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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: IONIS GHR-LRx
* Drug: Somatostatin Receptor Ligand (SRL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)<br>IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks. | Drug: IONIS GHR-LRx<br>* Participants will receive IONIS GHR-LRx by subcutaneous injection.<br>Drug: Somatostatin Receptor Ligand (SRL)<br>* Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.<br>* Other names: octreotide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of Adverse Events | Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal | Up to approximately 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels |  | Baseline and at Week 26 and Week 53 | 
| Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.2 Times of Gender and Age-Adjusted Upper Limits |  | Week 26 and at 28 days after the Week 53 dose | 
| Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age-Adjusted Upper Limits |  | Week 26 and at 28 days after the Week 53 dose | 
| Percentage of Participants who Begin Other Acromegaly Medication |  | Up to approximately 16 months | 
| Time From First Dose of IONIS GHR-LRx in this open label extension (CS3) to Date of Initiation of Other Acromegaly Medications |  | Up to approximately 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly, IONIS-GHR-LRx