What side effects are associated with this type of intervention?

Common treatments for Lupus, such as rituximab, mycophenolate mofetil, and glucocorticoids, have a range of side effects. Rituximab can cause infusion reactions, serum-sickness-like reactions, and in rare cases, progressive multifocal encephalopathy. Mycophenolate mofetil may lead to gastrointestinal issues, increased risk of infections, and bone marrow suppression. Glucocorticoids are associated with hyperglycemia, increased infection risk, bone loss, and neuropsychiatric effects. These side effects highlight the need for careful monitoring and management during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for systemic lupus erythematosus (SLE), including biologics and immunosuppressive agents. Belimumab, a monoclonal antibody targeting B-lymphocyte stimulator (BLyS), was the first new drug approved for lupus in over 50 years. Other treatments include hydroxychloroquine, corticosteroids, and immunosuppressive drugs like azathioprine and mycophenolate mofetil. While specific TLR7/8 inhibitors like M5049 are still under investigation, these existing therapies aim to modulate the immune system to reduce disease activity and manage symptoms.

What other types of research exist?

Promising novel alternatives to M5049 for Lupus patients include B-cell antagonists, which have shown promise in uncontrolled cohort and observational studies. Additionally, targeted molecular therapies such as monoclonal anti-CD40L and anti-CTLA4Ig are undergoing trials and may offer new treatment options. IVIg, an immunomodulator, has also been successful in treating SLE.

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M5049 for Lupus

Phase 2

Recruiting

Research Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (willow study), weeks 0, 2, 4, 12, 24, 36 and 48

Awards & highlights

Study Summary

This trial is testing the long-term safety and effectiveness of a drug called M5049 in people with lupus.

Who is the study for?

This trial is for people with certain types of lupus (SCLE, DLE, or SLE) who finished a previous 24-week Willow study. Participants should have a BMI between 18.5 and 35 and must not have serious infections, recent use of prohibited meds, other investigational drug studies post-Willow study Week 24, or severe health conditions that increase risk.Check my eligibility

What is being tested?

The Willow LTE Study tests the long-term safety and effectiveness of M5049 at various doses in treating lupus. It's an oral medication given to those who've completed the initial Willow study treatment period.See study design

What are the potential side effects?

While specific side effects are not listed here, participants from the original Willow study experiencing serious events related to M5049 were excluded, suggesting potential continuation of similar side effects such as infection risks or reactions related to immune system changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (willow study), weeks 0, 2, 4, 12, 24, 36 and 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (willow study), weeks 0, 2, 4, 12, 24, 36 and 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (willow study), weeks 0, 2, 4, 12, 24, 36 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)

Secondary outcome measures

Change from WILLOW Study Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Weeks 0, 2, 4, 12, 24, 36 and 48

Number of Participants With Based Composite Lupus Assessment (BICLA) Response

Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: M5049 very high dose + PlaceboExperimental Treatment2 Interventions

Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose.

Group II: M5049 medium dose+ PlaceboExperimental Treatment2 Interventions

Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo.

Group III: M5049 low dose + PlaceboExperimental Treatment2 Interventions

Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo.

Group IV: M5049 high dose + PlaceboExperimental Treatment2 Interventions

Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lupus include immunosuppressive drugs, biologics, and antimalarials. Immunosuppressive drugs like cyclophosphamide and methotrexate work by reducing the activity of the immune system to prevent it from attacking the body's own tissues. Biologics, such as belimumab, target specific proteins involved in the immune response, thereby reducing inflammation and autoantibody production. Antimalarials like hydroxychloroquine interfere with the communication between immune cells, reducing inflammation and preventing flare-ups. TLR7/8 inhibitors, such as M5049, specifically block toll-like receptors 7 and 8, which are involved in the activation of the immune system. This targeted approach can help reduce the overactive immune response seen in Lupus patients, potentially leading to fewer symptoms and flare-ups. Understanding these mechanisms is crucial for Lupus patients as it helps in selecting the most appropriate treatment to manage their condition effectively.

The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.A Systems Biology-Based Investigation into the Pharmacological Mechanisms of Sheng-ma-bie-jia-tang Acting on Systemic Lupus Erythematosus by Multi-Level Data Integration.Pharmacotherapy of lupus nephritis in children: a recommended treatment approach.

Find a Location

Who is running the clinical trial?

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyLead Sponsor

52 Previous Clinical Trials

6,625 Total Patients Enrolled

Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

292 Previous Clinical Trials

68,983 Total Patients Enrolled

Media Library

M5049 low dose Clinical Trial Eligibility Overview. Trial Name: NCT05540327 — Phase 2

Lupus Research Study Groups: M5049 high dose + Placebo, M5049 very high dose + Placebo, M5049 low dose + Placebo, M5049 medium dose+ Placebo

Lupus Clinical Trial 2023: M5049 low dose Highlights & Side Effects. Trial Name: NCT05540327 — Phase 2

M5049 low dose 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540327 — Phase 2

Lupus Patient Testimony for trial: Trial Name: NCT05540327 — Phase 2

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