AcromegalyPhase 2NCT03967249
Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
A Phase 2 study testing IONIS GHR-LRx and Somatostatin Receptor Ligand (SRL) in people with Acromegaly, run by Ionis Pharmaceuticals, Inc. at 22 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- IONIS GHR-LRx and Somatostatin Receptor Ligand (SRL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 25 Jul 2019to 7 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
Russia9 sites
Multi-field Medical Clinic Anturium LLC
Barnaul, 656043
Interregional Clinical Diagnostic Center
Kazan', 420101
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
Kemerovo, 650066
Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation
Moscow, 117036
I.M. Sechenov Moscow First State Medical University
Moscow, 119991
Novosibirsk State Regional Clinical Hospital
Novosibirsk, 630087
Orenburg Regional Clinical Hospital
Orenburg, 460018
Almazov National Medical Research Centre
Saint Petersburg, 194156
State Budget Healthcare Institution of the Tver Region (Regional Clinical Hospital)
Tver', 170036
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Cleveland Clinic
Cleveland, Ohio, 44195
Northwestern University
Evanston, Illinois, 60208
Palm Research Center, Inc.
Las Vegas, Nevada, 89149
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
Poland3 sites
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o. o.
Krakow, 31-011
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67-100
Mazowiecki Szpital Brodnowski
Warsaw, 03-242
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Endocrinology clinic
Kaunas, LT-50161
Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika
Vilnius, 9112
Hungary1 site
Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
Budapest, 1062
About this study
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)
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.
Read the 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.
- Conditions
- Acromegaly
- Being tested
- IONIS GHR-LRx, Somatostatin Receptor Ligand (SRL)
- Keywords
- Acromegaly, IONIS-GHR-LRx
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IONIS GHR-LRxDrug
Participants will receive IONIS GHR-LRx by subcutaneous injection.
Somatostatin Receptor Ligand (SRL)Drug
Also called lanreotide, octreotide
Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.
| Study group | Role | What they receive |
|---|---|---|
| IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL) | Experimental | IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks. Receives: Drug: IONIS GHR-LRx; Drug: Somatostatin Receptor Ligand (SRL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Adverse Events
Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal
Measured: Up to approximately 16 months
Secondary outcomes (5)
Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels
Measured: 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
Measured: 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
Measured: Week 26 and at 28 days after the Week 53 dose
Percentage of Participants who Begin Other Acromegaly Medication
Measured: 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
Measured: Up to approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start25 Jul 2019
- Primary completion31 Mar 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967249
- Sponsor's protocol ID
- ISIS 766720-CS3
- Other IDs
- 2019-000591-42, 2019
- Status last verified
- Mar 2023
- First submitted
- 23 May 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03967249
- Acronym / sponsor ID
- ISIS 766720-CS3
- Conditions
- Acromegaly
- Keywords
- Acromegaly, IONIS-GHR-LRx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL) | Experimental | Drug: IONIS GHR-LRx, Drug: Somatostatin Receptor Ligand (SRL)IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IONIS GHR-LRxParticipants will receive IONIS GHR-LRx by subcutaneous injection. | Drug | IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL) |
| Somatostatin Receptor Ligand (SRL)Also: lanreotide, octreotideParticipants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly. | Drug | IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL) |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IONIS GHR-LRx and Somatostatin Receptor Ligand (SRL) in people with Acromegaly, run by Ionis Pharmaceuticals, Inc. at 22 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Russia, United States, Poland, Lithuania, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Adverse Events (time frame: Up to approximately 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.