A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with IgAN.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

NCT05174221

Kidney Disease Glomerulonephritis

ACTIVE_NOT_RECRUITING PHASE1

A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation

NCT05379829

Chronic Kidney Disease and Systemic Inflammation

COMPLETED PHASE1

Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD

NCT05510323

Glomerulonephritis, IGA

RECRUITING PHASE3

Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis

NCT05517980

Glomerulonephritis

NOT_YET_RECRUITING PHASE2

Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade

NCT02384317

Immunoglobulin A Nephropathy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients with Immunoglobulin A Nephropathy

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immunoglobulin A Nephropathy (IgAN)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A study of cizutamig in patients with immunoglobulin A nephropathy

Experlmental: Cizutamig intravenous intervention

Group Type EXPERIMENTAL

Biological: cizutamig

Intervention Type DRUG

Cizutamig will be dosed according to the protocol.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biological: cizutamig

Cizutamig will be dosed according to the protocol.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 to 75 years of age at the time of signing the informed consent form (ICF).
* Biopsy-confirmed IgAN as specified in the protocol.
* 24-hour urine protein excretion ≥1.0 g/day or 24-hour urine protein to creatinine ratio (uPCR) ≥0.75 g/g .
* Inadequate response to ≥1 of the therapies defined in the protocol.
* eGFR \>30 mL/min/1.73m2.

Exclusion Criteria

* Inadequate clinical laboratory parameters at Screening.
* Receipt of or inability to discontinue any of the following excluded therapies as specified in the protocol.
* Receipt of live vaccine within 4 weeks prior to Screening.
* MEST-C score of T2 from the Oxford IgAN classification schema. If MEST-scoring was not performed, the presence of \>50% tubular atrophy/interstitial fibrosis is exclusionary.
* Rapidly progressing glomerulonephritis with eGFR reduction ≥50% within 12 weeks of Screening.
* Secondary IgAN (eg, chronic liver disease, celiac disease, HIV).
* History of IgA vasculitis.
* Presence of any concomitant autoimmune disease .
* History of progressive multifocal leukoencephalopathy.
* History of primary immunodeficiency or a hereditary deficiency of the complement system.
* Central nervous system (CNS) disease .
* Presence of 1 or more significant concurrent medical conditions per investigator judgment.
* Diagnosis or history of malignant disease within 5 years prior to Screening.
* Tonsillectomy within 24 weeks prior to Screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No