Clinical Trials

The purpose of this Randomized, double-blinded Controlled Trial is to better understand the causes of scleroderma-associated constipation, see how well Transcutaneous Electrostimulation works for people with different types of scleroderma-associated constipation and develop more effective treatment strategies for patients. The total amount of time you will be in the study is up to 8 weeks.

You will be asked to complete:

• Stool samples
• Blood samples
• Daily surveys about your symptoms
• Abdominal X-rays
• Anorectal Manometry study

Inclusion criteria:

• Be diagnosed with scleroderma
• Be 18 years of age or older
• Be seen by physicians at UTHealth Rheumatology in Houston, Texas
• Be able to give informed consent
• Have symptoms of scleroderma-associated constipation

Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)

This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy.

The primary objective is to estimate the effect of ublituximab as first add-on combination therapy at 24 weeks compared to placebo in treating early, active autoantibody positive immune-mediated necrotizing myopathy using the validated 2016 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Myositis Response Criteria, as measured by the Total Improvement Score (TIS)

Additional information can be found here: Study Details | NCT07103746 | Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy (external link)

Learn more about this and other myositis research opportunities through the Myositis Program’s Related Clinical Studies page.

The MIGHT Trial – An Exploratory Clinical Trial of Intravenous Immunoglobulin (IVIG) in Anti-3-Hydroxy-3-Methylglutaryl-CoA Reductase (HMGCR) Immune Mediated Necrotizing Myopathy (IMNM)

This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated necrotizing myopathy (IMNM). Planned enrollment is 12 individuals with active anti-HMGCR IMNM meeting inclusion and exclusion criteria. Assuming 20% drop-out, the investigators anticipate 10 participants will complete all study assessments. Enrolled participants will be randomized 1:1 to either IVIG 2g/kg or placebo (0.9% sodium chloride at equivalent volume) at weeks 0, 4, and 8. The primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12. After the randomized phase of the trial, all participants will be offered to continue on to an open-label extension phase in which participants will receive IVIG at weeks 12, 16, and 20. Participants will then return at week 24 for a final non-infusion visit to reassess safety, tolerability, and efficacy outcome.

Additional information can be found here: Study Details | NCT06599697 | The MIGHT Trial – An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy (external link)

Learn more about this and other myositis research opportunities through the Myositis Program’s Related Clinical Studies page.