Home » Trials » SLCTR/2022/028
Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy
-
SLCTR Registration Number
SLCTR/2022/028
Date of Registration
The date of last modification
Feb 03, 2023
Scientific Title of Trial
Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy
Public Title of Trial
Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy
Disease or Health Condition(s) Studied
Immunoglobulin A Nephropathy
Scientific Acronym
None
Public Acronym
None
Brief title
Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
Universal Trial Number
U1111-1280-7394
Any other number(s) assigned to the trial and issuing authority
NCT05248659
What is the research question being addressed?
What is the Efficacy, Safety and Tolerability of sibeprenlimab administered subcutaneously in subjects with Immunoglobulin A Nephropathy (IgAN)?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
Study Sites: • Sri Jayewardenepura General Hospital • National Hospital of Sri Lanka • National Hospital, Kandy • Kurunegala Teaching Hospital • Karapitiya Teaching Hospital
Intervention: This trial will evaluate a total of 26 doses of 400mg sibeprenlimab (administered every 4 weeks). The IMP will be supplied as vials or prefilled syringes (PFS). The IMP will be administered SC once every 4 weeks by trained, qualified personnel designated by the investigator or sponsor. The SC injection site will be the abdomen, thigh, or upper arm per subject discretion. The date and time of IMP administration, the volume of IMP administered, and the injection site location will be recorded for each IMP administration. A total of 26 doses are planned to be administered, with Dose 1 administered on Day 1 and Dose 26 administered in Week 100.Subjects will complete a follow-up visit in Week 104. The end-of-trial visit will take place in Week 112, at which time final assessments will be performed.
Subjects discontinuing treatment prior to Dose 26 will complete the early discontinuation visit where the assessments done at week 104 will be performed at the time of treatment discontinuation and will be encouraged to complete the remainder of all planned trial visits after treatment discontinuation.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Incidence of Treatment-emergent adverse events (TEAEs) graded by severity and as assessed by clinical laboratory tests (mentioned below), vital sign measurements, physical examinations, and injection site reactions. TEAEs are all Adverse Effects which started after the start of IMP treatment: or if the event was continuous from baseline and was worsening, serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. Hematology: Basophils (percentage and absolute count) Eosinophils (percentage and absolute count) Hematocrit Hemoglobin Lymphocytes (percentage and absolute count) Mean corpuscular hemoglobin Mean corpuscular hemoglobin concentration Mean corpuscular volume Monocytes (percentage and absolute count) Neutrophils (percentage and absolute count) Platelet count Red blood cell count Red blood cell distribution width White blood cell count Urinalysis: Bilirubin Blood Creatinine Glucose Ketones Leukocytes Nitrite pH and specific gravity Protein Urobilinogen Microscopic (only for abnormal urine stick test findings) Serum Chemistry: Albumin Alkaline phosphatase ALT AST Calcium Chloride Total cholesterol Creatinine Gamma glutamyl transferase eGFR (calculated using the CKD-EPI equation) Glucose HbA1c Lactate dehydrogenase Phosphorus Potassium Sodium Total bilirubin Total protein Triglycerides Uric acid Viral Serology: HBsAb HBsAg Hepatitis C virus antibody HBcAb HIV enzyme-linked immunosorbent assay Other Tests Hepatitis B virus DNA for subjects with isolated HBcAb Pregnancy test: serum/urine beta human chorionic gonadotropin (subjects of childbearing potential only) |
[ Baseline and end-of-trial visit in Week 112 ] |
Secondary outcome(s)
|
1.
|
[
|
Target number/sample size
600
Countries of recruitment
Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Philippines, Poland, Portugal, Singapore, Spain, Sri Lanka, Thailand, United Kingdom, United States, Viet Nam
Anticipated start date
2022-11-30
Anticipated end date
2029-10-31
Date of first enrollment
2023-01-24
Date of study completion
Recruitment status
Recruiting
Funding source
Otsuka Pharmaceutical Development & Commercialization, Inc.
Regulatory approvals
Pending
Status
Approved
Date of Approval
2022-04-26
Approval number
P/22/02/2022
Details of Ethics Review Committee
| Name: | Ethics Review Committee, University of Kelaniya |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94 11 2961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr Chinthana Galahitiyawa
Consultant Nephrologist
Sri Jayewardenepura General Hospital, Nugegoda – 10250, Sri Lanka
+94112778610
chintanag@hotmail.com
Contact Person for Public Queries
Dr Chinthana Galahitiyawa
Consultant Nephrologist
Sri Jayewardenepura General Hospital, Nugegoda – 10250, Sri Lanka
+94112778610
chintanag@hotmail.com
Primary study sponsor/organization
Otsuka Pharmaceutical Development & Commercialization, Inc.
2440 Research Boulevard Rockville, Maryland 20850, United State
844-687-8522
OtsukaUS@drugunfo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing. Supporting Materials: Study Protocol Supporting Materials: Statistical Analysis Plan (SAP) Supporting Materials: Informed Consent Form (ICF) Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data. Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/ URL: http://clinical-trials.otsuka.com
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
