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EncompaSSc : Évaluation du MTX-474 chez les participants atteints de sclérodermie systémique cutanée diffuse (dcSSc)

1 octobre 2026 mis à jour par: Mediar Therapeutics

Une étude randomisée de phase 2, en double aveugle et contrôlée par placebo, pour évaluer l'innocuité et l'efficacité du MTX-474 dans le traitement des participants atteints de sclérodermie systémique cutanée diffuse (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)

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

85

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jeffrey Bornstein, MD
  • Numéro de téléphone: 803 (617) 936-0960
  • E-mail: jeffrey@mediartx.com

Lieux d'étude

  • Australie
    • Queensland
      • Southport, Queensland, Australie, 4222
        • Recrutement
        • Griffith University (Clinical Trial Unit)
        • Contact:
        • Chercheur principal:
          • Gerald Tracey
      • Woolloongabba, Queensland, Australie, 4102
        • Recrutement
        • Veracity Clinical Research
        • Chercheur principal:
          • Lynda Spelman
        • Contact:
    • Victoria
      • Heidelberg, Victoria, Australie, 3084
        • Recrutement
        • Austin Health
        • Chercheur principal:
          • Jessica Leung
        • Contact:
  • Espagne
      • Barcelona, Espagne, 08003
        • Pas encore de recrutement
        • EncompaSSc site in Barcelona, Spain
        • Contact:
      • Barcelona, Espagne, 08025
        • Pas encore de recrutement
        • EncompaSSc site in Barcelona, Spain
        • Contact:
      • Córdoba, Espagne, 14004
        • Pas encore de recrutement
        • EncompaSSc site in Córdoba, Spain
        • Contact:
      • Málaga, Espagne, 29004
        • Pas encore de recrutement
        • EncompaSSc site in Malaga, Spain
        • Contact:
      • Valencia, Espagne, 46026
        • Pas encore de recrutement
        • EncompaSSc site in Valencia, Spain
        • Contact:
  • France
      • La Tronche, France, 38700
        • Pas encore de recrutement
        • EncompaSSc site in La Tronche, France
        • Contact:
      • Montpellier, France, 34090
        • Pas encore de recrutement
        • EncompaSSc site in Montpellier, France
        • Contact:
      • Paris, France, 75014
        • Pas encore de recrutement
        • EncompaSSc site in Paris, France
        • Contact:
      • Strasbourg, France, 67000
        • Pas encore de recrutement
        • EncompaSSc site in Strasbourg, France
        • Contact:
      • Toulouse, France, 31059
        • Pas encore de recrutement
        • EncompaSSc site in Toulouse, France
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54500
        • Pas encore de recrutement
        • EncompaSSc site in Vandœuvre-lès-Nancy, France
        • Contact:
  • Italie
      • Ancona, Italie, 60126
        • Pas encore de recrutement
        • EncompaSSc site in Ancona, Italy
        • Contact:
      • Catania, Italie, 95123
        • Pas encore de recrutement
        • EncompaSSc site in Catania, Italy
        • Contact:
      • Genoa, Italie, 16132
        • Pas encore de recrutement
        • EncompaSSc site in Genoa, Italy
        • Contact:
      • Milan, Italie, 20122
        • Pas encore de recrutement
        • EncompaSSc site in Milan, Italy
        • Contact:
      • Modena, Italie, 41124
        • Pas encore de recrutement
        • EncompaSSc site in Modena, Italy
        • Contact:
      • Roma, Italie, 00128
        • Pas encore de recrutement
        • EncompaSSc site in Roma, Italy
        • Contact:
  • Nouvelle-Zélande
      • Auckland, Nouvelle-Zélande, 2025
        • Recrutement
        • Aotearoa Clinical Trials
        • Chercheur principal:
          • Mark Sapsford
        • Contact:
      • Hamilton, Nouvelle-Zélande, 3204
        • Recrutement
        • Waikato Hospital
        • Contact:
        • Chercheur principal:
          • Kamal Solanki
  • Pays-Bas
      • Groningen, Pays-Bas, 9713 GZ
        • Pas encore de recrutement
        • EncompaSSc site in Groningen, Netherlands
        • Contact:
  • Pologne
      • Bydgoszcz, Pologne, 85-168
        • Pas encore de recrutement
        • EncompaSSc site in Bydgoszcz, Poland
        • Contact:
      • Nowa Sól, Pologne, 67-100
        • Pas encore de recrutement
        • EncompaSSc site in Nowa Sól, Poland
        • Contact:
      • Warsaw, Pologne, 00-874
        • Pas encore de recrutement
        • EncompaSSc site in Warszawa, Poland
        • Contact:
      • Warsaw, Pologne, 02-507
        • Pas encore de recrutement
        • EncompaSSc site in Warszawa, Poland
        • Contact:
  • Roumanie
      • Brasov, Roumanie, 500283
        • Pas encore de recrutement
        • EncompaSSc site in Brasov, Romania
        • Contact:
      • Bucharest, Roumanie, 030463
        • Pas encore de recrutement
        • EncompaSSc site in Bucharest, Romania
        • Contact:
      • Bucharest, Roumanie, 041303
        • Pas encore de recrutement
        • EncompaSSc site in Bucharest, Romania
        • Contact:
      • Timișoara, Roumanie, 300133
        • Pas encore de recrutement
        • EncompaSSc site in Timişoara, Romania
        • Contact:
  • Royaume-Uni
      • Coventry, Royaume-Uni, CV2 2DX
        • Pas encore de recrutement
        • EncompaSSc site in Walsgrave Coventry, UK
        • Contact:
      • Liverpool, Royaume-Uni, L7 8XP
        • Recrutement
        • Royal Liverpool University Hospital
        • Chercheur principal:
          • Marina Anderson
        • Contact:
      • London, Royaume-Uni, SW8 3RN
        • Pas encore de recrutement
        • EncompaSSc site in London, UK
        • Contact:
      • Westcliff-on-Sea, Royaume-Uni, SS0 0RY
        • Pas encore de recrutement
        • EncompaSSc site in Westcliff-on-Sea, UK
        • Contact:
  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85054
        • Pas encore de recrutement
        • EncompaSSc site in Phoenix, AZ
        • Contact:
    • California
      • La Jolla, California, États-Unis, 92037
        • Pas encore de recrutement
        • EncompaSSc site in La Jolla, CA
        • Contact:
      • Loma Linda, California, États-Unis, 92350
        • Pas encore de recrutement
        • EncompaSSc site in Loma Linda, CA
        • Contact:
      • Los Angeles, California, États-Unis, 90095
        • Recrutement
        • University of California Los Angeles Scleroderma Center
        • Chercheur principal:
          • Elizabeth Volkmann
        • Contact:
      • Newport Beach, California, États-Unis, 92663
        • Recrutement
        • NewportNativeMD, Inc.
        • Chercheur principal:
          • Ryan Klein
        • Contact:
      • Palo Alto, California, États-Unis, 94304
        • Pas encore de recrutement
        • EncompaSSc site in Palo Alto, CA
        • Contact:
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • Recrutement
        • University of Colorado Center for Lungs/Breathing/Scleroderma Clinic
        • Contact:
        • Chercheur principal:
          • Melissa Griffith
    • Florida
      • Clearwater, Florida, États-Unis, 33765
        • Recrutement
        • Clinical Research of West Florida
        • Chercheur principal:
          • Rodney Daniel
        • Contact:
      • Sarasota, Florida, États-Unis, 34239
        • Recrutement
        • Sarasota Arthritis Center
        • Chercheur principal:
          • Jesse Boodoo
        • Contact:
      • Tampa, Florida, États-Unis, 33606
        • Recrutement
        • Clinical Research of West Florida
        • Chercheur principal:
          • John Carter
        • Contact:
    • Kansas
      • Kansas City, Kansas, États-Unis, 66103
        • Pas encore de recrutement
        • EncompaSSc site in Kansas City, KS
        • Contact:
    • Maryland
      • Baltimore, Maryland, États-Unis, 21205
        • Recrutement
        • Johns Hopkins University
        • Chercheur principal:
          • Laura Hummers
        • Contact:
          • Gwen Leatherman
          • Numéro de téléphone: 617 802 6568
          • E-mail: gleathe1@jh.edu
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
        • Recrutement
        • Brigham and Women's Hospital
        • Contact:
        • Chercheur principal:
          • Avery LaChance
      • Boston, Massachusetts, États-Unis, 02118
        • Recrutement
        • Boston Medical Center
        • Contact:
          • Kimberly Finch
          • Numéro de téléphone: 617 802 6568
          • E-mail: kimtobin@bu.edu
        • Chercheur principal:
          • Andreea Bujor
    • Minnesota
      • Minneapolis, Minnesota, États-Unis, 55455
        • Pas encore de recrutement
        • EncompaSSc site in Minneapolis, MN
        • Contact:
    • New York
      • Brooklyn, New York, États-Unis, 11201
        • Recrutement
        • NYU Langone Health
        • Chercheur principal:
          • David Goddard
        • Contact:
    • Ohio
      • Cleveland, Ohio, États-Unis, 44195
        • Pas encore de recrutement
        • EncompaSSc site in Cleveland, OH
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • Recrutement
        • The University of Oklahoma Health Sciences Center
        • Contact:
          • Tiffany Moore
          • Numéro de téléphone: 405-271-3480
          • E-mail: OSCTR@ouhsc.edu
        • Chercheur principal:
          • Aikaterini Thanou
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Pas encore de recrutement
        • EncompaSSc site in Philadelphia, PA
        • Contact:
      • Pittsburgh, Pennsylvania, États-Unis, 15219
        • Recrutement
        • University of Pittsburgh Medical Center
        • Contact:
        • Chercheur principal:
          • Christina Padilla
    • Texas
      • Allen, Texas, États-Unis, 75013
        • Recrutement
        • Stryde Research - DFW
        • Chercheur principal:
          • John Lavery
        • Contact:
      • Dallas, Texas, États-Unis, 75246
        • Recrutement
        • Baylor Scott & White Research Institute
        • Contact:
        • Chercheur principal:
          • Susan Mathai
      • Houston, Texas, États-Unis, 77030
        • Pas encore de recrutement
        • EncompaSSc site in Houston, TX
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo

Placebo
Autre: Placebo

Placebo
Expérimental: MTX-474

MTX-474
Biologique: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Modified Rodnan Skin Score (mRSS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of participants with a gene signature response in skin biopsy
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Proportion of participants with a response on the revised American College of Rheumatology Composite Response Index in Systemic Sclerosis (rACR-CRISS)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Mediar Therapeutics

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 avril 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

18 novembre 2025

Première soumission répondant aux critères de contrôle qualité

12 décembre 2025

Première publication (Réel)

17 décembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MTX-474-S201
  • 2025-523288-39 (Numéro EudraCT)
  • 2025 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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