Study Summary
This trial is testing a new drug for rheumatoid arthritis to see if it is safe, effective, and tolerated by patients.
- Rheumatoid Arthritis
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
9 Primary · 9 Secondary · Reporting Duration: Predose on Days 1-169
Trial Safety
Phase-Based Safety
Trial Design
16 Treatment Groups
Cohort 1 KPL-404
1 of 16
Cohort 2 KPL-404
1 of 16
Cohort 3 KPL-404 and Placebo
1 of 16
Cohort 3 KPL-404
1 of 16
Medium Dose KPL-404
1 of 16
Low Dose KPL-404
1 of 16
High Dose KPL-404
1 of 16
High Dose KPL-404 (follow up)
1 of 16
Medium Dose KPL-404 (follow up)
1 of 16
Cohort 1 Placebo
1 of 16
Cohort 2 Placebo
1 of 16
Cohort 3 Placebo
1 of 16
Low Dose Placebo
1 of 16
Medium Dose Placebo
1 of 16
High Dose Placebo
1 of 16
Medium or High Dose Placebo (follow up)
1 of 16
Experimental Treatment
Non-Treatment Group
91 Total Participants · 16 Treatment Groups
Primary Treatment: KPL-404 · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| New Jersey | 22.2% |
| Texas | 11.1% |
| Kentucky | 11.1% |
| Other | 55.6% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Study Site 840004 | 20.0% |
| Northwell Health, Division of Rheumatology | 20.0% |
| DM Clinical Research | 20.0% |
| Other | 40.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I have tried hundreds of meds to no advantage"
How many prior treatments have patients received?
| 0 | 100.0% |
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor