Clinical Trials

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

Current Clinical Trials

Novel Rehabilitation Strategies to Improve Arm Function in Patients with Scleroderma (REACH)

Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

  • Currently Recruiting
  • Have a diagnosis of systemic sclerosis, diffuse cutaneous subset; disease duration < 5 years from 1st non-Raynaud phenomenon sign or symptom
  • Have a contracture of the hand and other joint in at least one arm, such as wrist, elbow, or shoulder, with the ability to demonstrate active range of motion in that arm
  • Willing to travel to participate in therapy and outcome assessments
  • Have an Android, iPhone, iPad, or computer tablet to load the home exercise App

Study Coordinator: Jennifer Serrano, 734-936-4555, jenserra@med.umich.edu
Principal Investigators: Dinesh Khanna, MD, MSc; Susan Murphy, ScD, OTR

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 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 August 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: Jennifer Serrano, 734-936-4555, jenserra@med.umich.edu
Principal Investigator: Vivek Nagaraja, MBBS

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

 

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