Trial of Sibeprenlimab in the Treatment of Sjögren’s Disease
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants with Sjögren’s Disease
IRAS ID
1010881
Contact name
Boris Reznichenko
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc
Eudract number
2024-516295-14
Research summary
Otsuka Pharmaceutical Development & Commercialization, Inc (OPDC) is studying an investigational drug called sibeprenlimab. An investigational drug is a drug that is being studied for approval by the Medicines & Healthcare products Regulatory Agency (MHRA). This drug is not available for sale in the United Kingdom or in any other country. Sibeprenlimab is being studied as a possible treatment of Sjogren’s Disease.
This study aims to:
• Compare the effects of sibeprenlimab with a placebo (a liquid that does not contain any active medicine).
• See how sibeprenlimab affects body (also known as pharmacodynamics [PD]) by studying the biomarkers. (Biomarkers are substances in the body that help to understand the effect of sibeprenlimab and the presence and extent of disease activity.)
• Determine if the body can make antibodies (proteins made by the body’s immune system that recognize and help fight infections and other foreign substances) against sibeprenlimab (this immune response is called immunogenicity).
• Evaluate how the body uses sibeprenlimab by measuring the levels of sibeprenlimab in your blood (known as pharmacokinetics).Participants will be enrolled from approximately 50 study sites in up to 15 countries. About 80 participants who have Sjogren’s Disease and are between 18 to 75 years of age will take part in this study. In the first part of the study, the participants will receive either drug or placebo at a 1:1 ratio. Once they complete the first part of the study (24 weeks) they can opt into the second part of the study. All participants will receive the IP in the second part. The full duration of each participant in the study will be for approximately 68 weeks and participants must visit the study site approximately 19 times unless a home or telephone visit has been approved.
REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0245
Date of REC Opinion
20 May 2025
REC opinion
Further Information Unfavourable Opinion