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

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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

60

Start Date

July 25, 2019

Completion Date

January 2021

Primary Completion Date

January 2021

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

, 800-679-4747, [email protected]

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

, ,

Verification Date

March 2020