Amgen lays out two distinct Phase III programs for dazodalibep in Sjögren’s disease, one targeting systemic manifestations and the other symptomatic burden, each with tailored endpoints. The company highlights unmet patient need, cites differences in measurement tools (ESSDAI vs ESSPRI and diary-based PROs), and projects learning more in H2 with enrollment of 621 systemic and 434 symptomatic participants.
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What did management say about Dazodalibep systemic vs symptomatic trials?
Management said Amgen is pursuing two distinct Phase III investigations of dazodalibep—one in the systemic population and one in the symptomatic population—because the patient populations and clinical “useful scores” differ, requiring different endpoints and study design. 12
They also emphasized the unmet need in both populations: they cited 350,000+ patients with Sjögren’s disease and noted that therapies currently FDA-approved are “by and large, local and symptomatic management therapies.” 1
Management explained that for the systemic population, the Phase III study uses the ESSDAI score, described as a physician-observed score reporting systemic manifestations of Sjögren’s disease, with a single endpoint. 2
They also referenced Phase II data (to justify the Phase III direction), stating that in Population 1 (systemic disease, n=74) they saw significant movement in ESSDAI at day 169 of 6.3 vs 4.1 on placebo. 1
Management stated that the symptomatic population can have more localized disease, but still measurable symptoms, and therefore the trial is designed around different, patient-reported outcomes and related measures. 2
They described Phase II results in Population 2 (symptomatic disease, n=109), stating that at day 169, the ESSPRI score (appropriate for symptom constellation) was superior to placebo: -1.8 vs -0.5. 1
For Phase III symptomatic evaluation, management said they selected both ESSPRI and the diary-based “patient reported” measure of Sjögren’s, with a stated objective of using two validated measures to capture both aspects of subjective patient experience; they also referenced timing as week 48 and explained this was informed by interactions with regulators/trialists and internal guidance. 2
Management explicitly framed the two studies as “rightly studied distinctly because there are different clinically useful scores that physicians use to follow them.” 1
In the Q&A, management also acknowledged the differentiation question raised by others (interest from KOLs, and how systemic patients naturally have glandular manifestations while symptomatic patients represent more extra-glandular manifestations) and positioned the existence of both studies as a basis for differentiated clinical understanding and potentially differentiated labeling—while also emphasizing that they must be studied differently because different endpoints apply. 312
Management said they are “deep in Phase III” and that they will learn more about the impact in H2 of this year. 1
They provided enrollment numbers in each Phase III study:
From the excerpts, management’s core message is:
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Answer outline
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Answer outline
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Answer outline
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Answer outline
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Answer outline
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