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Updated: Jul 21, 2025

An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells
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Improving resource utilisation in SLE drug development through innovative trial design.

Sandra Garces1, Elaine Karis2, Joan T Merrill3

  • 1Amgen Inc, Thousand Oaks, California, USA sgarces@amgen.com.

Lupus Science & Medicine
|July 25, 2023
PubMed
Summary

Innovative adaptive trial designs for Systemic Lupus Erythematosus (SLE) reduce patient numbers and trial duration. These methods improve efficiency and data collection for novel therapies like efavaleukin alfa and rozibafusp alfa.

Keywords:
Adaptive Clinical Trial DesignAutoimmune DiseasesLupus Erythematosus, Systemic

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Area of Science:

  • Immunology
  • Rheumatology
  • Clinical Trial Design

Background:

  • Systemic Lupus Erythematosus (SLE) is a complex autoimmune disease with significant unmet medical needs.
  • Current clinical trial enrollment strains resources, leading to inefficiencies and enrollment challenges.
  • There is a critical need for innovative trial designs to improve evidence generation for novel SLE therapies.

Purpose of the Study:

  • To present the design of two innovative Phase IIb studies for SLE treatments: efavaleukin alfa and rozibafusp alfa.
  • To showcase the application of adaptive study design in SLE clinical trials.
  • To highlight how adaptive designs can enhance efficiency and rigor in drug development.

Main Methods:

  • Utilized an adaptive study design, selected as a case study for efavaleukin alfa in the FDA's Complex Innovative Trial Design Pilot Program.
  • Incorporated prospectively planned modifications at predefined interim timepoints.
  • Employed interim futility assessments for early trial termination and response-adaptive randomization to favor efficacious dose arms while maintaining constant placebo allocation.

Main Results:

  • Adaptive designs can improve statistical power for treatment effect estimation.
  • Increased collection of safety and efficacy data for optimal dose selection.
  • Potential to provide evidence for regulatory approval, reducing the need for multiple Phase III trials.

Conclusions:

  • Adaptive trial designs offer a more efficient approach to developing novel SLE therapies.
  • These designs can reduce patient requirements, exposure risks, and overall development time and cost.
  • Innovative designs like these are crucial for addressing unmet needs in complex autoimmune diseases.