J&J to Launch Late-Stage Trial for SLE Treatment After Meeting Endpoint in Mid-Stage Trial

Dow Jones

Jan 06

By Connor Hart

Johnson & Johnson said it will initiate a Phase 3 trial of its treatment for systemic lupus erythematosus, or SLE, after a recent study of the therapy met its primary endpoint.

The company said Tuesday that a statistically significant percentage of patients using the treatment, nipocalimab, saw improvements based on results from the systemic lupus erythematosus responder index, a composite measure used to assess treatment response in patients with SLE during clinical studies.

Key secondary and exploratory endpoints were met as well, J&J said, and the therapy's safety and tolerability profile was consistent with previous studies, with no new safety signals identified.

J&J said these data represent the first positive results of an investigational FcRn blocker treatment to treat SLE, an autoimmune disease that causes one's own immune system to mistakenly attack various tissues.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

January 06, 2026 09:09 ET (14:09 GMT)

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style=\"white-space: pre\">\n \n</pre>\n<p>\n  Johnson &amp; Johnson said it will initiate a Phase 3 trial of its treatment for systemic lupus erythematosus, or SLE, after a recent study of the therapy met its primary endpoint. \n</p>\n<p>\n  The company said Tuesday that a statistically significant percentage of patients using the treatment, nipocalimab, saw improvements based on results from the systemic lupus erythematosus responder index, a composite measure used to assess treatment response in patients with SLE during clinical studies. \n</p>\n<p>\n  Key secondary and exploratory endpoints were met as well, J&amp;J said, and the therapy's safety and tolerability profile was consistent with previous studies, with no new safety signals identified. \n</p>\n<p>\n  J&amp;J said these data represent the first positive results of an investigational FcRn blocker treatment to treat SLE, an autoimmune disease that causes one's own immune system to mistakenly attack various tissues. 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class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Connor Hart \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Johnson &amp; Johnson said it will initiate a Phase 3 trial of its treatment for systemic lupus erythematosus, or SLE, after a recent study of the therapy met its primary endpoint. \n</p>\n<p>\n  The company said Tuesday that a statistically significant percentage of patients using the treatment, nipocalimab, saw improvements based on results from the systemic lupus erythematosus responder index, a composite measure used to assess treatment response in patients with SLE during clinical studies. \n</p>\n<p>\n  Key secondary and exploratory endpoints were met as well, J&amp;J said, and the therapy's safety and tolerability profile was consistent with previous studies, with no new safety signals identified. \n</p>\n<p>\n  J&amp;J said these data represent the first positive results of an investigational FcRn blocker treatment to treat SLE, an autoimmune disease that 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