Safety and Dose Ranging Study of Insulin Receptor MoAb-IDS Fusion Protein in Patients With Hunter Syndrome

Completed · Phase 1

Conditions studied: Mucopolysaccharidosis II

In brief

AGT-182 is a fusion protein containing idursulfase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is a safety and dose ranging study to obtain safety and exposure data, as well as information on the biological activity of the investigational drug.

Key facts

Study ID

NCT02262338

Run by

ArmaGen, Inc

People needed

6

Starts

2015-04-01

Expected to finish

2017-03-27

Last updated by the study team

2018-09-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male age 18 years or older
• Diagnosis of Hunter Syndrome (documented fibroblast or leukocyte IDS enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory - or any level of enzyme deficiency together with the presence of a pathogenic mutation in the IDS gene - and documentation of normal enzymatic activity of at least 1 other sulfatase.)
• Must fall into one of the following groups:
• currently receiving standard enzyme replacement therapy (ERT) and be willing to discontinue it for the study duration, taking AGT-182 instead
• have not received standard ERT for at least 3 months and have elevated uGAGs of at least 3.5 fold above age-related normals at study screening
• have never received ERT
• Voluntary written consent
• Sexually mature males must be advised to use a medically accepted method of contraception throughout the study.

You may not qualify if…

• Refusal to complete screening/baseline evaluations
• Receipt of an investigational drug within the prior 90 days
• Any medical condition or other circumstances that may significantly interfere with study compliance
• Clinically significant spinal cord compression, evidence of cervical instability
• Known hypersensitivity to idursulfase or any of the components of AGT-182
• Known to be nonresponsive to standard ERT treatment (i.e., high uGAG values despite taking full dose standard ERT)
• History of diabetes mellitus or hypoglycemia
• Contraindication to lumbar puncture, if the patient agrees to this optional assessment

Where it is running

• Children's Hospital Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Emory University — Decatur, Georgia, United States
• ZKJM MC University of Mainz — Mainz, Germany
• Institute of Human Genetics, National Inst of Health, University of the Philippines — Manila, Philippines

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.