Not recruitingRare disease

Study of ALXN2420 with somatostatin analogs for adults with acromegaly to evaluate effectiveness in lowering IGF-1 levels

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Acromegaly, a condition caused by a tumor in the pituitary gland that produces excess growth hormone. The research evaluates a new medication called ALXN2420 used together with existing treatments called somatostatin analogs (octreotide acetate or lanreotide acetate). These medications help control the excessive hormone production that causes the symptoms of acromegaly.

The purpose of this study is to determine if ALXN2420 can help lower levels of a hormone called IGF-1 in people with acromegaly when combined with standard treatments. The study compares ALXN2420 to placebo, with both being given alongside regular acromegaly medications. The treatment period lasts for 15 weeks, during which participants receive either ALXN2420 or placebo through injections under the skin.

Throughout the study, participants continue their regular acromegaly medications, which are given as injections either into the muscle or under the skin once every four weeks. The study monitors how well the combination of treatments works by measuring hormone levels and tracking any changes in symptoms. Participants also complete questionnaires about their quality of life and overall health during the study period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
You will begin the study after meeting specific requirements, including having acromegaly confirmed by MRI or pathology report
Your current treatment must include long-acting somatostatin analogs (SSAs) for at least 6 months before starting the study
Your IGF-1 levels will be checked twice during screening, with measurements taken at least 7 days apart
Step 2
Treatment assignment
You will be randomly assigned to receive either ALXN2420 or a matching placebo
The medication will be given by subcutaneous injection (under the skin)
You will continue your regular SSA treatment throughout the study
Step 3
Treatment period
The treatment period lasts for 15 weeks
Your IGF-1 levels will be monitored throughout the study
You will complete several questionnaires about your symptoms and quality of life
Regular blood tests will check the concentration of the study medication in your system
Your health status will be monitored for any side effects or reactions to the treatment
Step 4
Final assessment
At week 15, final measurements of your IGF-1 levels will be taken
You will complete final questionnaires about your symptoms and quality of life
The medical team will perform a final evaluation of your health status
Blood samples will be checked for the presence of antidrug antibodies

Who can join the trial?

9 criteria

Age between 18 and 80 years old at the time of screening
Must have a confirmed diagnosis of acromegaly with documented evidence of a growth hormone (GH) producing pituitary tumor shown by MRI scan or tissue examination
check
Must be currently taking long-acting SSA medication (a type of hormone therapy) with the following conditions:
- Taking the maximum or highest tolerable dose as determined by your doctor
- Been on the medication for at least 6 months
- Receiving treatment once every month (approximately every 4 weeks)
- Must show partial response to SSA therapy, meaning your IGF-1 levels (a hormone that indicates disease activity) have decreased by more than 20% while on treatment
- check
  Must have IGF-1 levels that are:
  - At least 1.3 times higher than the normal upper limit
  - Not more than 5 times the normal upper limit
  - Confirmed by two separate blood tests taken at least 7 days apart

Who cannot join the trial?

15 criteria

History of pituitary surgery (brain surgery to remove tumors from the pituitary gland) within 6 months before starting the study
Radiation therapy to the pituitary gland within the last 10 years
Previous treatment with growth hormone receptor blockers in the past 6 months
Severe or uncontrolled high blood pressure (blood pressure readings above 160/100 mmHg)
History of heart attack or stroke in the past 6 months
Severe liver problems (liver function tests more than 3 times above normal limits)
Severe kidney problems (requiring dialysis or with severely reduced kidney function)
Active or chronic infections
Current cancer diagnosis or cancer treatment within the past 5 years
Pregnant or breastfeeding women
Participation in another clinical trial within 30 days before this study
Known allergies to similar medications or their components
Unstable mental health conditions
Alcohol or drug abuse within the past year
Any condition that, in the opinion of the study doctor, would make participation unsafe

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

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Investigated drugs

ALXN2420
is an experimental medication that works as a growth hormone receptor antagonist. It is designed to block the effects of growth hormone in the body. This medication is given as an injection under the skin (subcutaneously) to treat acromegaly, a condition where the body produces too much growth hormone.
Somatostatin Analogs (SSAs)
are medications that help control hormone production in the body. They work by reducing the release of growth hormone and are commonly used to treat acromegaly. These medications are used in combination with ALXN2420 in this trial to better manage the condition.

What is already known about the treatment

ALXN2420 - A novel growth hormone receptor antagonist administered through subcutaneous injection, currently being investigated in Phase 2 clinical trials for the treatment of acromegaly in combination with somatostatin analogs (SSA). This experimental medication works by blocking growth hormone receptors at the molecular level, which helps reduce insulin-like growth factor 1 (IGF-1) levels in patients with acromegaly. The drug belongs to the pharmacological class of growth hormone receptor antagonists, representing a potential new treatment option for patients whose acromegaly is not adequately controlled by current standard therapies. Note: Since the trial data only mentions one investigational product (ALXN2420), I have provided a single description. The medication is still in clinical trials and not yet approved for general medical use.

Investigated diseases

Acromegaly - A hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood. The condition results in gradual enlargement of body tissues, including hands, feet, facial features, and internal organs. People with acromegaly may notice increased ring size, shoe size, and changes in facial appearance, such as protruding brow and lower jaw, enlarged nose, and widened spaces between teeth. The condition typically develops slowly over many years, and changes can be so gradual that they're often not noticed by people who see the affected person daily. Acromegaly can also cause other symptoms like joint pain, increased sweating, and fatigue. The disorder affects both men and women equally.