Overview

This trial has been completed.

Condition adult growth hormone deficiency
Treatment somavaratan
Phase phase 2
Sponsor Versartis Inc.
Collaborator Premier Research Group plc
Start date July 2015
End date October 2016
Trial size 36 participants
Trial identifier NCT02526420, 15VR7

Summary

A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age
somavaratan VRS-317
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
(Experimental)
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age
somavaratan VRS-317
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
(Experimental)
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)
somavaratan VRS-317
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly

Primary Outcomes

Measure
Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams
time frame: 5 months
Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )
time frame: 5 months
Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)
time frame: 5 months

Secondary Outcomes

Measure
Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
time frame: 5 months
Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)
time frame: 5 months

Eligibility Criteria

Male or female participants from 23 years up to 70 years old.

Inclusion Criteria: - Female subjects of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods - Subjects must have documented GHD during adulthood. - Subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months. - Subjects with underlying disorders responsible for the subject's GHD must have been clinically stable for at least 6 months. - Subjects receiving daily rhGH injections must washout for 14 days. - Subjects must provide signed informed consent. - Subjects must have a BMI (kg/m2) between 19.0 and 35.0. Exclusion Criteria: - Subjects with diabetes mellitus or inadequate glucose control - Subjects with untreated adrenal insufficiency. - Subjects with free thyroxine outside the normal reference range. - Subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies. - Subjects with current significant cardiovascular disease, heart insufficiency of NYHA class > 2. - Subjects with current significant cerebrovascular, pulmonary, neurological, renal, inflammatory, or hepatobiliary disease. - Subjects with current papilledema. - Subjects with a history of persistent or recurring migraines. - Subjects with current edema (≥ CTCAE Grade 2). - Subjects with current drug or alcohol abuse. - Subjects with a documented history of HIV, current HBV or HCV infection - Subjects with a prior history of malignancy excluding adequately treated non-melanoma skin cancers or in situ carcinoma of the cervix. - Women who are pregnant or breastfeeding. - Subjects with a significant abnormality in Screening laboratory results

Additional Information

Official title An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)
Description A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing regimen in adults with GHD. This is an open-label, international, multicenter study with VRS-317 treatment for five months. This treatment period will include monthly dose titrations until a subject's mean IGF-I SDS value is within a target range for two consecutive months. Subjects will be stratified into three cohorts based on sensitivity to rhGH.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Versartis Inc..