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

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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.

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 2

Trial 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?

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

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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