Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)

NCT02719990 | Terminated Phase 2 Results

• 1 other identifier: 15VR8
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).

Conditions

Adult Growth Hormone Deficiency (AGHD)

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

  From first dose of study drug up to approximately 2 years

Secondary Outcomes (6)

• Average Dose Level During Titration/Maintenance

  Up to Month 12

• Number of Participants With Dose Adjustments

  Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

• Number of Participants Who Were Anti-drug Antibody (ADA) Positive

  Up to approximately 2 years

• Number of Participants With Positive Neutralizing Antibodies (NABs)

  Up to approximately 2 years

• Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period

  Baseline, Month 2 Day 1, Month 2 Day 8, Month 3 Day 1, Month 3 Day 8, Month 4 Day 1, Month 4 Day 8, Month 5 Day 1, Month 5 Day 8, Month 6 Day 1, Month 6 Day 8, Month 7 Day 1, Month 7 Day 8, Month 8 Day 1, Month 8 Day 8, Month 10 Day 1, and Month 10 Day 8

Study Arms (1)

Somavaratan

EXPERIMENTAL

Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly in adult participants with GHD

Drug: somavaratan

Interventions

somavaratan DRUG

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

Also known as: VRS-317

Somavaratan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods
• Documented GHD during adulthood
• Participants naive to somavaratan must have an IGF-1 SDS value ≤ 0 at Screening
• Participants taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months
• Underlying disorders responsible for the participant's GHD must have been clinically stable for at least 6 months
• Participants receiving daily rhGH injections must washout for ≥ 14 days
• Body mass index (BMI) (kilograms \[kg\]/meter square \[m\^2\]) between 18.0 and 40.0

You may not qualify if:

• 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 human immunodeficiency virus (HIV) wasting syndrome (HIV testing not required)
• History of malignancy in adulthood (participants 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

Sponsors & Collaborators

• Versartis Inc.: lead

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Operating Officer
• Organization: Aravive, Inc.

clinicaltrials@aravive.com

(936) 355-1910

Study Officials

• Will Charlton, MD

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 25, 2016
• Study Start: February 11, 2016
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2018
• Last Updated: April 13, 2023
• Results First Posted: April 13, 2023

Record last verified: 2023-03