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

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SLCTR Registration Number

SLCTR/2022/028


Date of Registration

23 Nov 2022

The date of last modification

Dec 15, 2022



Application Summary


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


Trial Details


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

  1. Subjects who completed Trial 417-201-00007;NCT05248646 (at least 20 of the 26 doses and the end-of-trial visit) or Trial VIS649-201;NCT04287985 (at least 9 of the 12 doses and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN
  2. eGFR >20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion criteria

  1. Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.
  2. Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement that would preclude rollover into this trial


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.
  1. Annualized slope of Estimated Glomerular Filtration Rate (eGFR)
  2. Urine protein/creatinine ratio (uPCR) in a 24-hour collection
  3. Proportion of Subjects with Clinical Remission as defined in the protocol
  4. Time to Progression of Chronic Kidney Disease, as defined in the protocol (available to download under supporting documents)
[
  1. Annualized slope of Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Over 12 and 24 months ]
  2. Urine protein/creatinine ratio (uPCR) in a 24-hour collection [ Time Frame: At 12 and 24 months ]
  3. Proportion of Subjects with Clinical Remission as defined in the protocol [ Time Frame: At 12 and 24 months ]
  4. Time to Progression of Chronic Kidney Disease, as defined in the protocol [ Time Frame: Over 24 months ]
]

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


Date of study completion


Recruitment status

Pending


Funding source

Otsuka Pharmaceutical Development & Commercialization, Inc.


Regulatory approvals

Pending



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)







Trial Completion details


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