NCT02526420

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
4 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

August 13, 2015

Last Update Submit

July 22, 2022

Conditions

Adult Growth Hormone Deficiency

Keywords

VRS-317Long Acting Growth HormoneVersartissomavaratanGrowth Hormone DeficiencyAdult Growth Hormone DeficiencyAGHDGrowth Hormone ReplacementGrowth Hormone Replacement TherapyXTEN

Outcome Measures

Primary Outcomes (3)

  • Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams

    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 )

    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)

    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 Outcomes (2)

  • 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)

    5 months

Study Arms (3)

Cohort A: Somavaratan in Older Adults

EXPERIMENTAL

Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \>= 35 years of age

Drug: somavaratan

Cohort B: Somavaratan in Younger Adults

EXPERIMENTAL

Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \< 35 years of age

Drug: somavaratan

Cohort C: Somavaratan in Women on Estrogen

EXPERIMENTAL

Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)

Drug: somavaratan

Interventions

somavaratanDRUG

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

Also known as: VRS-317
Cohort A: Somavaratan in Older AdultsCohort B: Somavaratan in Younger AdultsCohort C: Somavaratan in Women on Estrogen

Eligibility Criteria

Age23 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

AMCR Institute Inc.

Escondido, California, 92025, United States

Location

Therapeutic Research Institute of Orange County

Laguna Hills, California, 92653, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Palm Research Center

Las Vegas, Nevada, 89128, United States

Location

Endocrine Associates of Dallas

Plano, Texas, 75093, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Charite-Universitätsmedizin

Berlin, 10117, Germany

Location

Universitätsklinikum Essen

Essen, D- 45147, Germany

Location

Queen Elizabeth Hospital

Birmingham, B152gw, United Kingdom

Location

William Harvey Research Institute

London, EC1M 6BQ, United Kingdom

Location

Hull Royal Infirmary

Hull, East Yorkshire, HU3 2RW, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Daniela Rogoff, MD, PhD

    Versartis Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 18, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

US(9)DE(2)AU(3)GB(4)