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Monoclonal Antibodies

KPL-404 for Rheumatoid Arthritis

Phase 2
Waitlist Available
Research Sponsored by Kiniksa Pharmaceuticals, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must meet specific disease activity criteria including joint counts, C-reactive protein levels, and seropositivity for Rheumatoid Factor (RF) and/or Anti-citrullinated protein antibody (ACPA)
Diagnosis of Rheumatoid Arthritis (RA) for at least 3 months meeting the 2010 ACR/EULAR classification criteria for RA and categorized as ACR RA functional Class 1-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on days 1-169
Awards & highlights

Study Summary

This trial is testing a new drug for rheumatoid arthritis to see if it is safe, effective, and tolerated by patients.

Who is the study for?
Adults with moderate to severe Rheumatoid Arthritis who haven't responded well or are intolerant to at least one biologic DMARD or a JAK inhibitor. They should be on stable csDMARD therapy, have active disease indicated by joint counts and lab tests, and must have completed their COVID-19 vaccination. Excluded are those with recent steroid injections, prior anti-CD40/CD40L treatment, early arthritis onset before age 16, high thromboembolic risk, certain heart conditions, uncontrolled hypertension, significant ECG abnormalities or a history of cancer (except some skin cancers).Check my eligibility
What is being tested?
The trial is testing KPL-404's safety and effectiveness in people with Rheumatoid Arthritis compared to a placebo. It's looking at how the body processes the drug (pharmacokinetics), how it affects the body (pharmacodynamics), and if it improves symptoms.See study design
What are the potential side effects?
Potential side effects for KPL-404 aren't specified but may include typical reactions seen in immune-modulating therapies such as injection site reactions, increased infection risk due to immune system suppression, gastrointestinal issues like nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My arthritis shows active disease with specific blood test results.
Select...
I have been diagnosed with Rheumatoid Arthritis for at least 3 months and can perform daily activities with little to some difficulty.
Select...
I have rheumatoid arthritis and treatments with bDMARDs or JAKi for over 3 months didn't work or caused side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on days 1-169
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on days 1-169 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 3 and 4: Change from Baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) at Week 12
Cohorts 1 and 2: Area Under the Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
Cohorts 1 and 2: Incidence of Treatment-Emergent Adverse Events (TEAEs)
+1 more
Secondary outcome measures
Cohort 3 and 4: AUC0-t
Cohort 3 and 4: Cmax
Cohort 3 and 4: Incidence of TEAEs
+1 more

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 4 KPL-404Experimental Treatment1 Intervention
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at weeks 4 and 8.
Group II: Cohort 3 KPL-404 and PlaceboExperimental Treatment2 Interventions
KPL-404 5mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks
Group III: Cohort 3 KPL-404Experimental Treatment1 Intervention
KPL-404 5mg/kg SC qwk for 12 weeks
Group IV: Cohort 2 KPL-404Experimental Treatment1 Intervention
KPL-404 5mg/kg SC q2wk for 12 weeks
Group V: Cohort 1 KPL-404Experimental Treatment1 Intervention
KPL-404 2mg/kg Subcutaneous (SC) q2wk for 12 weeks
Group VI: Cohort 2 PlaceboPlacebo Group1 Intervention
Placebo for KPL-404 SC q2wk for 12 weeks
Group VII: Cohort 3 PlaceboPlacebo Group1 Intervention
Placebo for KPL-404 SC qwk for 12 weeks
Group VIII: Cohort 4 PlaceboPlacebo Group1 Intervention
Placebo for KPL-404 SC q4wk for 12 weeks
Group IX: Cohort 1 PlaceboPlacebo Group1 Intervention
Placebo for KPL-404 SC q2wk for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KPL-404
2019
Completed Phase 1
~60
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Kiniksa Pharmaceuticals, Ltd.Lead Sponsor
8 Previous Clinical Trials
1,287 Total Patients Enrolled

Media Library

KPL-404 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05198310 — Phase 2
Rheumatoid Arthritis Research Study Groups: Cohort 4 KPL-404, Cohort 2 Placebo, Cohort 3 KPL-404 and Placebo, Cohort 3 Placebo, Cohort 1 KPL-404, Cohort 2 KPL-404, Cohort 4 Placebo, Cohort 1 Placebo, Cohort 3 KPL-404
Rheumatoid Arthritis Clinical Trial 2023: KPL-404 Highlights & Side Effects. Trial Name: NCT05198310 — Phase 2
KPL-404 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05198310 — Phase 2
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT05198310 — Phase 2

Frequently Asked Questions

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

Are there different branch locations running this research in various states?

"21 centres across the country are enrolling patients for this study, some of which include Graves Gilbert Clinic in Bowling Green, Rheumatology Clinic of Houston in Tomball, and San Marcus Research Clinic, Inc. in Covina."

Answered by AI

Does KPL-404 have the FDA's go-ahead for public consumption?

"KPL-404's safety is only supported by Phase 2 data, meaning that while there are no reports of serious adverse effects, there is also no evidence that the medication is effective. Consequently, our team gave it a score of 2."

Answered by AI

Is this research project currently recruiting participants?

"The clinicaltrials.gov website does show that this study is still looking for participants. 91 patients are needed, and so far 21 locations have agreed to take part in the trial. The dates you are seeing correspond to when the study was first posted (12/14/2021) and when it was last updated (11/2/2022)."

Answered by AI

How many people have signed up to be a part of this research?

"Out of the 91 potential participants that meet the prerequisites, this clinical trial requires full enrollment. Patients have the option to participate in this study from Graves Gilbert Clinic in Bowling Green, Kentucky or Rheumatology Clinic of Houston in Tomball, Texas."

Answered by AI

Might I be eligible to participate in this clinical trial?

"This study is looking for 91 patients that suffer from arthritis or rheumatoid between the ages of 18 and 80. Most importantly, patients must meet the following criteria: Body weight ≥ 40 to ≤ 100 kg for all cohorts., A combination of up to 2 background csDMARDs is allowed, except the combination of MTX and leflunomide., Six or more swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at screening and baseline visits;, Seropositivity for serum Rheumatoid Factor (RF) and/or Anti-citrullinated protein"

Answered by AI

Is this clinical trial available to people who are middle-aged?

"The age requirement for this study is that patients must be over 18 and under 80 years old."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
New Jersey
California
Other
How old are they?
18 - 65
What site did they apply to?
Millennium Research
Northwell Health, Division of Rheumatology
Study Site 840004
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I have tried hundreds of meds to no advantage.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor
2021. "Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05198310.
All > Rheumatoid Arthritis > Ra
~43 spots leftby Apr 2025
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