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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IONIS GHR-LRx
Somatostatin Receptor Ligand (SRL)
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, IONIS-GHR-LRx

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Northwestern University
  • Palm Research Center, Inc.
  • Memorial Sloan Kettering Cancer Center
  • Cleveland Clinic
  • Oregon Health & Science University
  • Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
  • Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Endocrinology clinic
  • Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika
  • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o. o.
  • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Mazowiecki Szpital Brodnowski
  • Multi-field Medical Clinic Anturium LLC
  • Interregional Clinical Diagnostic Center
  • Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
  • Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation
  • I.M. Sechenov Moscow First State Medical University
  • Novosibirsk State Regional Clinical Hospital
  • Orenburg Regional Clinical Hospital
  • Almazov National Medical Research Centre
  • State Budget Healthcare Institution of the Tver Region (Regional Clinical Hospital)
  • Clinical Center of Serbia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)

Arm Description

IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels
Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.2 Times of Gender and Age-Adjusted Upper Limits
Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age-Adjusted Upper Limits
Percentage of Participants who Begin Other Acromegaly Medication
Time From First Dose of IONIS GHR-LRx in this open label extension (CS3) to Date of Initiation of Other Acromegaly Medications

Full Information

First Posted
May 23, 2019
Last Updated
March 17, 2023
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03967249
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
July 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, IONIS-GHR-LRx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)
Arm Type
Experimental
Arm Description
IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks.
Intervention Type
Drug
Intervention Name(s)
IONIS GHR-LRx
Intervention Description
Participants will receive IONIS GHR-LRx by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Somatostatin Receptor Ligand (SRL)
Other Intervention Name(s)
lanreotide, octreotide
Intervention Description
Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.
Primary Outcome Measure Information:
Title
The Incidence of Adverse Events
Description
Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal
Time Frame
Up to approximately 16 months
Secondary Outcome Measure Information:
Title
Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels
Time Frame
Baseline and at Week 26 and Week 53
Title
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
Title
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
Title
Percentage of Participants who Begin Other Acromegaly Medication
Time Frame
Up to approximately 16 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Palm Research Center, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89149
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Endocrinology clinic
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Facility Name
Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika
City
Vilnius
ZIP/Postal Code
9112
Country
Lithuania
Facility Name
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o. o.
City
Kraków
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Mazowiecki Szpital Brodnowski
City
Warsaw
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Multi-field Medical Clinic Anturium LLC
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
Interregional Clinical Diagnostic Center
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
I.M. Sechenov Moscow First State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Novosibirsk State Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Hospital
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre
City
Saint Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
State Budget Healthcare Institution of the Tver Region (Regional Clinical Hospital)
City
Tver
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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