DRUG
IONIS GHR-LRx
Participants will receive IONIS GHR-LRx by subcutaneous injection.
Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Status
Completed
Phase
Phase 2
Enrollment
39
Locations
22
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Somatostatin Receptor Ligand (SRL)
Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.
Timeline
From registration to results.
First posted
May 30, 2019
Study start
Jul 25, 2019
Primary completion
Mar 31, 2022
Study completion
Jul 7, 2022
Results posted
Not reported
Registry updated
Mar 22, 2023
Outcomes
What the study measures.
Primary outcomes
The Incidence of Adverse Events
Time frame · Up to approximately 16 months
Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal
Secondary outcomes
Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels
Time frame · 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
Time frame · 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
Time frame · Week 26 and at 28 days after the Week 53 dose
Percentage of Participants who Begin Other Acromegaly Medication
Time frame · 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
Time frame · Up to approximately 16 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
22 registered sites.
Hungary · Lithuania · Poland · Russia · Serbia · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama at Birmingham
Birmingham, Alabama, 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
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
Budapest, Hungary
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Endocrinology clinic
Kaunas, Lithuania
Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika
Vilnius, Lithuania
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o. o.
Krakow, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Poland
Mazowiecki Szpital Brodnowski
Warsaw, Poland
Multi-field Medical Clinic Anturium LLC
Barnaul, Russia
Interregional Clinical Diagnostic Center
Kazan', Russia
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
Kemerovo, Russia
Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation
Moscow, Russia
I.M. Sechenov Moscow First State Medical University
Moscow, Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, Russia
Orenburg Regional Clinical Hospital
Orenburg, Russia
Almazov National Medical Research Centre
Saint Petersburg, Russia
State Budget Healthcare Institution of the Tver Region (Regional Clinical Hospital)
Tver', Russia
Clinical Center of Serbia
Belgrade, Serbia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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