Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000989842
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
13/09/2012
Date last updated
9/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase II Randomised, Open-Label, Parallel Group Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Two Subcutaneous Dosing Regimens of ATL1103 in Adult Patients with Acromegaly.
Scientific title
A Phase II Randomised, Open-Label, Parallel Group Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Two Subcutaneous Dosing Regimens of ATL1103 in Adult Patients with Acromegaly.
Secondary ID [1] 280765 0
1103-CT02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 286821 0
Condition category
Condition code
Metabolic and Endocrine 287133 287133 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive ATL1103 (growth hormone (GH) receptor antisense oligonucleotide) as a sterile aqueous solution administered by subcutaneous injection

Dose regimen 1 - 200mg on Day 1, 4, and 7 and then once weekly for 12 weeks
Intervention code [1] 285191 0
Treatment: Drugs
Comparator / control treatment
Subjects will receive ATL1103 (growth hormone (GH) receptor antisense oligonucleotide) as a sterile aqueous solution administered by subcutaneous injection

Dose regimen 2 - 200mg on Day 1, 4 and 7 and then twice weekly for 12 weeks
Control group
Dose comparison

Outcomes
Primary outcome [1] 287448 0
Safety and tolerability will be assessed by serum chemistry, haematology, urinalysis, physical exam, vital signs, electrocardiogram, MRI, and monitoring and recording adverse events
Timepoint [1] 287448 0
Over 13 weeks of treatment and 8 weeks of follow up
Primary outcome [2] 287449 0
Single and multiple dose pharmacokinetic parameters
Timepoint [2] 287449 0
Plasma will be collected for ATL1103 assays pre-dose and at 1, 2, 3, 4 and 6 hours post first and last doses, and pre-dose only on Day 4 of Weeks 1, 2, 4, 6, 8, 10, and 12.
Secondary outcome [1] 298173 0
Efficacy of ATL1103 will be assessed by measurement of serum insulin-like growth factor (IGF)-I levels.
Timepoint [1] 298173 0
Week 14 compared to Baseline.
Secondary outcome [2] 298174 0
To explore pharmacodynamic effects of ATL1103 on laboratory parameters (GH, GHBP, IGFBP-3, ALS, and IGF-II)
Timepoint [2] 298174 0
Week 14 compared to Baseline
Secondary outcome [3] 299187 0
To explore pharmacodynamic effects of ATL1103 on ring size assessment
Timepoint [3] 299187 0
Week 14 compared to Baseline
Secondary outcome [4] 299188 0
To explore pharmacodynamic effects of ATL1103 on Signs and Symptoms Scale
Timepoint [4] 299188 0
Week 14 compared to Baseline
Secondary outcome [5] 299189 0
To explore pharmacodynamic effects of ATL1103 on Acromegaly Quality-of-Life questionnaire
Timepoint [5] 299189 0
Week 14 compared to Baseline

Eligibility
Key inclusion criteria
- Provide written informed consent in accordance with local regulations.
- Are 18 to 80 years of age inclusive.
- Have acromegaly due to pituitary adenoma (micro or macro adenoma) identified by Magnetic Resonance Imaging (MRI).
- Have serum IGF-I level at Screening >1.3 times the upper limit of normal (ULN).
- Have nadir serum GH levels > 1ng/mL at all test time points within the 2 hours post oral glucose load for an oral glucose tolerance test (OGTT).
- Are acromegaly treatment naive, or who have not taken other acromegaly medications for a period of 6 weeks to 4 months, depending on the medication.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have acromegaly due to reasons other than pituitary adenoma.
- Have participated in any clinical investigation with an investigational drug within 3 months (4 months if the drug is a new chemical entity) preceding the Baseline visit or during the washout period.
- Have a history of clinically relevant gastrointestinal, hepatic, renal, endocrine (other than acromegaly), haematological, metabolic, neurologic or psychiatric disease that in the investigator’s opinion may compromise their safety or effect results from this study.
- Have any other medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study, or are otherwise unsuitable for participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/12/2012
Actual
15/02/2013
Date of last participant enrolment
Anticipated
Actual
14/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 7739 0
5000 - Adelaide
Recruitment postcode(s) [2] 7740 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 4384 0
France
State/province [1] 4384 0
Country [2] 4385 0
Spain
State/province [2] 4385 0
Country [3] 4386 0
United Kingdom
State/province [3] 4386 0

Funding & Sponsors
Funding source category [1] 285553 0
Commercial sector/Industry
Name [1] 285553 0
Antisense Therapeutics Limited
Country [1] 285553 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Antisense Therapeutics Limited
Address
6 Wallace Avenue
Toorak Vic 3142
Country
Australia
Secondary sponsor category [1] 284392 0
None
Name [1] 284392 0
Address [1] 284392 0
Country [1] 284392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288015 0
NRES Committee East Midlands
Ethics committee address [1] 288015 0
Ethics committee country [1] 288015 0
Date submitted for ethics approval [1] 288015 0
17/09/2012
Approval date [1] 288015 0
20/11/2012
Ethics approval number [1] 288015 0

Summary
Brief summary
ATL1103 is being developed as a potential treatment for acromegaly, a disease of excessive growth hormone and insulin-like growth hormone (IGF-I) action. Twenty four acromegaly patients will receive 200mg ATL1103 three times in week one and then either once or twice a week for a further 12 weeks. All treatments will be administered by subcutaneous injection.

The primary objectives of the study are to evaluate the safety and tolerability of the two dosing regimens of 1103, and to investigate the pharmacokinetic profiles of ATL1103. The effect of ATL1103 on serum IGF-I levels and on other pharmacodynamic markers will also be measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34383 0
Prof Peter Trainer
Address 34383 0
Christie Hospital
550 Wilmslow Rd
Manchester M20 4BX
United Kingdom
Country 34383 0
United Kingdom
Phone 34383 0
+44 (0) 161 446 3664
Fax 34383 0
Email 34383 0
[email protected]
Contact person for public queries
Name 17630 0
Ms Sue Turner
Address 17630 0
6 Wallace Avenue
Toorak VIC 3142
Country 17630 0
Australia
Phone 17630 0
+61 3 9827 8999
Fax 17630 0
Email 17630 0
[email protected]
Contact person for scientific queries
Name 8558 0
Dr Lynne Atley
Address 8558 0
6 Wallace Avenue
Toorak VIC 3142
Country 8558 0
Australia
Phone 8558 0
+61 3 9827 8999
Fax 8558 0
Email 8558 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.