Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Completed · Phase 2
Conditions studied: Acromegaly
In brief
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.
Key facts
- Study ID
- NCT03967249
- Run by
- Ionis Pharmaceuticals, Inc.
- People needed
- 39
- Starts
- 2019-07-25
- Expected to finish
- 2022-07-07
- Last updated by the study team
- 2023-03-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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