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Monoclonal Antibodies

Standard-of-care treatment for Lupus Nephritis (ORCHID-LN Trial)

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At screening and randomization, must be receiving oral glucocorticoids at minimum prednisone equivalent dose of 10 milligrams per day (mg/day) and maximum 1 mg/kg/day or less than or equal to (<=) 60 mg/day, whichever is lower.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 to week 24
Awards & highlights

ORCHID-LN Trial Summary

This trial will test whether the drug guselkumab can effectively treat lupus nephritis, a kidney inflammation caused by lupus.

Eligible Conditions
  • Lupus Nephritis

ORCHID-LN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are taking a medication called oral glucocorticoids, and the dose is between 10 milligrams and 60 milligrams per day, depending on your weight.

ORCHID-LN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 to week 24 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 at Least 50 Percentage (%) Decrease in Proteinuria
Secondary outcome measures
Change From Baseline in Laboratory Parameters
Number of Participants With Serious Infections
Number of Participants with AE Leading to Discontinuation of Study Intervention
+16 more

ORCHID-LN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Guselkumab+Standard of CareExperimental Treatment3 Interventions
Participants will receive guselkumab Dose 1 intravenously (IV) at Weeks 0, 4 and 8 and guselkumab Dose 2 subcutaneous (SC) every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the long-term extension (LTE).
Group II: Placebo+Standard of CarePlacebo Group2 Interventions
Participants will receive placebo IV at Weeks 0, 4 and 8 and placebo SC q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the LTE of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab Dose 1
2018
Completed Phase 2
~280
Guselkumab Dose 2
2018
Completed Phase 2
~280
Standard-of-care treatment
2018
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,275 Total Patients Enrolled
3 Trials studying Lupus Nephritis
205 Patients Enrolled for Lupus Nephritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,872 Total Patients Enrolled
2 Trials studying Lupus Nephritis
105 Patients Enrolled for Lupus Nephritis

Frequently Asked Questions

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

Is this a pioneering clinical trial?

"Since the 2018 inception of Janssen Research & Development, LLC's pioneering study involving 1406 participants, Standard-of-care treatment has gained Phase 2 and 3 drug authorisation. Currently 19 trials are underway in 286 cities across 57 nations."

Answered by AI

Are there openings for participation in this investigation?

"According to clinicaltrials.gov, this particular trial is not presently recruiting participants; the protocol was first announced on September 15th 2020 and recently edited on November 3rd 2022. However, there are currently 59 other medical studies that are actively looking for volunteers."

Answered by AI

Are adults aged 30 and above considered to be applicable for this trial?

"The study requirements specify that applicants must be aged between 18 and 75. There is an additional 10 studies for minors and 50 specifically designed for seniors."

Answered by AI

What criteria best qualifies participants for this clinical research?

"To qualify for this trial, prospective participants must be afflicted with lupus nephritis and situated between 18 to 75 years of age. The research team is enrolling 33 individuals in total."

Answered by AI

Have there been prior studies utilizing the accepted medical protocol?

"Currently, 19 studies are being conducted to evaluate the efficacy of Standard-of-care treatment. Of these active clinical trials, 7 have progressed to Phase 3. While Milan and Kansas both feature a number of sites for evaluating this therapy, there is an expansive network of 2732 locations around the world running similar experiments."

Answered by AI

Are any Canadian medical facilities carrying out this clinical investigation?

"At the moment, this experimental trial is being conducted at 5 different sites. These locations are situated in La Jolla, Los Angeles and Aurora among other areas. To reduce any travel burdens associated with participation, it is recommended to select a site nearest you."

Answered by AI

What is the upper boundary of participants in this trial?

"Unfortunately, this trial is no longer recruiting participants. Initial postings were made on September 15th 2020 and the study was last edited on November 3rd 2022. If you're looking for other trials, there are presently 40 studies admitting patients with lupus nephritis and 19 clinical trials finding individuals to receive standard-of-care treatments."

Answered by AI

Does the accepted best practice pose any risks to individuals?

"While there is evidence of safety, no data in regards to efficacy exists yet. Therefore its risk score falls at a moderate 2 on the 1-3 scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Guselkumab in Participants With Active Lupus Nephritis
2020. "A Study of Guselkumab in Participants With Active Lupus Nephritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04376827.
~7 spots leftby Apr 2025
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