

  • Program: Fenebrutinib
  • Study ID(s): NCT03693625
  • Phase: Phase 2
  • Indication: Urticaria
  • Status: Terminated
  • Sponsor: Genentech, Inc.

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: NA
  • Intervention model: SINGLE_GROUP
  • Masking: NONE
  • Primary purpose: TREATMENT
  • Enrollment: 31 (ACTUAL)

Population

  • Conditions: Urticaria
  • Sex: ALL
  • Age range: 18 Years to 75 Years
  • Healthy volunteers: False
  • Summary: This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU) who have completed the treatment period in a fenebrutinib CSU parent study. Participants may enroll in this OLE study at any time after completing the treatment period of the parent study. Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg) orally twice a day. Treatment may continue until the end of the study.

Operational design summary

  • Arms represented in current CT.gov export: 2
  • Active dose regimens represented in current local source layer: 1
  • Total study enrollment in CT.gov: 31 (ACTUAL)
  • Design interpretation: Open-label fenebrutinib extension study that re-treated participants according to parent-study assignment in cohort 2 of GS39684.
  • Per-arm sample size summary: ClinicalTrials.gov results-section denominators support parent-study GDC-0853 n=23 and parent-study placebo n=8, totaling 31 participants.
  • 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
Parent Study: GDC-0853 EXPERIMENTAL 200mg NR Oral Participants (who had received 50, 150 and 200mg GDC-0853 in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day. 23 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Parent Study: Placebo PLACEBO_COMPARATOR 200mg NR Oral Participants (who had received Placebo in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day. 8 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Endpoints

  • Primary outcomes:
  • Percentage of Participants With Adverse Events (AEs) (time frame: Baseline up until 4 weeks after the last dose of study drug (up to 10 months).)

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/NCT03693625
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT03693625.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):
  • NCT03693625
  • ../raw/clinicaltrials/markdown/NCT03693625.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.