Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Otsuka Pharmaceutical Development & Commercialization Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

16 Feb 2023 → ongoing

Decision date (initial)

2024-09-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2023-507233-19-00

EudraCT number

2021-005526-17

ClinicalTrials.gov

NCT05248659

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Pharmacodynamic, Safety, Efficacy

To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN.

Secondary objectives 4

1. To evaluate the long-term efficacy of sibeprenlimab in subjects with IgAN.
2. To evaluate Ig response in subjects with IgAN.
3. To evaluate immunogenicity in subjects with IgAN.
4. To evaluate the treatment effect of sibeprenlimab on the progression to a composite kidney failure endpoint (as measured by time to event or proportion of subjects).

Conditions and MedDRA coding

Treatment of IgAN

Regulatory references

Plan to share IPD

Yes

IPD 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. 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. Otsuka will share data supported by the protocol, statistical analysis plan (SAP) and clinical study report (CSR) on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses over a 2-year duration and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over a 1-year duration 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. Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.

Exclusion criteria 5

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.
3. Noncompliance, due to subject’s repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject’s eligibility.
4. Subjects who have a positive pregnancy test result prior to receiving IMP.
5. Heterosexually biological active males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject’s participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety and tolerability: Incidence of TEAEs graded by severity and as assessed by clinical laboratory tests, vital sign measurements, physical examinations, and injection site reactions.

Secondary endpoints 8

1. The slope of eGFR over the course of approximately 12 and 24 months.
2. Mean change of eGFR from baseline at 12 and 24 months.
3. Overall rate of proteinuric remission, based on 24-hour urine collection, and defined as the proportion of subjects achieving urine total protein < 0.5 g/day at 12 and 24 months.
4. Relative change from baseline in terms of uPCR at 12 and 24 months, based on 24-hour urine collection.
5. Progression to CKF, as assessed by: - Time to progression to CKF (time from first IMP date to first occurrence of CKF). - Proportion of subjects with progression to CKF.
6. Pharmacodynamics: Change from baseline in total serum IgA, IgG, and IgM concentrations.
7. Other: Evaluation of serum ADA levels.
8. Estimate the time-normalized AUC for eGFR at 12 and 24 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Otsuka Pharmaceutical Development & Commercialization Inc.

Sponsor organisation

Otsuka Pharmaceutical Development & Commercialization Inc.

Address

2440 Research Boulevard

City

Rockville

Postcode

20850-3238

Country

United States

Scientific contact point

Organisation

Otsuka Pharmaceutical Development & Commercialization Inc.

Contact name

EU Clinical Trials Helpdesk

Public contact point

Organisation

Otsuka Pharmaceutical Development & Commercialization Inc.

Contact name

EU Clinical Trials Helpdesk

Third parties 19

Locations

12 EU/EEA countries · 39 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 345 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

25 submissions — initial application plus substantial / non-substantial modifications