OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)

• Register: EUCTR
• Last refreshed on: 13 November 2023
• Main ID: EUCTR2018-000075-33-LT
• Date of registration: 23/04/2018
• Prospective Registration: Yes
• Primary sponsor: Omeros Corporation
• Public title: OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN
• Date of first enrolment: 15/06/2018
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000075-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Czechia, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Lithuania, Poland, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Anita Burroughs
• Affiliation: Syneos Health LLC

• Name: Anita Burroughs
• Affiliation: Syneos Health LLC

Key inclusion & exclusion criteria

Inclusion criteria:
• Age 18 years or older at the onset of Screening
• Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening or Run In Visit 1
• Documented history of proteinuria of > 1 g/day within 6 months prior to Screening, or uPCR > 0.75 by spot urine at Screening
• Mean of two proteinuria measurements > 1 g/day at baseline
• Estimated glomerular filtration rate of = 30 mL/min/1.73 m2 at Screening and baseline
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 410
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
• Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), Chinese Traditional Medicine with immunosuppressive function, cytotoxic drugs, or eculizumab within 8 weeks prior to Screening, unless such treatment is given for indications other than IgAN
• Treatment with systemic corticosteroids within 8 weeks prior to Screening
• Uncontrolled BP, a systolic BP of > 150 mmHg and a diastolic BP of >100 mmHg at rest despite the combination of two or more antihypertensives including ACE inhibiters, ARBs, or direct renin inhibitors
• Female patients who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug, including possible retreatments. Males who are planning to father children up through 12 weeks after the last dose of study drug, including possible retreatments.
• Clinical or biological evidence of Type 1 diabetes mellitus (DM) or poorly controlled DM with hemoglobin A1c > 7.5, or with evidence of diabetic nephropathy on biopsy, systemic lupus erythematosus, IgA Vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal
disease, during Screening or Run-In
• Presence of significant morbidity or other major illness or disease that may confound the interpretation of the clinical trial results or may result in death within 2 years of Screening
• History of renal transplantation
• Have a known hypersensitivity to any constituent of the investigational product
• Rapidly progressive glomerulonephritis, defined as a fall in eGFR of > 30 mL/min/1.73 m2 within 24 weeks or > 15 mL/min/1.73 m2 within 12 weeks prior to Screening. During the Run-In period a patient will be excluded if they experience a decrease in eGFR of > 15 mL/min/1.73 m2 from their best eGFR from the beginning of Screening.
• Significant abnormalities in clinical laboratory values including any of the following at the time of evaluation during Screening and Run-In:
a. hemoglobin < 9.0 g/dL
b. platelet count < 100,000 cells/mm3
c. absolute neutrophil count < 500 cells/mm3
d. alanine transaminase or aspartate transaminase (AST) > 3.0 × the upper limit of normal (ULN)
e. serum bilirubin > 2 × ULN
• History of human immunodeficiency virus (HIV), evidence of immune suppression, active hepatitis C virus (HCV) infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), and/or HBV hepatitis B virus (HBV) infection (patients with positive HBsAg are excluded. For patients with isolated positive anti-HBc antibody, HBV DNA test by PCR must be non-detectable to enroll).
• Diagnosis of a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for = 5 years
• Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit (SV) or within 5 times the plasma half-life of the administered experimental drug, whichever is longer
• Treatment with or change in dosing of sodium glucose co-transporter 2 inhibitors (SGLT2i) during Screening and Run-In Periods. However, a stable dose regimen established at least 8 weeks prior to screening is acceptable.
• Treatment with TARPEYO™ (budesonide) or other approved treatments for IgAN within 6 months prior to screening. Treatment with TARPEYO is not allowed during Screening and Run-In Periods.
• Treatment with Kerendia® (finerenone) within 6 months prior to s

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

IgA nephropathy (IgAN)
MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders

Intervention(s)

Product Name: Narsoplimab
Product Code: OMS721
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Narsoplimab
CAS Number: 2108782-45-0
Current Sponsor code: OMS721
Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 185-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To evaluate the effect of narsoplimab on 24-hour UPE in patients with IgA nephropathy (IgAN) on patients with high baseline proteinuria (high-risk proteinuria group; 24-hour urine protein excretion (UPE) in = 2 g/day) assessed at 36 weeks from baseline

Secondary Objective: To evaluate the effect of narsoplimab in patients with IgAN on:

- Renal function as determined by the rate of change in estimated glomerular filtration rate (eGFR) up to 96 weeks from baseline in patients with high baseline proteinuria (the high-risk proteinuria group; 24-hour UPE = 2 g/day)
- Proteinuria assessed by 24-hour UPE at 36 weeks from baseline in the all patients population
- Renal function as determined by the rate of change in eGFR at up to 96 weeks from baseline in the all-patients population
- Durability of proteinuria response from 36 weeks in patients with high baseline proteinuria (the high-risk proteinuria group; 24-hour UPE = 2 g/day) and in the all-patients population
- Change from baseline in log-transformed 24-hour UPE at Week 36 in the all-patients population (24-hour UPE > 1 g/day)

Refer to protocol for exhaustive list of secondary objectives

Primary end point(s): • The primary endpoint of this study is the change from baseline in log-transformed 24-hour UPE in g/day at 36 weeks in patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE = 2 g/day)

Timepoint(s) of evaluation of this end point: 36 weeks

Secondary Outcome(s)

Secondary end point(s): Key Secondary Endpoints
• The rate of change in eGFR up to 96 weeks from baseline in patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE = 2 g/day)
• The rate of change in eGFR up to 96 weeks from baseline in the all-patients population (24-hour UPE > 1 g/day)

Other Secondary Endpoints
• Change from baseline in log-transformed 24-hour UPE at Week 36 in the all patients population. (24-hour UPE > 1 g/day)
• Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 weeks and 48 weeks in patients with = 2 g/day UPE at baseline (high-risk proteinuria group)
• Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 weeks and 72 weeks in patients with = 2 g/day UPE at baseline (high-risk proteinuria group)
• Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 weeks and 48 weeks in the all-patients population
• Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 weeks and 72 weeks in the all-patients population

Timepoint(s) of evaluation of this end point: 36, 48, and 72 weeks for UPE, and 96 week for the rate of change in eGFR.

Secondary ID(s)

2018-000075-33-HU

OMS721-IGA-001

NCT03608033

Source(s) of Monetary Support

Omeros Corporation

Ethics review

Status: Approved
Approval date: 17/05/2018
Contact: