Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

EncompaSSc: Avaliação do MTX-474 em Participantes com Esclerose Sistémica Cutânea Difusa (dcSSc)

1 de outubro de 2026 atualizado por: Mediar Therapeutics

Um Estudo Randomizado de Fase 2, Duplamente Cego, Controlado por Placebo para Avaliar a Segurança e Eficácia do MTX-474 no Tratamento de Participantes com Esclerose Sistémica Cutânea Difusa (dcSSc)

A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-474 in Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Participants with dcSSc who meet the study's inclusion and exclusion criteria will be randomly assigned in a 3:2 ratio to receive MTX-474 or a matching placebo by intravenous (IV) infusion. Concomitant use of one of the approved dcSSc therapies (immunosuppressive therapy, systemic glucocorticoids or other antifibrotic agents) is permitted under certain criteria. Participants randomized to the MTX-474 arm of the study will receive an IV infusion every 4 weeks, beginning at Day 0 and ending at Week 20. The End of Treatment Visit will occur at Week 24, and a Safety Follow-Up Visit will occur at Week 28, 8 weeks after the final infusion. mRSS assessments will occur at Screening, Baseline, and at all subsequent treatment visits up to and including Week 24. Spirometry will be performed at screening and Weeks 12. HRCT will be performed at screening and week 24. DLCO will be performed at Screening. Skin biopsies will be performed at Baseline and Week 12. Participants will have blood drawn for safety assessment and to assess Ephrin receptor levels at Screening, Baseline and every 4 weeks until Week 28. Blood will be drawn for serum PK analyses relative to the first and last doses of MTX-474.

Tipo de estudo

Intervencional

Inscrição (Estimado)

85

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Austrália
    • Queensland
      • Southport, Queensland, Austrália, 4222
        • Recrutamento
        • Griffith University (Clinical Trial Unit)
        • Contato:
        • Investigador principal:
          • Gerald Tracey
      • Woolloongabba, Queensland, Austrália, 4102
        • Recrutamento
        • Veracity Clinical Research
        • Investigador principal:
          • Lynda Spelman
        • Contato:
    • Victoria
      • Heidelberg, Victoria, Austrália, 3084
        • Recrutamento
        • Austin Health
        • Investigador principal:
          • Jessica Leung
        • Contato:
  • Espanha
      • Barcelona, Espanha, 08003
        • Ainda não está recrutando
        • EncompaSSc site in Barcelona, Spain
        • Contato:
      • Barcelona, Espanha, 08025
        • Ainda não está recrutando
        • EncompaSSc site in Barcelona, Spain
        • Contato:
      • Córdoba, Espanha, 14004
        • Ainda não está recrutando
        • EncompaSSc site in Córdoba, Spain
        • Contato:
      • Málaga, Espanha, 29004
        • Ainda não está recrutando
        • EncompaSSc site in Malaga, Spain
        • Contato:
      • Valencia, Espanha, 46026
        • Ainda não está recrutando
        • EncompaSSc site in Valencia, Spain
        • Contato:
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85054
        • Ainda não está recrutando
        • EncompaSSc site in Phoenix, AZ
        • Contato:
    • California
      • La Jolla, California, Estados Unidos, 92037
        • Ainda não está recrutando
        • EncompaSSc site in La Jolla, CA
        • Contato:
      • Loma Linda, California, Estados Unidos, 92350
        • Ainda não está recrutando
        • EncompaSSc site in Loma Linda, CA
        • Contato:
      • Los Angeles, California, Estados Unidos, 90095
        • Recrutamento
        • University of California Los Angeles Scleroderma Center
        • Investigador principal:
          • Elizabeth Volkmann
        • Contato:
      • Newport Beach, California, Estados Unidos, 92663
        • Recrutamento
        • NewportNativeMD, Inc.
        • Investigador principal:
          • Ryan Klein
        • Contato:
      • Palo Alto, California, Estados Unidos, 94304
        • Ainda não está recrutando
        • EncompaSSc site in Palo Alto, CA
        • Contato:
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Recrutamento
        • University of Colorado Center for Lungs/Breathing/Scleroderma Clinic
        • Contato:
        • Investigador principal:
          • Melissa Griffith
    • Florida
      • Clearwater, Florida, Estados Unidos, 33765
        • Recrutamento
        • Clinical Research of West Florida
        • Investigador principal:
          • Rodney Daniel
        • Contato:
      • Sarasota, Florida, Estados Unidos, 34239
        • Recrutamento
        • Sarasota Arthritis Center
        • Investigador principal:
          • Jesse Boodoo
        • Contato:
      • Tampa, Florida, Estados Unidos, 33606
        • Recrutamento
        • Clinical Research of West Florida
        • Investigador principal:
          • John Carter
        • Contato:
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66103
        • Ainda não está recrutando
        • EncompaSSc site in Kansas City, KS
        • Contato:
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Recrutamento
        • Johns Hopkins University
        • Investigador principal:
          • Laura Hummers
        • Contato:
          • Gwen Leatherman
          • Número de telefone: 617 802 6568
          • E-mail: gleathe1@jh.edu
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Recrutamento
        • Brigham and Women's Hospital
        • Contato:
        • Investigador principal:
          • Avery LaChance
      • Boston, Massachusetts, Estados Unidos, 02118
        • Recrutamento
        • Boston Medical Center
        • Contato:
        • Investigador principal:
          • Andreea Bujor
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Ainda não está recrutando
        • EncompaSSc site in Minneapolis, MN
        • Contato:
    • New York
      • Brooklyn, New York, Estados Unidos, 11201
        • Recrutamento
        • NYU Langone Health
        • Investigador principal:
          • David Goddard
        • Contato:
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Ainda não está recrutando
        • EncompaSSc site in Cleveland, OH
        • Contato:
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Recrutamento
        • The University of Oklahoma Health Sciences Center
        • Contato:
        • Investigador principal:
          • Aikaterini Thanou
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Ainda não está recrutando
        • EncompaSSc site in Philadelphia, PA
        • Contato:
      • Pittsburgh, Pennsylvania, Estados Unidos, 15219
        • Recrutamento
        • University of Pittsburgh Medical Center
        • Contato:
        • Investigador principal:
          • Christina Padilla
    • Texas
      • Allen, Texas, Estados Unidos, 75013
        • Recrutamento
        • Stryde Research - DFW
        • Investigador principal:
          • John Lavery
        • Contato:
      • Dallas, Texas, Estados Unidos, 75246
        • Recrutamento
        • Baylor Scott & White Research Institute
        • Contato:
        • Investigador principal:
          • Susan Mathai
      • Houston, Texas, Estados Unidos, 77030
        • Ainda não está recrutando
        • EncompaSSc site in Houston, TX
        • Contato:
  • França
      • La Tronche, França, 38700
        • Ainda não está recrutando
        • EncompaSSc site in La Tronche, France
        • Contato:
      • Montpellier, França, 34090
        • Ainda não está recrutando
        • EncompaSSc site in Montpellier, France
        • Contato:
      • Paris, França, 75014
        • Ainda não está recrutando
        • EncompaSSc site in Paris, France
        • Contato:
      • Strasbourg, França, 67000
        • Ainda não está recrutando
        • EncompaSSc site in Strasbourg, France
        • Contato:
      • Toulouse, França, 31059
        • Ainda não está recrutando
        • EncompaSSc site in Toulouse, France
        • Contato:
      • Vandœuvre-lès-Nancy, França, 54500
        • Ainda não está recrutando
        • EncompaSSc site in Vandœuvre-lès-Nancy, France
        • Contato:
  • Holanda
      • Groningen, Holanda, 9713 GZ
        • Ainda não está recrutando
        • EncompaSSc site in Groningen, Netherlands
        • Contato:
  • Itália
      • Ancona, Itália, 60126
        • Ainda não está recrutando
        • EncompaSSc site in Ancona, Italy
        • Contato:
      • Catania, Itália, 95123
        • Ainda não está recrutando
        • EncompaSSc site in Catania, Italy
        • Contato:
      • Genoa, Itália, 16132
        • Ainda não está recrutando
        • EncompaSSc site in Genoa, Italy
        • Contato:
      • Milan, Itália, 20122
        • Ainda não está recrutando
        • EncompaSSc site in Milan, Italy
        • Contato:
      • Modena, Itália, 41124
        • Ainda não está recrutando
        • EncompaSSc site in Modena, Italy
        • Contato:
      • Roma, Itália, 00128
        • Ainda não está recrutando
        • EncompaSSc site in Roma, Italy
        • Contato:
  • Nova Zelândia
      • Auckland, Nova Zelândia, 2025
        • Recrutamento
        • Aotearoa Clinical Trials
        • Investigador principal:
          • Mark Sapsford
        • Contato:
      • Hamilton, Nova Zelândia, 3204
        • Recrutamento
        • Waikato Hospital
        • Contato:
        • Investigador principal:
          • Kamal Solanki
  • Polônia
      • Bydgoszcz, Polônia, 85-168
        • Ainda não está recrutando
        • EncompaSSc site in Bydgoszcz, Poland
        • Contato:
      • Nowa Sól, Polônia, 67-100
        • Ainda não está recrutando
        • EncompaSSc site in Nowa Sól, Poland
        • Contato:
      • Warsaw, Polônia, 00-874
        • Ainda não está recrutando
        • EncompaSSc site in Warszawa, Poland
        • Contato:
      • Warsaw, Polônia, 02-507
        • Ainda não está recrutando
        • EncompaSSc site in Warszawa, Poland
        • Contato:
  • Reino Unido
      • Coventry, Reino Unido, CV2 2DX
        • Ainda não está recrutando
        • EncompaSSc site in Walsgrave Coventry, UK
        • Contato:
      • Liverpool, Reino Unido, L7 8XP
        • Recrutamento
        • Royal Liverpool University Hospital
        • Investigador principal:
          • Marina Anderson
        • Contato:
      • London, Reino Unido, SW8 3RN
        • Ainda não está recrutando
        • EncompaSSc site in London, UK
        • Contato:
      • Westcliff-on-Sea, Reino Unido, SS0 0RY
        • Ainda não está recrutando
        • EncompaSSc site in Westcliff-on-Sea, UK
        • Contato:
  • Romênia
      • Brasov, Romênia, 500283
        • Ainda não está recrutando
        • EncompaSSc site in Brasov, Romania
        • Contato:
      • Bucharest, Romênia, 030463
        • Ainda não está recrutando
        • EncompaSSc site in Bucharest, Romania
        • Contato:
      • Bucharest, Romênia, 041303
        • Ainda não está recrutando
        • EncompaSSc site in Bucharest, Romania
        • Contato:
      • Timișoara, Romênia, 300133
        • Ainda não está recrutando
        • EncompaSSc site in Timişoara, Romania
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Diagnosis of diffuse cutaneous systemic sclerosis, classified according to 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR)

  2. Participant is either:

    1. Within 2 years of their first non-Raynaud's symptom and their mRSS is >7; OR
    2. >2 and ≤5 years from their first non-Raynaud's symptom, their mRSS is between 10 and 30, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS on exams performed by the same clinician, or (2) they were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done; OR
    3. >5 and ≤10 years from their first non-Raynaud's symptom, their mRSS is between >15 and ≤25, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS, or (2) were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done.

  3. Participant is ≥18 years of age at time of signing the ICF.

  4. Able to understand the study and provide a signed, written ICF

  5. Able to read and understand the language of the ICF and other study-related materials

  6. Forced vital capacity (FVCpp) of ≥45 pp10

  7. Have diffusing capacity of the lungs for carbon monoxide (DLCO) of ≥30 percent predicted at Screening

  8. Willing and able to complete all protocol-required study visits and procedures

  9. Participants of childbearing potential must have a negative serum pregnancy test at Screening.

  10. All participants with reproductive potential must agree to use and follow medically approved, highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose, whichever is longer

Exclusion Criteria:

  1. Concomitantly have another serious medical illness, which, in the opinion of the Investigator, would interfere with the participant's ability to complete the study

  2. Participant is currently on immunosuppressive therapy, systemic glucocorticoids or other antifibrotic agents detailed as follows:

    1. Immunosuppresive agents: Cyclophosphamide (IV or oral if used in the 6 months prior to Screening), calcineurin inhibitors (if used in the 30 days prior to Screening), azathioprine (if used in the 30 days prior to Screening), Janus-kinase inhibitors (if used in the 30 days prior to Screening), rituximab (if used in the 6 months prior to Screening), tocilizumab (if used in the 60 days prior to Screening) or any other biologic Disease-Modifying Antirheumatic Drugs (DMARD, if used in the last 30 days or 3 half-lives prior to Screening, whichever is longer)
    2. Antifibrotic agents: nintedanib or pirfenidone (if used in the 30 days prior to Screening). Also, exclusionary if used within 3 months of Screening are tyrosine-kinase inhibitors with recognized anti-fibrotic activity (imatinib, nilotinib, etc.)
    3. Systemic glucocorticoids: equivalent doses of prednisone greater than 10 mg/day (≤10 mg/day allowed). Has received any pulse intramuscular (IM) or intravenous (IV) steroid within 1 month of Screening
    4. Other agents:

    i. mycophenolate mofetil unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; ii. mycophenolic acid unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; iii. hydroxychloroquine unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study; and iv. methotrexate unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study.

  3. Previous or planned hematopoietic stem cell or solid organ transplantation

  4. Previous treatment with chimeric antigen receptor (CAR)-T/CAR-NK therapy

  5. Clinically significant PAH as determined by the Investigator at, or prior to first day of dosing (Baseline)

  6. Current use of PAH medication (endothelin receptor antagonists, prostacyclin analogues, soluble guanylate cyclase stimulators) excluding calcium channel blockers and phosphodiesterase-5 inhibitors

  7. Pregnant or currently breastfeeding

  8. Aspartate transaminase (AST) or alanine transaminase (ALT) >2.0 upper limit of normal

  9. Creatinine clearance <45mL/min

  10. History of myocardial infarction, angina or congestive heart failure

  11. International normalized ratio >2 or partial thromboplastin time >1.5 × upper limit of normal

  12. Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

  13. History of clinically significant thrombotic event within 12 months prior to Screening

  14. Positive anticentromere antibody

  15. Systemic sclerosis renal crisis within 12 months prior to Screening

  16. Confirmed diagnosis of overlap syndrome, systemic lupus erythematosus with anti-double strand (ds)DNA antibody, rheumatoid arthritis with anti-cyclic citrullinated peptide (anti-CCP) antibody, or systemic sclerosis mimics (eosinophilic fasciitis, scleromyxedema) at the time of inclusion in the study

  17. Known malignancy or history of malignancy within 5 years of Screening other than non-melanoma skin cancer and in situ cervical cancer

  18. Major surgery within 8 weeks prior to Screening or planned surgery during study period

  19. Unable to routinely access veins for blood draws and IV infusions

  20. Currently receiving another experimental agent or participating in another clinical trial. If a participant has recently received another experimental agent, then the last dose must have been at least 5 half-lives or 30 days (whichever is longer) prior to Screening

  21. History of myocardial infarction, angina or congestive heart failure

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo

Placebo
Outro: Placebo

Placebo
Experimental: MTX-474

MTX-474
Biológico: MTX-474

Dosage level: 4 mg/kg Unit dose strength: 50mg/ml MTX-474 is a human immunoglobulin G1 (IgG1) monoclonal antibody that binds the human EphrinB2 with high specificity and high affinity. MTX-474 is being developed as a therapy for patients with systemic sclerosis (SSc).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in Modified Rodnan Skin Score (mRSS)
Prazo: Baseline to week 24

Mean change from baseline to week 24 in the modified Rodnan Skin Score, a clinician-assessed measure of skin thickness across 17 body areas.

Unit of measure: Score (range 0-51)
Baseline to week 24

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of participants with a gene signature response in skin biopsy
Prazo: 12 weeks

Proportion of participants in each arm (MTX-474 and placebo) demonstrating a dcSSc gene expression signature response on skin biopsy at Week 12.

Unit of Measure: Participants (%)
12 weeks
Number of participants with clinically significant findings on physical examination, vital signs, and clinical laboratory tests
Prazo: Baseline through end of study (week 28)

Number of participants with clinically significant findings on physical examination, vital signs, and clinical laboratory tests Unit of Measure: Participants (%)
Baseline through end of study (week 28)
Number of participants with dose interruptions or treatment discontinuations due to adverse events
Prazo: Baseline through end of study (week 28)

Number of participants with dose interruptions or treatment discontinuations due to adverse events Unit of Measure: Participants (%)
Baseline through end of study (week 28)
Safety and tolerability of MTX-474 in participants with dcSSc: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs)
Prazo: Baseline through end of study (week 28)

Incidence, seriousness, and severity of TEAEs and TRAEs as determined by investigator assessment.

Unit of measure: Participants (%)
Baseline through end of study (week 28)
Serum concentration of MTX-474 at sparse PK time points
Prazo: Baseline to week 28

Serum MTX-474 concentrations collected at predefined sparse PK time points to support population pharmacokinetic (popPK) analysis Unit of Measure: ng/mL
Baseline to week 28
Clearance (CL) of MTX-474
Prazo: Baseline to week 28

Clearance of MTX-474 calculated from serial PK sampling using noncompartmental analysis Unit of Measure: L/hour
Baseline to week 28
Terminal elimination half-life (t½) of MTX-474
Prazo: Baseline to week 28

Terminal elimination half-life of MTX-474 derived from serial PK sampling. Unit of Measure: Hours
Baseline to week 28
Area under the plasma concentration-time curve (AUC) of MTX-474
Prazo: Baseline to week 28

AUC of MTX-474 calculated from serial PK sampling using noncompartmental analysis.

Unit of Measure: ng·h/mL
Baseline to week 28

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Proportion of participants with a response on the revised American College of Rheumatology Composite Response Index in Systemic Sclerosis (rACR-CRISS)
Prazo: Baseline to week 24

Proportion of participants achieving rACR-CRISS composite response Unit of Measure: Participants (%)
Baseline to week 24
Change from baseline in Physician Global Assessment (PhGA) of disease status
Prazo: Baseline to week 24

Mean change from baseline to week 24 in the physician global assessment (phGA) of disease status in each arm Unit of Measure: Units on 0-10 visual analog scale (higher score = worse disease)
Baseline to week 24
Change from baseline in Patient Global Assessment (PtGA) of disease status
Prazo: Baseline to week 24

Mean change from baseline to week 24 in the patient global assessment (PtGA) of disease status in each arm Unit of Measure: Units on 0-10 visual analog scale (higher score = worse disease)
Baseline to week 24
Change from baseline in percent predicted forced vital capacity (FVCpp)
Prazo: Baseline to week 24

Mean change from baseline to week 24 on percent predicted forced vital capacity (FVCpp) Unit of Measure: Percent predicted (%)
Baseline to week 24
Change from baseline in quantitative interstitial lung disease (QILD) score by high-resolution computed tomography (HRCT)
Prazo: Baseline to week 24

Mean change from baseline to week 24 in the QILD score by high resolution computed tomography scan (HRCT) in each arm Unit of Measure: Units on QILD score (0-100 scale; higher score = greater fibrosis)
Baseline to week 24
Change from Baseline in free EphrinB2 levels
Prazo: Baseline to week 24

Median change from baseline to Week 24 in serum free EphrinB2 levels in each treatment arm.

Unit of Measure: pg/mL
Baseline to week 24
Change from baseline in forced vital capacity (FVC) by EphrinB2 levels
Prazo: Baseline to week 24

Mean change from baseline to Week 24 in FVC, analyzed by baseline EphrinB2 levels, in the subset of participants with interstitial lung disease (ILD).

Unit of Measure: Percent predicted (%)
Baseline to week 24
Proportion of participants achieving rACR-CRISS response by EphrinB2 levels
Prazo: Up to 24 weeks

Proportion of participants achieving a response on the revised ACR Composite Response Index in Systemic Sclerosis (rACR-CRISS), stratified by baseline EphrinB2 levels.

Unit of Measure: Participants (%)
Up to 24 weeks
To assess the presence, titer and impact of antidrug antibodies (ADA) against MTX-474
Prazo: Baseline to week 28

Samples will be collected from baseline until Week 28 to assess the rate at which antibodies develop to the study drug Unit of Measure: Titer units
Baseline to week 28
Change from baseline in expression of total and phosphorylated EphB2, EphB3, and EphB4 receptors in skin
Prazo: Baseline to Week 12

Mean change from baseline to Week 12 in total and phosphorylated EphB2, EphB3, and EphB4 receptor expression in skin biopsy samples.

Unit of Measure: Relative expression units (fold change from baseline)
Baseline to Week 12
Change from baseline in transcriptomic profile
Prazo: Baseline to Week 12

Change from baseline to Week 12 in global transcriptomic profile via bulk RNA sequencing analysis of skin biopsies in each arm.

Unit of Measure: Differential gene expression (log₂ fold change)
Baseline to Week 12
Change from baseline in serum biomarkers of organ involvement
Prazo: Baseline to weeks 12 and 24

Change from baseline to Weeks 12 and 24 in serum levels biomarkers, including but not limited to, ProC3 and IL-6 associated with organ involvement Unit of Measure: ng/mL (or unit per biomarker)
Baseline to weeks 12 and 24
Change from baseline in fatigue symptoms (FACIT-Fatigue score)
Prazo: Baseline to week 24

Mean change from baseline to Week 24 in fatigue symptoms as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.

Unit of Measure: Units on FACIT-Fatigue scale (range 0-52; higher score = less fatigue)
Baseline to week 24
Change from baseline in gastrointestinal (GI) symptoms (UCLA SCTC GIT 2.0 score)
Prazo: Baseline to week 24

Mean change from baseline to Week 24 in GI symptom burden assessed by the UCLA SCTC GIT 2.0 questionnaire.

Unit of Measure: Units on UCLA SCTC GIT 2.0 total score (range 0-3; higher score = worse symptoms)
Baseline to week 24
Change from baseline in anxiety and depression symptoms (HADS)
Prazo: Baseline to week 24

Mean change from baseline to Week 24 in symptoms of anxiety and depression measured by the HADS instrument.

Unit of Measure: Units on Hospital Anxiety and Depression Scale (HADS total and subscale scores; range 0-21 per subscale; higher score = worse symptoms)
Baseline to week 24
Change from baseline in HAQ-DI
Prazo: Baseline to week 24

Mean change from Baseline in functional disability as assessed by HAQ-DI. Unit of measure: Score (0-3 scale)
Baseline to week 24

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Mediar Therapeutics

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de abril de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de novembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de dezembro de 2025

Primeira postagem (Real)

17 de dezembro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MTX-474-S201
  • 2025-523288-39 (Número EudraCT)
  • 2025 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever