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New treatment option for Diffuse Cutaneous Systemic Sclerosis
Official title EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
ClinicalTrials.gov ID: NCT07287670
What this study is testing
What is MTX-474?
MTX-474 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse cutaneous systemic sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of diffuse cutaneous systemic sclerosis, classified according to 2013 American College of Rheumatology/European League Against Rheumatism...
- Participant is either:
- Within 2 years of their first non-Raynaud's symptom and their mRSS is \>7; OR
- \>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...
- \>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...
You likely can't join if
- Concomitantly have another serious medical illness, which, in the opinion of the Investigator, would interfere with the participant's ability to...
- Participant is currently on immunosuppressive therapy, systemic glucocorticoids or other antifibrotic agents detailed as follows:
- Immunosuppresive agents: Cyclophosphamide (IV or oral if used in the 6 months prior to Screening), calcineurin inhibitors (if used in the 30 days...
- Antifibrotic agents: nintedanib or pirfenidone (if used in the 30 days prior to Screening). Also, exclusionary if used within 3 months of Screening...
- Systemic glucocorticoids: equivalent doses of prednisone greater than 10 mg/day (≤10 mg/day allowed). Has received any pulse intramuscular (IM) or...
- 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...
See the full eligibility criteria
- Diagnosis of diffuse cutaneous systemic sclerosis, classified according to 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR)
- Participant is either:
- Within 2 years of their first non-Raynaud's symptom and their mRSS is \>7; OR
- \>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...
- \>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...
- Participant is ≥18 years of age at time of signing the ICF.
- Able to understand the study and provide a signed, written ICF
- Able to read and understand the language of the ICF and other study-related materials
- Forced vital capacity (FVCpp) of ≥45 pp10
- Have diffusing capacity of the lungs for carbon monoxide (DLCO) of ≥30 percent predicted at Screening
- Willing and able to complete all protocol-required study visits and procedures
- Participants of childbearing potential must have a negative serum pregnancy test at Screening.
- 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...
- Concomitantly have another serious medical illness, which, in the opinion of the Investigator, would interfere with the participant's ability to complete the study
- Participant is currently on immunosuppressive therapy, systemic glucocorticoids or other antifibrotic agents detailed as follows:
- 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...
- 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...
- 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
- 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...
- Previous or planned hematopoietic stem cell or solid organ transplantation
- Previous treatment with chimeric antigen receptor (CAR)-T/CAR-NK therapy
- Clinically significant PAH as determined by the Investigator at, or prior to first day of dosing (Baseline)
- Current use of PAH medication (endothelin receptor antagonists, prostacyclin analogues, soluble guanylate cyclase stimulators) excluding calcium channel blockers and phosphodiesterase-5 inhibitors
- Pregnant or currently breastfeeding
- Aspartate transaminase (AST) or alanine transaminase (ALT) \>2.0 upper limit of normal
- Creatinine clearance \<45mL/min
- History of myocardial infarction, angina or congestive heart failure
- International normalized ratio \>2 or partial thromboplastin time \>1.5 × upper limit of normal
- Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- History of clinically significant thrombotic event within 12 months prior to Screening
- Positive anticentromere antibody
- Systemic sclerosis renal crisis within 12 months prior to Screening
- 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...
- Known malignancy or history of malignancy within 5 years of Screening other than non-melanoma skin cancer and in situ cervical cancer
- Major surgery within 8 weeks prior to Screening or planned surgery during study period
- Unable to routinely access veins for blood draws and IV infusions
- 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...
- History of myocardial infarction, angina or congestive heart failure
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Clearwater, Florida, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Clearwater, Florida, United States; Tampa, Florida, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.