Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT03608033
• Date of registration: 21/06/2018
• Prospective Registration: No
• Primary sponsor: Omeros Corporation
• Public title: Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
• 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)
• Date of first enrolment: February 16, 2018
• Target sample size: 356
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03608033
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

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

- 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

Exclusion Criteria:

- Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or
cytotoxic drugs, for IgA within 8 weeks prior to Screening. Treatment with
immunosuppressants or cytotoxic drugs for IgAN is not allowed during the Run-In
Period. Treatment with immunosuppressants are allowed if such treatment is for
indications other than IgAN.

- Treatment with eculizumab within 8 weeks prior to Screening. Treatment with eculizumab
is not allowed during the Run-In Period.

- Treatment with systemic corticosteroids within 8 weeks prior to Screening. Treatment
with systemic corticosteroids is not allowed during the Run-In Period.

- Uncontrolled BP, a systolic BP of > 150 mmHg and a diastolic BP of > 100 mmHg at rest
despite the combination of two or more anti-hypertensives including ACEIs, ARBs, or
direct renin inhibitors at Screening and baseline

- 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 and Run-In

- History of renal transplantation

- Have a known hypersensitivity to any constituent of the investigational product

- Rapidly progressive glomerulonephritis

- Significant abnormalities in clinical laboratory values

- History of human immunodeficiency virus (HIV), evidence of immune suppression, active
HCV infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR
can enroll), 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
and/or treatments within 30 days of the Screening Visit (SV)

- Initiation 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 screening. Treatment
with Kerendia is not allowed during Screening and Run-In Periods

- Initiation of treatment with Filspari™ (sparsentan), a dual Endothelin Angiotensin
Receptor Antagonist (dEARA) or similar medication within three months prior to
screening. A stable dose initiated at minimum 3 months before screening is acceptable
and will take the place of ACEi/ARB as background therapy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Other: Vehicle (D5W or saline)

Biological: OMS721

Primary Outcome(s)

Change from baseline in 24-hour UPE in IgA nephropathy (IgAN) patients assessed at 36 weeks from baseline [Time Frame: 36 Weeks]

Secondary Outcome(s)

Change from baseline in log-transformed 24-hour uPCR through 36 weeks. [Time Frame: Week 36]

Assessment of pharmacodynamics of narsoplimab intravenous infusion [Time Frame: Week 12]

Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 and 72 weeks [Time Frame: 36 and 72 Weeks]

Assessment of percentage of participants with presence of neutralizing antibodies [Time Frame: Week 12]

Assessment of pharmacokinetics of narsoplimab intravenous infusion [Time Frame: Week 12]

Renal function as determined by the rate of change in eGFR at up to 96 weeks from baseline. [Time Frame: 96 Weeks]

Safety and tolerability of narsoplimab for the treatment of IgAN [Time Frame: Week 112]

Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 weeks and 48 weeks [Time Frame: 36 and 48 Weeks]

Assessment of pharmacodynamics of narsoplimab intravenous infusion with presence of positive anti-drug antibodies [Time Frame: Week 12]

Pharmacokinetics of narsoplimab intravenous infusion [Time Frame: Week 12]

Secondary ID(s)

OMS721-IGA-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors