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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alexion Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

10 May 2021 → 18 Aug 2025

Decision date (initial)

2024-03-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Alexion Pharmaceuticals, Inc., United States

External identifiers

EU CT number

2023-507977-16-00

EudraCT number

2020-001537-13

ClinicalTrials.gov

NCT04564339

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Efficacy, Others, Therapy, Safety

Efficacy of ravulizumab compared with placebo in adult participants with LN and IgAN

Secondary objectives 1

1. Safety and tolerability of ravulizumab and additional efficacy measures

Conditions and MedDRA coding

Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN)

Regulatory references

Scientific advice from competent authorities

U.S. Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Common to both disease cohorts: - 18 - 75 years of age - Proteinuria ≥ 1 (g/d or g/g) - Vaccinated against meningococcal infection - Vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae For LN cohort: - Diagnosis of active focal or diffuse proliferative LN Class III or IV - Clinical active LN, requiring/receiving immunosuppression induction treatment For IgAN cohort: - Diagnosis of primary IgAN - Compliance with stable and optimal dose of RAS inhibitor treatment for ≥ 3 months For a full list of inclusion criteria please refer to the clinical study protocol, section 5.1.

Exclusion criteria 1

1. Common to both disease cohorts: - Estimated GFR < 30 mL/min/1.73 m^2 - Previously received a complement inhibitor (eg, eculizumab) at any time - Concomitant significant renal disease other than LN or IgAN - History of kidney transplant or planned kidney transplant during the Treatment Period - History of other solid organ or bone marrow transplant - Uncontrolled hypertension For IgAN cohort: - Diagnosis of rapid progressive glomerulonephritis - Prednisone or prednisone equivalent > 20 mg for > 14 consecutive days or any other immunosuppression within 6 months For a full list of exclusion criteria please refer to the clinical study protocol, section 5.2.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage change in proteinuria

Secondary endpoints 3

1. Common to both disease cohorts: - Percentage change in proteinuria - Change from baseline in eGFR
2. For LN: - Percentage of participants meeting the criteria for Complete Renal Response - Percentage of participants meeting the criteria for Partial Renal Response - Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g - Percentage of participants achieving corticosteroid taper to 7.5 mg/day - Percentage of participants with Renal Flare - Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare
3. For IgAN: - Percentage of participants meeting the criteria for Partial Remission

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alexion Pharmaceuticals Inc.

Sponsor organisation

Alexion Pharmaceuticals Inc.

Address

121 Seaport Boulevard

City

Boston

Postcode

02210-2050

Country

United States

Scientific contact point

Organisation

Alexion Pharmaceuticals Inc.

Contact name

European Clinical Trial Information

Public contact point

Organisation

Alexion Pharmaceuticals Inc.

Contact name

European Clinical Trial Information

Third parties 7

Locations

7 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 70 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications