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

checkorphan
Learn more about:
Acromegaly
Related Access Program
Novartis Pharmaceuticals – Acromegaly
Related Clinical Trial
Micromegaly and Discrepancy Between Growth Hormone and IGF1 at the Diagnosis and Follow-up of Acromegalic Patients Vitamin D Metabolism in Patients With Endocrine Disorders A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly The TMS Treatment for Postoperative Headache in GH Tumor A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly Rhinological Outcomes in Endonasal Pituitary Surgery Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma Study in Polish Acromegalic Patients Treated With Somatuline Autogel Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery The Observational Study of Growth Hormone-secreting Pituitary Tumors Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788 Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects Phase II Study With ITF2984 in Acromegalic Patients Non Interventional Study For Patients Treated With Somavert® Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients. Estrogen Treatment in Acromegalic Women Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg, Imported And Distributed By The Laboratory Chemical Pharmaceutical Bergamo Ltda., Compared To Product Sandostatin LAR ® (Octreotide Acetate LAR) 30 MG Manufactured By Novartis Biosciences S / A. ACRODAT Prospective Evaluation Study Pegvisomant And Sandostatin LAR Combination Study Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly Canadian Pegvisomant Compassionate Study In Acromegalic Patients Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues Tissue Biomarker for Pegvisomant Action Sandostatin LAR Depot vs. Surgery for Treating Acromegaly Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Predictive Factors Study Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism. Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT) Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly Acromegaly – Before and After Treatment Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly Measurement of Outcome of Surgical Treatment in Patients With Acromegaly Non Interventional Post Marketing Programme in Acromegaly Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients Cardiovascular Outcome After Surgery or Somatostatin Analogues Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas Long Term Study With B2036-PEG Octreotide Efficacy and Safety in First-line Acromegalic Patients Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly Clomiphene Citrate for Treatment of Acromegaly Cardiac (CMRI) Assessment of Acromegaly Acromegaly Combination Treatment Study Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Assessment of Changes in Metabolic Activity in Liver & Skeletal Muscle in Patients Suffering From Acromegaly Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide Pasireotide LAR and Pegvisomant Study in Acromegaly Effects of Sandostatin LAR® in Acromegaly Open Label Study of Octreotide Implant in Patients With Acromegaly Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Somatuline Autogel: Acromegaly Self/Partner Injection Study A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly Impact of Somatostatin Analogs vs. Surgery on Glucose Metabolism in Acromegaly Prospective Study on Changes in Acromegaly Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly Assessment of Airway in Patients With Acromegaly for Predicting Successful Tracheal Intubation Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment. A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance) An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge) Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG) IGF-I and Free Fatty Acids Isn Glucose Metabolism in Acromegaly Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing’s Disease or Acromegaly Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism? Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly Rehabilitation Program in Patients With Acromegaly Acute Application of Pegvisomant and Octreotide in Acromegaly Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly Prediction of Tumor Shrinkage in Acromegaly Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly SAGIT for Classification of Patients With Acromegaly in Clinical Practice Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients Late Effects of Radiosurgery on Acromegaly Study Ultrasound Guided Octreotide LAR Injection in Acromegaly Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly Strict IGF-1 Control in Acromegaly Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target Fractionated Stereotactic Radiotherapy in Patients With Acromegaly Validation Study of the SAGIT® Instrument in Acromegaly Developing a Simple Recognition System of Acromegaly Glucose Tolerance in Acromegaly: The Influence of GH-excess on Glucose Metabolism and Insulin Resistance Surgical Versus Medical Treatment of Acromegaly A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve) Acromegaly & Sleep Apnoea Somatuline Predictive Factors in Acromegaly and NET Acromegaly Treatment Quality of Life Study Lanreotide Levels in Acromegaly Description of Sign-and-symptom Associations at Acromegaly Diagnosis. Treatment Patterns and Treatment Outcomes for Acromegaly Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly Physiopathology of Sodium Retention in Acromegaly Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study Peri- and Post-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly During the First Year After Surgical Resection The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research Preoperative Octreotide Treatment of Acromegaly The Treatment and Natural History of Acromegaly Bone MicroArchitecture in Acromegaly Reproducibility and Utility of OGTT in Acromegaly A Prospective Study of Outcome After Therapy for Acromegaly Epidemiology of Acromegaly in Denmark 1991-2010 Programme of Acromegaly Screening in Patients With Associated Somatic Disorders Acromegaly: Patient And Physician Perspectives

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)

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

The Incidence of Adverse Events

Secondary Outcome

 Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels

Condition

Acromegaly

Intervention

IONIS GHR-LRx

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

39

Start Date

July 25, 2019

Completion Date

July 2023

Primary Completion Date

July 2023

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

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Hungary

Location Countries

Hungary

Administrative Informations

NCT ID

NCT03967249

Organization ID

ISIS 766720-CS3

Secondary IDs

2019-000591-42

Responsible Party

Sponsor

Study Sponsor

Ionis Pharmaceuticals, Inc.

Study Sponsor

, ,

Verification Date

July 2021