OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)

• Register: EUCTR
• Last refreshed on: 18 June 2018
• Main ID: EUCTR2018-000075-33-HU
• Date of registration: 29/03/2018
• 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: 07/06/2018
• Target sample size: 434
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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

Australia, Canada, Hungary, United States

Contacts

• Name: Anita Burroughs
• Affiliation: INC Research LLC

• Name: Anita Burroughs
• Affiliation: INC Research LLC

Key inclusion & exclusion criteria

Inclusion criteria:
• Age 18 years or older at the onset of Screening
• Biopsy confirmed diagnosis of IgAN within 10 years prior to Screening
• Proteinuria of > 1 g in 24-hour urine collection at Screening and baseline
• Estimated glomerular filtration rate of = 30 and = 90 mL/min/1.73 m2 at Screening and baseline
• Currently on physician-directed, stable treatment with RAS blockade (ACEIs, ARBs, direct renin inhibitors) and have a systolic BP of < 150 mmHg and a diastolic BP of < 100 mmHg at rest

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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion criteria:
• Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), cytotoxic drugs, or eculizumab within 24 weeks prior to Screening
• Unwilling or unable to discontinue systemic corticosteroids 12 weeks prior to Randomization
• 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
• Clinical or biological evidence of diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch Schonlein purpura), secondary IgAN, or other renal disease
• 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 3 months prior to Screening
• Significant abnormalities in clinical laboratory values
• Body mass index = 35 kg/m²
• History of human immunodeficiency virus (HIV), hepatitis B infection (including the presence of isolated anti-hepatitis B core), hepatitis C infection without prior curative treatment and sustained virologic cure, or evidence of immune suppression
• 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)
• Previously received OMS721



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

Health Condition(s) or Problem(s) studied

IgA nephropathy (IgAN)

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

Intervention(s)

Product Code: OMS721
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective: To evaluate the effect of OMS721 in patients with IgAN on:
• Safety and tolerability assessed by adverse events (AEs), vital signs, clinical laboratory tests, and electrocardiograms (ECGs)
• Renal function as determined by the rate of change in estimated glomerular filtration rate (eGFR) up to 144 weeks from BOT
• Proteinuria assessed by UPE at 24 weeks from BOT in the subset of patients with baseline high proteinuria (defined as 24-hour UPE = 2 g/day)
• Per-protocol-defined responder at 24 weeks
• Per-protocol-defined partial-responder at 24 weeks
• Time-averaged change in urine protein/creatinine ratio (uPCR)
• Proportion of patients who achieve partial proteinuria remission (24-hour UPE < 0.6 g/day)
• Proportion of patients who achieve complete proteinuria remission (24-hour UPE < 0.3 g/day)
• Proportion of patients who received rescue therapy for IgAN at any time during the study
• Pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721

Primary end point(s): • The primary endpoint of this study is the change from baseline in 24-hour UPE at 24 weeks from BOT.

Main Objective: • To evaluate the effect of OMS721 in patients with IgA nephropathy (IgAN) on proteinuria assessed by 24-hour urine protein excretion (UPE) in g/day at 24 weeks from beginning of treatment (BOT)

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome(s)

Secondary end point(s): • Safety and tolerability of OMS721 for the treatment of IgAN as assessed by AEs, vital signs, clinical laboratory tests, and ECGs
• The rate of change in eGFR up to 144 weeks from BOT
• Change from baseline in 24-hour UPE at 24 weeks from BOT in patients with baseline 24 hour UPE = 2 g
• Achievement of a treatment response defined as = 30% reduction from baseline in 24 hour UPE at 24 weeks
• Achievement of a partial response defined as a reduction between = 15% and < 30% from baseline in 24-hour UPE at 24 weeks
• Time averaged change from baseline in uPCR through 24 weeks. This will be measured as the time adjusted area-under-the-curve
• Achievement of partial proteinuria remission defined as 24-hour UPE < 0.6 g/day at any time during study
• Achievement of complete proteinuria remission defined as 24-hour UPE < 0.3 g/day at any time during study
• Use of rescue therapy for IgAN at any time during the study
• Change from baseline in eGFR at 24 weeks from BOT
• Pharmacokinetics and pharmacodynamics of OMS721
• Occurrence of ADA and, if present, NAb

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary ID(s)

OMS721-IGA-001

Source(s) of Monetary Support

Omeros Corporation