BIVV020 (SAR445088) in prevention and treatment of antibody-mediated rejection (AMR)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

9 Jun 2022 → ongoing

Decision date (initial)

2024-06-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2023-509936-25-00

EudraCT number

2021-000010-41

WHO UTN

U1111-1267-2612

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

• Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR
• Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR

Secondary objectives 4

1. To assess the overall efficacy of BIVV020 in prevention or treatment of AMR
2. To characterize the safety and tolerability of BIVV020 in kidney transplant participants
3. To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants
4. To evaluate the immunogenicity of BIVV020

Conditions and MedDRA coding

Transplant Rejection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant intended to receive SOC therapy per Investigator’s judgment and local practice. Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor . Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR. BMI ≤ 40 kg/m2. Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant). Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
2. Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor . Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR.
3. BMI ≤ 40 kg/m2.
4. Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
5. Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).

Exclusion criteria 6

1. Participants who are ABO incompatible with their donors.
2. Participants with known active ongoing infection as per below: a) Positive HIV. b) Positive HBV. c) HCV with detectable HCV RNA. d) Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection i, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention
3. History of active tuberculosis (TB) regardless of treatment.
4. Participants with clinical diagnosis of systemic lupus erythematosus (SLE).
5. Prior treatment with complement system inhibitor within 5 times the half-life.
6. Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Cohort A: Treatment failure rate
2. Cohort B: AMR resolution rate

Secondary endpoints 11

1. Cohort A: Treatment failure rate
2. Cohort B: AMR resolution rate
3. Change in renal function from baseline per central laboratory assessment of estimated glomerular filtration rate (eGFR) from serum creatinine using Modification of Diet in Renal Disease equation (MDRD)
4. Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio
5. Change in allograft histopathology Banff score
6. Graft survival as predicted by iBOX
7. Assessment of adverse events (AEs)
8. Change in systemic lupus erythematosus (SLE) panel
9. Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin
10. Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC
11. Number of participants with anti-BIVV020 antibodies

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 11

Locations

5 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 56 files

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

Application history

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