A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease
IRAS ID
1010305
Contact name
Eric Jenkins
Contact email
Sponsor organisation
Kiniksa Pharmaceuticals, GmbH
Eudract number
2024-512986-15
Clinicaltrials.gov Identifier
Research summary
Research Summary
Sjögren’s Disease is an autoimmune disease that happens when the immune system damages the part of the body that produces fluids like tears and spit (saliva). Currently there is no cure for Sjögren’s Disease, the treatments that are available help to reduce symptoms. There is a need for new, safer and more effective treatments to be developed for the treatment of Sjögren’s Disease. Kiniksa Pharmaceuticals, GmbH (the Sponsor) are running a study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease. Abiprubart is the study medication being investigated in this research study. The aim of this clinical research study is to test the effectiveness and safety of abiprubart compared to placebo (dummy substance) in the treatment of patients with Sjögren’s Disease. Participants are expected to be in this study for about 14 months. Prior to undergoing any study procedures participants must sign an informed consent form . The main research study has 4 periods, the screening period to see if you are eligible to join the trial, the Double-blind Treatment period, the Active Treatment Extension Period and the safety follow-up period. Double- blind is when neither the doctor or participant know what treatment they are receiving. The treatment will be administered via a subcutaneous (under the skin) injection. The participants will be informed how they can administer the treatment at home. This study is expected to include 200 participants aged between 18 and 81years old. Study participants will visit the study site at the %me points specified in the main informed consent form. Participants will also undergo procedures such as blood and urine tests, ECGs, and a physical examination throughout the study. In addition to the main research study, there are 3 optional sub-studies: Ocular Staining, Salivary Gland Ultrasound and Salivary Gland Biopsies. Participants can take part in the main research study without having to join the sub-studies.Lay Summary of study results
The researchers asked for the help of men and women with Sjögren’s Disease. This trial included 3 participants in the United States.
The body’s immune system helps to fight off infections. In people with Sjögren’s Disease, the body’s immune system does not work the way it should. When that happens, the immune system can attack the body, including the parts of the body that make fluids, as well as other organs and tissues. People with Sjögren’s Disease may have dryness of the mouth, eyes, and other areas. Sjögren’s Disease can also affect other parts of the body like the joints, skin, lungs, kidneys, and nerves. People with Sjögren’s Disease may also have pain and tiredness that can severely affect their daily lives. The trial treatment, abiprubart, was being developed as a potential treatment for Sjögren’s Disease. Abiprubart was designed to target a protein on the surface of immune system cells that contributes to these immune system attacks.
In this trial, the researchers wanted to learn if abiprubart can help reduce symptoms and signs of disease in participants with Sjögren’s Disease. They also wanted to learn more about the safety of abiprubart and to find out if the participants had any side effects.
This trial had 2 parts, called Part A and Part B. Participants could be in both parts. In Part A, participants received abiprubart only (1 participant), abiprubart and a placebo (1 participant), or a placebo only (1 participant). A placebo looks like a treatment but does not have any active medicine in it. The researchers used a placebo to see if the effects of abiprubart they found in the trial were actually caused by abiprubart. The participants received their treatments as injections under the skin.
In Part B participants received abiprubart, but not the placebo (1 participant).
Part A was “double-blind”. This means the people in the trial, the doctors, and the staff did not know which treatment each person received. Some trials or parts of trials are done this way because knowing what treatment the participants are receiving can change the results of the
trial. In Part A, a computer program picked the treatment each participant received. This helped make sure that comparing the results of the trial treatments was as accurate as possible.
The researchers decided to end the trial early. Only 3 participants were enrolled in the study, and the participants were not able to receive all of their planned doses. The choice to end the trial early was not due to safety concerns.
The participants were in this trial for up to about 10 months. This trial started in July 2024 and ended in May 2025.
In both Parts A and B the doctors checked the participant’s health and Sjögren’s Disease signs and symptoms and asked questions about what medications they were taking.
It is unknown if abiprubart helped to reduce the participants’ Sjögren’s Disease symptoms and signs of disease activity. This was because the trial was stopped early. There were too few participants in the trial, and not all planned data collection was completed.
The researchers used a scoring scale called the European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index, also called the ESSDAI. This tool gives a score from 0 to 123 to measure the severity of a person’s Sjögren’s Disease signs and symptoms across different parts of their body. A lower score means less severe disease symptoms.
The researchers planned to compare the ESSDAI results among the participants at the end of Part A. But they could not learn if abiprubart helped to reduce the participants’ Sjögren’s Disease symptoms due to the small number of participants in the trial.
Medical problems are called “side effects”. A side effect can be “serious” or “non-serious”. A side effect is considered serious when it is life-threatening or causes death, causes disability, causes the participant to be admitted to a hospital, or causes a baby to be born with medical problems. While possibly related to trial treatment, side effects may or may not actually be caused by the treatments. This is because the results from several trials are needed to confirm if a treatment causes a side effect.
There was 1 participant who had a non-serious side effect during Part A of this trial. None of the participants had serious side effects or died during this trial.
Even though this trial ended early, it helped researchers begin to learn more about abiprubart and how safe it is in participants with Sjögren’s Disease.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0215
Date of REC Opinion
22 Oct 2024
REC opinion
Further Information Favourable Opinion