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EncompaSSc: Evaluering af MTX-474 hos deltagere med diffust kutan systemisk sklerose (dcSSc)

1. oktober 2026 opdateret af: Mediar Therapeutics

En fase 2 randomiseret, dobbeltblind, placebo-kontrolleret undersøgelse til vurdering af sikkerhed og effekt af MTX-474 i behandlingen af deltagere med diffust kutan systemisk sklerose (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)

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

85

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo

Placebo
Andet: Placebo

Placebo
Eksperimentel: MTX-474

MTX-474
Biologisk: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Modified Rodnan Skin Score (mRSS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with a gene signature response in skin biopsy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with a response on the revised American College of Rheumatology Composite Response Index in Systemic Sclerosis (rACR-CRISS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mediar Therapeutics

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. april 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

18. november 2025

Først indsendt, der opfyldte QC-kriterier

12. december 2025

Først opslået (Faktiske)

17. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MTX-474-S201
  • 2025-523288-39 (EudraCT nummer)
  • 2025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Abonner