Clinical Trials List
Protocol NumberOMS721-IGA-001
2019-11-01 - 2023-07-30
Phase III
Recruiting4
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)
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Trial Applicant
Syneos Health
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2023/03/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王智賢 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Wei Chen Division of Nephrology
- Mei-Yi Wu Division of Nephrology
- 鄒居霖 Division of Nephrology
- Li-Yee Hong Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Immunoglobulin A (IgA) Nephropathy
Objectives
Primary 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 36 weeks from baseline
Secondary Objectives:
To evaluate the effect of OMS721 in patients with IgAN on:
•Proteinuria assessed by 24-hour UPE at 36 weeks from baseline in the subset of patients with high baseline proteinuria (defined as 24-hour UPE ≥ 2 g)
•Durability of proteinuria response from 36 weeks
•Renal function as determined by the rate of change in estimated glomerular filtration rate (eGFR) up to 144 weeks from baseline
•Safety and tolerability
•Pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721
Test Drug
OMS721
Active Ingredient
Dosage Form
Dosage
185 mg/mL
Endpoints
Primary Endpoint:
• The primary endpoint of this study is the change from baseline in log-transformed
24-hour UPE in g/day at 36 weeks from baseline
Key Secondary Endpoints
• Proteinuria responder, defined as having a 24-hour UPE of at least 50% reduction
from baseline as assessed at Week 36 (patients with ≥ 2 g/day UPE at baseline only)
• The rate of change in eGFR up to 144 weeks from baseline
Other Secondary Endpoints
• Time-averaged change from baseline in the log-transformed 24-hour UPE between
36 weeks and 48 weeks
• Time-averaged change from baseline in the log-transformed 24-hour UPE between
36 weeks and 72 weeks
• Time-averaged 24-hour UPE from 36 weeks to 48 weeks to a level at least 50%
reduced from the baseline 24-hour UPE (patients with ≥ 2 g/day UPE at baseline
only)
• Time-averaged 24-hour UPE from 36 weeks to 72 weeks to a level at least 50%
reduced from the baseline 24-hour UPE (patients with ≥ 2 g/day UPE at baseline
only)
Safety and Other Endpoints
• Safety and tolerability of OMS721 for the treatment of IgAN as assessed by AEs,
vital signs, clinical laboratory tests, and ECGs
• Change from baseline in log-transformed 24-hour UPE at 36 weeks from baseline in
patients with baseline 24-hour UPE ≥ 2 g
• Change from baseline in log-transformed 24-hour uPCR over time
• Achievement of ≥ 50% reduction from baseline in 24-hour UPE at 36 weeks in
patients with baseline 24-hour UPE ≥ 2 g
• Achievement of ≥ 30% reduction from baseline in 24-hour UPE at 36 weeks
• Time averaged change from baseline in the log-transformed 24-hour uPCR through
36 weeks
• Achievement of partial proteinuria remission defined as 24-hour UPE < 0.6 g at any
time post baseline
• Achievement of complete proteinuria remission defined as 24-hour UPE < 0.3 g at
any time post baseline
• Use of rescue therapy for IgAN at any time post baseline
• Change from baseline in eGFR at 36 weeks
• Pharmacokinetics and pharmacodynamics of OMS721
• Occurrence of ADA and, if present, Nab
• The primary endpoint of this study is the change from baseline in log-transformed
24-hour UPE in g/day at 36 weeks from baseline
Key Secondary Endpoints
• Proteinuria responder, defined as having a 24-hour UPE of at least 50% reduction
from baseline as assessed at Week 36 (patients with ≥ 2 g/day UPE at baseline only)
• The rate of change in eGFR up to 144 weeks from baseline
Other Secondary Endpoints
• Time-averaged change from baseline in the log-transformed 24-hour UPE between
36 weeks and 48 weeks
• Time-averaged change from baseline in the log-transformed 24-hour UPE between
36 weeks and 72 weeks
• Time-averaged 24-hour UPE from 36 weeks to 48 weeks to a level at least 50%
reduced from the baseline 24-hour UPE (patients with ≥ 2 g/day UPE at baseline
only)
• Time-averaged 24-hour UPE from 36 weeks to 72 weeks to a level at least 50%
reduced from the baseline 24-hour UPE (patients with ≥ 2 g/day UPE at baseline
only)
Safety and Other Endpoints
• Safety and tolerability of OMS721 for the treatment of IgAN as assessed by AEs,
vital signs, clinical laboratory tests, and ECGs
• Change from baseline in log-transformed 24-hour UPE at 36 weeks from baseline in
patients with baseline 24-hour UPE ≥ 2 g
• Change from baseline in log-transformed 24-hour uPCR over time
• Achievement of ≥ 50% reduction from baseline in 24-hour UPE at 36 weeks in
patients with baseline 24-hour UPE ≥ 2 g
• Achievement of ≥ 30% reduction from baseline in 24-hour UPE at 36 weeks
• Time averaged change from baseline in the log-transformed 24-hour uPCR through
36 weeks
• Achievement of partial proteinuria remission defined as 24-hour UPE < 0.6 g at any
time post baseline
• Achievement of complete proteinuria remission defined as 24-hour UPE < 0.3 g at
any time post baseline
• Use of rescue therapy for IgAN at any time post baseline
• Change from baseline in eGFR at 36 weeks
• Pharmacokinetics and pharmacodynamics of OMS721
• Occurrence of ADA and, if present, Nab
Inclution Criteria
1. Age 18 years or older at the onset of Screening (In Taiwan, age 20 years or older at the onset of Screening)
2. Understand and voluntarily sign an informed consent form in accordance with regulations and governing institutional review board (IRB) or independent ethics committee (IEC) requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study
3. Biopsy-confirmed diagnosis of IgAN within 8 years prior to Screening
4. Documented history of proteinuria > 1 g/day within 6 months prior to Screening or uPCR > 0.75 by spot urine at Screening
5. Mean of two proteinuria measurements > 1 g/day at baseline
6. Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m2 calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening and baseline
7. Females having heterosexual intercourse should either a) not be of childbearing potential (i.e., surgically sterilized or postmenopausal for > 1 year), b) have a negative pregnancy test at Screening and baseline and, if sexually active, must agree to use two medically reliable forms of contraception throughout the study and for at least 12 week after the last dose of study drug, including possible retreatments, or c) have a medically sterilized male partner. Acceptable methods of contraception include a reliable intrauterine device, hormonal contraception, or a barrier method.
8. Males having heterosexual intercourse should either a) not be of reproductive potential or b) if sexually active, must agree to use a medically reliable form of contraception throughout the study and for at least 12 weeks after the last dose of study drug, including possible retreatments. Acceptable methods of birth control include spermicide in combination with a barrier method, or patient’s female partner is willing to use medically acceptable methods of birth control (i.e., intrauterine device, hormonal contraception, or a barrier method).
9. Male patients must be willing to avoid fathering children for at least 12 weeks following the last dose of study medication.
2. Understand and voluntarily sign an informed consent form in accordance with regulations and governing institutional review board (IRB) or independent ethics committee (IEC) requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study
3. Biopsy-confirmed diagnosis of IgAN within 8 years prior to Screening
4. Documented history of proteinuria > 1 g/day within 6 months prior to Screening or uPCR > 0.75 by spot urine at Screening
5. Mean of two proteinuria measurements > 1 g/day at baseline
6. Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m2 calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening and baseline
7. Females having heterosexual intercourse should either a) not be of childbearing potential (i.e., surgically sterilized or postmenopausal for > 1 year), b) have a negative pregnancy test at Screening and baseline and, if sexually active, must agree to use two medically reliable forms of contraception throughout the study and for at least 12 week after the last dose of study drug, including possible retreatments, or c) have a medically sterilized male partner. Acceptable methods of contraception include a reliable intrauterine device, hormonal contraception, or a barrier method.
8. Males having heterosexual intercourse should either a) not be of reproductive potential or b) if sexually active, must agree to use a medically reliable form of contraception throughout the study and for at least 12 weeks after the last dose of study drug, including possible retreatments. Acceptable methods of birth control include spermicide in combination with a barrier method, or patient’s female partner is willing to use medically acceptable methods of birth control (i.e., intrauterine device, hormonal contraception, or a barrier method).
9. Male patients must be willing to avoid fathering children for at least 12 weeks following the last dose of study medication.
Exclusion Criteria
1. Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or cytotoxic drugs, for IgAN 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.
2. Treatment with eculizumab within 8 weeks prior to Screening. Treatment with eculizumab is not allowed during the Run-In Period.
3. Treatment with systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In Period.
4. 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
5. Female patients who are pregnant, breast feeding, or planning to become pregnant until 12 weeks after the last dose of study drug, including possible retreatments
6. 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
7. 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
8. History of renal transplantation
9. Have a known hypersensitivity to any constituent of the investigational product
10. 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 of 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.
11. 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
12. History of 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).
13. 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
14. Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit or within 5 times the plasma half-life of the administered experimental drug, whichever is longer
15. Previously received OMS721
16. Is an employee of Omeros, the investigative site (whereas site is meant as the clinic, department, or Clinical Research Unit in which the Investigator works or conducts the trial), a study staff member, or their immediate family member
17. Presence of any condition that the Investigator believes would put the patient at risk from participation
18. Any patient who, in the opinion of the Investigator, is likely to be noncompliant or who is not suitable for the study
19. Presence of active infection occurring within 7 days of Screening or at the time of Screening
2. Treatment with eculizumab within 8 weeks prior to Screening. Treatment with eculizumab is not allowed during the Run-In Period.
3. Treatment with systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In Period.
4. 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
5. Female patients who are pregnant, breast feeding, or planning to become pregnant until 12 weeks after the last dose of study drug, including possible retreatments
6. 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
7. 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
8. History of renal transplantation
9. Have a known hypersensitivity to any constituent of the investigational product
10. 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 of 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.
11. 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
12. History of 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).
13. 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
14. Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit or within 5 times the plasma half-life of the administered experimental drug, whichever is longer
15. Previously received OMS721
16. Is an employee of Omeros, the investigative site (whereas site is meant as the clinic, department, or Clinical Research Unit in which the Investigator works or conducts the trial), a study staff member, or their immediate family member
17. Presence of any condition that the Investigator believes would put the patient at risk from participation
18. Any patient who, in the opinion of the Investigator, is likely to be noncompliant or who is not suitable for the study
19. Presence of active infection occurring within 7 days of Screening or at the time of Screening
The Estimated Number of Participants
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Taiwan
14 participants
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Global
450 participants
