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NOT YET RECRUITING
NCT07503561
PHASE2

A Study to Understand How a New, Unlicensed Drug Works, Compared With a Placebo, Against BK Virus in Patients Who Have Had a Kidney Transplant.

Sponsor: AiCuris Anti-infective Cures AG

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood. Researchers will compare AIC263029 to a placebo (a look-alike injection with no active drug). Participants will be assigned by chance to receive AIC263029 or placebo and will receive weekly injections under the skin for 4 weeks. Participants will have clinic visits and blood tests during treatment and follow-up to monitor safety and measure BKV levels, and will be followed for up to about 24 weeks after treatment.

Official title: A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Operationally Seamless Phase 2/3 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of AIC263029 in the Treatment of BKV Infection in Kidney Transplant Recipients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-06-15

Completion Date

2026-12-31

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

AIC263029

AIC263029 supplied in vials for injection (110 mg/mL) and administered by subcutaneous injection; Part A uses weekly dosing over 4 weeks in planned dose cohorts (100 mg, 200 mg, 330 mg).

DRUG

Placebo

Matching placebo administered by subcutaneous injection