A study of the long-term effects of fenebrutinib treatment in patients with lupus

An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Autoimmune Disorder

For Patient
For Medical Professional
Download
Print

Basic Details

Gender

All

Age

≥ 18 Years & ≤ 76 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT03407482, GA30066, 2017-001764-37

This clinical trial was done to study a new medicine called, “fenebrutinib”, for the treatment of patients with “lupus”. Researchers wanted to know if fenebrutinib was safe over a long-term period when given to patients with lupus. One hundred and sixty patients took part in this study at 49 study centers in 11 countries.

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

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

What you can do next

Save the study number

To find this study again later, copy and save the study number:

Talk to a doctor or nurse

To see if this study is a good fit, talk to your doctor or nurse you trust.

Together, you can look at the For Medical Professional tab and look into your medical history.

Reach out for more info

Some medical centers in this study offer a contact line. Click "Find participating medical centers" in the map below.

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Genentech, Inc.

Phase Phase 2

Trial Identifier NCT03407482, GA30066, 2017-001764-37

Condition Lupus Erythematosus, Systemic

Official Title A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

Study Summary

This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.

Eligibility Criteria

Gender

All

Age

≥ 18 Years & ≤ 76 Years

Healthy Volunteers

Inclusion Criteria

Able to comply with the study protocol, in the investigator's judgment
Completion of Study GA30044 up to 48 weeks
Acceptable safety and tolerability during Study GA30044 as determined by the investigator

Exclusion Criteria

Met protocol-defined treatment-stopping criteria during Study GA30044
An adverse event in Study GA30044 that required permanent discontinuation of study drug
In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective
Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor

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 the long-term effects of fenebrutinib treatment in patients with lupus

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

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

Contact Genentech

Contact the hospital directly

Thank you

Something went wrong

Request a call back

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

A study of the long-term effects of fenebrutinib treatment in patients with lupus

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