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出境医 / 临床实验 / Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Study Description
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 39 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 : | July 2023 |
| Estimated Study Completion Date : | July 2023 |
Arms and Interventions
| 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
Primary Outcome Measures :
- 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 :
- 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 Criteria
| 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
Locations
Show 22 study locations
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 23, 2019 | ||||
| First Posted Date ICMJE | May 30, 2019 | ||||
| Last Update Posted Date | May 19, 2021 | ||||
| Actual Study Start Date ICMJE | July 25, 2019 | ||||
| Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| 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 |
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| Condition ICMJE | Acromegaly | ||||
| Intervention ICMJE |
|
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| 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:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE |
39 | ||||
| Original Estimated Enrollment ICMJE |
42 | ||||
| Estimated Study Completion Date ICMJE | July 2023 | ||||
| Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| 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 ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Ionis Pharmaceuticals, Inc. | ||||
| Study Sponsor ICMJE | Ionis Pharmaceuticals, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Ionis Pharmaceuticals, Inc. | ||||
| Verification Date | May 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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