Lupus Clinical Trials

Before a new drug can be given to people living with a disease, it must first go through clinical trials. These studies span months to years and use volunteers with a certain disease to test whether a new drug is effective or better than currently available ones.

Current lupus clinical trials are investigating a mix of new and already-existing treatments to best help those living with lupus. These include targeted therapies that work specifically on one part of the immune system or in cells, and immunosuppressives. Learning about current studies and what investigators look for in participants can open doors for you to try new treatments and play a role in advancing medicine.

Current Clinical Trials for Lupus

Every year, researchers continue to find new potential ways of treating lupus. This includes developing new therapies or using existing therapies that are approved for treating other autoimmune diseases. The drugs mentioned below aren’t reflective of all lupus clinical trials currently ongoing, but they represent the different types of therapies being studied.1

Monoclonal Antibodies

Monoclonal antibodies (mAbs) are man-made antibodies designed to target a specific part of the immune system in order to dampen inflammation. mAbs are used to treat lupus and other autoimmune diseases, such as rheumatoid arthritis (RA), psoriasis, and psoriatic arthritis (PsA). mAbs currently being studied in clinical trials include secukinumab (Cosentyx®), guselkumab (Tremfya®), and itolizumab.

Researchers believe secukinumab and guselkumab may also be helpful in treating lupus nephritis, or kidney damage caused by systemic lupus erythematosus (SLE). Some trials studying these therapies to treat lupus nephritis are currently underway, including a phase 3 trial for secukinumab that’s recruiting as of fall 2022 and a phase 2 trial for guselkumab that’s ongoing.2,3 Itolizumab is an investigational mAb that is being studied for treating SLE with or without lupus nephritis. Researchers are currently recruiting for a phase 1 clinical trial.4

Other Therapies

Other types of therapies are also being investigated for treating lupus. Deucravacitinib (SotyktuTM) is newly approved by the FDA for treating moderate to severe plaque psoriasis. It is currently being studied in a phase 2 clinical trial for treating SLE.5 Another medication in clinical trials is sirolimus (Rapamune®), which is an immunosuppressive drug used to prevent rejection after a kidney transplant. Researchers believe it may also be helpful in reducing inflammation in people with SLE. A phase 2 clinical trial is registered for studying sirolimus in those with SLE, but it hasn’t started recruitment yet.6

Enrolling in Lupus Clinical Trials

In order to join one of the many lupus research studies, there are a few steps to take. The first step is deciding whether or not you want to participate in a clinical trial. Many people join to help move a treatment forward so themselves and others may benefit. Other people may join to try the newest treatments when their current therapies aren’t working.7 Whatever your reasons may be, the decision should be what’s best for you.

Clinical Trials for Lupus

Eligibility in Lupus Clinical Trials

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If you’re interested in joining a particular trial, you next have to find out if you’re eligible to participate. Investigators carefully set up the inclusion and exclusion criteria for participants before the study begins to ensure they gather the data they need. Inclusion criteria are requirements you must meet to be included in the study. On the other hand, exclusion criteria usually include a list of conditions or situations that will prevent you from entering a study.8

Although each study is different, current lupus clinical trials have inclusion criteria such as:2

  • Adult male and female subjects ages 18 to 75 years old
  • Confirmed diagnosis of SLE and lupus nephritis
  • Having active lupus nephritis

Exclusion criteria you may see in lupus studies can include:

  • Severe kidney dysfunction/impairment
  • Significant underlying health problems caused by lupus such as heart and lung inflammation
  • Other active inflammatory diseases
  • Previous treatment with other lupus medications
  • Pregnant or breastfeeding women

In lupus clinical trials, these strict exclusion criteria prevent many people from entering trials. A 2021 study found that in a survey of people with moderate to severe lupus, around 63 percent of them couldn’t participate in phase 3 clinical trials because they didn’t meet the criteria. Additionally, 43 percent of those surveyed who had active lupus nephritis wouldn’t have been eligible to participate in a phase 3 trial for the condition.9  Different trials will have different inclusion and exclusion criteria.

The most common exclusion criteria for non-lupus nephritis studies included low disease activity (not actively having a lupus flare) and having active kidney disease/lupus nephritis. People who have other underlying health conditions were also more likely to be excluded from trials. These strict criteria have led to many lupus studies ending early because they can’t recruit enough participants to study. While exclusion criteria may seem harsh at times, investigators use it to keep people safe who may otherwise be harmed by an investigational drug.

The information provided in this article is not a substitute for the advice of qualified healthcare professionals. While we strive to publish accurate information, it is not possible to cover all potential scenarios, including drug or treatment effects, interactions, or usage. You should not rely solely on this article to determine whether a particular treatment, drug, or clinical trial is suitable for you or any other individual. Always consult a healthcare professional before starting or changing any treatments.