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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 : Completed
First Posted : May 30, 2019
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date August 8, 2022
Actual Study Start Date  ICMJE July 25, 2019
Actual Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acromegaly
Intervention  ICMJE
  • Drug: IONIS GHR-LRx
    IONIS GHR-LRx subcutaneous injection
  • Drug: SRL
    Participants will receive SRL once monthly
Study Arms  ICMJE 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.
Interventions:
  • Drug: IONIS GHR-LRx
  • Drug: SRL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2021)
39
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
42
Actual Study Completion Date  ICMJE July 7, 2022
Actual Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Lithuania,   Poland,   Russian Federation,   Serbia,   United States
Removed Location Countries Romania
 
Administrative Information
NCT Number  ICMJE NCT03967249
Other Study ID Numbers  ICMJE ISIS 766720-CS3
2019-000591-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ionis Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ionis Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ionis Pharmaceuticals, Inc.
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP