FRI0084 safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of rozibafusp alfa in subjects with rheumatoid arthritis: interim analysis of a phase 1B randomized, placebo-controlled, multiple ascending dose clinical trial
Abstract
Autoimmune diseases, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), are associated with autoantibody production and dysregulated T- and B-cell responses. Rozibafusp alfa (AMG 570) is a first-in-class bispecific antibody-peptide conjugate targeting T- and B-cell activity through inhibition of ICOSL and BAFF and is currently in phase 2 clinical development for the treatment of SLE.This interim analysis of a phase 1b study (NCT03156023) reports the safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of rozibafusp alfa in subjects with RA.Subjects (N~34; age 18–75 years) with active RA, defined as a disease activity score (DAS28-CRP) >2.6, were randomized 3:1 to receive rozibafusp alfa or placebo subcutaneously every 2 weeks for 10 weeks (6 doses), with 24 weeks of follow-up. Subjects were divided into 4 cohorts to study 4 ascending doses of rozibafusp alfa. All subjects were maintained on a stable dose of methotrexate. The primary endpoint was the subject incidence of treatment-emergent adverse events (TEAEs). Additional assessments included serum PK profiles, PD (eg, ICOSL receptor occupancy [RO], changes in peripheral blood B cells), incidence of anti-rozibafusp alfa antibodies, and Patient and Physician Global Assessments (PtGA and PhGA) of disease activity.As of June 5, 2019, 34 subjects were enrolled and included in this interim analysis. Rozibafusp alfa was generally well tolerated. TEAEs occurred in…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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