A study of long-term effects of fenebrutinib treatment in patients with chronic spontaneous urticaria

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

Infectious Diseases

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Basic Details

Gender

All

Age

≥ 18 Years & ≤ 75 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT03693625, GS40868, 2018-002296-17

This clinical trial was done to study a new medicine called, “fenebrutinib”, for the treatment of patients with “chronic spontaneous urticaria” or “CSU”. This study was done to find out if the long-term use of fenebrutinib was safe for patients with CSU. Researchers also wanted to find out whether fenebrutinib could provide improvements to CSU symptoms in patients when used long-term. Thirty-one patients took part in this study at nine study centers in the USA.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT03693625, GS40868, 2018-002296-17

Condition Urticaria

Official Title A Phase II Open-Label Extension Study To Evaluate The Long-Term Safety And Efficacy Of Fenebrutinib In Patients Previously Enrolled In A Fenebrutinib Chronic Spontaneous Urticaria Study

Study 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.

Eligibility Criteria

Gender

All

Age

≥ 18 Years & ≤ 75 Years

Healthy Volunteers

Inclusion Criteria

Ability to comply with the study protocol, in the investigator's judgment
Completion of the treatment period as specified in the parent study
Acceptable demonstration of tolerance to study drug during the parent study as determined by the investigator or Medical Monitor
For participants receiving treatment with proton-pump inhibitors (PPIs) or H2-receptor antagonists (H2RAs), agreement to maintain treatment at a stable dose for the first 12 weeks of the study
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria

Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 weeks after the final dose of fenebrutinib
Treatment with any investigational agent or live/attenuated vaccine in the preceding 6 weeks
Any signs or symptoms of infection judged by the investigator to be clinically significant since completing the treatment period of the parent study
Any significant changes (e.g., events, changes in medication) occurring after completion of participation in the parent study that, in the investigator's judgment, would increase the risk of adverse events in this OLE study

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study of long-term effects of fenebrutinib treatment in patients with chronic spontaneous urticaria

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

GS40868_LPS_July2020_English (PDF, 0.5 MB)

GS40868_LPS_July2020_Spanish_USA (PDF, 0.4 MB)

What is Clinical Research?

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A study of long-term effects of fenebrutinib treatment in patients with chronic spontaneous urticaria

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com