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

NCT03967249 | Completed Phase 2 FDA Drug

• 2 other identifiers: ISIS 766720-CS32019-000591-42
• Study Type: interventional
• Target: 39
• Locations: 6 countries
• Sites: 22

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.

Conditions

Acromegaly

Keywords

Acromegaly, IONIS-GHR-LRx

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)

EXPERIMENTAL

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

Drug: IONIS GHR-LRx; Drug: Somatostatin Receptor Ligand (SRL)

Interventions

IONIS GHR-LRx DRUG

Participants will receive IONIS GHR-LRx by subcutaneous injection.

IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)

Somatostatin Receptor Ligand (SRL) DRUG

Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.

Also known as: lanreotide, octreotide

IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ionis Pharmaceuticals, Inc.: lead

Study Sites (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Palm Research Center, Inc.

Las Vegas, Nevada, 89149, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly

Budapest, 1062, Hungary

Location

Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Endocrinology clinic

Kaunas, LT-50161, Lithuania

Location

Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika

Vilnius, 9112, Lithuania

Location

Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o. o.

Krakow, 31-011, Poland

Location

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, 67-100, Poland

Location

Mazowiecki Szpital Brodnowski

Warsaw, 03-242, Poland

Location

Multi-field Medical Clinic Anturium LLC

Barnaul, 656043, Russia

Location

Interregional Clinical Diagnostic Center

Kazan', 420101, Russia

Location

Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev

Kemerovo, 650066, Russia

Location

Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation

Moscow, 117036, Russia

Location

I.M. Sechenov Moscow First State Medical University

Moscow, 119991, Russia

Location

Novosibirsk State Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

Orenburg Regional Clinical Hospital

Orenburg, 460018, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, 194156, Russia

Location

State Budget Healthcare Institution of the Tver Region (Regional Clinical Hospital)

Tver', 170036, Russia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide; Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 30, 2019
• Study Start: July 25, 2019
• Primary Completion: March 31, 2022
• Study Completion: July 7, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); SE (1); PL (3); HU (1); LI (2); RU (9)