A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3667 Once Daily for 24 Weeks in Adult Subjects With Dermatomyositis

Status: Active_not_recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis (DM), followed by an open-label extension (OLE) period until Week 48.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Participant has probable or definite DM in accordance with the ACR/EULAR criteria for at least 3 months.

• Participant with DM diagnosed in the 3 years prior to screening must have undergone cancer screening (according to local standard of care or applicable guidelines) within 1 year prior to screening. Note: The evidence of cancer screening must be documented.

• Participant must present objective evidence of active disease as defined by fulfilling 1 of the criteria below (as confirmed by the sponsor):

‣ DM rash as defined by modified-Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (m-CDASI-A) ≥ 6 at screening, or

⁃ Creatine kinase (CK) \> 4x upper limit of normal (ULN) at screening, or

⁃ muscle biopsy evidence of active disease within 3 months prior to screening (defined as presence of active inflammation in muscle biopsy), or

⁃ muscle magnetic resonance imaging showing active inflammation (edema) of the proximal skeletal muscles within 3 months prior to screening, or

⁃ electromyography showing acute changes, such as spontaneous activity and myopathic changes not explained by other diseases within 3 months prior to screening, or

⁃ any other clinical evidence of active disease as confirmed by the steering committee.

• Participant has reduced muscle strength (defined as Manual Muscle Test-8 \< 142/150) and at least 2 additional abnormal core set measurements out of the following 5 at screening:

‣ Physician's Global Disease Activity score \> 2/10 cm on the visual analog scale (VAS),

⁃ Patient's Global Disease Activity score \> 2/10 cm on VAS,

⁃ extra-muscular disease activity \> 2/10 cm on VAS,

⁃ Health Assessment Questionnaire-Disability Index score \> 0.25,

⁃ elevated muscle enzymes (e.g. aldolase, CK, ALT, AST, and lactate dehydrogenase) with at least 1 muscle enzyme \> 1.5x ULN.

• Participant previously demonstrated failure to or intolerance to first-line treatment (defined as oral corticosteroid\[s\] and at least 1 other immunosuppressant/ hydroxychloroquine) OR active disease despite treatment with first-line drugs. Currently, the participant is receiving maximum 3 treatments for DM (oral corticosteroid\[s\] and/or allowed immunosuppressant\[s\]/hydroxychloroquine) for at least 3 months and is on a stable dose (defined as no change in dose, type of administration, or dose regimen) for at least 4 weeks prior to screening and during screening within maximum allowed doses as specified in the study protocol. Note: Participants receiving 1 or no concomitant treatment for DM are also eligible.

• Open Label Extension : Participant must meet both of the following inclusion criteria at Visit 8 to be eligible for participation in the OLE period of the study: participant who may benefit from open-label treatment with GLPG3667, according to the investigator's judgment; participant who completed the 24-week double-blind treatment period on investigational product.

Locations
United States
Arizona
HonorHealth Neurology
Scottsdale
California
Inland Rheumatology Clinical Trials, Inc.
Upland
Florida
New Access Research and Medical Center
Kendall
Omega Research Orlando, LLC
Orlando
Georgia
Augusta University
Augusta
Minnesota
St. Paul Rheumatology
Eagan
New York
Northwell Health, LLC PRIME
Lake Success
Pennsylvania
Altoona Center for Clinical Research, P.C.
Duncansville
Other Locations
Argentina
Fundacion Respirar Consultorios Médicos Dr. Doreski
Buenos Aires
Hospital Cordoba
Córdoba
Framingham Centro Medico
La Plata
Hospital Italiano de La Plata
La Plata
Instituto Medico CER
Quilmes
Belgium
UZ Leuven
Leuven
Chile
BioMedica Research Group Psicomedica Clinical and Research Group
Santiago
Enroll SpA
Santiago
Colombia
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla
Clinica de la Costa S.A.S
Barranquilla
Healthy Medical Center
Zipaquirá
Croatia
Polyclinic Bonifarm
Zagreb
Solmed Polyclinic
Zagreb
France
CHU de Nice Hôpital Pasteur 2 Centre de Réf des Maladies Neuromusculaires et SLA
Nice
Groupe Hospitalier Pitie-Salpetriere service de médecine interne et immunologie cliniqu
Paris
CHU Strasbourg - Hôpital Hautepierre service de rhumatologie
Strasbourg
Germany
Charité - Campus Charité Mitte - Klinik für Dermatologie, Venerologie und Allergologie
Berlin
Helios Fachklinik Vogelsang-Gommern
Gommern
Universitätsklinikum Tübingen - Universitäts-Hautklinik
Tübingen
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Medicina Interna
Brescia
Azienda Ospedaliero Universitaria Policlinico. PO San Marco
Catania
Ospedale San Raffaele U.O. di Medicina Gen. Ind. Immunologico-Clinica
Milan
Azienda Ospedaliero Universitaria Pisana U.O. Reumatologia Universitaria
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Istituto Clinico Humanitas U.O. Reumatologia
Rozzano
Ospedale San Giovanni Bosco
Torino
Mexico
Medical Care & Research SA de CV
Mérida
Centro de Investigacion Clínica GRAMEL S.C
México
Consultorio de Reumatologia Hospital Angeles Lindavista
México
Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
San Luis Potosí City
Poland
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok
Centrum Medyczne Plejady
Krakow
Zespol Poradni Specjalistycznych Reumed
Lublin
Klinika Ambroziak ESTEDERM
Warsaw
Romania
Spitalul Clinic 'Sf. Maria' Clinica de Medicina Interna si Reumatologie
Bucharest
Spitalul Clinic Colentina parent
Bucharest
Sc Medaudio-Optica SRL
Râmnicu Vâlcea
Spain
Hospital Clinic de Barcelona Servicio de Medicina Interna
Barcelona
Hospital Universitari Vall d'Hebron Internal Medicine Dept.
Barcelona
Hospital Universitari de Bellvitge Servicio de Cardiologia
L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Madrid
United Kingdom
St. Peter´s Hospital Dept of Rheumatology
Chertsey
Western General Hospital Dept of Rheumatology
Edinburgh
King's College Hospital Dept of Rheumatology
London
Salford Care Organisation Dept of Rheumatology
Salford
Time Frame
Start Date: 2023-02-27
Completion Date: 2026-04
Participants
Target number of participants: 40
Treatments
Experimental: GLPG3667 During DB + During OLE
Participants will receive GLPG3667 dose A orally once daily for 24 weeks in the double-blind (DB) treatment period. Eligible participants will roll-over to an open-label extension (OLE) period to receive the same dose for another 24 weeks.
Placebo_comparator: Placebo During DB + GLPG3667 During OLE
Participants will receive placebo matching to GLPG3667 orally once daily for 24 weeks in the DB treatment period. Eligible participants will roll-over to an OLE period to receive GLPG3667 dose A orally once daily for another 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Galapagos NV

This content was sourced from clinicaltrials.gov