EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

August 3, 2026 updated by: Mediar Therapeutics

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4222
        • Not yet recruiting
        • EncompaSSc site in Southport, Australia
        • Contact:
      • Woolloongabba, Queensland, Australia, 4102
        • Not yet recruiting
        • EncompaSSc site in Woolloongabba, Australia
        • Contact:
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
        • Principal Investigator:
          • Jessica Leung
  • France
      • La Tronche, France, 38700
        • Not yet recruiting
        • EncompaSSc site in La Tronche, France
        • Contact:
      • Montpellier, France, 34090
        • Not yet recruiting
        • EncompaSSc site in Montpellier, France
        • Contact:
      • Paris, France, 75014
        • Not yet recruiting
        • EncompaSSc site in Paris, France
        • Contact:
      • Strasbourg, France, 67000
        • Not yet recruiting
        • EncompaSSc site in Strasbourg, France
        • Contact:
      • Toulouse, France, 31059
        • Not yet recruiting
        • EncompaSSc site in Toulouse, France
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54500
        • Not yet recruiting
        • EncompaSSc site in Vandœuvre-lès-Nancy, France
        • Contact:
  • Italy
      • Ancona, Italy, 60126
        • Not yet recruiting
        • EncompaSSc site in Ancona, Italy
        • Contact:
      • Catania, Italy, 95123
        • Not yet recruiting
        • EncompaSSc site in Catania, Italy
        • Contact:
      • Genoa, Italy, 16132
        • Not yet recruiting
        • EncompaSSc site in Genoa, Italy
        • Contact:
      • Milan, Italy, 20122
        • Not yet recruiting
        • EncompaSSc site in Milan, Italy
        • Contact:
      • Modena, Italy, 41124
        • Not yet recruiting
        • EncompaSSc site in Modena, Italy
        • Contact:
      • Roma, Italy, 00128
        • Not yet recruiting
        • EncompaSSc site in Roma, Italy
        • Contact:
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Not yet recruiting
        • EncompaSSc site in Groningen, Netherlands
        • Contact:
  • New Zealand
      • Auckland, New Zealand, 2025
        • Recruiting
        • Aotearoa Clinical Trials
        • Principal Investigator:
          • Mark Sapsford
        • Contact:
      • Hamilton, New Zealand, 3204
        • Not yet recruiting
        • EncompaSSc site in Hamilton, NZ
        • Contact:
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Not yet recruiting
        • EncompaSSc site in Bydgoszcz, Poland
        • Contact:
      • Nowa Sól, Poland, 67-100
        • Not yet recruiting
        • EncompaSSc site in Nowa Sól, Poland
        • Contact:
      • Warsaw, Poland, 00-874
        • Not yet recruiting
        • EncompaSSc site in Warszawa, Poland
        • Contact:
      • Warsaw, Poland, 02-507
        • Not yet recruiting
        • EncompaSSc site in Warszawa, Poland
        • Contact:
  • Romania
      • Brasov, Romania, 500283
        • Not yet recruiting
        • EncompaSSc site in Brasov, Romania
        • Contact:
      • Bucharest, Romania, 030463
        • Not yet recruiting
        • EncompaSSc site in Bucharest, Romania
        • Contact:
      • Bucharest, Romania, 041303
        • Not yet recruiting
        • EncompaSSc site in Bucharest, Romania
        • Contact:
      • Timișoara, Romania, 300133
        • Not yet recruiting
        • EncompaSSc site in Timişoara, Romania
        • Contact:
  • Spain
      • Barcelona, Spain, 08003
        • Not yet recruiting
        • EncompaSSc site in Barcelona, Spain
        • Contact:
      • Barcelona, Spain, 08025
        • Not yet recruiting
        • EncompaSSc site in Barcelona, Spain
        • Contact:
      • Córdoba, Spain, 14004
        • Not yet recruiting
        • EncompaSSc site in Córdoba, Spain
        • Contact:
      • Málaga, Spain, 29004
        • Not yet recruiting
        • EncompaSSc site in Malaga, Spain
        • Contact:
      • Valencia, Spain, 46026
        • Not yet recruiting
        • EncompaSSc site in Valencia, Spain
        • Contact:
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Not yet recruiting
        • EncompaSSc site in Walsgrave Coventry, UK
        • Contact:
      • Liverpool, United Kingdom, L7 8XP
        • Not yet recruiting
        • EncompaSSc site in Liverpool, UK
        • Contact:
      • London, United Kingdom, SW8 3RN
        • Not yet recruiting
        • EncompaSSc site in London, UK
        • Contact:
      • Westcliff-on-Sea, United Kingdom, SS0 0RY
        • Not yet recruiting
        • EncompaSSc site in Westcliff-on-Sea, UK
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Not yet recruiting
        • EncompaSSc site in Phoenix, AZ
        • Contact:
    • California
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • EncompaSSc site in La Jolla, CA
        • Contact:
      • Loma Linda, California, United States, 92350
        • Not yet recruiting
        • EncompaSSc site in Loma Linda, CA
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles Scleroderma Center
        • Principal Investigator:
          • Elizabeth Volkmann
        • Contact:
      • Newport Beach, California, United States, 92663
        • Recruiting
        • NewportNativeMD, Inc.
        • Principal Investigator:
          • Ryan Klein
        • Contact:
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • EncompaSSc site in Palo Alto, CA
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Center for Lungs/Breathing/Scleroderma Clinic
        • Contact:
        • Principal Investigator:
          • Melissa Griffith
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida
        • Principal Investigator:
          • Rodney Daniel
        • Contact:
      • Sarasota, Florida, United States, 34239
        • Not yet recruiting
        • EncompaSSc site in Sarasota, FL
        • Contact:
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida
        • Principal Investigator:
          • John Carter
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Not yet recruiting
        • EncompaSSc site in Kansas City, KS
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Laura Hummers
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Avery LaChance
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Principal Investigator:
          • Andreea Bujor
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • EncompaSSc site in Minneapolis, MN
        • Contact:
    • New York
      • Brooklyn, New York, United States, 11201
        • Not yet recruiting
        • EncompaSSc site in Brooklyn, NY
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • EncompaSSc site in Cleveland, OH
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Not yet recruiting
        • EncompaSSc site in Oklahoma City, OK
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • EncompaSSc site in Philadelphia, PA
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15219
        • Not yet recruiting
        • EncompaSSc site in Pittsburgh, PA
        • Contact:
    • Texas
      • Allen, Texas, United States, 75013
        • Recruiting
        • Stryde Research - DFW
        • Principal Investigator:
          • John Lavery
        • Contact:
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Research Institute
        • Contact:
        • Principal Investigator:
          • Susan Mathai
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • EncompaSSc site in Houston, TX
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo
Experimental: MTX-474
Biological: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Modified Rodnan Skin Score (mRSS)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with a gene signature response in skin biopsy
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in expression of total and phosphorylated EphB2, EphB3, and EphB4 receptors in skin
Time Frame: 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
Time Frame: 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
Proportion of participants with a response on the revised American College of Rheumatology Composite Response Index in Systemic Sclerosis (rACR-CRISS)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 serum biomarkers of organ involvement
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mediar Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTX-474-S201
  • 2025-523288-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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