Clinical trial NCT02526420: Versartis International Trial in Adults With Long-Acting Growth Hormone
Official title: An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Growth Hormone Deficiency
Keywords: VRS-317
Long Acting Growth Hormone
Versartis
somavaratan
Growth Hormone Deficiency
Adult Growth Hormone Deficiency
AGHD
Growth Hormone Replacement
Growth Hormone Replacement Therapy
XTEN
Lead sponsor: Aravive, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2015-08-18
Enrollment: 36
Sex: ALL
Minimum age (years): 23
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams
timeFrame: 5 months
measure: Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )
timeFrame: 5 months
measure: Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)
timeFrame: 5 months
Secondary outcomes:
measure: Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
timeFrame: 5 months
measure: Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)
timeFrame: 5 months
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute Inc.
state: California
city: Laguna Hills
country: United States
facility: Therapeutic Research Institute of Orange County
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Plano
country: United States
facility: Endocrine Associates of Dallas
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Berlin
country: Germany
facility: Charite-Universitätsmedizin
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
state: B152gw
city: London
country: United Kingdom
facility: William Harvey Research Institute
state: Ec1m 6bq
city: Hull, East Yorkshire
country: United Kingdom
facility: Hull Royal Infirmary
state: Hu3 2rw
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: M20 4bx
Study officials:
affiliation: Versartis Inc.
name: Daniela Rogoff, MD, PhD
role: STUDY_DIRECTOR
References: