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Phase 2 Study of ALXN2420 versus Placebo in Combination with Somatostatin Analogs in Participants with Acromegaly
EU CTIS ID: 2025-521243-20-00
What this study is testing
To evaluate the efficacy of 15 week treatment with ALXN2420 versus placebo for decreasing IGF-1 levels, when administered in combination with SSA therapy to adult participants with acromegaly
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1_Aged 18 to 80 years (inclusive) at Screening
- 2_Documented diagnosis of acromegaly, that is, historically documented evidence of a GH secreting pituitary adenoma based on MRI or pathology report
- 3_ Receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs and meet both of the following: - Received for ≥ 6 months prior to Screening - Receiving a once-monthly regimen (approximately every 4 weeks)
- 4_partial responder to SSAs at Screening, defined as > 20% relative IGF-1 reduction during the course of SSA therapy
- 5_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
You likely can't join if
- 1_Participants are excluded if they have any of the following medical conditions: 1. Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study 2. Pituitary adenoma that, per Investigator’s judgement, is worsening as assessed by pituitary/sellar MRI or computed tomography scan obtained ≤ 6 months prior to Screening 3. Pituitary adenoma causing compression of the chiasm 4. Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists 5. Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or glucocorticoid hormone replacement therapy for ≥ 3 months prior to Screening 6. Active, clinically significant cardiac disease as judged by the Investigator 7. History of unstable angina, stroke, or acute myocardial infarction ≤ 3 months prior to Screening 8. Known uncontrolled Type 2 diabetes (HbA1c >10%) 9. Active malignant disease ≤ 2 years prior to Screening with exception of basal and squamous cell carcinoma of the skin
- 2_Participants are excluded in case of Clinically significant renal or hepatic disease at the time of Screening, as judged by the Investigator or: - eGFR (CKD-EPI formula) < 30 mL/minute/1.73 m2 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 linked to a known Gilbert Syndrome) or AST, ALT, or alkaline phosphatase > 2 × ULN
- 3_Participants are excluded if received any of the following: - 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 radiotherapy or a second surgical adenectomy during the study - pegvisomant ≤ 8 weeks prior to Screening - dopamine agonists ≤ 4 weeks prior to Screening - pasireotide long-acting release ≤ 4 months prior to Screening
- 4_Known allergy or sensitivity to ALXN2420 or any of the excipients
The study team makes the final eligibility decision.
Where it's taking place
- China
- United States
- Argentina
- Brazil
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; United States; Argentina; Brazil. 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 EU CTIS; the study team decides eligibility.