BridgeMD
T-Guard in dcSSc
EU CTIS ID: 2024-517283-28-00
What this study is testing
To evaluate the safety of T-Guard in patients with early diffuse cutaneous systemic sclerosis (dcSSc), evaluated in all 13 study participants
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged between 18-75 at the time of signing informed consent.
- With early dcSSc, defined as skin involvement above and below elbows and/or knees, disease duration ≤36 months from first non-Raynaud phenomenon.
- Modified Rodnan skin scores (MRSS) scores ≥15
- Progressive skin or musculoskeletal (MKS)disease, e.g. worsening of skin with new areas of involvement or tendon friction rubs (TFR), with either Health Assessment Questionnaire Disability Index (HAQ-DI) >1.0 or elevated erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP).
- Interstitial lung disease (ILD) with forced vital capacity (FVC) 50-<80% predicted or lung diffusion testing (DLCO)(Hb corrected) 45-75% or >10% lung involvement on visual rad high-resolution computed tomography (HRCT) scan or those with progressive ILD, defined as progressive pulmonary fibrosis (PPF)-ILD in: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9851481/.
- Participants should have failed at least one established systemic immunosuppressive treatment for dcSSc (e.g., MTX, MMF , azathioprine, rituximab, tocilizumab, intravenous immunoglobulin [IVIG], or cyclophosphamide), each tried for at least 3 months, and: a. Have received treatment with MTX or MMF for at least 3 months prior to enrollment, with the dose stable for at least 8 weeks prior to enrollment; and b. Be able and willing, in the opinion of the investigator, to continue this background therapy at the stable dose throughout the study, unless dose reduction or discontinuation is clinically indicated due to adverse events.
You likely can't join if
- Creatinine greater than or equal to 2mg/dL or creatinine clearance less than 60 mL/min or requiring hemodialysis. History or presence of glomerulonephritis, acute tubular necrosis, and/or interstitial nephritis or clinically significant findings as determined by urinalysis at screening
- White blood cell count (WBC) <3000 µl
- On continuous oxygen therapy
- Significant gastrointestinal (GI) dysmotility requiring total parenteral nutrition or G or J tube
- Latent infection with mycobacterium tuberculosis, unless history of treatment.
- Known active infection with Hepatitis B, C, or E at screening (prior infections are not excluded), HIV or HTLV1 positivity.
See the full eligibility criteria
Who can join
- Aged between 18-75 at the time of signing informed consent.
- With early dcSSc, defined as skin involvement above and below elbows and/or knees, disease duration ≤36 months from first non-Raynaud phenomenon.
- Modified Rodnan skin scores (MRSS) scores ≥15
- Progressive skin or musculoskeletal (MKS)disease, e.g. worsening of skin with new areas of involvement or tendon friction rubs (TFR), with either Health Assessment Questionnaire Disability Index (HAQ-DI) >1.0 or elevated erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP).
- Interstitial lung disease (ILD) with forced vital capacity (FVC) 50-<80% predicted or lung diffusion testing (DLCO)(Hb corrected) 45-75% or >10% lung involvement on visual rad high-resolution computed tomography (HRCT) scan or those with progressive ILD, defined as progressive pulmonary fibrosis (PPF)-ILD in: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9851481/.
- Participants should have failed at least one established systemic immunosuppressive treatment for dcSSc (e.g., MTX, MMF , azathioprine, rituximab, tocilizumab, intravenous immunoglobulin [IVIG], or cyclophosphamide), each tried for at least 3 months, and: a. Have received treatment with MTX or MMF for at least 3 months prior to enrollment, with the dose stable for at least 8 weeks prior to enrollment; and b. Be able and willing, in the opinion of the investigator, to continue this background therapy at the stable dose throughout the study, unless dose reduction or discontinuation is clinically indicated due to adverse events.
- Participants should have given written informed consent
What rules you out
- Creatinine greater than or equal to 2mg/dL or creatinine clearance less than 60 mL/min or requiring hemodialysis. History or presence of glomerulonephritis, acute tubular necrosis, and/or interstitial nephritis or clinically significant findings as determined by urinalysis at screening
- White blood cell count (WBC) <3000 µl
- On continuous oxygen therapy
- Significant gastrointestinal (GI) dysmotility requiring total parenteral nutrition or G or J tube
- Latent infection with mycobacterium tuberculosis, unless history of treatment.
- Known active infection with Hepatitis B, C, or E at screening (prior infections are not excluded), HIV or HTLV1 positivity.
- Malignancy within the past 5 years, except for non-melanoma skin cancer or cervical cancer situ.
- Vascular prosthesis.
- Need for mechanical ventilation and/or vasopressor support or requiring hemodialysis.
- Uncontrolled infection (infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present) are not eligible for this trial.
- Known hypersensitivity to any of the components of murine monoclonal antibodies (mAb), or Recombinant Ricin Toxin A-chain (RTA).
- Platelets <100,000/mm3
- Participants who continue to receive any systemic treatment for systemic sclerosis, other than MTX or MMF, including but not limited to azathioprine, cyclosphosphamide, IVIG, rituximab, and tocilizumab, within three months prior to the baseline visit will be excluded. Continuation of oral corticosteroids (≤10 mg/day of prednisone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) is permitted if the participant is on a stable dose for at least two weeks prior to and including the baseline visit.
- Evidence of heart failure defined as left ventricular ejection fraction (LVEF) <45% as assessed by either echocardiography or multigated acquisition (MUGA) scan in the last 6 months
- Echocardiographic features consistent with pulmonary hypertension, unless right heart catheterization (RHC) is normal
- Moderate to severe restrictive lung disease defined as FVC <50% predicted and/or DLCO Hb-corrected <45% predicted and presence of ILD on HRCT
- Patients who have been diagnosed with scleroderma renal crisis (SRC) or another cause TMA anytime during their lifetime.
- Albumin of less than or equal to 25 g/L
- Creatine kinase (CK) level greater than 5 times the upper limit of normal (ULN)
- Hemoglobulin (Hb) <9 g/dl
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.