A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination With Somatostatin Analogs in Adult Participants With Acromegaly

Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Research Site
NOT_YET_RECRUITING
Los Angeles
Research Site
NOT_YET_RECRUITING
Los Angeles
Research Site
RECRUITING
Torrance
Colorado
Research Site
WITHDRAWN
Aurora
Massachusetts
Research Site
NOT_YET_RECRUITING
Boston
Michigan
Research Site
RECRUITING
Ann Arbor
Nevada
Research Site
RECRUITING
Las Vegas
New York
Research Site
NOT_YET_RECRUITING
New York
Oregon
Research Site
NOT_YET_RECRUITING
Portland
Other Locations
Argentina
Research Site
RECRUITING
Caba
Research Site
NOT_YET_RECRUITING
Ciudad De Buenos Aires
Research Site
NOT_YET_RECRUITING
Ciudad De Buenos Aires
Research Site
NOT_YET_RECRUITING
Ciudad De Buenos Aires
Brazil
Research Site
NOT_YET_RECRUITING
Curitiba
Research Site
NOT_YET_RECRUITING
Ribeirão Preto
Research Site
NOT_YET_RECRUITING
Rio De Janeiro
Research Site
NOT_YET_RECRUITING
São Paulo
China
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Kunming
Research Site
NOT_YET_RECRUITING
Shanghai
Denmark
Research Site
NOT_YET_RECRUITING
Copenhagen
Research Site
NOT_YET_RECRUITING
Odense
Hungary
Research Site
NOT_YET_RECRUITING
Budapest
Research Site
NOT_YET_RECRUITING
Budapest
Research Site
RECRUITING
Pécs
Research Site
NOT_YET_RECRUITING
Szeged
Italy
Research Site
RECRUITING
Cona
Research Site
NOT_YET_RECRUITING
Genoa
Research Site
NOT_YET_RECRUITING
Messina
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Napoli
Research Site
RECRUITING
Pisa
Research Site
NOT_YET_RECRUITING
Roma
Lithuania
Research Site
RECRUITING
Kaunas
Research Site
RECRUITING
Vilnius
Netherlands
Research Site
NOT_YET_RECRUITING
Leiden
Research Site
NOT_YET_RECRUITING
Rotterdam
Poland
Research Site
WITHDRAWN
Bydgoszcz
Research Site
NOT_YET_RECRUITING
Gliwice
Research Site
NOT_YET_RECRUITING
Krakow
Research Site
NOT_YET_RECRUITING
Warsaw
Research Site
NOT_YET_RECRUITING
Wroclaw
Romania
Research Site
RECRUITING
Bucharest
Research Site
NOT_YET_RECRUITING
Cluj-napoca
Contact Information
Primary
Alexion Pharmaceuticals, Inc. (Sponsor)
clinicaltrials@alexion.com
1-855-752-2356
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2027-11-11
Participants
Target number of participants: 60
Treatments
Experimental: ALXN2420
During the Primary Evaluation Period, participants will receive the first dose of ALXN2420 via SC injection on Day 1, followed by daily administration thereafter for a total of 15 weeks.
Placebo_comparator: Placebo
During the Primary Evaluation Period, participants will receive the first dose of placebo via SC injection on Day 1, followed by daily administration thereafter for a total of 15 weeks.
Experimental: Open-label Extension Period
During the Open-label Extension (OLE) Period, participants in the ALXN2420 treatment groups will continue receiving ALXN2420 treatment and participants in the placebo groups will crossover to receive ALXN2420 at Week 15. At the Week 15 Visit, the dose level and the dosing regimen of ALXN2420 will be determined for each participant based on the Week 13 IGF-1 level. The OLE Period assessments will be performed at Weeks 19, 26, 32, 39, 45, and 52.
Sponsors
Leads: Alexion Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov