Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).

Study Snapshot

  • Program: Fenebrutinib
  • Study ID(s): NCT03137069
  • Phase: Phase 2
  • Indication: Urticaria
  • Status: Completed
  • Sponsor: Genentech, Inc.

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: QUADRUPLE
  • Primary purpose: TREATMENT
  • Enrollment: 134 (ACTUAL)

Population

  • Conditions: Urticaria
  • Sex: ALL
  • Age range: 18 Years to 75 Years
  • Healthy volunteers: False
  • Summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria (CSU) already treated with anti-histamines. Participants have the option to enter the Open-Label Extension (OLE) study after completing the 8-week treatment period.

Operational design summary

  • Arms represented in current CT.gov export: 6
  • Active dose regimens represented in current local source layer: 3
  • Total study enrollment in CT.gov: 134 (ACTUAL)
  • Design interpretation: Pilot plus dose-ranging fenebrutinib phase 2 study with separate cohort 1 and cohort 2 structures.
  • Per-arm sample size summary: ClinicalTrials.gov results-section denominators support cohort 1 placebo n=13 and fenebrutinib 200 mg BID n=28, plus cohort 2 placebo n=23, fenebrutinib 50 mg daily n=23, 150 mg daily n=24, and 200 mg twice daily n=23, totaling 134 participants.
  • Arm-size evidence source: ClinicalTrials.gov API v2 resultsSection participant flow and baseline-characteristics denominators; PMCID PMC8604722 full text remains the linked manuscript source.

Arms

Arm Type Dose Frequency Route Description N Evidence status
Cohort 1: Placebo PLACEBO_COMPARATOR NR BID NR Participants received matching placebo twice daily from Day 1 to 56. 13 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Cohort 1: GDC-0853 200mg BID EXPERIMENTAL 200mg BID NR Participants received GDC-0853 200mg twice daily from Day 1 to 56. 28 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Cohort 2: Placebo PLACEBO_COMPARATOR NR BID NR Participants received matching placebo up to twice daily from Day 1 to 56. 23 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Cohort 2: GDC-0853 50mg QD EXPERIMENTAL 50mg QD NR Participants received GDC-0853 50mg once daily from Day 1 to 56. 23 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Cohort 2: GDC-0853 150mg QD EXPERIMENTAL 150mg QD NR Participants received GDC-0853 150mg once daily from Day 1 to 56. 24 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Cohort 2: GDC-0853 200mg BID EXPERIMENTAL 200mg BID NR Participants received GDC-0853 200mg twice daily from Day 1 to 56. 23 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Key Efficacy and Safety Findings

  • Result status: Published

Efficacy

  • Cohort 2 primary endpoint (UAS7 change at week 8, LS mean difference versus placebo): 200 mg BID -9.5 (95% CI -16.7 to -2.4; significant), 150 mg QD -6.4 (95% CI -13.4 to 0.6; trend), 50 mg QD -0.5 (not significant).
  • Well-controlled disease (UAS7 <= 6) at week 8: 200 mg BID 57%, 150 mg 46%, 50 mg 35%, placebo 22%.
  • Complete response (UAS7 = 0) at week 8: 200 mg BID 39%, 150 mg 25%, 50 mg 13%, placebo 4%.
  • Rapid onset: 200 mg BID week-4 UAS7 LS mean difference -10.8 versus placebo (95% CI -18.2 to -3.3).
  • Exploratory: all doses reduced IgG-anti-FcεRI autoantibodies (median change -43.7% to -53.6% versus +20.4% placebo).

Safety

  • No SAEs in Cohort 2; most common AEs: urticaria (15%), nasopharyngitis (11%), headache (6%).
  • Grade 2/3 liver transaminase elevations in 2 patients each at 150 mg QD and 200 mg BID; all asymptomatic and reversible.
  • Dose-dependent creatinine increases starting week 1; no serious or opportunistic infections.
  • Note: further CSU studies of fenebrutinib are not planned; program pivoted to MS.

Result source(s)

  • PMID 34750553
  • PMCID PMC8604722

Endpoints

  • Primary outcomes:
  • Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Day 57 (time frame: Baseline and Day 57)

Clinical Pharmacology Findings

  • PK: ClinicalTrials.gov summary text indicates pharmacokinetics were part of the study objectives or assessments.
  • 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/NCT03137069
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT03137069.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):
  • NCT03137069
  • ../raw/clinicaltrials/markdown/NCT03137069.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.