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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06209736




Registration number
NCT06209736
Ethics application status
Date submitted
4/01/2024
Date registered
17/01/2024

Titles & IDs
Public title
Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
Scientific title
A Phase 2 Proof of Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of OMS906 in Patients With C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)
Secondary ID [1] 0 0
OMS906-C3G-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
C3 Glomerulopathy 0 0
Idiopathic Immune Complex-Mediated Glomerulonephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OMS906 study drug

Experimental: Study Drug OMS906 - Repeat-dose OMS906 5 mg/kg IV administration at 4-week intervals


Treatment: Drugs: OMS906 study drug
OMS906 study drug dose 5mg/kg IV administration at 4-week internals
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN.
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Change in proteinuria measured by 24-hour urine protein/creatinine ratio (UPCR).
Timepoint [1] 0 0
12, 24, 48 weeks
Secondary outcome [2] 0 0
Change in proteinuria measured by 24-hour urine protein excretion (UPE).
Timepoint [2] 0 0
12, 24, and 48 weeks.
Secondary outcome [3] 0 0
Change in proteinuria measured as 24-hour urine albumin excretion (UAE).
Timepoint [3] 0 0
Time Frame: 12, 24, and 48 weeks.
Secondary outcome [4] 0 0
Change in proteinuria measured as 24-hour urine albumin/creatinine ratio (UACR).
Timepoint [4] 0 0
12, 24, and 48 weeks.
Secondary outcome [5] 0 0
Incidence of participants with a change from baseline of estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at 24 and 48 weeks.
Timepoint [5] 0 0
24 and 48 weeks
Secondary outcome [6] 0 0
Incidence of participants with a change from baseline serum creatinine concentration at 24 and 48 weeks.
Timepoint [6] 0 0
24 and 48 weeks
Secondary outcome [7] 0 0
Pharmacodynamics (PD) of multiple-dose administration of OMS906.
Timepoint [7] 0 0
48 weeks
Secondary outcome [8] 0 0
Pharmacokinetics (PK) of multiple-dose administration of OMS906 - Cmax.
Timepoint [8] 0 0
48 weeks
Secondary outcome [9] 0 0
Pharmacokinetics (PK) of multiple-dose administration of OMS906 - AUC.
Timepoint [9] 0 0
48 weeks
Secondary outcome [10] 0 0
OMS906 anti-drug antibodies (ADA).
Timepoint [10] 0 0
48 weeks

Eligibility
Key inclusion criteria
1. Male or female adults 18 years and older.
2. Competent to provide informed consent and has completed informed consent procedures.
3. Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening.
4. Two 24-hour UPCR = 0.8 gm/gm with the 2 collections separated by 14 - 28 days.
5. GFR estimated by the CKD-EPI equation = 45 mL/min/1.73 m2.
6. Serum C3 concentration less than the lower limit of laboratory normal during screening.
7. Must be on stable maximally tolerated or allowed dose of ACE inhibitor or ARB for at least 90 days.
8. If receiving a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, must be on a stable dose for at least 90 days.
9. If receiving mycophenolate mofetil, a mineralocorticoid receptor antagonist, or a corticosteroid, must be on stable dose for at least 90 days.
10. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Haemophilus influenza (where available) and agree to maintain vaccination throughout the study.

Patients who have not received these vaccinations at the time of screening may be vaccinated at any time prior to 2 weeks before the first study drug administration. Vaccine serotypes will be chosen by the local standard of care and serotype prevalence.
11. Female patients of child-bearing potential must have a negative highly sensitive pregnancy test at screening and prior to each dose of OMS906.
12. Females must use highly effective birth control* to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug.
13. Males must use highly effective birth control* with a female partner to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of major organ transplant or hematopoietic stem cell/marrow transplant.
2. Have known congenital deficiency of any of complement factors C1q, C1r, C1s, C2 or C4.
3. Have rapidly progressing glomerulonephritis defined as a 50% or greater decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
4. Have renal biopsy findings showing interstitial fibrosis/tubular atrophy of more than 50%.
5. Immunodeficiency or treatment with immunosuppressive agents (except mycophenolate mofetil or corticosteroids at the prednisone equivalent of = 7.5 mg/day in patients with C3G only) within 90 days of screening.
6. Treatment with rituximab within 6 months of screening.
7. Resting blood pressure > 140/90 mmHg during screening.
8. History of any active malignancy within 5 years of screening except non-melanoma skin cancers.
9. History of monoclonal gammopathy of unknown significance or any autoimmune disorder.
10. Elevation of liver function tests, defined as total bilirubin > 2 × upper limit of normal (ULN), direct bilirubin > 1.5 × ULN, and elevated transaminases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × ULN.
11. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.
12. Significant active bacterial or viral infection within the 2 weeks prior to screening including Covid-19 infection.
13. Use of any other complement inhibitor within 6 months prior to the screening visit.
14. Have human immunodeficiency virus, hepatitis B, or untreated hepatitis C infection.
15. Pregnant, planning to become pregnant, or nursing female patient.
16. Recent surgery requiring general anesthesia within the 2 weeks prior to screening or expected to have surgery requiring general anesthesia during the treatment period.
17. History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the study.
18. Treatment with any investigational medicinal product or investigational device within 30 days (or within 5 × its half-life in days, whichever is the longer period) prior to screening, or participation in another concurrent clinical trial involving a therapeutic intervention. Participation in observational and/or registry studies is permitted.
19. Unable or unwilling to comply with the requirements of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Lithuania
State/province [1] 0 0
Kaunas
Country [2] 0 0
Lithuania
State/province [2] 0 0
Vilnius
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Poland
State/province [4] 0 0
Lódz
Country [5] 0 0
Tunisia
State/province [5] 0 0
Monastir
Country [6] 0 0
Tunisia
State/province [6] 0 0
Tunis
Country [7] 0 0
Turkey
State/province [7] 0 0
Adana
Country [8] 0 0
Turkey
State/province [8] 0 0
Ankara
Country [9] 0 0
Turkey
State/province [9] 0 0
Denizli
Country [10] 0 0
Turkey
State/province [10] 0 0
Kayseri
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Leicester
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Omeros Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steve Whitaker, MD
Address 0 0
Omeros Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Omeros Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
206-676-5000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06209736