February 1, 2019
The Lupus Research Alliance announced that its affiliate Lupus Therapeutics is working with the pharmaceutical company, Janssen, to help conduct a Phase 3 trial to evaluate whether their drug ustekinumab (Stelara®) may offer benefit to people with lupus. Called LOTUS, the international study is being conducted in over 200 sites, 20 of which are members of Lupus Therapeutics’ Lupus Clinical Investigators Network (LuCIN).
The U.S. Food and Drug Administration (FDA) gave Janssen the go-ahead to further evaluate the safety and efficacy of Stelara® based on results of a Phase 2 trial that demonstrated effectiveness for lupus patients. Stelara® is not approved by the FDA as a treatment of lupus but is indicated for certain other autoimmune diseases.
“With all too few treatment options, new drugs are urgently needed to improve symptoms of this need devastating autoimmune disease,” noted Kenneth M. Farber, President and CEO of the Lupus Research Alliance. “We are grateful to Janssen for their commitment to the lupus community.”
Background on Lupus Research Alliance Role in Stelara® Testing for Lupus
Looking at Stelara® in lupus is an outcome of the drug repurposing program Lupus Research Alliance had initiated to accelerate availability of new treatments by identifying viable options among drugs already approved by the FDA for other conditions. In this comprehensive analysis, Stelara® was the top of the list among biologics as offering potential benefit in treating lupus.
“Having identified Stelara® as offering potential benefit for people with lupus,” noted Albert Roy, Executive Director of Lupus Therapeutics, “we are particularly excited about helping evaluate its safety and effectiveness in Phase 3 studies. “Located throughout the U.S. and Canada, LuCIN sites are ready to enroll patients in the study to provide the data needed for the FDA to evaluate and hopefully approve the use of this already well-tested drug as a new treatment for lupus.”
