← Back to Search

Monoclonal Antibodies

Base Study: Dose 1 for Lupus

Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score of ≥6 and clinical hybrid SLEDAI score of ≥4.
Has + antinuclear antibody (+ANA) (titer ≥1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Sm antibody, or positive anti-SSA/Ro antibody.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

Study Summary

This trial is testing a medication called MK-6194 to see if it is effective and safe for adults with Systemic Lupus Erythematosus. The main goal is to find out if

Who is the study for?
Adults with Systemic Lupus Erythematosus (SLE) for at least 6 months, currently on treatment like immunosuppressants or steroids, and have certain SLE symptoms such as a lupus rash or joint pain. They must also test positive for specific antibodies related to SLE.Check my eligibility
What is being tested?
The trial is testing the effectiveness of MK-6194 compared to a placebo in improving SLE symptoms. Success is measured by the number of participants showing improvement on the SRI-4 scale at Week 28.See study design
What are the potential side effects?
While not specified here, common side effects may include reactions at injection sites, gastrointestinal issues, increased risk of infections due to immune system suppression, and potential liver or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lupus activity score is high, indicating active disease.
Select...
I have tested positive for specific autoimmune antibodies.
Select...
I have an active lupus rash or more than 2 swollen/tender joints in my hands.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Percentage of Participants Discontinuing Study Treatment Due to an AE
Percentage of Participants Experiencing Adverse Events (AEs)
Secondary outcome measures
Change From Baseline of 28 Joint Count at Week 28
Change From Baseline of 28 Joint Count at Week 52
Change From Baseline of Corticosteroid Dose at Week 28
+10 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Extension: Dose 2Experimental Treatment2 Interventions
Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
Group II: Extension: Dose 1Experimental Treatment2 Interventions
Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
Group III: Base Study: Dose 2Experimental Treatment1 Intervention
Participants receive SC MK-6194 dose regimen 2.
Group IV: Base Study: Dose 1Experimental Treatment1 Intervention
Participants receive subcutaneous (SC) MK-6194 dose regimen 1.
Group V: Base Study: PlaceboPlacebo Group2 Interventions
Participants receive an SC placebo regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,876 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,949 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants involved in this research endeavor?

"To meet the requirements of this trial, we are seeking a total of 270 eligible participants. Patients have the opportunity to enroll in this study at various locations, including Arthritis & Osteoporosis Medical Center - La Palma (Site 0108) situated in La Palma, California and DJL Clinical Research, PLLC (Site 0103) located in Charlotte, North carolina."

Answered by AI

Are there any available openings for patients to participate in this study?

"Indeed, the data available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible individuals. The study was initially posted on December 27th, 2023 and recently updated on January 4th, 2024. A total of three locations are enrolling participants for a target sample size of 270 individuals."

Answered by AI

Can individuals under the age of 18 participate in this medical study?

"Eligible candidates for this clinical trial must fall within the age range of 18 to 75 years old. It is worth noting that there are 24 studies available specifically for individuals under the age of 18, as well as an additional 120 studies catering to those over the age of 65."

Answered by AI

What is the level of safety associated with Base Study: Dose 2 when administered to individuals?

"Given that the Base Study: Dose 2 is a Phase 2 trial, our team at Power rates its safety as a 2. This indicates that while there is existing data supporting safety, no evidence has been found yet to support efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Epic Medical Research ( Site 0113)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
2023. "Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161116.
All > Systemic Lupus Erythematosus > Greensboro
~180 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top