Versartis International Trial in Adults With Long-Acting Growth Hormone (VITAL)

July 22, 2022 updated by: Versartis Inc.

An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Germany
      • Berlin, Germany, 10117
        • Charité-Universitätsmedizin
      • Essen, Germany, D- 45147
        • Universitätsklinikum Essen
  • United Kingdom
    • B152gw
      • Birmingham, B152gw, United Kingdom
        • Queen Elizabeth Hospital
    • Ec1m 6bq
      • London, Ec1m 6bq, United Kingdom
        • William Harvey Research Institute
    • Hu3 2rw
      • Hull, East Yorkshire, Hu3 2rw, United Kingdom
        • Hull Royal Infirmary
    • M20 4bx
      • Manchester, M20 4bx, United Kingdom
        • The Christie NHS Foundation Trust
  • United States
    • California
      • Escondido, California, United States, 92025
        • AMCR Institute Inc.
      • Laguna Hills, California, United States, 92653
        • Therapeutic Research Institute of Orange County
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center
    • Texas
      • Plano, Texas, United States, 75093
        • Endocrine Associates of Dallas
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: Somavaratan in Older Adults
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other Names:
  • VRS-317
Experimental: Cohort B: Somavaratan in Younger Adults
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other Names:
  • VRS-317
Experimental: Cohort C: Somavaratan in Women on Estrogen
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other Names:
  • VRS-317

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams
Time Frame: 5 months
Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams.
5 months
Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )
Time Frame: 5 months
To evaluate the starting doses of VRS-317 for each cohort as measured by the proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval (one month after the first dose)
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
To evaluate the dose titration plan of VRS-317 for each cohort as measured by the proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
Time Frame: 5 months
To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
5 months
Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)
Time Frame: 5 months
To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versartis Inc.

Collaborators

Premier Research Group plc

Investigators

  • Study Director: Daniela Rogoff, MD, PhD, Versartis Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15VR7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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