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DermatomyositisPhase 2GALARISSONCT05695950

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

A Phase 2 study testing GLPG3667 in people with Dermatomyositis, run by Lakefront Biotherapeutics NV at 54 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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), followed by an open-label extension (OLE) period until Week 48. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dermatomyositis
What is being tested?
GLPG3667
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
54 sitesin 15 countries
Study dates
27 Feb 2023to 20 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.
  • Open Label Extension : Participant meeting one or more of the criteria at Visit 8 as defined in the protocol, cannot be selected for the OLE period of this clinical study. 1. Participant has total bilirubin >1.5x ULN; however, participant with an isolated increase in total bilirubin <3 x ULN due to Gilbert's Syndrome, with normal direct bilirubin, can be enrolled in the OLE period. 2. Participant has AST or ALT >1.5 x ULN (hepatic injury), or AST or ALT >=5 x ULN if judged to be of muscular origin (and confirmed by the steering committee) at Visit 7 and Visit 8.

Trial locations and contacts

54 sites in 15 countries.

54 sites in 15 countries

United States8 sites

  • Augusta University

    Augusta, Georgia, 30912

  • Altoona Center for Clinical Research, P.C.

    Duncansville, Pennsylvania, 16635

  • St. Paul Rheumatology

    Eagan, Minnesota, 55121

  • New Access Research and Medical Center

    Kendall, Florida, 33186

  • Northwell Health, LLC PRIME

    Lake Success, New York, 11042

  • Omega Research Orlando, LLC

    Orlando, Florida, 32808

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

Other trials in United States

Italy7 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Medicina Interna

    Brescia, 25123

  • Azienda Ospedaliero Universitaria Policlinico. PO San Marco

    Catania, 95100

  • Ospedale San Raffaele U.O. di Medicina Gen. Ind. Immunologico-Clinica

    Milan, 20132

  • Azienda Ospedaliero Universitaria Pisana U.O. Reumatologia Universitaria

    Pisa, 56100

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Istituto Clinico Humanitas U.O. Reumatologia

    Rozzano, 20089

  • Ospedale San Giovanni Bosco

    Torino, 10154

Other trials in Italy

Argentina5 sites

  • Fundacion Respirar Consultorios Médicos Dr. Doreski

    Buenos Aires, C1426ABO

  • Hospital Cordoba

    Córdoba, X5004CDT

  • Hospital Italiano de La Plata

    La Plata, B1900

  • Framingham Centro Medico

    La Plata, B1902

  • Instituto Medico CER

    Quilmes, B1878DVB

Other trials in Argentina

Mexico4 sites

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Centro de Investigacion Clínica GRAMEL S.C

    México, 03720

  • Consultorio de Reumatologia Hospital Angeles Lindavista

    México, 07760

  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.

    San Luis Potosí City, 78213

Other trials in Mexico

Poland4 sites

  • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, 15-707

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Zespol Poradni Specjalistycznych Reumed

    Lublin, 20-582

  • Klinika Ambroziak ESTEDERM

    Warsaw, 02-953

Other trials in Poland

Spain4 sites

  • Hospital Universitari Vall d'Hebron Internal Medicine Dept.

    Barcelona, 08035

  • Hospital Clinic de Barcelona Servicio de Medicina Interna

    Barcelona, 08036

  • Hospital Universitari de Bellvitge Servicio de Cardiologia

    L'Hospitalet de Llobregat, 08907

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

Other trials in Spain

United Kingdom4 sites

  • St. Peter´s Hospital Dept of Rheumatology

    Chertsey, KT16 OPZ

  • Western General Hospital Dept of Rheumatology

    Edinburgh, EH4 2XU

  • King's College Hospital Dept of Rheumatology

    London, SE5 9RS

  • Salford Care Organisation Dept of Rheumatology

    Salford, M6 8HD

Other trials in United Kingdom

Colombia3 sites

  • Clinica de la Costa S.A.S

    Barranquilla, 080020

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, 80020

  • Healthy Medical Center

    Zipaquirá, 250252

Other trials in Colombia

France3 sites

  • CHU de Nice Hôpital Pasteur 2 Centre de Réf des Maladies Neuromusculaires et SLA

    Nice, 06001

  • Groupe Hospitalier Pitie-Salpetriere service de médecine interne et immunologie cliniqu

    Paris, 75651

  • CHU Strasbourg - Hôpital Hautepierre service de rhumatologie

    Strasbourg, 67091

Other trials in France

Germany3 sites

  • Charité - Campus Charité Mitte - Klinik für Dermatologie, Venerologie und Allergologie

    Berlin, 10117

  • Helios Fachklinik Vogelsang-Gommern

    Gommern, 39245

  • Universitätsklinikum Tübingen - Universitäts-Hautklinik

    Tübingen, 72076

Other trials in Germany

Romania3 sites

  • Spitalul Clinic Colentina parent

    Bucharest, 020125

  • Spitalul Clinic 'Sf. Maria' Clinica de Medicina Interna si Reumatologie

    Bucharest, 11172

  • Sc Medaudio-Optica SRL

    Râmnicu Vâlcea, 240762

Other trials in Romania

Chile2 sites

  • Enroll SpA

    Santiago, 7500587

  • BioMedica Research Group Psicomedica Clinical and Research Group

    Santiago, 7500710

Other trials in Chile

Croatia2 sites

  • Polyclinic Bonifarm

    Zagreb, 10000

  • Solmed Polyclinic

    Zagreb, 10000

Other trials in Croatia

Belgium1 site

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Czechia1 site

  • Revmatologicky Ustav

    Prague, 12850

Other trials in Czechia

About this study

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

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.

Conditions
Dermatomyositis
Being tested
GLPG3667, Placebo
Medical subject headings
Dermatomyositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLPG3667Drug

    Also called Cadefrecitinib

    GLPG3667 capsules will be administered per dose and schedule specified in the arm description.

  • PlaceboDrug

    Placebo matching to GLPG3667 capsules will be administered per schedule specified in the arm description.

Study groups in NCT05695950
Study groupRoleWhat they receive
GLPG3667 During DB + During OLEExperimentalParticipants 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.
Receives: Drug: GLPG3667
Placebo During DB + GLPG3667 During OLEPlacebo comparatorParticipants 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.
Receives: Drug: GLPG3667; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total improvement score [TIS] according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria

    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.

    Measured: Week 24

Secondary outcomes (8)

  1. Percentage of Participants With at Least Minimal Improvement According to the ACR/EULAR Criteria

    Minimal improvement per ACR/EULAR was defined as TIS of ≥ 20 points. The TIS is a score derived from the evaluation of the results from 6 CSMs of myositis disease activity: Physician's Global Disease Activity Assessment; Patient's Global Disease Activity Assessment; MMT-8; HAQ-DI; Enzymes (aldolase, CK, ALT, AST, and 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.

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. 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.

    Measured: Week 24

  4. 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.

    Measured: Week 24

  5. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation

    Measured: Baseline (Day 1) up to Week 24

  6. Maximum Plasma Concentration (Cmax) of GLPG3667

    Measured: Week 4

  7. Area Under the Plasma Concentration-Time Curve (AUC) of GLPG3667

    Measured: Week 4

  8. Plasma Trough Concentration (Ctrough) at Steady State of GLPG3667

    Measured: Week 2 predose until Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start27 Feb 2023
  3. Primary completion13 Oct 2025
  4. Study completion20 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695950
Sponsor's protocol ID
GLPG3667-CL-214
Other IDs
2022-501097-19-00
Acronym
GALARISSO
Status last verified
Dec 2025
First submitted
13 Jan 2023
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mammoliti O, Martina S, Claes P, Coti G, Blanque R, Jagerschmidt C, Shoji K, Borgonovi M, De Vos S, Marsais F, Oste L, Quinton E, Lopez-Ramos M, Amantini D, Brys R, Jimenez JM, Galien R, van der Plas S. Discovery of GLPG3667, a Selective ATP Competitive Tyrosine Kinase 2 Inhibitor for the Treatment of Autoimmune Diseases. J Med Chem. 2024 Jun 13;67(11):8545-8568. doi: 10.1021/acs.jmedchem.4c00769. Epub 2024 May 28.

    PubMed 38805213

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLPG3667 in people with Dermatomyositis, run by Lakefront Biotherapeutics NV at 54 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Italy, Argentina, Mexico, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total improvement score [TIS] according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695950, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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