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Compares treatment options for Acromegaly
Official title ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
ClinicalTrials.gov ID: NCT07037420
What this study is testing
What is ALXN2420?
ALXN2420 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acromegaly.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the efficacy of 15-week treatment with ALXN2420 versus placebo for decreasing insulin-like growth factor IGF-1 levels, when administered in combination with somatostatin analog (SSA) therapy to adult participants with acromegaly.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report
- Must be receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs (octreotide or lanreotide LAR) and meet...
- Received for ≥ 6 months prior to screening
- Receiving a once-monthly regimen (approximately every 4 weeks). Note: participants on stable regimens of other durations (for example, every 3 or 6...
- Must be a partial responder to SSAs defined as \> 20% relative IGF 1 reduction during the course of SSA therapy
You likely can't join if
- Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study
- Pituitary adenoma that, per Investigator's judgment, is worsening as assessed by pituitary/sellar MRI or computed tomography scan obtained ≤ 6 months...
- Pituitary adenoma causing compression of the chiasm
- Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists
- Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or glucocorticoid hormone replacement therapy for ≥ 3...
- Active, clinically significant cardiac disease as judged by the Investigator
See the full eligibility criteria
- Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report
- Must be receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs (octreotide or lanreotide LAR) and meet both of the following:
- Received for ≥ 6 months prior to screening
- Receiving a once-monthly regimen (approximately every 4 weeks). Note: participants on stable regimens of other durations (for example, every 3 or 6 weeks) are not eligible
- Must be a partial responder to SSAs defined as \> 20% relative IGF 1 reduction during the course of SSA therapy
- Serum IGF-1 levels \> 1.3 to 5\ ULN inclusive, as assessed at a central laboratory and adjusted for age and sex, based on average of 2 consecutive values obtained during the Screening Period and obtained ≥ 7 days apart
- Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study
- Pituitary adenoma that, per Investigator's judgment, is worsening as assessed by pituitary/sellar MRI or computed tomography scan obtained ≤ 6 months prior to screening
- Pituitary adenoma causing compression of the chiasm
- Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists
- Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or glucocorticoid hormone replacement therapy for ≥ 3 months prior to Screening
- Active, clinically significant cardiac disease as judged by the Investigator
- History of unstable angina, stroke, or acute myocardial infarction ≤ 3 months prior to screening
- Known uncontrolled type 2 diabetes (HbA1c \> 10%)
- Active malignant disease ≤ 2 years prior to screening with exception of basal and squamous cell carcinoma of the skin
- Received any type of fractionated radiotherapy or a second surgical adenectomy for pituitary adenoma within the last 3 years (5 years for conventional radiation) before starting treatment and/or are planning to receive...
- Received pegvisomant ≤ 8 weeks prior to screening
- Received dopamine agonists ≤ 4 weeks prior to screening
- Received pasireotide LAR ≤ 4 months prior to screening
- Clinically significant renal or hepatic disease at the time of screening, as judged by the Investigator
- eGFR (CKD-EPI formula) \< 30 mL/minute/1.73 m\^2 documented based on recent value (\< 3 months prior to randomization)
- Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis, as judged by the Investigator, including, but not limited to, total bilirubin \> 1.5\ ULN (except if in free bilirubin...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Portland, Oregon, United States
- CABA, Argentina
- Ciudad de Buenos Aires, Argentina
- Curitiba, Brazil
- Ribeirão Preto, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Beijing, China
- Guangzhou, China
- Kunming, China
- Shanghai, China
- Copenhagen, Denmark
- Odense, Denmark
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Torrance, California, United States; Aurora, Colorado, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Las Vegas, Nevada, United States and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.