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EncompaSSc: Valutazione di MTX-474 in Partecipanti con Sclerosi Sistemica Cutanea Diffusa (dcSSc)

1 ottobre 2026 aggiornato da: Mediar Therapeutics

Uno Studio di Fase 2 Randomizzato, in Doppio Cieco, Controllato con Placebo per Valutare la Sicurezza e l'Efficacia di MTX-474 nel Trattamento dei Partecipanti con Sclerosi Sistemica Cutanea Diffusa (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)

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

85

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo

Placebo
Altro: Placebo

Placebo
Sperimentale: MTX-474

MTX-474
Biologico: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in Modified Rodnan Skin Score (mRSS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants with a gene signature response in skin biopsy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants with a response on the revised American College of Rheumatology Composite Response Index in Systemic Sclerosis (rACR-CRISS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mediar Therapeutics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 aprile 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

18 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

12 dicembre 2025

Primo Inserito (Effettivo)

17 dicembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MTX-474-S201
  • 2025-523288-39 (Numero EudraCT)
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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