A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Camurus AB72 enrolled

Overview

The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acromegaly

Interventions

CAM2029 (octreotide subcutaneous depot)DRUG

Octreotide subcutaneous depot for monthly injections in acromegaly patients

Matching placeboDRUG

Matching placebo for CAM2029

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 long-acting repeatable (LAR) or lanreotide autogel (ATG) for at least 3 months as monotherapy prior to screening * Insulin-like growth factor-1 (IGF-1) levels ≤1x upper limit of normal (ULN) at screening * Adequate liver, pancreatic, renal and bone marrow functions * Normal ECG Exclusion Criteria: * Growth hormone (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%)

Locations (63)

Outcomes

Primary Outcomes

Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24

If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the intention-to-treat (ITT) analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".

Time frame: Week 22 and 24

Secondary Outcomes

Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction

First key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP and/or was switched to rescue medication. For this endpoint, a patient who had their dose reduced was not directly classified as a non-responder. No participant had their dose reduced during the trial. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants"

Time frame: Week 22 and 24

Proportion of Participants With Mean IGF-1 Levels ≤1xULN at Week 22/Week 24 and Mean Growth Hormone (GH) Levels <2.5 µg/L at Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

UCLA Department of Medicine Division of Endocrinology

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Prufen Clinical Research LLC

Miami, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University in St. Louis, School of Medicine

St Louis, Missouri, United States

Palm Research Center

Las Vegas, Nevada, United States

Columbia University Medical Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

...and 53 more locations

Second key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample or no GH value at Week 24. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if they discontinued IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".

Time frame: Week 22 and 24

Proportion of Participants With Mean GH Levels <2.5 µg/L at Week 24

For the responder analysis of mean GH \<2.5 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".

Time frame: Week 24

Proportion of Participants With Mean GH Levels <1.0 µg/L at Week 24

For the responder analysis of mean GH \<1.0 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".

Time frame: Week 24

Number of Participants With Treatment Emergent Adverse Events

A treatment emergent adverse event was defined as an adverse event that occurred during or after the first administration of the IMP to the end of trial visit or the next dose of any acromegaly treatment, whichever came first.

Time frame: Week 0 to 24

Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention

During participants'/partners' first three attempts during the trial period of 24 weeks whenever these visits took place. Percentages were based on those who opted for self-/partner-administration.

Time frame: Week 0 to 20 and Week 24

Octreotide Plasma Concentrations Over Time

Plasma samples were taken pre-dose on dosing days.

Time frame: Week 0 to 24