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

• ClinicalTrials.gov Identifier: NCT02526420
• Recruitment Status: Completed
• First Posted: August 18, 2015
• Last Update Posted: November 9, 2016
• Sponsor: Versartis Inc.
• Collaborator: Premier Research Group plc
• Information provided by (Responsible Party): Versartis Inc.

Tracking Information

• First Submitted Date: August 13, 2015
• First Posted Date: August 18, 2015
• Last Update Posted Date: November 9, 2016
• Study Start Date: July 2015
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2015)

• 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.
• 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)
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 14, 2015)

• 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
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Adult Growth Hormone Deficiency

Intervention

Drug: somavaratan

Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly

Other Name: VRS-317

Study Arms

• Experimental: Cohort A: Somavaratan in Older Adults
  Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age
  Intervention: Drug: somavaratan
• Experimental: Cohort B: Somavaratan in Younger Adults
  Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age
  Intervention: Drug: somavaratan
• 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)
  Intervention: Drug: somavaratan

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2016): 36
• Original Estimated Enrollment (submitted: August 14, 2015): 40
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 23 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Germany, United Kingdom, United States

Administrative Information

• NCT Number: NCT02526420
• Other Study ID Numbers: 15VR7
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Versartis Inc.
• Study Sponsor: Versartis Inc.
• Collaborators: Premier Research Group plc

Investigators

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

• PRS Account: Versartis Inc.
• Verification Date: November 2016