J&J’s Blockbuster Tremfya Flops in Phase II Giant Cell Arteritis Trial

Published: Jun 25, 2024 By Tyler Patchen

J&J Office in Spain_iStock, BrasilNut1

Pictured: J&J’s office in Madrid, Spain/iStock, BrasilNut1

Johnson & Johnson is halting a mid-stage trial investigating its monoclonal antibody Tremfya (guselkumab) in giant cell arteritis after it failed to reach the primary endpoint.

According to an update on clinicaltrials.gov, the Phase II THEIA study did not meet the primary endpoint—the percentage of participants achieving glucocorticoid (GC)-free remission—but the exact details were not disclosed. However, the company did find “insufficient efficacy findings” which did not lead to further support for the study, a J&J spokesperson told BioSpace in an email statement. The spokesperson also said no new safety concerns were found.

“This is an indication-specific decision that does not impact other guselkumab development programs, and although this decision is disappointing, Johnson & Johnson remains committed to developing transformational…
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