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Completed

NCT Number: NCT03967249

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

The purpose of this study is to assess the safety and efficacy of extended dosing with IONIS GHR-LRx in participants with acromegaly as add-on to somatostatin receptor ligands (SRL) therapy.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly, Budapest, Hungary

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About this study

This extension study will include participants up to 60 participants with acromegaly from Study NCT03548415. All participants will remain on the same dose from the previous study and receive IONIS GHR-LRx (SC) injection once every 28 days as add-on to SRL therapy for 53 weeks. At the end of 53 weeks, participants will enter a 14-week post-treatment (PT) evaluation period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Randomized in index trial (CS2) and completed the entire study, or completion of the treatment period for CS2 and completed or plan to complete PTWK5 visit with an acceptable safety profile, per investigator judgment
  • Participants with confirmed stable monthly regimen of SRL for 3 months prior to screening
  • Able and willing to participate in a 53-week treatment and 14-week post-treatment study

Exclusion criteria

  • Treatment with any other acromegaly medications taken prior to Day 1 within the time period: bromocriptine: 2 weeks, carbergoline: 4 weeks, quinagolide: 4 weeks, pegvisomant: 4 weeks and pasireotide: 4 months
  • Participant who received surgery for pituitary adenoma in the last 3 months prior to screening and participants needing and/or planning to receive surgery for the pituitary adenoma during the trial
  • Unwilling to comply with required study procedures during the treatment and post-treatment periods

Treatment and study plan

IONIS GHR-LRx

Drug

Participants will receive IONIS GHR-LRx by subcutaneous injection.

Somatostatin Receptor Ligand (SRL)

Drug

Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.

Other names: lanreotide, octreotide

Primary outcomes

  1. The Incidence of Adverse Events

    Time frame: Up to approximately 16 months

    Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal

Secondary outcomes

  1. Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels

    Time frame: Baseline and at Week 26 and Week 53

  2. Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.2 Times of Gender and Age-Adjusted Upper Limits

    Time frame: Week 26 and at 28 days after the Week 53 dose

  3. Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age-Adjusted Upper Limits

    Time frame: Week 26 and at 28 days after the Week 53 dose

  4. Percentage of Participants who Begin Other Acromegaly Medication

    Time frame: Up to approximately 16 months

  5. Time From First Dose of IONIS GHR-LRx in this open label extension (CS3) to Date of Initiation of Other Acromegaly Medications

    Time frame: Up to approximately 16 months

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Registry information

Official study title

An Open-Label Extension Trial of IONIS GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor Administered Monthly Subcutaneously to Patients With Acromegaly Being Treated With Long-Acting Somatostatin Receptor Ligands (SRL)

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 30, 2019
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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