Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHD

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02719990
• Date of registration: 16/03/2016
• Prospective Registration: No
• Primary sponsor: Versartis Inc.
• Public title: Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHD
• Scientific title: An Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)
• Date of first enrolment: February 9, 2016
• Target sample size: 34
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02719990
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female subjects of childbearing potential must have negative pregnancy test and use
appropriate contraceptive methods

- Documented GHD during adulthood

- Subjects naive to somavaratan must have an IGF-1 SDS value = 0 at Screening

- Subjects taking other hormone replacement therapy must have been on a stable course of
treatment for at least 3 months

- 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

- BMI (kg/m2) between 18.0 and 40.0

Exclusion Criteria:

- Untreated adrenal insufficiency

- Recently diagnosed thyroid dysfunction which is not being treated or has not been
stable on therapy for at least 3 months

- Currently taking anti-inflammatory dose of glucocorticoids that could potentially
compromise safety or efficacy assessments

- Currently taking a GHRH or IGF-I product

- Current significant cardiovascular disease, heart insufficiency of New York Heart
Association (NYHA) class > 2

- Current significant disease thought to increase risk of receiving growth hormone or
confound assessment of study outcomes

- History of diabetes mellitus or inadequate glucose control

- Current drug or alcohol abuse

- Current HIV wasting syndrome (HIV testing not required)

- History of malignancy in adulthood (subjects with a history of childhood malignancy
that were subsequently treated with rhGH in childhood and remain GHD in adulthood may
be enrolled)

- Women who are pregnant or breastfeeding

- Treatment with an investigational drug other than somavaratan within 30 days prior to
Screening

- A significant abnormality in Screening laboratory results



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Adult Growth Hormone Deficiency (AGHD)

Intervention(s)

Drug: somavaratan

Primary Outcome(s)

Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams [Time Frame: up to 4 years]

Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams [Time Frame: up to first 5 months]

Secondary Outcome(s)

Immunogenicity of VRS-317 by measurement and characterization of serum anti-drug antibody (ADA) titers [Time Frame: Quarterly for up to 4 years]

Evaluation of the maintenance dose and dose titration plan [Time Frame: Quarterly for up to 4 years]

Evaluation of the starting dose and dose titration plan [Time Frame: Monthly for 5 months]

Pharmacodynamics of VRS-317 by measurement of serum Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) [Time Frame: Quarterly for up to 4 years]

Secondary ID(s)

15VR8

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Premier Research Group plc