BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eledon Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune system processes [G12]

Trial duration

28 Feb 2025 → ongoing

Decision date (initial)

2025-01-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Eledon Pharmceuticals , Inc

External identifiers

EU CT number

2023-503337-21-00

WHO UTN

U1111-1284-6127

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Prophylaxis

To assess the long-term safety of tegoprubart 20 mg/kg intravenous (IV) as part of a
regimen along with mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) in
kidney transplant recipients.

Secondary objectives 4

1. To assess participant and graft survival at various timepoints in tegoprubart-treated participants compared to tacrolimus-treated participants
2. To assess graft functional impairment at various timepoints in tegoprubart-treated participants compared to tacrolimus-treated participants
3. To assess graft function as measured by estimated glomerular filtration rate (eGFR) in tegoprubart-treated participants compared to tacrolimus-treated participants
4. To assess proportion of participants with biopsy-proven acute rejection (BPAR) at various timepoints in tegoprubart-treated participants compared to tacrolimus-treated participants; the BPAR objective is based on for-cause biopsies and central pathologist evaluation.

Conditions and MedDRA coding

Prophylaxis of Renal Allograft Rejection

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. A participant meeting the following criteria at the time of baseline will be considered for admission to the study: Successfully completed qualifying Parent study, where entry into the OLE was offered;
2. Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent
3. Agree not to participate in another interventional study while on treatment
4. If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline through 120 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6 and Table 7 (UK only)
5. If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 120 days after last administration of the study drug and agree to not donate sperm for 120days after last administration of the study drug

Exclusion criteria 3

1. A participant who meets any of the following criteria will be excluded from this study: Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator
2. Met any of the stopping criteria or discontinued study drug in the Parent study
3. Pregnant or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs).
2. Changes in vital signs and clinical laboratory measures.
3. Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) at baseline and 12, 24, 36, and 48 months.

Secondary endpoints 5

1. Efficacy endpoints: The proportion of participant and graft survival events at 12, 24, 36, and 48 months. Participant and graft survival events are defined as the earliest of either A) Death, B) Re-transplantation or C) Requirement for regular dialysis
2. The proportion of graft functional impairment at 12, 24, 36, and 48 months. A subject is considered to have graft functional impairment if they have an eGFR < 60 mL/min/1.73 m2
3. The mean eGFR at 12, 24, 36, and 48 months
4. Proportion of participants with BPAR at 12, 24, 36, and 48 months
5. Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months

Investigational products

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

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eledon Pharmaceuticals Inc.

Sponsor organisation

Eledon Pharmaceuticals Inc.

Address

19900 Macarthur Boulevard Suite 550

City

Irvine

Postcode

92612-8426

Country

United States

Scientific contact point

Organisation

Eledon Pharmaceuticals Inc.

Contact name

Chief Regulatory Officer

Public contact point

Organisation

Eledon Pharmaceuticals Inc.

Contact name

Clinical Operations

Third parties 4

Locations

3 EU/EEA countries · 13 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 31 files

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

Application history

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