Cenerimod for Lupus Nephritis

Overseen By Viatris Innovation Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viatris Innovation GmbH

Must be taking: Mycophenolate, Corticosteroids

Must not be taking: Cyclosporine, Tacrolimus, Methotrexate, others

Disqualifiers: Severe CNS lupus, Heart disease, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 76 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cenerimod, a new treatment, to determine if it improves kidney function in people with active lupus nephritis, a kidney condition caused by lupus (an autoimmune disease where the immune system attacks its own tissues). Participants will take either cenerimod or a placebo (a substance with no therapeutic effect) alongside their usual treatment to compare results. The trial will also monitor for any side effects or medical issues from taking cenerimod. It suits those diagnosed with lupus nephritis who are currently experiencing active kidney disease, especially if they are already on certain lupus medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that cenerimod is likely to be safe for humans?

Research has shown that cenerimod has been tested in people with systemic lupus erythematosus (SLE), which is linked to lupus nephritis. One study on cenerimod's safety found that participants generally tolerated it well, although some experienced mild side effects like headaches and colds. Another study examined different doses of cenerimod and also found it to be generally safe, with similar mild side effects.

Cenerimod remains under study, so while it appears well-tolerated, more information is needed to fully understand its safety. Participants in ongoing trials like this one will help researchers learn more about any potential side effects when cenerimod is used to treat lupus nephritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cenerimod is unique because it targets the sphingosine-1-phosphate 1 (S1P1) receptor, a different mechanism compared to standard treatments like corticosteroids and immunosuppressants used for lupus nephritis. This receptor modulation could help better control inflammation and immune system activity, potentially reducing kidney damage more effectively. Researchers are excited about cenerimod because it promises a novel way to manage lupus nephritis, possibly offering improved outcomes with fewer side effects compared to existing therapies.

What evidence suggests that cenerimod might be an effective treatment for lupus nephritis?

Research has shown that cenerimod may help treat systemic lupus erythematosus (SLE), a condition related to lupus nephritis. Studies have found that cenerimod can lower disease activity in SLE patients. In one study, patients taking cenerimod experienced a noticeable drop in their disease activity scores, suggesting it might also help kidney function in lupus nephritis. Cenerimod works by affecting certain parts of the immune system involved in inflammation. Early results indicate that cenerimod is generally safe to use. This trial will evaluate cenerimod as a promising option for people with lupus nephritis, with participants receiving either cenerimod or a matching placebo in addition to their background lupus nephritis therapy. ^{2 3 5 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Viatris Innovation GmbH

Are You a Good Fit for This Trial?

Adults with systemic lupus erythematosus and active lupus nephritis can join this trial. They must have had a kidney biopsy within the last 6 months showing specific types of glomerulonephritis or be willing to undergo a biopsy during screening.

Inclusion Criteria

My lupus diagnosis follows the 2019 EULAR/ACR criteria.

I had a kidney biopsy showing specific types of kidney inflammation within the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take cenerimod or a placebo daily for 76 weeks, in addition to regular treatment

76 weeks

Clinic visits every 1 to 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cenerimod

Trial Overview

The trial is testing if cenerimod, added to regular treatment for lupus nephritis, improves kidney function compared to a placebo. Participants will take either cenerimod or placebo daily for about 1.5 years and visit the clinic regularly for checkups.

How Is the Trial Designed?

Group I: Cenerimod 4 mg Experimental Treatment 1 Intervention

Participants will receive cenerimod once daily in addition to background lupus nephritis (LN) therapy.

Group II: Matching placebo Placebo Group 1 Intervention

Participants will receive matching placebo once daily in addition to background LN therapy.

Who Is Running the Clinical Trial?

Viatris Innovation GmbH

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03742037

Study Details | NCT03742037 | Efficacy and Safety of Four ...

The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).

2.

jrheum.org

jrheum.org/content/52/Suppl_1/183.1

RESULTS FROM THE PHASE 2 CARE STUDY

Cenerimod had a significant effect on the primary endpoint, the change in modified SLE disease activity index-2000 score (mSLEDAI 2K, which ...

3.

thelancet.com

thelancet.com/journals/lanrhe/article/PIIS2665-9913(24)00246-7/abstract

Cenerimod, a sphingosine-1-phosphate receptor ...

We aimed to determine the efficacy, safety, and tolerability of four doses of cenerimod in adults with moderate-to-severe SLE receiving ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6861098/

First use of cenerimod, a selective S1P1 receptor modulator ...

With an acceptable safety profile, the efficacy findings suggest that cenerimod has the potential to treat patients with SLE.

5.

idorsia.com

idorsia.com/dam/jcr:3de1be0b-a128-4529-a28a-f2bfa08eb925/2022-cenerimod-initiation-webcast.pdf

Cenerimod Phase 3 in systemic lupus erythematosus

Secondary efficacy endpoint. • Response on SRI-4 at Month 12 compared to baseline. To evaluate the effectiveness of cenerimod 4 mg at reducing disease.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06475742

Study Details | NCT06475742 | Long-term Safety and ...

The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7877840/

Pharmacokinetics and Pharmacodynamics of Cenerimod, ...

This study compared the pharmacokinetic (PK), pharmacodynamic (PD), and safety of cenerimod between white and Asian subjects.