A Study to Understand How a New, Unlicensed Drug (AIC468) Works, Compared With a Placebo, Against BK Virus in Patients Who Have Had a Kidney Transplant.

NCT07503561 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AIC468-01-II/III-01
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

BK Virus Infection

Keywords

BK Virus; BK Viremia in kidney transplant; antisense oligonucleotide; AIC263029

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of treatment-emergent adverse events (TEAEs)

  Frequency and severity of treatment emergent adverse events

  Day 1 to Day 30 of the dosing period.

Study Arms (2)

AIC263029

EXPERIMENTAL

Weekly subcutaneous AIC263029 administered over 4 weeks. Three initial dose cohorts are planned (100 mg, 200 mg, 330 mg), with 5 weekly injections over 4 weeks; within each cohort, participants are randomized 3:1 to AIC263029 vs placebo. Up to 3 additional optional cohorts may be enrolled.

Drug: AIC263029

Placebo

PLACEBO COMPARATOR

Matching placebo administered by subcutaneous injection on the same schedule as active treatment within each cohort

Drug: Placebo

Interventions

AIC263029 DRUG

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).

AIC263029

Placebo DRUG

Matching placebo administered by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 years or older
• Kidney transplantation within 12 months prior to randomization
• First episode of detectable BKV DNA in plasma since last kidney transplantation. As defined by either:
• positive BKV DNA test of one time \>104 IU/mL and \<106 IU/mL, within 30 days prior to randomization, or
• \>103 IU/mL and ≤104 IU/mL sustained for at least 2 weeks (confirmed by at least 2 consecutive measurements), with the most recent measurement within 14 days prior to randomization.
• Female participants (if of childbearing potential) must agree to remain abstinent (refrain from heterosexual intercourse) or use at least one highly effective contraceptive method that result in a failure rate of \<1% per year until the end of the trial.
• Male participants must agree to refrain from donating sperm, and to remain abstinent (refrain from heterosexual intercourse) or use a condom with a female partner of childbearing potential until the end of the trial.
• Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test prior to randomization on Day 1.
• Able and willing to provide written informed consent and comply with trial protocol.

You may not qualify if:

• Known hypersensitivity to any component of the IMP
• Estimated glomerular filtration rate (\[e\]GFR) \<30 mL/minute/1.73 m2 at screening
• Alanine transaminase (ALT) \>2×upper limit of normal (ULN) or direct bilirubin \>1.1×ULN (except Gilbert's Disease) at screening
• Uncontrolled participants who are treated or planned to be treated with an mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the trial period
• Participants who have received a multi-organ transplant involving a kidney (e.g. kidney-pancreas, kidney-liver, kidney-heart)
• Participants who are treated or planned to be treated during trial participation with leflunomide, cidofovir, or medicinal products potentially active against BKV at the time of randomization and during the trial period until end of treatment.
• Participants who received antibody-depletion therapy within 3 months prior to randomization, or in the opinion of the Investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depletion therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)
• Participants with active kidney transplant rejection or those considered at high-risk of recurrence of native kidney disease (e.g. primary focal segmental glomerulosclerosis \[FSGS\], C3 glomerulopathy)
• Participants with known donor-specific antibodies (\[DSA\], de novo, or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (\<1,000 mean fluorescence intensity \[MFI\]) can be included if no impact on the trial assessments is expected by the discretion of the Investigator.
• Pregnant or nursing (lactating) women
• Uncontrolled acute or chronic infections such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV), cytomegalovirus (CMV), or Epstein-Barr virus (EBV)
• History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening
• Documented evidence of the use of another Investigational Medicinal Product (IMP) within 30 days or 5 half-lives of randomization, or until the expected PD effect has returned to baseline (whichever is longer)
• Known current alcoholism or drug addiction
• Any other condition or laboratory abnormality, that in the opinion of the Investigator, would interfere with the evaluation of the IMP or interpretation of the participant safety data or trial results.

Sponsors & Collaborators

• AiCuris Anti-infective Cures AG: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind; matching placebo; randomization performed via IxRS/IWRS.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group-sequential multiple-dose cohorts with within-cohort 3:1 randomization to AIC263029 vs placebo; weekly dosing over 4 weeks; optional additional cohorts may be added.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 31, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share