AcromegalyPhase 2DOPAACRO 002NCT03045302

Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly

A Phase 2 study testing BIM23B065 in people with Acromegaly, run by Ipsen at 6 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acromegaly
What is being tested?: BIM23B065
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 6 sitesin 4 countries
Study dates: 26 Jan 2017to 2 Jun 2017
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

Provided written informed consent prior to any study related procedures.
Subjects will have a documented diagnosis of acromegaly.
Subjects will have active acromegaly confirmed by a mean serum concentration of GH over 2 hours > 2.5 µg/L at screening analysed by central laboratory.
Subjects who have had pituitary surgery must be >8 weeks post-surgery.
18 to 75 years of age.
Negative pregnancy test (female subjects).
Female who is either of non-childbearing potential or who is not pregnant at screening and agrees to use highly effective contraception during whole duration of the study. Non-childbearing potential is defined as being postmenopausal for at least 1 year, or women with documented infertility (natural or acquired).
Male subjects must agree that, if their partner is at risk of becoming pregnant, they will use a medically accepted, effective method of contraception (i.e. condom) for the duration of the treatment period of the study.

Who cannot join

The subject has received long-acting Somatostatin Analogues (SSA) within 12 weeks prior screening (e.g.octreotide long acting release (LAR), lanreotide Autogel, pasireotide LAR).
The subject has received short-acting SSA within 1 week (e.g. octreotide SC) prior to screening.
The subject has received a dopamine agonist within 6 weeks (e.g., bromocriptine or cabergoline) prior to screening.
The subject has received GH antagonist within 12 weeks prior to screening (e.g., pegvisomant).
The subject had undergone radiotherapy to the pituitary gland at any time prior to study entry.
It is anticipated that the subject will undergo pituitary surgery or radiation to the pituitary gland during the study, or will require additional medical therapy for acromegaly (including SSA, pegvisomant, or dopamine agonists) during the study.

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The subject has unsubstituted/untreated adrenal insufficiency.
If the subject has any history of postural hypotension or evidence of postural hypotension at screening (>= 20 mm Hg decrease in Systolic blood pressure (SBP), >= 10 mm Hg decrease in diastolic blood pressure, or >=30 bpm increases in pulse rate, after standing for 2 minutes from resting supine position of at least 10 min).
Subject with poorly controlled diabetes mellitus (presence of ketoacidosis or a glycosylated hemoglobin level >10%).
Subject with diabetes treated with insulin for less than 6 weeks prior to study entry, or with an unstable insulin dose in the 6 weeks prior to study entry or HbA1c>10%.
Subject is taking beta-blockers (which can inhibit compensatory increases in HR during hypotensive episodes).
Subject is being treated for hypertension and in the opinion of the investigator their antihypertensive medication puts them at increased risk of postural hypotension.
Subject is hypotensive at screening as defined as systolic < 90 mmHg and/or diastolic <60 mmHg.
Subject has clinically significant hepatic abnormalities and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2 x ULN and/or alkaline phosphatase (AP) ≥2 x ULN and/or total bilirubin ≥1.5 x ULN and gamma-glutamyl transferase (GGT) ≥2.5 x ULN during the Screening period (local laboratory results).
Subject has a compression of the optic chiasm causing visual-field defects.
Subject is receiving any oestrogen-containing Hormone Replacement Therapy (HRT).
Subject has clinically significant pancreatic abnormalities and/or amylase and/or lipase ≥2 x ULN during the Screening period (local laboratory results).
Any significant renal abnormalities, including confirmed proteinuria and/or creatinine ≥1.5x ULN during screening assessed by the local laboratory.

Trial locations and contacts

6 sites in 4 countries.

Country

City, postcode or hospital

6 sites in 4 countries

Ukraine3 sites

"Institute of Endocrinological Pathology named after Danilevskij V.Ya., AMS of Ukraine", Department of General Endocrinology
Kharkiv, 61002
"Institute of Endocrinology and Metabolism named after V.P.Komisarenko, AMS Ukraine", Department of General Endocrinology
Kiev, 04114
Vinnitsa Regional Endocrinology Dispensary, Vinnitsa National Medical University named after M.I Pirogov, Therapeutic Department № 2
Vinnitsa, 21010

Other trials in Ukraine

Belgium1 site

CHU de Liège, University of Liège, Domaine Universitaire du Sart-Tilman
Liège, B-4000

Other trials in Belgium

Hungary1 site

Medical Centre, University of Pecs, I Department of Internal Medicine
Pécs, 7624

Other trials in Hungary

Serbia1 site

Clinical Center of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, 11000

Other trials in Serbia

About this study

Official title: A Phase IIa, Open-label, Single-arm, Two Stage, Multi-centre Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Repeated Subcutaneous Administration of BIM23B065 in Subjects With Acromegaly

The purpose of the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.

Conditions: Acromegaly
Being tested: BIM23B065
Medical subject headings: Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIM23B065Drug
Subcutaneous twice a day or three times a day administration of BIM23B065. Dose will be 0.4, 0.6, 0.8 or 1 mg (twice a day or three times a day).

Study groups in NCT03045302
Study group	Role	What they receive
BIM23B065	Experimental	Not described Receives: Drug: BIM23B065

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Subjects Who Were Growth Hormone (GH) Responders at Day 14 of the Treatment Period
A GH responder was defined as a subject with mean serum GH concentration ≤2.5 micrograms per litre (mcg/L) or >50% reduction from mean baseline GH concentration after a 6-day titration and an 8-day treatment period with BIM23B065. The mean serum concentration of GH was measured over 6 hours at baseline (Day -1) and on Day 14. The number of subjects who were GH responders at Day 14 of the treatment period is presented.
Measured: From baseline (Day -1) to Day 14.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 20172 Jun 2017

First posted7 Feb 2017 (estimated)
Study start26 Jan 2017
Primary completion17 May 2017
Study completion2 Jun 2017

Why it stopped: Early termination is a sponsor decision. No new safety signal or serious adverse event has been observed.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03045302
Sponsor's protocol ID: D-FR-10380-002
Other IDs: 2015-003868-37, 2015
Acronym: DOPAACRO 002
Status last verified: Mar 2019
First submitted: 10 Nov 2016
Last updated: 8 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

All Acromegaly trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Open-label, Single-arm, Two Stage, Multi-centre Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Repeated Subcutaneous Administration of BIM23B065 in Subjects With Acromegaly
ClinicalTrials.gov ID: NCT03045302
Acronym / sponsor ID: DOPAACRO 002 / D-FR-10380-002
Conditions: Acromegaly
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Early termination is a sponsor decision. No new safety signal or serious adverse event has been observed.
Enrolment: 4 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: 26 Jan 2017 (actual)
Primary completion: 17 May 2017 (actual)
Study completion: 2 Jun 2017 (actual)
First posted: 7 Feb 2017 (estimated)
Results: Posted 8 Mar 2019

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 the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BIM23B065	Experimental	Drug: BIM23B065

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Provided written informed consent prior to any study related procedures.
Subjects will have a documented diagnosis of acromegaly.
Subjects will have active acromegaly confirmed by a mean serum concentration of GH over 2 hours > 2.5 µg/L at screening analysed by central laboratory.
Subjects who have had pituitary surgery must be >8 weeks post-surgery.
18 to 75 years of age.

Key exclusion criteria (18 listed)

The subject has received long-acting Somatostatin Analogues (SSA) within 12 weeks prior screening (e.g.octreotide long acting release (LAR), lanreotide Autogel, pasireotide LAR).
The subject has received short-acting SSA within 1 week (e.g. octreotide SC) prior to screening.
The subject has received a dopamine agonist within 6 weeks (e.g., bromocriptine or cabergoline) prior to screening.
The subject has received GH antagonist within 12 weeks prior to screening (e.g., pegvisomant).
The subject had undergone radiotherapy to the pituitary gland at any time prior to study entry.

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
BIM23B065Subcutaneous twice a day or three times a day administration of BIM23B065. Dose will be 0.4, 0.6, 0.8 or 1 mg (twice a day or three times a day).	Drug	BIM23B065

Primary outcome

The Number of Subjects Who Were Growth Hormone (GH) Responders at Day 14 of the Treatment Period
Time frame: From baseline (Day -1) to Day 14.
A GH responder was defined as a subject with mean serum GH concentration ≤2.5 micrograms per litre (mcg/L) or >50% reduction from mean baseline GH concentration after a 6-day titration and an 8-day treatment period with BIM23B065. The mean serum concentration of GH was measured over 6 hours at baseline (Day -1) and on Day 14. The number of subjects who were GH responders at Day 14 of the treatment period is presented.

Results and safety

Results posted to the registry on 8 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIM23B065 BID Stage 1	4	3

Primary outcome: The Number of Subjects Who Were Growth Hormone (GH) Responders at Day 14 of the Treatment Period

Time frame: From baseline (Day -1) to Day 14.. Count of participants. Unit: Participants

Measure	BIM23B065 BID Stage 1 n = 3
Value	1

Population analysed: The Efficacy Evaluable population consisted of all subjects with at least 1 BIM23B065 administration with available pharmacodynamic (PD) data and no protocol deviations with relevant impact on PD data, who had an evaluable primary efficacy endpoint (mean concentration of GH over 6 hours) at baseline and at Day 14.

Adverse events

Time frame: Treatment emergent adverse events were collected from Day 1 of the treatment period up to the end of Week 4 (approximately 28 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIM23B065 BID Stage 1	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Limitations and caveats (from the sponsor): The sponsor stopped the study early as the preliminary results in 3 subjects dosed with BIM23B065 showed an inadequate PD profile and efficacy. The enrolled subjects only received BID treatment. Only the primary endpoint results are reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acromegaly

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

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 Study Director study director

Ipsen

6 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIM23B065 in people with Acromegaly, run by Ipsen at 6 sites in 4 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 8 inclusion and 18 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 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Ukraine, Belgium, Hungary, Serbia. 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 8 Mar 2019). 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?

The Number of Subjects Who Were Growth Hormone (GH) Responders at Day 14 of the Treatment Period (time frame: From baseline (Day -1) to Day 14.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03045302.

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 8 Mar 2019.