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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ALXN2420

    Drug

    ALXN2420 will be administered via subcutaneous (SC) injection

  • Placebo

    Drug

    Placebo will be administered via SC injection.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: ALXN2420Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Open-label Extension PeriodExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage Change From Baseline in Serum IGF-1 Level at Week 15

Time frame
Baseline, Week 15

Secondary outcomes

1

Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15

Time frame
Week 15
2

Number of Participants Who Achieve of Serum IGF-1 Level ≤1.0 ULN at Week 15

Time frame
Week 15
3

Change from Basline in Symptoms as assessed by disease specific questionnaire, at Week 15

Time frame
Baseline, Week 15
4

Change From Baseline in Serum IGF-1 Level at Week 15

Time frame
Baseline, Week 15

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexion Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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