UrticariaPhase 2NCT03137069

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

A Phase 2 study testing GDC-0853 in people with Urticaria, run by Genentech, Inc. at 27 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Urticaria
What is being tested?: GDC-0853
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 134 participants
Where: 27 sitesin 3 countries
Study dates: 26 May 2017to 25 Oct 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 18Show fewer

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

Trial locations and contacts

27 sites in 3 countries.

Country

City, postcode or hospital

27 sites in 3 countries

United States13 sites

Kern Allergy Med Clinic, Inc.
Bakersfield, California, 93301
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35209
Timber Lane Allergy and Asthma Research, LLC
Burlington, Vermont, 05403
Center for Clinical Studies
Cypress, Texas, 77433
Asthma, Nasal Disease, and Allergy Research Center of New England
East Providence, Rhode Island, 02914
New Horizon Research Center
Miami, Florida, 33165
Southern California Research Center
Mission Viejo, California, 92691
Renstar Medical Research
Ocala, Florida, 34470
Allergy & Asthma Consultants
Redwood City, California, 94063
Integrated Research Group Inc
Riverside, California, 92506
Allergy & Asthma Immunology Associates
Scottsdale, Arizona, 85251
Vital Prospects Clinical Research Institute PC - CRN
Tulsa, Oklahoma, 74136
Integrated Research of Inland
Upland, California, 91786

Other trials in United States

Canada8 sites

Private Practice - Dr. Isabelle Delorme
Drummondville, Quebec, J2B 5L4
Private Practice - Dr. Jason Ohayon
Hamilton, Ontario, L8S 1G5
Lynde Institute for Dermatology
Markham, Ontario, L3P 1X2
Cheema Research
Mississauga, Ontario, L5A 3V4
Yang Medicine
Ottawa, Ontario, K1G 6C6
Centre de Recherche Applique En Allergie de Quebec
Québec, Quebec, G1V 4M6
Gordon Sussman Clinical Research
Toronto, Ontario, M4V 1R2
University of British Columbia
Vancouver, British Columbia, V6T 1Z4

Other trials in Canada

Germany6 sites

Licca Clinical Research Institute
Augsburg, 86179
Charite Mitte; Klinik fur Dermatologie
Berlin, 10117
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
Dresden, 01307
Hautarztpraxis Mahlow
Mahlow, 15831
Universitätsmedizin Johannes Gutenberg Universität
Mainz, 55131
Klinik für Haut- und Geschlechtskrankheiten, Universitätsklinikum Münster
Münster, 48419

Other trials in Germany

About this study

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).

Conditions: Urticaria
Being tested: GDC-0853, Placebo
Medical subject headings: Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03137069
Study group	Role	What they receive
Cohort 1: Placebo	Placebo comparator	Participants received matching placebo twice daily from Day 1 to 56. Receives: Drug: Placebo
Cohort 1: GDC-0853 200mg BID	Experimental	Participants received GDC-0853 200mg twice daily from Day 1 to 56. Receives: Drug: GDC-0853
Cohort 2: Placebo	Placebo comparator	Participants received matching placebo up to twice daily from Day 1 to 56. Receives: Drug: Placebo
Cohort 2: GDC-0853 50mg QD	Experimental	Participants received GDC-0853 50mg once daily from Day 1 to 56. Receives: Drug: GDC-0853
Cohort 2: GDC-0853 150mg QD	Experimental	Participants received GDC-0853 150mg once daily from Day 1 to 56. Receives: Drug: GDC-0853
Cohort 2: GDC-0853 200mg BID	Experimental	Participants received GDC-0853 200mg twice daily from Day 1 to 56. Receives: Drug: GDC-0853

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at 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.
Measured: Baseline and Day 57

Secondary outcomes (4)

Percentage of Participants Who Are Well-Controlled (UAS7 ≤ 6)
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. Participants with UAS7 score ≤6 are considered well controlled.
Measured: Day 57
Change From Baseline in the UAS7 at Day 29
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 29 score minus Baseline score) indicates improvement.
Measured: Baseline and Day 29
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.
Measured: 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
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. Please note that the Placebo Cohorts were not evaluated for this Outcome Measure.
Measured: Days 1, 8 and 57.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 201725 Oct 2019

First posted2 May 2017
Study start26 May 2017
Primary completion27 Sep 2019
Study completion25 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for UrticariaStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03137069
Sponsor's protocol ID: GS39684
Other IDs: 2016-004624-35, 2016
Status last verified: Sep 2020
First submitted: 28 Apr 2017
Last updated: 29 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria
Not yet recruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
Hereditary Angioedema (HAE)

All Urticaria trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT03137069
Acronym / sponsor ID: GS39684
Conditions: Urticaria
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: 26 May 2017 (actual)
Primary completion: 27 Sep 2019 (actual)
Study completion: 25 Oct 2019 (actual)
First posted: 2 May 2017 (actual)
Results: Posted 29 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Cohort 1: Placebo	Placebo comparator	Drug: PlaceboParticipants received matching placebo twice daily from Day 1 to 56.
Cohort 1: GDC-0853 200mg BID	Experimental	Drug: GDC-0853Participants received GDC-0853 200mg twice daily from Day 1 to 56.
Cohort 2: Placebo	Placebo comparator	Drug: PlaceboParticipants received matching placebo up to twice daily from Day 1 to 56.
Cohort 2: GDC-0853 50mg QD	Experimental	Drug: GDC-0853Participants received GDC-0853 50mg once daily from Day 1 to 56.
Cohort 2: GDC-0853 150mg QD	Experimental	Drug: GDC-0853Participants received GDC-0853 150mg once daily from Day 1 to 56.
Cohort 2: GDC-0853 200mg BID	Experimental	Drug: GDC-0853Participants received GDC-0853 200mg twice daily from Day 1 to 56.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GDC-0853GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.	Drug	Cohort 1: GDC-0853 200mg BID, Cohort 2: GDC-0853 150mg QD, Cohort 2: GDC-0853 200mg BID, Cohort 2: GDC-0853 50mg QD
PlaceboMatching Placebo will be administered orally, as per the dosing schedules described above.	Drug	Cohort 1: Placebo, Cohort 2: Placebo

Primary outcome

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.

4 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.

Results and safety

Results posted to the registry on 29 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Placebo	13	12
Cohort 1: GDC-0853 200mg BID	28	22
Cohort 2: Placebo	23	20
Cohort 2: GDC-0853 50mg QD	23	17
Cohort 2: GDC-0853 150mg QD	24	22
Cohort 2: GDC-0853 200mg BID	23	21

Primary outcome: Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Day 57

Time frame: Baseline and Day 57. Mean (Standard Deviation). Unit: Score on a Scale

Measure	Cohort 1: Placebo n = 12	Cohort 1: GDC-0853 200mg BID n = 22	Cohort 2: Placebo n = 20	Cohort 2: GDC-0853 50mg QD n = 19	Cohort 2: GDC-0853 150mg QD n = 22	Cohort 2: GDC-0853 200mg BID n = 21
Value	-19.16 (13.49)	-24.05 (9.74)	-11.25 (10.81)	-15.69 (14.25)	-17.05 (10.19)	-21.80 (14.80)

Cohort 1: Placebo vs Cohort 1: GDC-0853 200mg BID: Least Squares Mean Difference: -7.02 (90% CI -13.01 to -1.03), p = 0.0559, Mixed Models Analysis
Cohort 2: Placebo vs Cohort 2: GDC-0853 50mg QD: Least Squares Mean Difference: -0.51 (90% CI -6.60 to 5.58), p = 0.8892, Mixed Models Analysis
Cohort 2: Placebo vs Cohort 2: GDC-0853 150mg QD: Least Squares Mean Difference: -6.43 (90% CI -12.29 to -0.57), p = 0.0717, Mixed Models Analysis

Population analysed: The Modified Intent-To-Treat (mITT) Population was defined as all participants who received at least one dose of study treatment grouped for analysis according to the treatment arm to which they were randomized. Data presented below is only for participants included in the actual analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Placebo	0 of 13 (0%)	8 of 13 (61.5%)	0 of 13
Cohort 1: GDC-0853 200mg BID	3 of 28 (10.7%)	16 of 28 (57.1%)	0 of 28
Cohort 2: Placebo	0 of 22 (0%)	7 of 22 (31.8%)	0 of 22
Cohort 2: GDC-0853 50mg QD	0 of 23 (0%)	7 of 23 (30.4%)	0 of 23
Cohort 2: GDC-0853 150mg QD	0 of 24 (0%)	13 of 24 (54.2%)	0 of 24
Cohort 2: GDC-0853 200mg BID	0 of 24 (0%)	12 of 24 (50%)	0 of 24

Limitations and caveats (from the sponsor): Recruitment was stopped after an interim analysis of Cohort 2 based on pre-specified internal criteria.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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).

Related trials for Urticaria

RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria
Not yet recruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
Hereditary Angioedema (HAE)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

27 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GDC-0853 in people with Urticaria, run by Genentech, Inc. at 27 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Day 57 (time frame: Baseline and Day 57). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03137069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.