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
Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Harvard Medical School
RECRUITING
Boston
Missouri
Washington University-School of Medicine
RECRUITING
St Louis
Nevada
Palm Research Center Inc
RECRUITING
Las Vegas
Ohio
The Cleveland Clinic
RECRUITING
Cleveland
The Ohio State University
RECRUITING
Columbus
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Other Locations
Austria
Medical University Graz
RECRUITING
Graz
Medizinische Universitaet Wien - Division of Endocrinology and Metabolism
RECRUITING
Vienna
Belgium
UZ Gent
RECRUITING
Ghent
Brazil
CETI - Centro de Estudos em Terapias Inovadoras
RECRUITING
Curitiba
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)
RECRUITING
Fortaleza
Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)
NOT_YET_RECRUITING
Rio De Janeiro
Hospital das Clinicas - University of Sao Paulo Medical School
RECRUITING
São Paulo
Bulgaria
University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD
RECRUITING
Sofia
Denmark
Rigshospitalet, Blegdamsvej 9
RECRUITING
Copenhagen
Zealand University Hospital
RECRUITING
Køge
Estonia
East Tallinn Central Hospital
RECRUITING
Tallinn
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
France
CHU d'Angers
RECRUITING
Angers
Hospices Civils de Lyon
RECRUITING
Bron
APHP - Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
RECRUITING
Marseille
Hopital Haut-Leveque
RECRUITING
Pessac
CHU Toulouse - Hôpital Larrey
RECRUITING
Toulouse
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi
RECRUITING
Munich
Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog
RECRUITING
Würzburg
Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia
RECRUITING
Budapest
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
RECRUITING
Budapest
University of Szeged Faculty of Medicine
RECRUITING
Szeged
Israel
Bnai Zion Medical Center
RECRUITING
Haifa
Rambam Health Care Campus
RECRUITING
Haifa
Rabin Medical Center - Beilinson Campus
RECRUITING
Petah Tikva
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda ospedaliero Universitaria di Ferrara
RECRUITING
Ferrara
Ospedale Policlinico San Martino IRCCS
RECRUITING
Genova
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
AOU Federico II Napoli
NOT_YET_RECRUITING
Napoli
Azienda Ospedale Università di Padova
RECRUITING
Padua
Fondazione Policlinico Universitario A Gemelli
RECRUITING
Roma
University of Torino
NOT_YET_RECRUITING
Torino
Latvia
Pauls Stradins Clinical University Hospital
RECRUITING
Riga
Lithuania
Lithuanian Health Science University Hospital Kauno klinikos
RECRUITING
Kaunas
Vaidotas Urbanavicius Sole Proprietor Enterprise
RECRUITING
Vilnius
Poland
Centrum Medyczne Intercor Sp. z o.o.
RECRUITING
Bydgoszcz
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
RECRUITING
Gliwice
Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences
RECRUITING
Poznan
Uniwersytecki Szpital Kliniczny we Wroclawiu
RECRUITING
Wroclaw
Romania
Delta Health Care
RECRUITING
Bucharest
Institutul National de Endocrinologie C.I. Parhon
RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
RECRUITING
Cluj-napoca
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
University Clinical Center of Serbia
NOT_YET_RECRUITING
Belgrade
Slovakia
Narodni endokrinologicky a diabetologicky ustav
RECRUITING
Ľubochňa
Spain
Hosiptal Universitario de la Ribera
RECRUITING
Alzira
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Germans Trias i Pujol
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Ramón y Cajal
RECRUITING
Madrid
Complexo Hospitalario Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Uppsala University Hospital
RECRUITING
Uppsala
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
NOT_YET_RECRUITING
Birmingham
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Contact Information
Primary
Debiopharm International S.A
clinicaltrials@debiopharm.com
+41 21 321 01 11
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2029-03
Participants
Target number of participants: 119
Treatments
Experimental: Arm A: Debio 4126
During Period 1 (double-blind treatment period), participants will receive an intramuscular (IM) injection of Debio 4126 once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.~Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
Placebo_comparator: Arm B: Placebo + Debio 4126
During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.~Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
Experimental: Arm C: Debio 4126 (Open-Label Treatment Period)
During the Treatment Period, participants will receive an IM injection of Debio 4126 once every 12 weeks over a total of between 60 and 96 weeks (between 5 and 8 injections in total).
Related Therapeutic Areas
Sponsors
Leads: Debiopharm International SA