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

Lupus Nephritis Clinical Trial

— SANCTUARY  

Official title:

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564339
• Other study ID #: ALXN1210-NEPH-202
• Secondary ID: 2020-001537-13
• Status: Recruiting
• Phase: Phase 2
• Start date: December 11, 2020
• Est. completion date: October 31, 2026

Study information

• Verified date: November 2023
• Source: Alexion Pharmaceuticals, Inc.
• Contact: Alexion Pharmaceuticals, Inc.
• Phone: 855-752-2356
• Email: clinicaltrials[@]alexion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Common to both disease cohorts:

• 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

For LN cohort:

• Diagnosis of active focal or diffuse proliferative LN Class III or IV
• Clinically active LN, requiring/receiving immunosuppression induction treatment

For IgAN cohort:

• Diagnosis of primary IgAN
• Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for = 3 months Exclusion Criteria:

Common to both disease cohorts:

• 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

For IgAN cohort:

• 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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• Immunoglobulin A Nephropathy
• Kidney Diseases
• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
• Placebo
Dosages (loading and maintenance) will be based on the participant's body weight.

Other:
• Background Therapy
Participants will receive background therapy consistent with the standard of care.

Locations

Country	Name	City	State
Australia	Clinical Study Site	Herston	Queensland
Australia	Clinical Study Site	Parkville	Melbourne
Australia	Clinical Study Site	Westmead	New South Wales
Canada	Clinical Study Site	London	Ontario
Canada	Clinical Study Site	Montreal	Quebec
Canada	Clinical Study Site	Quebec
France	Clinical Study Site	Clermont-Ferrand
France	Clinical Study Site	Créteil
France	Clinical Study Site	Le Kremlin-Bicêtre
France	Clinical Study Site	Montpellier
France	Clinical Study Site	Paris
France	Clinical Study Site	Saint-Étienne
France	Clinical Study Site	Strasbourg	Bas-Rhin
France	Clinical Study Site	Toulouse
Germany	Clinical Study Site	Berlin
Germany	Clinical Study Site	Essen
Germany	Clinical Study Site	Essen	North Rhine-Westphalia
Germany	Clinical Study Site	Hannover	Niedersachsen
Germany	Clinical Study Site	Lubeck
Italy	Clinical Study Site	Bergamo
Italy	Clinical Study Site	Bologna
Italy	Clinical Study Site	Brescia
Italy	Clinical Study Site	Firenze
Italy	Clinical Study Site	Monza
Italy	Clinical Study Site	Torino
Korea, Republic of	Clinical Study Site	Anyang-si	Gyeonggi-do
Korea, Republic of	Clinical Study Site	Seongnam	Gyeonggi-do
Korea, Republic of	Clinical Study Site	Seoul
Korea, Republic of	Clinical Study Site	Seoul
Korea, Republic of	Clinical Study Site	Seoul
Korea, Republic of	Clinical Study Site	Seoul
Netherlands	Clinical Study Site	Maastricht
Poland	Clinical Study Site	Bydgoszcz
Poland	Clinical Study Site	Lodz
Singapore	Clinical Study Site	Singapore
Spain	Clinical Study Site	Alicante
Spain	Clinical Study Site	Barcelona
Spain	Clinical Study Site	Barcelona
Spain	Clinical Study Site	Lleida
Spain	Clinical Study Site	Madrid
Spain	Clinical Study Site	Madrid
Spain	Clinical Study Site	Madrid
Spain	Clinical Study Site	Malaga
Spain	Clinical Study Site	Palma	Illes Balears
Spain	Clinical Study Site	Santiago De Compostela	A Coruña
Spain	Clinical Study Site	Sevilla	Andalucia
Spain	Clinical Study Site	Valencia	Comunidad
Spain	Clinical Study Site	Zaragoza
Sweden	Clinical Study Site	Orebro
Sweden	Clinical Study Site	Uppsala
Taiwan	Clinical Study Site	Kaohsiung City
Taiwan	Clinical Study Site	Kaohsiung City
Taiwan	Clinical Study Site	New Taipei City
Taiwan	Clinical Study Site	Taichung City
United Kingdom	Clinical Study Site	Birmingham
United Kingdom	Clinical Study Site	London
United Kingdom	Clinical Study Site	London
United Kingdom	Clinical Study Site	Nottingham
United Kingdom	Clinical Study Site	Salford
United States	Clinical Study Site	Boston	Massachusetts
United States	Clinical Study Site	Boston	Massachusetts
United States	Clinical Study Site	Chapel Hill	North Carolina
United States	Clinical Study Site	Columbus	Ohio
United States	Clinical Study Site	Dallas	Texas
United States	Clinical Study Site	El Paso	Texas
United States	Clinical Study Site	Fort Worth	Texas
United States	Clinical Study Site	Hollywood	Florida
United States	Clinical Study Site	Houston	Texas
United States	Clinical Study Site	Houston	Texas
United States	Clinical Study Site	Kansas City	Missouri
United States	Clinical Study Site	Lawrenceville	Georgia
United States	Clinical Study Site	Lexington	Kentucky
United States	Clinical Study Site	Los Angeles	California
United States	Clinical Study Site	Louisville	Kentucky
United States	Clinical Study Site	Milwaukee	Wisconsin
United States	Clinical Study Site	New York	New York
United States	Clinical Study Site	Orlando	Florida
United States	Clinical Study Site	S. Gate	California
United States	Clinical Study Site	Salt Lake City	Utah
United States	Clinical Study Site	San Dimas	California
United States	Clinical Study Site	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Singapore,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections		Baseline, Week 26
Secondary	Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections		Baseline, Week 50
Secondary	Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50		Baseline, Week 26, Week 50
Secondary	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
Secondary	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
Secondary	LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g		Baseline through Week 50
Secondary	LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day		Week 14, Week 26, and Week 50
Secondary	LN Cohort: Percentage Of Participants With Renal Flare		Baseline through Week 50
Secondary	LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare		Baseline through Week 50
Secondary	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