A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis

Dermatomyositis Clinical Trial

— GALARISSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695950
• Other study ID #: GLPG3667-CL-214
• Secondary ID: 2022-501097-19-0
• Status: Recruiting
• Phase: Phase 2
• Start date: February 27, 2023
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Galapagos NV
• Contact: Galapagos Medical Information
• Phone: +3215342900
• Email: medicalinfo[@]glpg.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• Participant has cancer-associated myositis (defined as myositis diagnosed within 2 years of cancer diagnosis with the exception of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ uterine cervical carcinoma that has been excised and cured). Note: At least 1 year for basal cell carcinoma and squamous cell carcinoma or 5 years for in situ uterine cervical carcinoma must have passed since the excision.
• Participant has other causes of myositis (e.g. connective tissue disease) associated DM, polymyositis, juvenile DM, inclusion body myositis, or necrotizing idiopathic inflammatory myopathies (with or without rash) with the exception of overlap with secondary Sjogren's syndrome.
• Participant has permanent muscle weakness due to muscle damage (e.g. participant is wheelchair bound or has significant muscle atrophy on magnetic resonance imaging [MRI]) or a non-DM cause (drug-induced myopathy, including glucocorticoid-induced myopathy as primary cause of muscle weakness), according to investigator's judgement.
• Participant has taken any prohibited therapies within the defined washout periods before screening, and during screening as listed in the study protocol.

Related Conditions & MeSH terms

• Dermatomyositis

Intervention

Drug:
• GLPG3667
GLPG3667 capsules will be administered per dose and schedule specified in the arm description.
• Placebo
Placebo matching to GLPG3667 capsules will be administered per schedule specified in the arm description.

Locations

Country	Name	City	State
Argentina	Hospital Cordoba	Cordoba
Argentina	Centro Medico Framingham	La Plata
Argentina	Hospital Italiano de La Plata	La Plata
Belgium	UZ Leuven	Leuven
Bulgaria	DCC Focus 5 - MEOH OOD	Sofia
Chile	BioMedica Research Group	Santiago
Chile	Enroll SpA	Santiago
Chile	Clinical Research Chile SpA.	Valdivia
Colombia	Fundacion Cardiovascular de Colombia - Instituto del Corazon	Floridablanca
Colombia	Healthy Medical Center	Zipaquirá
Croatia	Polyclinic Bonifarm	Zagreb
Croatia	Solmed Polyclinic	Zagreb
Czechia	Revmatologicky Ustav	Praha 2
France	CHU de Nice Hôpital Pasteur 2	Nice
France	Groupe Hospitalier Pitie-Salpetriere	Paris cedex 13
France	CHU Strasbourg - Hôpital Hautepierre	Strasbourg cedex
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Medicina Interna	Brescia
Italy	Azienda Ospedaliero Universitaria Policlinico. PO San Marco	Catania
Italy	Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico	Milano
Italy	Ospedale San Raffaele U.O. di Medicina Gen. Ind. Immunologico-Clinica	Milano
Italy	Azienda Ospedaliero Universitaria Pisana U.O. Reumatologia Universitaria	Pisa
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma
Italy	Istituto Clinico Humanitas U.O. Reumatologia	Rozzano
Poland	Nova Reuma Spolka Partnerska	Bialystok
Poland	Centrum Medyczne Plejady	Krakow
Poland	Zespol Poradni Specjalistycznych Reumed	Lublin
Poland	Klinika Ambroziak ESTEDERM	Warsawa
Romania	Spitalul Clinic "Sf. Maria"	Bucharest
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Sc Medaudio-Optica SRL	Râmnicu Vâlcea
Spain	Hospital Clinic de Barcelona Servicio de Medicina Interna	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
United Kingdom	St. Peter´s hospital	Chertsey
United Kingdom	King's College Hospital Dept of Rheumatology	London
United Kingdom	Salford Care Organisation	Salford
United States	Augusta University	Augusta	Georgia
United States	Omega Research Consultants	DeBary	Florida
United States	Altoona Center for Clinical Research, P.C.	Duncansville	Pennsylvania
United States	Northwell Health, LLC PRIME	Great Neck	New York
United States	New Access Research and Medical Center	Kendall	Florida
United States	St. Paul Rheumatology	Saint Paul	Minnesota
United States	HonorHealth Neurology	Scottsdale	Arizona
United States	Inland Rheumatology Clinical Trials, Inc.	Upland	California
United States	Arthritis & Osteoporosis Clinic	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Chile,  Colombia,  Croatia,  Czechia,  France,  Italy,  Poland,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least Minimal Improvement at Week 24 According to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria	Minimal improvement per ACR/EULAR was defined as total improvement score (TIS) of = 20 points. The TIS is a score derived from the evaluation of the results from 6 core set measurements (CSMs) of myositis disease activity: Physician's Global Disease Activity Assessment; Patient's Global Disease Activity Assessment; Muscle Manual Test-8 (MMT-8); Health Assessment Questionnaire-Disability Index (HAQ-DI); Enzymes (aldolase, creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH); and Extra-muscular disease activity. The TIS is a scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM.	Week 24
Secondary	Change From Baseline in Modified-Cutaneous DM Disease Area and Severity Index Activity Score (m-CDASI-A) at Week 24	The CDASI is a clinician-scored single page instrument that separately measures activity (m-CDASI-A) and damage (m-CDASI-D) in the skin of DM participants. The m-CDASI-A consists of 3 activity measures (erythema, scale, and erosion/ulceration) assessed over 15 body areas along with the activity of Gottron's papules on hands and activity of periungual changes and alopecia. m-CDASI-A ranges from 0-100. Higher scores indicate more disease activity.	Week 24
Secondary	Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24	The HAQ-DI is a generic rather than a disease-specific instrument, comprised of 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 [without any difficulty] to 3 [unable to do]. For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8.	Week 24
Secondary	Change from baseline in the manual muscle test (MMT-8) at Week 24	MMT-8 is a set of 8 designated muscles, 7 of them being tested bilaterally (potential score 0-140). Axial (neck flexors) testing is included, so that potential maximum MMT-8 score = 150.	Week 24
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation		Baseline (Day 1) up to Week 24
Secondary	Maximum Plasma Concentration (Cmax) of GLPG3667		Week 4
Secondary	Area Under the Plasma Concentration-Time Curve (AUC) of GLPG3667		Week 4
Secondary	Plasma Trough Concentration (Ctrough) at Steady State of GLPG3667		Week 2 predose until Week 24