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Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

PHASE2RECRUITING

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

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Study details:

This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Proteinuria ≥1 (gram [g]/day or g/g)

Vaccinated against meningococcal infection

Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements

Diagnosis of active focal or diffuse proliferative LN Class III or IV

Clinically active LN, requiring/receiving immunosuppression induction treatment

Diagnosis of primary IgAN

Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months

Exclusion criteria

eGFR < 30 milliliters/minute/1.73 meters squared

Previously received a complement inhibitor (for example, eculizumab)

Concomitant significant renal disease other than LN or IgAN

History of other solid organ or bone marrow transplant

Uncontrolled hypertension

Diagnosis of rapid progressive glomerulonephritis

Prednisone or prednisone equivalent > 20 milligram (mg) per day for > 14 consecutive days or any other immunosuppression within 6 months

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-01-19

Primary completion: 2025-04-15

Study completion finish: 2026-05-27

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT04564339

Intervention or treatment

DRUG: Ravulizumab

DRUG: Placebo

OTHER: Background Therapy

Conditions

• Immunoglobulin A Nephropathy
• Lupus Nephritis

Image related to Immunoglobulin A Nephropathy

Condition: Immunoglobulin A Nephropathy, Lupus Nephritis
DRUG: Ravulizumab and other drugs
Herston, Not Specified, Australia and more
Sponsor: Alexion Pharmaceuticals, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Research Site

Research sites nearby

Select from list below to view details:

Research Site
Herston, Not Specified, Australia
Research Site
Parkville, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ravulizumab: LN Cohort Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.	DRUG: Ravulizumab Dosages (loading and maintenance) will be based on the participant's body weight.
PLACEBO_COMPARATOR: Placebo: LN Cohort Eligible participants will receive placebo IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.	DRUG: Placebo Dosages (loading and maintenance) will be based on the participant's body weight.
EXPERIMENTAL: Ravulizumab: IgAN Cohort Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.	DRUG: Ravulizumab Dosages (loading and maintenance) will be based on the participant's body weight.
PLACEBO_COMPARATOR: Placebo: IgAN Cohort Eligible participants will receive placebo IV infusion in combination with background therapy during the Initial Evaluation Period (26 weeks) and will switch to ravulizumab for the Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.	DRUG: Ravulizumab Dosages (loading and maintenance) will be based on the participant's body weight.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections	Not Specified	Baseline, Week 26

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections	Not Specified	Baseline, Week 50
Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50	Not Specified	Baseline, Week 26, Week 50
LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response	Complete renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure.	Week 26 and Week 50
LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response	Partial renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure.	Week 26 and Week 50
LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g	Not Specified	Baseline through Week 50
LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day	Not Specified	Week 14, Week 26, and Week 50
LN Cohort: Percentage Of Participants With Renal Flare	Not Specified	Baseline through Week 50
LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare	Not Specified	Baseline through Week 50
IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission	Partial remission will be determined by assessing proteinuria on 24-hour urine collections.	Week 26 and Week 50

Frequently Asked Questions

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References

Clinical Trials Gov: Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)