AcromegalyPhase 2TULIPIANCT00994214
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
A Phase 2 study testing BIM 23A760 in people with Acromegaly, run by Ipsen at 23 sites in 13 countries.
Trial summary
The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- BIM 23A760
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 23 sitesin 13 countries
- Study dates
- Oct 2009to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- IGF-1 ≥1.3 x upper limit normal (ULN)
- Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
- Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.
Who cannot join
- The patient has received long acting somatostatin analogues within 6 months of study entry
- The patient has undergone radiotherapy at any time prior to study entry
- The time between pituitary surgery (if any) and study entry is less than 6 weeks
- The patient suffers from macroadenoma with visual field defects due to chiasmatic compression
Trial locations and contacts
23 sites in 13 countries.
23 sites in 13 countries
United States3 sites
Massachusetts General Hospital / Neuroendocrine Unit
Boston, Massachusetts, 02114
Pituitary Center
Los Angeles, California, 90048
Oregon University, Dept. of Endocrinology and Neurosurgery
Portland, Oregon, 97239
Ukraine3 sites
Academy of Medical Science of Ukraine, Department of Clinical Endocrinology
Kharkiv, 61002
Administration of Medical Services and Rehabilitation of "ARTEM"
Kyiv, 04050
National Medical University n.a. M.I.Pirogov
Vinnitsa, 21010
Belgium2 sites
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, B-4000
Brazil2 sites
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, 21941-913
Hospital das Clínicas de São Paulo
São Paulo, 05403-0000
Czechia2 sites
University Hospital Olomouc, Clinic of Internal Medicine
Olomouc, 775 20
General University Hospital, Clinic of Internal Medicine,
Prague, 128 08
France2 sites
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275 Cedex
Hôpital de la Timone
Marseille, 13385 Cedex 05
Lithuania2 sites
Kaunas Medical University Hospital
Kaunas, LT-50009
Vilnius University Hospital "Santariskiu Klinikos"
Vilnius, LT-08661
Mexico2 sites
Insituto Nacional de Neurologia y Neurocirugia
México, 14269 México
UIM Endocrinología Experimental, Hospital de Especialidades
Mexico City, DF
Netherlands1 site
Department of Endocrinology, Erasmus MC
Rotterdam, 3000 CA
Romania1 site
"C.I. Parhon" National Institute of Endocrinology
Bucharest, 011863
About this study
Official title: Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients
The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.
- Conditions
- Acromegaly
- Being tested
- BIM 23A760
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIM 23A760Drug
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| BIM 23A760 1 mg | Experimental | Not described Receives: Drug: BIM 23A760 |
| BIM 23A760 2 mg | Experimental | Not described Receives: Drug: BIM 23A760 |
| BIM 23A760 4 mg | Experimental | Not described Receives: Drug: BIM 23A760 |
| BIM 23A760 6 mg | Experimental | Not described Receives: Drug: BIM 23A760 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Measured: At Month 6
Secondary outcomes (6)
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Measured: At Month 3
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Measured: At Month 1
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline
Measured: 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6
Changes in IGF-1
Measured: Baseline (Day 1) and Month 6
Percentage Change in Ring Finger Circumference
Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.
Measured: Baseline (Day 1) and Month 6
Number of Subjects Reported Adverse Events During the Study
For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen.
TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.
Measured: Up to Visit 10 (An average of 6.5 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Preliminary data from this study does not support expected inhibition of GH and IGF-1
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994214
- Sponsor's protocol ID
- 2-55-52060-003
- Other IDs
- 2009-010787-42, 2009
- Acronym
- TULIPIA
- Status last verified
- Nov 2019
- First submitted
- 13 Oct 2009
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients
- ClinicalTrials.gov ID
- NCT00994214
- Acronym / sponsor ID
- TULIPIA / 2-55-52060-003
- Conditions
- Acromegaly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary data from this study does not support expected inhibition of GH and IGF-1
- Enrolment
- 109 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Posted 10 Feb 2016
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 efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIM 23A760 1 mg | Experimental | Drug: BIM 23A760 |
| BIM 23A760 2 mg | Experimental | Drug: BIM 23A760 |
| BIM 23A760 4 mg | Experimental | Drug: BIM 23A760 |
| BIM 23A760 6 mg | Experimental | Drug: BIM 23A760 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IGF-1 ≥1.3 x upper limit normal (ULN)
- Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
- Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.
Key exclusion criteria (4 listed)
- The patient has received long acting somatostatin analogues within 6 months of study entry
- The patient has undergone radiotherapy at any time prior to study entry
- The time between pituitary surgery (if any) and study entry is less than 6 weeks
- The patient suffers from macroadenoma with visual field defects due to chiasmatic compression
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 |
|---|---|---|
| BIM 23A760Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops. | Drug | BIM 23A760 1 mg, BIM 23A760 2 mg, BIM 23A760 4 mg, BIM 23A760 6 mg |
Primary outcome
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time frame: At Month 6
6 secondary outcomes
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time frame: At Month 3
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time frame: At Month 1
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
Time frame: 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6
Changes in IGF-1
Time frame: Baseline (Day 1) and Month 6
Percentage Change in Ring Finger Circumference
Time frame: Baseline (Day 1) and Month 6
Number of Subjects Reported Adverse Events During the Study
Time frame: Up to Visit 10 (An average of 6.5 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ipsen Medical Director study director
Ipsen
23 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIM 23A760 in people with Acromegaly, run by Ipsen at 23 sites in 13 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 4 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: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Ukraine, Belgium, Brazil, Czechia and 8 more countries. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 (time frame: At Month 6). 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 Nov 2019.