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

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ClinicalTrials.gov Identifier: NCT03967249
Recruitment Status : Enrolling by invitation
First Posted : May 30, 2019
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: IONIS GHR-LRx Drug: SRL Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IONIS GHR-LRx + SRL
IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks.
 Drug: IONIS GHR-LRx
IONIS GHR-LRx subcutaneous injection

Drug: SRL
Participants will receive SRL once monthly


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels [ Time Frame: Baseline and at Week 26 and Week 53 ]
  2. 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 ]
  3. 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 ]
  4. Percentage of Participants who Begin Other Acromegaly Medication [ Time Frame: Up to approximately 16 months ]
  5. 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 Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967249


Locations
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Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
More Information
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Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03967249    
Other Study ID Numbers: ISIS 766720-CS3
2019-000591-42 ( EudraCT Number )
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ionis Pharmaceuticals, Inc.:
Acromegaly, IONIS-GHR-LRx
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases