A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

Official title

A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs

Overview

The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.

Interventions

• Drug Debio 4126
  IM injection, a 12-week extended-release formulation of octreotide
• Drug Placebo
  IM injection of mannitol suspension

Primary outcome measures

• Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN [Time frame: 36 Weeks]

Secondary outcome measures (10)

• Arm C: Percentage of Participants With IGF-1 ≤1x ULN [Time frame: 36 Weeks]
• Percent Change From Baseline in IGF-1 Values [Time frame: Up to 108 Weeks]
• Percentage of Participants With IGF-1 ≤1x ULN [Time frame: Up to 108 Weeks]
• Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL [Time frame: Up to 108 Weeks]
• Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) [Time frame: Up to 36 Weeks]
• Percentage of Participants Who Experienced at Least One TEAE [Time frame: Up to 113 Weeks]
• Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment [Time frame: Up to 108 Weeks]
• Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score [Time frame: Up to 108 Weeks]
• Double-blind Period: Percentage of Participants Taking Rescue Medication [Time frame: Up to 36 Weeks]
• Trough Plasma Concentration (Ctrough) of Debio 4126 [Time frame: Up to 96 Weeks]

Eligibility criteria

Inclusion criteria

• Patients ≥18 years of age
• Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
• IGF-1 at screening ≤1x ULN
• Acromegaly diagnosis, defined as per protocol
• Adequate bone marrow, hepatic and renal function
• To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication
• Other protocol-defined criteria apply

Exclusion criteria

• Compression of optic chiasm causing visual defects
• Symptomatic cholelithiasis or bile duct dilatation
• Planned cholecystectomy during the trial duration
• Acute or chronic pancreatitis
• Pituitary radiotherapy
• Uncontrolled hypothyroidism
• Uncontrolled diabetes
• Pituitary surgery within 6 months before screening or planned on trial
• Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening
• Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
• Other protocol-defined criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 10 centers

• Cedars Sinai Medical Center — Los Angeles
• Northwestern University — Chicago
• Harvard Medical School — Boston
• Washington University-School of Medicine — St Louis
• Palm Research Center Inc — Las Vegas
• NYU Grossman School of Medicine — New York
• The Cleveland Clinic — Cleveland
• The Ohio State University — Columbus
• … and 2 more centers

Italy · 9 centers

• Azienda ospedaliero Universitaria di Ferrara — Ferrara
• Ospedale Policlinico San Martino IRCCS — Genova
• ASST Grande Ospedale Metropolitano Niguarda — Milan
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano — Milan
• IRCCS Ospedale San Raffaele — Milan
• AOU Federico II Napoli — Naples
• Azienda Ospedale Università di Padova — Padova
• Fondazione Policlinico Universitario A Gemelli — Roma
• … and 1 more center

Spain · 7 centers

• Hosiptal Universitario de la Ribera — Alzira
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitario Vall d'Hebron — Barcelona
• Hospital Universitario Germans Trias i Pujol — Barcelona
• Hospital Ramón y Cajal — Madrid
• Complexo Hospitalario Universitario de Santiago de Compostela — Santiago de Compostela
• Hospital Universitario Virgen del Rocio — Seville

France · 6 centers

• CHU d'Angers — Angers
• Hospices Civils de Lyon — Bron
• APHP - Hôpital Bicêtre — Le Kremlin-Bicêtre
• Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception — Marseille
• Hopital Haut-Leveque — Pessac
• CHU Toulouse - Hôpital Larrey — Toulouse

Brazil · 5 centers

• CETI - Centro de Estudos em Terapias Inovadoras — Curitiba
• Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM) — Fortaleza
• Hospital das Clinicas da UFMG — Minas Gerais
• Instituto Estadual do Cérebro Paulo Niemeyer (IECPN) — Rio de Janeiro
• Hospital das Clinicas - University of Sao Paulo Medical School — São Paulo

Israel · 4 centers

• Bnai Zion Medical Center — Haifa
• Rambam Health Care Campus — Haifa
• Rabin Medical Center - Beilinson Campus — Petah Tikva
• Tel Aviv Sourasky Medical Center — Tel Aviv

Poland · 4 centers

• Centrum Medyczne Intercor Sp. z o.o. — Bydgoszcz
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie — Gliwice
• Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medica — Poznan
• Uniwersytecki Szpital Kliniczny we Wroclawiu — Wroclaw

Germany · 3 centers

• Charité Universitätsmedizin Berlin — Berlin
• Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi — Munich
• Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog — Würzburg

Hungary · 3 centers

• Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika — Budapest
• Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia — Budapest
• University of Szeged Faculty of Medicine — Szeged

Romania · 3 centers

• Institutul National de Endocrinologie "C.I. Parhon" — Bucharest
• Delta Health Care — Bucharest
• Spitalul Clinic Judetean de Urgenta Cluj-Napoca — Cluj-Napoca

Austria · 2 centers

• Medical University Graz — Graz
• Medizinische Universitaet Wien - Division of Endocrinology and Metabolism — Vienna

Denmark · 2 centers

• Rigshospitalet, Blegdamsvej 9 — Copenhagen
• Zealand University Hospital — Køge

Estonia · 2 centers

• East Tallinn Central Hospital — Tallinn
• North Estonia Medical Centre Foundation — Tallinn

Lithuania · 2 centers

• Lithuanian Health Science University Hospital Kauno klinikos — Kaunas
• Vaidotas Urbanavicius Sole Proprietor Enterprise — Vilnius

Serbia · 2 centers

• University Clinical Center of Serbia — Belgrade
• University Clinical Center of Serbia — Belgrade

Sweden · 2 centers

• Karolinska University Hospital — Stockholm
• Uppsala University Hospital — Uppsala

United Kingdom · 2 centers

• University Hospitals Birmingham NHS Foundation Trust — Birmingham
• Leeds Teaching Hospitals NHS Trust — Leeds

Belgium · 1 center

• UZ Gent — Ghent

Bulgaria · 1 center

• University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD — Sofia

Latvia · 1 center

• Pauls Stradins Clinical University Hospital — Riga

Slovakia · 1 center

• Narodni endokrinologicky a diabetologicky ustav — Ľubochňa

Identifiers

NCT: NCT06930625 · Debio 4126-301 · 2024-516616-24 · U1111-1310-8427

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗