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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
First received
Last updated
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
Health authority
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

Study Design


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
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