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 (32) 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
Massachusetts
Harvard Medical School
NOT_YET_RECRUITING
Boston
Missouri
Washington University-School of Medicine
RECRUITING
St Louis
Nevada
Palm Research Center Inc
RECRUITING
Las Vegas
Ohio
The Ohio State University
RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Other Locations
Austria
Medical University Graz
RECRUITING
Graz
Belgium
UZ Gent
RECRUITING
Ghent
Estonia
East Tallinn Central Hospital
RECRUITING
Tallinn
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
NOT_YET_RECRUITING
Marseille
Germany
Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi
NOT_YET_RECRUITING
Munich
Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog
NOT_YET_RECRUITING
Würzburg
Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
NOT_YET_RECRUITING
Budapest
University of Szeged Faculty of Medicine
NOT_YET_RECRUITING
Szeged
Israel
Rambam Health Care Campus
NOT_YET_RECRUITING
Haifa
Rabin Medical Center - Beilinson Campus
NOT_YET_RECRUITING
Petah Tikva
Tel Aviv Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Italy
Azienda ospedaliero Universitaria di Ferrara
NOT_YET_RECRUITING
Ferrara
Ospedale Policlinico San Martino IRCCS
NOT_YET_RECRUITING
Genova
Fondazione Policlinico Universitario A Gemelli
NOT_YET_RECRUITING
Roma
Latvia
Pauls Stradins Clinical University Hospital
RECRUITING
Riga
Lithuania
Lithuanian Health Science University Hospital Kauno klinikos
NOT_YET_RECRUITING
Kaunas
Vaidotas Urbanavicius Sole Proprietor Enterprise
NOT_YET_RECRUITING
Vilnius
Poland
Centrum Medyczne Intercor Sp. z o.o.
RECRUITING
Bydgoszcz
Romania
Delta Health Care
RECRUITING
Bucharest
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
Slovakia
Narodni endokrinologicky a diabetologicky ustav
RECRUITING
Ľubochňa
Spain
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Contact Information
Primary
Debiopharm International S.A
clinicaltrials@debiopharm.com
+41 21 321 01 11
Time Frame
Start Date: 2025-11
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