E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Acromegaly is a chronic metabolic disorder in which there is too much growth hormone and the body tissues gradually enlarge. |
La acromegalia es un trastorno metabólico crónico en el que hay excesiva secreción de la hormona del crecimiento y los tejidos del cuerpo aumentan gradualmente |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000599 |
E.1.2 | Term | Acromegaly |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
•To assess maintenance of biochemical control of CAM2029 compared to placebo |
•Evaluar la superioridad de CAM2029 en comparación con placebo en la respuesta bioquímica |
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E.2.2 | Secondary objectives of the trial |
-to assess maintenance of biochemical control, based on GH, with CAM2029 compared to placebo; -To evaluate the safety profile of CAM2029 compared to placebo -To assess self or partner administration -To assess plasma concentrations of octreotide after administration of CAM2029 |
-Evaluar la eficacia de CAM2029 frente a placebo en cuanto a los niveles de GH - Evaluaar la segurdad de CAM2029 frente a placebo.• - Evaluar la autoadministración supervisada o la administración por un colaborador de CAM2029 y placebo - Evaluar las concertaciones de octreotide despues de la adminstración de CAM2029 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female patients, ≥18 years at screening - Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed - Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly - Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening - IGF-1 levels ≤1xULN at screening - Adequate liver, pancreatic, renal and bone marrow functions - Normal ECG |
- Pacientes mayor o igula a 18 años al Screening - Pacientes con la capacidad suficiente para firmar el consentimiento informado del estudio y realizar los procedimientos del mismo. -Diagnóstico de acromegalia (persistente o recidivante) -Tratamiento con una dosis estable de octreotida LP (10 mg, 20 mg, 30 mg o 40 mg) o lanreotida ATG (60 mg, 90 mg o 120 mg) durante al menos 3 meses en monoterapia antes de la selección -Niveles de IGF-1 ≤ 1 x LSN, según el valor medio de una primera medición realizada en la selección y una segunda medición 2 semanas antes del día 1 -Funciones hepática, pancreática, renal y medular adecuadas -ECG normal |
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E.4 | Principal exclusion criteria |
- GH ≥2.5 μg/L at screening (cycle) • Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer]) • Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) • Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated • Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening • Patients who have undergone pituitary surgery within 6 months prior to screening • Patients who have received prior pituitary irradiation • Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%) |
• GH ≥ 2,5 µg/l en la selección (ciclo) • Haber recibido tratamiento médico para la acromegalia con pasireotida (en los 6 meses anteriores a la selección), pegvisomant (en los 3 meses anteriores a la selección), agonistas dopaminérgicos (en los 3 meses anteriores a la selección) u otros fármacos en investigación (en los 30 días o 5 semividas antes de la selección [lo que sea más largo]) • Pacientes que toman habitualmente octreotida LP o lanreotida ATG con una frecuencia inferior a cada 4 semanas (p. ej., cada 6 o cada 8 semanas) • Pacientes con compresión del quiasma óptico que provoque algún defecto del campo visual para el que esté indicado la cirugía • Pacientes sometidos a tratamiento quirúrgico/cirugía mayor por cualquier causa en el plazo de 1 mes antes de la selección • Pacientes sometidos a cirugía hipofisaria en los 6 meses anteriores a la selección • Pacientes que hayan recibido radioterapia hipofisaria • Pacientes con diabetes mellitus mal controlada (hemoglobina A1c > 8,0 %) |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Proportion of patients with biochemical response, defined as mean IGF-1 levels ≤1x upper limit of normal (ULN) at Week 22 and Week 24 |
La proporción de pacientes con respuesta bioquímica, definida como unos niveles medios de IGF-1 ≤ 1 x LSN en la semana 22 y la semana 24. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 22 and Week 24 |
Semana 22 y semana 24 |
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E.5.2 | Secondary end point(s) |
-Proportion of patients with mean GH levels <2.5 µg/L at Week 22 and Week 24 - Proportion of patients/partners declared competent by healthcare professional to administer CAM2029 or placebo -Incidence of adverse events (AEs) and laboratory and electrocardiogram (ECG) abnormalities - Octreotide plasma concentrations over time |
-Proporción de pacientes con niveles medios de GH < 2,5 µg/l en la semana 22 y la semana 24 -Proporción de pacientes/colaboradores declarados aptos por el profesional sanitario para administrar el CAM2029 o placebo. -Incidencia de eventos adversos (EA) y anomalías de laboratorio y electrocardiograma (ECG) - Concentraciones plasmáticas de octreótido en el tiempo. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 22 and Week 24 |
Semana 22 y semana 24 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Bulgaria |
Germany |
Greece |
Hungary |
Italy |
Netherlands |
Poland |
Russian Federation |
Serbia |
Spain |
Sweden |
Turkey |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |