Acromegaly
Conditions
Keywords
IGF-1, Growth hormone, Pituitary gland, Gigantism
Brief summary
The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.
Interventions
DRUGDebio 4126
IM injection, a 12-week extended-release formulation of octreotide
DRUGPlacebo
IM injection of mannitol suspension
Sponsors
Debiopharm International SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Arms A and B: Period 1 (Double-blind) and Period 2 (Open-label). Arm C: Open-label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥18 years of age 2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks. 3. IGF-1 at screening ≤1x ULN 4. Acromegaly diagnosis, defined as per protocol 5. Adequate bone marrow, hepatic and renal function 6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication 7. Other protocol-defined criteria apply
Exclusion criteria
1. Compression of optic chiasm causing visual defects 2. Symptomatic cholelithiasis or bile duct dilatation 3. Planned cholecystectomy during the trial duration 4. Acute or chronic pancreatitis 5. Pituitary radiotherapy 6. Uncontrolled hypothyroidism 7. Uncontrolled diabetes 8. Pituitary surgery within 6 months before screening or planned on trial 9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening 10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism 11. Other protocol-defined criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN | 36 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment | Up to 108 Weeks |
| Double-blind Period: Percentage of Participants Taking Rescue Medication | Up to 36 Weeks |
| Arm C: Percentage of Participants With IGF-1 ≤1x ULN | 36 Weeks |
| Percent Change From Baseline in IGF-1 Values | Up to 108 Weeks |
| Percentage of Participants With IGF-1 ≤1x ULN | Up to 108 Weeks |
| Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL | Up to 108 Weeks |
| Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | Up to 36 Weeks |
| Percentage of Participants Who Experienced at Least One TEAE | Up to 113 Weeks |
| Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score | Up to 108 Weeks |
| Trough Plasma Concentration (Ctrough) of Debio 4126 | Up to 96 Weeks |
Countries
Austria, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
CONTACTDebiopharm International S.A
Outcome results
None listed