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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002296-17 | EudraCT Number |
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Recruitment was stopped after an interim analysis of the parent GS39684 study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent Study: GDC-0853 | Experimental | 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. |
|
| Parent Study: Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0853 | Drug | Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. | Baseline up until 4 weeks after the last dose of study drug (up to 10 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Plasma Concentration Data for fenebrutinib (GDC-0853) will be tabulated and summarised by visits. Descriptive summary statistics for Arithmetic Mean and Standard Deviation will be presented. | Week 1 Day 1; Weeks 12 and 24; Study Completion/Early Discontinuation |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35209 | United States | ||
| Allergy & Asthma Immunology Associates |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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A total of 31 participants were enrolled at 9 centers.
The study was conducted at 9 centers in 1 country.
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| ID | Title | Description |
|---|---|---|
| FG000 | Parent Study: GDC-0853 | 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. |
| FG001 | Parent Study: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2018 |
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| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Kern Allergy Med Clinic, Inc. | Bakersfield | California | 93301 | United States |
| Southern California Research Center | Mission Viejo | California | 92691 | United States |
| Allergy & Asthma Consultants | Redwood City | California | 94063 | United States |
| Integrated Research Group Inc | Riverside | California | 92506 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Vital Prospects Clinical Research Institute PC - CRN | Tulsa | Oklahoma | 74136 | United States |
| Asthma, Nasal Disease, and Allergy Research Center of New England | East Providence | Rhode Island | 02914 | United States |
| Timber Lane Allergy and Asthma Research, LLC | Burlington | Vermont | 05403 | United States |
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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Parent Study: GDC-0853 | 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. |
| BG001 | Parent Study: Placebo | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. | The Safety-evaluable population was defined as all participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | Baseline up until 4 weeks after the last dose of study drug (up to 10 months). |
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| Secondary | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Plasma Concentration Data for fenebrutinib (GDC-0853) will be tabulated and summarised by visits. Descriptive summary statistics for Arithmetic Mean and Standard Deviation will be presented. | The PK population was defined as all participants who received at least one dose of study drug and had at least 1 evaluable PK sample. | Posted | Mean | Standard Deviation | ng/mL | Week 1 Day 1; Weeks 12 and 24; Study Completion/Early Discontinuation |
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Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parent Study: GDC-0853 | 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. | 0 | 23 | 0 | 23 | 4 | 23 |
| EG001 | Parent Study: Placebo | 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. | 0 | 8 | 0 | 8 | 5 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| ABSCESS LIMB | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
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| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 22.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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Recruitment was stopped after an interim analysis of the parent GS39684 study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Sep 2, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000619415 | fenebrutinib |
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| Male |
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| Not Hispanic or Latino |
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| Unknown |
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| Black or African American |
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| White |
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