ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
ConditionAcromegaly
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAlexion Pharmaceuticals, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ALXN2420
- Placebo
Treatment groups
60 Participants
are divided into 3 treatment groupsLocations
45Argentina
Research SiteC1012AAR, CABA Argentina
Research SiteC1180AAD, Ciudad de Buenos Aires Argentina
Research SiteC1199, Ciudad de Buenos Aires Argentina
Research SiteC1405DCS, Ciudad de Buenos Aires Argentina
Sponsors and collaborators
Alexion Pharmaceuticals, Inc.
Lead sponsor
Source ClinicalTrials.gov