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Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Adult Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

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ClinicalTrials.gov Identifier: NCT03548415
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The purpose is to assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Patients with Acromegaly

Condition or disease Intervention/treatment Phase
Acromegaly Drug: IONIS-GHR-LRx Drug: Placebo Phase 2

Detailed Description:
This short-term study will assess changes in serum insulin-like growth factor 1 (IGF-1) over a 16-week treatment period in a patient population diagnosed with Acromegaly being treated with Long-acting Somatostatin Receptor Ligands (SRL)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS-GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (SRL)
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IONIS-GHR-LRx
Single Dose of IONIS GHR-LRx administered subcutaneously once every 4 weeks for 16 weeks
 Drug: IONIS-GHR-LRx
Single Dose of IONIS GHR-LRx administered subcutaneously once every 4 weeks for 16 weeks
Placebo Comparator: Placebo
Placebo (sterile saline 0.9%) Calculated volume to match active comparator administered subcutaneously every 4 weeks for 16 weeks
 Drug: Placebo
Placebo (sterile saline 0.9%) Calculated volume to match active comparator administered subcutaneously every 4 weeks for 16 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of IONIS GHR-LRx as percent change in serum IGF-1 from Baseline to 28 days after last dose [ Time Frame: Baseline and 28 days after the last dose ]
  2. Incidence and severity of adverse events that are related to treatment with IONIS GHR-LRx. [ Time Frame: Up to 211 days ]

Secondary Outcome Measures :
  1. Proportion of patients achieving normalized IGF-1 levels to within 1.2 times of gender and age limits at 28 days after last dose [ Time Frame: 28 days after the last dose ]
  2. Proportion of patients achieving normalized IGF-1 levels to within 1.0 times of gender and age limits at 28 days after last dose [ Time Frame: 28 days after the last dose ]
  3. Change from Baseline in serum IGF-1 over time [ Time Frame: Up to 31 weeks ]
  4. Percent change from Baseline in Serum IGF-1 over time [ Time Frame: Up to 31 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females with documented diagnosis of Acromegaly, aged 18-75 years old (inclusive) at the time of informed consent
  2. Patients must be on stable maximum or maximally tolerated dose of SRL (Lanreotide Autogel or Octreotide LAR, per treating physician judgment) every 28 days for a minimum of 3 months prior to screening and will be required to continue their stable dose of SRL throughout the study. Prior use of other medications for treating acromegaly is allowed but not within 6 weeks of screening.
  3. At Screening, serum IGF-1 (performed at central lab) between 1.3 to 5 x ULN, inclusive, adjusted for age and sex
  4. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, abstinent, or using 1 highly effective method of birth control

Exclusion Criteria:

  1. Patients who received surgery for pituitary adenoma within the last 6 months before the trial, or planning to receive surgery during the trial
  2. Patients who received radiotherapy for pituitary adenoma within the last 3 years before the trial, and/or planning to receive radiotherapy during the trial
  3. Patients with pituitary tumor that, per Investigator judgement, is worsening as assessed by pituitary/sellar MRI protocol at Screen or within 6 months of screening
  4. Evidence of decompensated cardiac function per medical judgement and/or NYHA class 3 or 4
  5. Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment
  6. Patients may not have insulin, chronic systemic use of glucocorticoids, weight loss medications or participate in weight loss programs within 2 months before randomization and during study participation.
  7. Patients on anti-diabetes medication or estrogen containing medications must be on a stable dose and regimen for >= 3 months prior to screening and throughout the trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548415


Contacts
Contact: Ionis Pharmaceuticals 800-679-4747 patients@ionisph.com

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Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
More Information
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Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03548415     History of Changes
Other Study ID Numbers: ISIS 766720-CS2
2017-004259-22 ( EudraCT Number )
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ionis Pharmaceuticals, Inc.:
Acromegaly, IONIS-GHR-LRx

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs