Study of Cenerimod in participants with Lupus disease
Research type
Research Study
Full title
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)
IRAS ID
253868
Contact name
David D'Cruz
Contact email
Sponsor organisation
Idorsia Pharmaceuticals Ltd
Eudract number
2018-001808-11
Duration of Study in the UK
3 years, 1 months, days
Research summary
Research Summary
Systemic Lupus Erythematosus (SLE) also known as Lupus, is where the body's immune system wrongly attacks healthy tissue in many parts of the body such as skin, joints, kidneys, heart, brain and other organs. The symptoms experienced by lupus patients, e.g. fatigue, directly affects their quality of life. Lupus can also affect patients’ emotions, social health, family, employment, leisure, appearance, and independence.
Currently, the treatment of lupus consists of medications of little effectiveness and also causes significant side effects. Belimumab, the most recently approved treatment for lupus, only demonstrated a short-term therapeutic effects in previous studies. There is therefore and unmet need for a safe and effective treatment for lupus patients.The purpose of this study is to assess if Cenerimod, the study medication, can reduce the symptoms of lupus when given and to learn which dose(s) is the most effective and safe for people with Lupus. Cenerimod is a study medication that has the ability to reduce the number of certain white blood cells (WBCs- called lymphocytes) that are involved in Lupus. This effect of Cenerimod is sustained with continued daily oral use but is reversible when the medication is no longer being taken.
Participants in this study will be chosen at random to either take cenerimod or placebo (sugar pill), both of which will be tested in this study. Cenerimod can be used in 4 doses, so the study has 5 different treatment options: placebo, 0.5 mg/day, 1 mg/day, 2 mg/day and 4 mg/day. All 5 treatment options will be tested in addition to normal treatment medications used to treat lupus. Approximately 400 participants will take cenerimod, while approximately 100 participants will take placebo. Each participant will receive 1 of the treatment options as study treatment for a minimum of 6 months and up to a maximum of 12 months.
Summary of Results
The goal of this study was to find the best dose of cenerimod that patients with moderate to severe systemic lupus erythematosus (SLE) could take to reduce disease activity.
Systemic lupus erythematosus – known more simply as lupus – is an autoimmune disease, which means that the body’s immune system malfunctions and attacks the body's own tissues. Some autoimmune diseases affect just one organ, but in the case of lupus, all parts of the body can be affected.
In the study some patients took placebo as a study medication (the placebo was a tablet that looks exactly like the cenerimod tablet but did not contain active substance). Placebo in the study allowed researchers to analyse the efficacy of cenerimod treatment taken on top of the stable dosages of lupus medications they were already taking.
The study randomly assigned 427 adult patients with lupus on background therapy, in equal proportions to cenerimod (0.5, 1, 2, 4 mg) or placebo. Patients randomized to cenerimod 4 mg showed an improvement in the modified-Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score compared to placebo from baseline to Month 6. This single comparison showed a statistically significant difference between the doses. However, this result did not reach statistical significance when adjusting for the four-tests for each dose versus placebo. There was no significant improvement in patients assigned to the 0.5 mg, 1 mg and 2 mg cenerimod treatment arms in the single comparison with placebo.
Cenerimod was well tolerated in all treatment groups such that similar rates of adverse events were reported across all treatment groups. For further information on side effects observed during this study, please refer to the record on ClinicalTrials.gov (NCT03742037).REC name
West of Scotland REC 1
REC reference
18/WS/0199
Date of REC Opinion
17 Dec 2018
REC opinion
Further Information Favourable Opinion