---
title: A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
nct_id: NCT03137069
overall_status: COMPLETED
phase: PHASE2
sponsor: Genentech, Inc.
study_type: INTERVENTIONAL
primary_condition: Urticaria
countries: United States, Canada, Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03137069.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03137069"
ct_last_update_post_date: 2020-09-29
last_seen_at: "2026-05-12T07:05:39.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).

**Official Title:** A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of GDC-0853 in Patients With Refractory Chronic Spontaneous Urticaria (CSU).

**NCT ID:** [NCT03137069](https://clinicaltrials.gov/study/NCT03137069)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 134
- **Lead Sponsor:** Genentech, Inc.
- **Conditions:** Urticaria
- **Start Date:** 2017-05-26
- **Completion Date:** 2019-10-25
- **CT.gov Last Update:** 2020-09-29

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Aged 18-75 years, inclusive
* Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1 antihistamines at the time of randomization
* Willing and able to complete an Urticaria Participant Daily eDiary for the duration of the study
* No evidence of active or latent or inadequately treated infection with tuberculosis (TB)
* Partcipants with a history of Bacille Calmette-Guérin (BCG) vaccination should be screened using the QuantiFERON-TB-Gold (QFT) test
* Only for participants currently receiving proton-pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs): Treatment must be at a stable dose during the 2-week screening period prior to randomization and with a plan to remain at a stable dose for the duration of the study
* For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 4 weeks after the last dose of study drug. Women must refrain from donating eggs during this same period.

Exclusion Criteria:

* Treatment with omalizumab or other monoclonal antibody therapies used to treat CSU within 4 months prior to screening or primary nonresponse to omalizumab
* Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to study drug administration on Day 1 (or within 5 half-lives of the investigational product, whichever is greater)
* Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior to study drug administration on Day 1
* Previous treatment with GDC-0853 or other Bruton's tyrosine kinase (BTK) inhibitors
* Participants whose urticaria is solely due to physical urticaria
* Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, or leukemia
* Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or other skin disease associated with itch such as psoriasis
* Routine doses of the following medications within 30 days prior to screening: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
* Prior utilization of intravenous (IV) steroids for treatment of laryngeal angioedema
* Intravenous immunoglobulin G (IV IG) or plasmapheresis within 30 days prior to screening
* History of anaphylactic shock without clearly identifiable avoidable antigen
* Hypersensitivity to GDC-0853 or any component of the formulation
* Major surgery within 8 weeks prior to screening or surgery planned prior to end of study (12 weeks after randomization)
* Require any prohibited concomitant medications
* History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during study drug treatment
* Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal (GI) disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participant participation
* Current treatment with astemizole, terfenadine, and/or ebastine
* Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
```

## Arms

- **Cohort 1: Placebo** (PLACEBO_COMPARATOR) — Participants received matching placebo twice daily from Day 1 to 56.
- **Cohort 1: GDC-0853 200mg BID** (EXPERIMENTAL) — Participants received GDC-0853 200mg twice daily from Day 1 to 56.
- **Cohort 2: Placebo** (PLACEBO_COMPARATOR) — Participants received matching placebo up to twice daily from Day 1 to 56.
- **Cohort 2: GDC-0853 50mg QD** (EXPERIMENTAL) — Participants received GDC-0853 50mg once daily from Day 1 to 56.
- **Cohort 2: GDC-0853 150mg QD** (EXPERIMENTAL) — Participants received GDC-0853 150mg once daily from Day 1 to 56.
- **Cohort 2: GDC-0853 200mg BID** (EXPERIMENTAL) — Participants received GDC-0853 200mg twice daily from Day 1 to 56.

## Interventions

- **GDC-0853** (DRUG) — GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.
- **Placebo** (DRUG) — Matching Placebo will be administered orally, as per the dosing schedules described above.

## Primary Outcomes

- **Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Day 57** _(time frame: Baseline and Day 57)_ — The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (Day 57 score minus Baseline score) indicates improvement.

## Secondary Outcomes

- **Percentage of Participants Who Are Well-Controlled (UAS7 ≤ 6)** _(time frame: Day 57)_
- **Change From Baseline in the UAS7 at Day 29** _(time frame: Baseline and Day 29)_
- **Percentage of Participants With Adverse Events (AEs)** _(time frame: Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).)_
- **Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints** _(time frame: Days 1, 8 and 57.)_

## Locations (27)

- Clinical Research Center of Alabama, LLC, Birmingham, Alabama, United States
- Allergy & Asthma Immunology Associates, Scottsdale, Arizona, United States
- Kern Allergy Med Clinic, Inc., Bakersfield, California, United States
- Southern California Research Center, Mission Viejo, California, United States
- Allergy & Asthma Consultants, Redwood City, California, United States
- Integrated Research Group Inc, Riverside, California, United States
- Integrated Research of Inland, Upland, California, United States
- New Horizon Research Center, Miami, Florida, United States
- Renstar Medical Research, Ocala, Florida, United States
- Vital Prospects Clinical Research Institute PC - CRN, Tulsa, Oklahoma, United States
- Asthma, Nasal Disease, and Allergy Research Center of New England, East Providence, Rhode Island, United States
- Center for Clinical Studies, Cypress, Texas, United States
- Timber Lane Allergy and Asthma Research, LLC, Burlington, Vermont, United States
- University of British Columbia, Vancouver, British Columbia, Canada
- Private Practice - Dr. Jason Ohayon, Hamilton, Ontario, Canada
- Lynde Institute for Dermatology, Markham, Ontario, Canada
- Cheema Research, Mississauga, Ontario, Canada
- Yang Medicine, Ottawa, Ontario, Canada
- Gordon Sussman Clinical Research, Toronto, Ontario, Canada
- Private Practice - Dr. Isabelle Delorme, Drummondville, Quebec, Canada
- Centre de Recherche Applique En Allergie de Quebec, Québec, Quebec, Canada
- Licca Clinical Research Institute, Augsburg, Germany
- Charite Mitte; Klinik fur Dermatologie, Berlin, Germany
- Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde, Dresden, Germany
- Hautarztpraxis Mahlow, Mahlow, Germany
- Universitätsmedizin Johannes Gutenberg Universität, Mainz, Germany
- Klinik für Haut- und Geschlechtskrankheiten, Universitätsklinikum Münster, Münster, Germany

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clinical research center of alabama, llc|birmingham|alabama|united states` — added _(2026-05-12)_
- `locations.allergy & asthma immunology associates|scottsdale|arizona|united states` — added _(2026-05-12)_
- `locations.kern allergy med clinic, inc.|bakersfield|california|united states` — added _(2026-05-12)_
- `locations.southern california research center|mission viejo|california|united states` — added _(2026-05-12)_
- `locations.allergy & asthma consultants|redwood city|california|united states` — added _(2026-05-12)_
- `locations.integrated research group inc|riverside|california|united states` — added _(2026-05-12)_
- `locations.integrated research of inland|upland|california|united states` — added _(2026-05-12)_
- `locations.new horizon research center|miami|florida|united states` — added _(2026-05-12)_
- `locations.renstar medical research|ocala|florida|united states` — added _(2026-05-12)_
- `locations.vital prospects clinical research institute pc - crn|tulsa|oklahoma|united states` — added _(2026-05-12)_
- `locations.asthma, nasal disease, and allergy research center of new england|east providence|rhode island|united states` — added _(2026-05-12)_
- `locations.center for clinical studies|cypress|texas|united states` — added _(2026-05-12)_
- `locations.timber lane allergy and asthma research, llc|burlington|vermont|united states` — added _(2026-05-12)_
- `locations.university of british columbia|vancouver|british columbia|canada` — added _(2026-05-12)_
- `locations.private practice - dr. jason ohayon|hamilton|ontario|canada` — added _(2026-05-12)_
- `locations.lynde institute for dermatology|markham|ontario|canada` — added _(2026-05-12)_
- `locations.cheema research|mississauga|ontario|canada` — added _(2026-05-12)_
- `locations.yang medicine|ottawa|ontario|canada` — added _(2026-05-12)_
- `locations.gordon sussman clinical research|toronto|ontario|canada` — added _(2026-05-12)_
- `locations.private practice - dr. isabelle delorme|drummondville|quebec|canada` — added _(2026-05-12)_
- `locations.centre de recherche applique en allergie de quebec|québec|quebec|canada` — added _(2026-05-12)_
- `locations.licca clinical research institute|augsburg||germany` — added _(2026-05-12)_
- `locations.charite mitte; klinik fur dermatologie|berlin||germany` — added _(2026-05-12)_
- `locations.universitätsklinikum carl gustav carus, klinik und poliklinik für augenheilkunde|dresden||germany` — added _(2026-05-12)_
- `locations.hautarztpraxis mahlow|mahlow||germany` — added _(2026-05-12)_
- `locations.universitätsmedizin johannes gutenberg universität|mainz||germany` — added _(2026-05-12)_
- `locations.klinik für haut- und geschlechtskrankheiten, universitätsklinikum münster|münster||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03137069.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03137069*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*