Brief Title
Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Official 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)
Brief Summary
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The Incidence of Adverse Events
Secondary Outcome
Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels
Condition
Acromegaly
Intervention
IONIS GHR-LRx
Study Arms / Comparison Groups
IONIS GHR-LRx + SRL
Description: IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
39
Start Date
July 25, 2019
Completion Date
July 2023
Primary Completion Date
July 2023
Eligibility Criteria
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Hungary
Location Countries
Hungary
Administrative Informations
NCT ID
NCT03967249
Organization ID
ISIS 766720-CS3
Secondary IDs
2019-000591-42
Responsible Party
Sponsor
Study Sponsor
Ionis Pharmaceuticals, Inc.
Study Sponsor
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Verification Date
July 2021