The Temple Lupus Program, part of the Lupus Clinical Investigators Network (LuCIN), is an academic-based clinical trials network consisting of some of the most prestigious academic medical centers and experienced lupus physician/investigators in North America. Recently, Temple Health was showcased in local Philadelphia media as a trial site seeking to enroll lupus patients to participate in a clinical trial. With no therapeutic breakthrough in half a century, the Philadelphia-based academic medical center hopes to change this via research. Lupus is serious business and can even lead to death. TrialSite’s connection to the autoimmune disease is close as family members have died due to organ failure associated with this disease.
Known as systemic lupus erythematosus (SLE), this autoimmune disease involves the patient’s immune system actually attacking healthy tissue in many parts of the patient’s body. The symptoms can vary from mild to severe, and the condition can lead to organ failure and death.
While the cause isn’t clear, it’s thought to involve genetics combined with environmental factors. For example, if among identical twins one has lupus then there is a 24% probability that the other twin will be affected. Female sex hormones, sunlight, smoking and vitamin D deficiency as well as some infections may also contribute to the risk associated with the condition.
The mechanisms associated with lupus involves the immune response by autoantibodies targeting a person’s own tissues. These are most commonly anti-nuclear antibodies and they result in inflammation. The diagnosis can be difficult and is often based on a combination of symptoms and laboratory tests. There are a number of types of lupus, including discoid lupus erythematosus, neonatal lupus and subacute cutaneous lupus erythematosus.
The condition usually surfaces between the ages of 15 and 45 and the 15 year survival is about 80%. The autoimmune disease occurs with a frequency of between 2-7 persons per 10,000 and is treated with various drugs including NSAIDs, corticosteroids, immunosuppressants, hydroxychloroquine and methotrexate. There is no cure for this disease.
A Recent Philadelphia Story
Recently on local 6 ABC, a resident from North Philadelphia, Linda Poole, was highlighted as a lupus patient battling with the disease for decades. Now at 63, she reports it was very difficult early on getting the right diagnosis. Ms. Poole shared with local media: “They just kept telling me something’s wrong with my blood and they didn’t know what.” Testing finally indicted lupus. When Ms. Poole learned that there has been no treatment breakthroughs in 50 years, she was disappointed to say the least.
The Temple Health Program
Dr. Roberto Caricchio, director of Temple’s Lupus Program, shared with the local media: “Lupus is the quintessential disease where the body attacks itself. So it’s an autoimmune disease and by that means that the immune system mistakenly attacks its own organs.”
Now Temple Health offers clinical trials, including one that according to Dr. Caricchio looks at preventing flare ups rather than treating them. As it turns out, most lupus patients experience one or two flare ups per year regardless of therapy. For example, one can be feeling fine and “…suddenly you started having skin rash, or joint pain or swelling or difficulty breathing,” reports Dr. Caricchio.
Ms. Poole has actually participated in one of the double-blind clinical trials, which of course means she is not sure if she received the study drug or not. Ms. Pool went on the record that she felt like she received the study drug as she noted, “…I really could tell a difference.”
Temple Health Studies
Temple reports a few different studies involving investigation into lupus-related treatments. The particular study Ms. Poole participates in is a Phase 2 study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with Corbus Pharmaceuticals, while Autoimmunity Centers of Excellence and Rho Federal Systems Division (a CRO) evaluates the efficacy, safety and tolerability of JBT-101 (known as lenabasum) in systemic lupus erythematosus (SLE).
In this study targeting 100 adults with active joint disease and at least moderate pain, the study team evaluates the use of JBT-101, a synthetic endocannabinoid receptor type 2 (CB2) agonist and an activator of the body’s normal processes, to resolve innate immune responses without immunosuppression. In this study, participants receive 2 doses of JBT-101 by mouth (three groups with varying doses) or placebo, for 84 days and will continue to be monitored for an additional 28 days. The study team assesses endpoints on Day 1, then every 2 weeks twice, then every four week three times, for a total of six visits. The study team assesses the change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (visit 1) and every visit thereafter.
This study started back in late 2017 and runs through to September of 2021. Dr. Robert Caricchio is the principal investigator representing Temple Health for this multi-site study.
JBT-101 is an oral drug that is aimed at promoting the resolution of inflammation.
Another Phase 2 study (NCT03943147) conducted at Temple Health is sponsored by Bristol-Myers Squibb. In this study, the investigational team evaluates the safety and efficacy of an investigational drug called BMS-986165 as compared to a placebo with regards to the measure of kidney function in participants with lupus.
Targeting 78 participants this study started July 2019 and runs through till January 2023. is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. Deucravacitinib’s selectivity is driven by a unique mechanism of action that is distinct from other kinase inhibitors. TYK2 is an intracellular signaling kinase that mediates signaling of IL-23, IL-12 and Type I IFN, which are naturally occurring cytokines involved in inflammatory immune response.
Deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1, Bristol Myers Squibb is evaluating deucravacitinib in four additional Phase 3 studies: POETYK PSO-2 (NCT03611751); POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435). This investigational product is not approved for use in any country.
Lead Research/Investigator (Temple Health)
Call to Action: If you are based in the Philadelphia area and have a loved one diagnosed with lupus, consider reaching out to Temple’s Lupus Program to learn more about the state of research.