A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

A Multicenter, Randomized, Placebo-Controlled Investigator-Blind, Participant-Blind Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI).

Study Overview

• Status: Terminated
• Conditions: Chronic Allograft Injury
• Intervention / Treatment: Drug: Zampilimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Nedlands, Australia
    • Cai001 403
• Belgium
  • Leuven, Belgium
    • Cai001 101
• Spain
  • Barcelona, Spain
    • Cai001 301
  • Hospitalet de Llobregat, Spain
    • Cai001 302
• United Kingdom
  • London, United Kingdom
    • Cai001 501

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Functioning living or deceased donor allograft >=1 year post-transplantation
• Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (>=25% IF/TA)
• Progressive loss in kidney function observed after the first year post-transplant, defined as an estimated glomerular filtration rate (eGFR) decline of ≥3 mL/min/year for at least 24 months prior to screening, with a minimum of 2 documented measurements per year (minimum of 4 documented measurements in the 24-month period, performed at least 1 month apart)
• An eGFR >=30 mL/min/1.73 m^2 for a period of 6 months up to screening
• Stable standard of care concomitant medication for 3 months prior to screening
• Participant is male or female, >=18 years of age

Exclusion Criteria:

• Recipient of multi-organ transplant (with the exception of repeated kidney transplant recipients, and/or corneal transplant recipients)
• Screening biopsy shows evidence of significant active antibody-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the Principal Investigator (PI)
• Screening biopsy shows evidence of T cell-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the PI
• Screening biopsy shows evidence of de novo or recurrent glomerular disease that may affect the conduct of the study (eg, require change in treatment) according to the PI
• Proteinuria ≥1500 mg/g at screening
• Participant who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening
• Participant has had major surgery (including joint surgery) within 6 months prior to screening, or has planned surgery within 6 months after the last dose of investigational medicinal product (IMP)
• Participant has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer or history of delayed wound healing
• Participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zampilimab Cohorts; Participants will be randomized to receive zampilimab (UCB7858).	Drug: Zampilimab; Participants will receive zampilimab (UCB7858) at pre-specified time-points.; Other Names: UCB7858
Placebo Comparator: Placebo; Participants randomized to this arm will receive matching Placebo.	Drug: Placebo; Participants will receive matching placebo (PBO) at pre-specified time-points.; Other Names: PBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the administration of investigational medicinal product (IMP) or any unresolved event already present before administration of IMP that worsens in intensity following exposure to the treatment.	From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of zampilimab	Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit	From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Urine concentration of zampilimab	Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit	From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Principal Investigator: UCB Cares, 001 844 599 2273

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Kidney transplantation; Chronic Allograft Injury; UCB7858; CAI; zampilimab
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CAI001; 2017-004807-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No