Clinical Trials

Clinical studies in a variety of areas are continuously being conducted by researchers in the Scleroderma Program.

Current Clinical Trials

Abatacept Systemic Sclerosis Trial (ASSET)

A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis (ASSET)

  • Ongoing, Not Recruiting
  • ASSET (Abatacept Systemic SclErosis Trial) is an international, placebo-controlled, double blind, randomized trial of early diffuse cutaneous systemic sclerosis (SSc)
  • This trial assesses abatacept (Orencia®, a recombinant fusion protein consisting of the extracellular domain of human CTLA4  is FDA approved biologic medication for rheumatoid arthritis and juvenile arthritis) in patients with early diffuse SSc with less than or equal to 36 months
  • The primary outcomes are to assess improvement in skin thickness and safety
  • The trial is a 12 month double blind study and is followed by a 6 month open label extension. Secondary and exploratory outcomes will include changes in the patient-reported outcomes, pulmonary function tests, joint swelling and tenderness, and other laboratory measures
  • ASSET website

Lead Investigator: Dinesh Khanna, MD, MSc

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study

  • Currently Recruiting
  • 24-week Double Blind/11 week follow up
  • 94 subjects
  • Some low dose background therapies are allowed (methotrexate ≤ 15 mg, mycophenolate ≤2 g)
  • Weekly SAR156597/placebo 200 mg sub cutaneous injections
  • Disease duration: ≤ 36 and mRSS >10 and < than 35 at screening

Study Coordinator: Monica Sanborn, 734-232-2090, monsan@med.umich.edu
Principal Investigator: Amber Young, MD

Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, and Explore Efficacy of GSK2330811

A multi-centre, randomized, double-blind (sponsor open), placebo-controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis

  • Currently Recruiting
  • 12 week Double Blind/ 16 week follow up
  • 20-40 subjects across two cohorts
  • Some background therapies including mycophenolate (3 grams/stable dose last 3 months) and low dose oral corticosteroids (≤10 mg stable 1 month) are allowed
  • Bi-weekly 100/300 mg of GSK2330811 or placebo sub cutaneous injections. Totaling 6 injections of the course of the study
  • Disease duration: ≤60 and mRSS >10 and < than 35 at screening plus additional active disease criteria: increasing skin involvement in the last 6 months, disease duration of ≤18 months or CRP of ≥6 mg/l)
  • FVC ≤50% of predicted or DLCO corrected ≤40% of predicted are exclusionary
  • Optional blister biopsy

Study Coordinator: Monica Sanborn, 734-232-2090, monsan@med.umich.edu
Principal Investigator: Vivek Nagaraja, MBBS

Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Evaluation of tofacitinib in early diffuse cutaneous systemic sclerosis (dcSSc): A phase I/II two center safety and tolerability study

  • Currently Recruiting
  • 24-week Double Blind/ 24 weeks of open label extension
  • 15 subjects across two centers
  • Some background therapies including mycophenolate (2 grams/1-month stable prior to baseline; methotrexate ≤25mg) and low dose oral corticosteroids (stable ≤10mg) are allowed
  • Daily tofacitinib/placebo, 5mg, oral tablets BID
  • Disease duration: ≤60 and mRSS ≥ 10 and ≤45
  • Must have had Zostavax or be willing to obtain following protocol guidelines during screening
  • FVC ≤50% of predicted or DLCO corrected ≤40% of predicted are exclusionary
  • 4 visits + 1 phone during DB portion and 3 visits plus 2 phone calls for open label extension
  • Biopsies at two time points

Study Coordinator: Monica Sanborn, 734-232-2090, monsan@med.umich.edu
Principal Investigator: Dinesh Khanna, MD, MSc

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase ½ Multicenter Randomized, Double Blinded, Safety Study

  • Currently Recruiting
  • Three ascending dose cohorts will receive brentuximab/placebo (0.6mg/kg, 1.2mg/kg and 1.8mg/kg. Each cohort will receive intravenous administration every 3 weeks for 21 weeks, with a total of 8 doses. 24 participants with 8 in each cohort
  • Double blind treatment for 21 weeks followed by 27 weeks of follow up
  • Disease duration: ≤60 and mRSS ≥ 10 and ≤45 at screening plus additional active disease criteria: increasing skin involvement in the last 6 months or an mRSS that has not decreased >3 units within last 6 months or meets protocol specific criteria around SSc lung disease
  • Documentation of at least 12 weeks of ongoing immunosuppressive therapy for SSc at time of enrollment with 4 weeks of stable dose for: methotrexate ≤25mg, mycophenolate ≤3g, or Azathioprine ≤3mg/kg/day
  • FVC ≤60% of predicted or DLCO corrected ≤60% of predicted are exclusionary
  • Skin biopsies at two time points

Study Coordinator: Monica Sanborn, 734-232-2090, monsan@med.umich.edu
Principal Investigator: Dinesh Khanna, MD, MSc

Evaluation of Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

  • Recruiting March 2018
  • Double blind treatment for 21 weeks followed by optional open label extension
  • 11 visits four to six weeks a part
  • 3 cohorts: 5mg, 20mg and placebo capsules with 1:1:1 randomization
  • Disease duration: ≤6 years from the first non-Raynaud’s. If duration is >3 years and less than 6, then mRSS must be ≥15
  • Overlap disease is allowed if SSc is the dominant clinical disease
  • Immunosuppressive therapy allowed, new or increased doses of medication should not occur within 8 weeks prior to screening
  • Skin biopsies at two time points

Study Coordinator: Erica Bush, 734-936-5615, ebush@med.umich.edu
Principal Investigator: Vivek Nagaraja, MBBS

Riociguat in Scleroderma Associated Digital Ulcers

Pilot study to assess the efficacy and safety of riociguat vs. placebo in scleroderma–associated digital ulcers

  • Currently Recruiting
  • 16 week double blind (8 week titration/8 week dose maintenance
  • 16 week Open Label
  • 20 subject, 5 centers
  • TID dosing of riociguat/placebo titrated up beginning with 1mg to 2.5 mg (0.5 is also available should tolerance be an issue)
  • Diagnosis of SSc and one visible, active, ischemic DU at baseline located at or distal to the proximal interphalangeal joint, and that developed or worsened within 8 weeks prior to screening
  • Additional information

Study Coordinator: Erica Bush, 734-936-5615, ebush@med.umich.edu
Principal Investigator: Vivek Nagaraja, MBBS

Abituzumab in SSc-ILD

A phase II, randomized, double-blind, placebo-controlled, parallel group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with system sclerosis-associated interstitial lung disease

  • Currently Recruiting
  • 104 week double blind treatment period with a 12 week safety follow up
  • 175 subjects, 60 centers
  • Abituzumab(1500 or 500mg)/placebo administered as an intravenous infusion over 1 hour once every 4 weeks with last dose at week 100
  • Stable Mycophenolate is required up to 3 grams a day
  • Diagnosis of SSc with disease duration of <7 years from first non-Raynaud’s
  • DLCO ≥ 30% predicted, FVC 40%-85% predicted and ratio of FVC% predicted to DLCO % predicted <1.8. If these criteria are met the HRCT will be performed and must show 5% fibrosis for the subject to be eligible

Study Coordinator: Monica Sanborn, 734-232-2090, monsan@med.umich.edu
Principal Investigator: Dinesh Khanna, MD, MSc

Scleroderma Lung Study III - Combining Pirfenidone with Mycophenolate (SLSIII)

Combining the anti‐fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma‐related interstitial lung disease

  • Currently Recruiting
  • 18 month double blind, phase 2 with 1 month follow up visit
  • 150 subjects
  • Mycophenolate 250mg capsules + Pirfenidone 267mg capsules or placebo. The dosage will escalate if tolerated over a monthly 4 step titration plan
  • FVC‐% of ≤80% at screening and Grade ≥2 on the Magnitude of Task component of the Mahler Modified Dyspnea Index are inclusionary
  • FVS-% of 45% at screening or baseline; FEV1/FVC ration <0.68 at screening or baseline and DLCO corrected -% of 30% are all exclusionary
  • Disease duration of ≤84 months
  • Extensive prohibited medication list with wash-out of at least 30 days, refer to protocol

Study Coordinator: Monica Sanborn, 734-232-2090, monsan@med.umich.edu
Principal Investigator: Vivek Nagaraja, MBBS

 

 

Past Significant Trials

 

Return to Home