A study to compare different doses of fenebrutinib with a “placebo” – in patients with lupus

Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Autoimmune Disorder
Systemic Lupus Erythematosus

For Patient
For Medical Professional
Results
Download
Print

Basic Details

Gender

All

Age

≥ 18 Years & ≤ 75 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT02908100, GA30044, 2016-001039-11

Researchers wanted to find out what effect, good or bad, fenebrutinib caused in comparison to a placebo, in patients with systemic lupus erythematosus (lupus). A computer randomly decided which patients joined one of two fenebrutinib dose groups and which patients joined the placebo group. This was a double-blind study where patients and researchers did not know which of the 3 groups each patient belonged to.

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.

Results Disclaimer

What you can do next

Save the study number

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

Interested in more than one study? Log in to your ForPatients account to bookmark studies and get updates.

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

Study Identifier NCT02908100, GA30044, 2016-001039-11

Condition Systemic Lupus Erythematosus

Official Title A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

Study Summary

This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).

Eligibility Criteria

Gender

All

Age

≥ 18 Years & ≤ 75 Years

Healthy Volunteers

Inclusion Criteria

Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or equivalent)
Stable doses of anti-malarial or immunosuppressive therapies
Participants must be willing to avoid pregnancy

Exclusion Criteria

Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
History of having required hemodialysis or high dose corticosteroids (>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
Neuropsychiatric or central nervous system lupus manifestations
Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
History of receiving a solid organ transplant
Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
Evidence of chronic and/or active hepatitis B or C

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 to compare different doses of fenebrutinib with a “placebo” – in patients with lupus

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS GA30044 ATHOS Final Results May 2020 Brazil Portuguese (PDF, 0.1 MB)

LPS GA30044 ATHOS Final Results May 2020 Bulgarian (PDF, 0.2 MB)

LPS GA30044 ATHOS Final Results May 2020 Korean (PDF, 0.3 MB)

LPS GA30044 ATHOS Final Results May 2020 English (PDF, 0.1 MB)

LPS GA30044 ATHOS Final Results May 2020 German (PDF, 0.1 MB)

LPS GA30044 ATHOS Final Results May 2020 Latin America Spanish (PDF, 0.1 MB)

LPS GA30044 ATHOS Final Results May 2020 Spain Spanish (PDF, 0.1 MB)

LPS GA30044 ATHOS Final Results May 2020 Taiwan Chinese (PDF, 0.2 MB)

LPS GA30044 ATHOS Final Results May 2020 USA Spanish (PDF, 0.1 MB)

What is Clinical Research?

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

Directly contact Roche for questions

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 to compare different doses of fenebrutinib with a “placebo” – 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