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

Acromegaly Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967249
• Other study ID #: ISIS 766720-CS3
• Secondary ID: 2019-000591-42
• Status: Completed
• Phase: Phase 2
• Start date: July 25, 2019
• Est. completion date: July 7, 2022

Study information

• Verified date: March 2023
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 7, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• IONIS GHR-LRx
Participants will receive IONIS GHR-LRx by subcutaneous injection.
• Somatostatin Receptor Ligand (SRL)
Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.

Locations

Country	Name	City	State
Hungary	Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly	Budapest
Lithuania	Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Endocrinology clinic	Kaunas
Lithuania	Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika	Vilnius
Poland	Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o. o.	Kraków
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sól
Poland	Mazowiecki Szpital Brodnowski	Warsaw
Russian Federation	Multi-field Medical Clinic Anturium LLC	Barnaul
Russian Federation	Interregional Clinical Diagnostic Center	Kazan
Russian Federation	Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev	Kemerovo
Russian Federation	Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation	Moscow
Russian Federation	I.M. Sechenov Moscow First State Medical University	Moscow
Russian Federation	Novosibirsk State Regional Clinical Hospital	Novosibirsk
Russian Federation	Orenburg Regional Clinical Hospital	Orenburg
Russian Federation	Almazov National Medical Research Centre	Saint Petersburg
Russian Federation	State Budget Healthcare Institution of the Tver Region (Regional Clinical Hospital)	Tver
Serbia	Clinical Center of Serbia	Belgrade
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cleveland Clinic	Cleveland	Ohio
United States	Northwestern University	Evanston	Illinois
United States	Palm Research Center, Inc.	Las Vegas	Nevada
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Hungary,  Lithuania,  Poland,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels		Baseline and at Week 26 and Week 53
Secondary	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
Secondary	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
Secondary	Percentage of Participants who Begin Other Acromegaly Medication		Up to approximately 16 months
Secondary	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