search
Back to results

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

Primary Purpose

Arthritis, Rheumatoid

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KPL-404
Placebo
Sponsored by
Kiniksa Pharmaceuticals, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring inadequate responders, moderate to severe, Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body weight ≥ 40 to ≤ 100 kg for all cohorts.
  • Diagnosis of RA for ≥ 3 months fulfilling the 2010 American College of Rheumatology (ACR)/European Union League Against Rheumatism (EULAR) classification criteria for RA and that is categorized as ACR RA functional Class 1-3.
  • Treated with a biological disease-modifying anti-rheumatic drug (bDMARDs) OR Janus kinase inhibitor (JAKi) therapy for RA for ≥ 3 months and had inadequate response or had to discontinue bDMARD OR JAKi therapy due to intolerance or toxicity, regardless of treatment duration.
  • Currently receiving conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks before the first dose of investigational product.

    1. The following csDMARDs are allowed: oral or parenteral methotrexate ([MTX]; 7.5 to 25 mg/week), sulfasalazine (≤ 3000 mg/day), hydroxychloroquine (≤ 400 mg/day), chloroquine (≤ 250 mg/day), and leflunomide (≤ 20 mg/day).
    2. A combination of up to 2 background csDMARDs is allowed, except the combination of MTX and leflunomide.
  • Meets all of the following disease activity criteria:

    1. Six or more swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at screening and baseline visits;
    2. Level of high-sensitivity C-reactive protein ≥ 5 mg/L (by central laboratory);
    3. Seropositivity for serum Rheumatoid Factor (RF) and/or Anti-citrullinated protein antibody (ACPA) at screening, according to the central laboratory's definition of positivity.
  • Has completed a locally approved authorized COVID-19 vaccine regimen according to local guidance at least 3 weeks before the first dose of the Investigational Product.
  • Must have discontinued all bDMARDs or JAKi prior to the first dose of investigational product. The washout period for bDMARDs or JAKi prior to the first dose of investigational product is specified below. For bDMARDs or JAKi not listed below washout should be at least 5 times the mean elimination half-life of a drug:

    1. ≥ 4 weeks for etanercept;
    2. ≥ 8 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
    3. ≥ 1 year for rituximab;
    4. ≥ 2 weeks for JAKi (either investigational or commercially available treatment).
  • Voluntarily sign and date an informed consent form approved by independent ethics committee/Institutional Review Board (IRB)

Exclusion Criteria:

  • Prior exposure to any other anti-CD40/CD40L agent.
  • Prior treatment failure, inadequate response, or intolerance to both a bDMARD and a JAKi.
  • Injectable corticosteroids (including intra-articular) or treatment with > 10 mg/day dose oral prednisone or equivalent within 8 weeks prior to randomization.
  • History of any arthritis with onset prior to age 16 years or current diagnosis of inflammatory joint disease other than RA (Current diagnosis of secondary Sjogren's syndrome is permitted).
  • History of thromboembolic event or a significant risk of future thromboembolic events
  • Clinically significant active infection including signs/symptoms suggestive of infection, any significant recurrent or chronic infection, or subjects at a high risk of infection
  • History of cancer within the last 5 years from screening, except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured.
  • History of any of the following cardiovascular conditions:

    1. Moderate to severe congestive heart failure (New York Heart Association class III or IV);
    2. Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting;
    3. Uncontrolled hypertension as defined by a confirmed systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
  • Clinically relevant or significant electrocardiogram (ECG) abnormalities, including ECG with QT interval corrected for heart rate (QTc) > 500 msec.

Sites / Locations

  • Pinnacle Research Group, LLCRecruiting
  • Carewell Arthritis CenterRecruiting
  • Attune Health Research Inc.Recruiting
  • Wallace Rheumatic Studies Center, LLC
  • Medvin Clinical ResearchRecruiting
  • TriWest Research AssociatesRecruiting
  • Medvin Clinical ResearchRecruiting
  • Inland Rheumatology Clinical TrialsRecruiting
  • Medvin Clinical ResearchRecruiting
  • International Medical ResearchRecruiting
  • Sweet Hope Research Specialty, Inc.Recruiting
  • San Marcus Research Clinic, Inc.Recruiting
  • Millennium ResearchRecruiting
  • West Broward Rheumatology Associates, Inc.Recruiting
  • Center for Advanced Research & Education
  • Graves Gilbert ClinicRecruiting
  • Bluegrass Community Research, Inc
  • Accurate Clinical Research, Inc.Recruiting
  • Johns Hopkins University - Johns Hopkins Arthritis CenterRecruiting
  • SUNY Downstate Medical Center
  • Northwell Health, Division of RheumatologyRecruiting
  • Altoona Center for Clinical ResearchRecruiting
  • West Tennessee Research InstituteRecruiting
  • Saint Francis Hospital- MemphisRecruiting
  • Arthritis and Rheumatology Research InstituteRecruiting
  • Trinity Universal Research AssocRecruiting
  • Arthritis & Osteoporosis Center of Coastal BendRecruiting
  • Corpus Christi RheumatologyRecruiting
  • Dallas Fort Worth Clinical Research Associates
  • Southwest Rheumatology Research LLCRecruiting
  • DM Clinical ResearchRecruiting
  • Rheumatology Clinic of HoustonRecruiting
  • Rheumatology and Pulmonary ClinicRecruiting
  • UMHAT "Dr. Georgi Stranski"Recruiting
  • Medical center "Artmed" LTDRecruiting
  • UMHAT Sveti Ivan RilskiRecruiting
  • Vesalion s.r.o.Recruiting
  • CCR Czech a.s.,Recruiting
  • Revmatologicky UtsavRecruiting
  • Medical Plus S.R.O.Recruiting
  • Aleksandre Aladashvili Clinic LLCRecruiting
  • LTD Israel-Georgian Medical Research Clinic HelsicoreRecruiting
  • JSC Evex HospitalsRecruiting
  • LTD Georgian-Dutch HospitalRecruiting
  • Universitätsklinikum FreiburgRecruiting
  • University Hospital Cologne AöRRecruiting
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontRecruiting
  • Qualiclinic Ltd (Qualiclinic Inc)Recruiting
  • Magyar Honvedseg Egeszsegugyi KozpontRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Porcika KlinikaRecruiting
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi OktatokorhazRecruiting
  • Vita Verum Medical EgeszsegugyRecruiting
  • Centrum Kliniczno-BadawczeRecruiting
  • Silmedic sp. z o.o.Recruiting
  • NZOZ Lecznica MAK-MED s.c.Recruiting
  • Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel HrycajRecruiting
  • RCMed Oddzial SochaczewRecruiting
  • Centrum Medyczne Reuma ParkRecruiting
  • Clinresco Centres (Pty) LtdRecruiting
  • Jacaranda HospitalRecruiting
  • Umhlanga Hospital Medical CenterRecruiting
  • Panorama Medical CentreRecruiting
  • Winelands Medical Research CenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cohort 1 KPL-404

Cohort 1 Placebo

Cohort 2 KPL-404

Cohort 2 Placebo

Cohort 3 KPL-404

Cohort 3 KPL-404 and Placebo

Cohort 3 Placebo

Cohort 4 KPL-404

Cohort 4 Placebo

Arm Description

KPL-404 2mg/kg Subcutaneous (SC) q2wk for 12 weeks

Placebo for KPL-404 SC q2wk for 12 weeks

KPL-404 5mg/kg SC q2wk for 12 weeks

Placebo for KPL-404 SC q2wk for 12 weeks

KPL-404 5mg/kg SC qwk for 12 weeks

KPL-404 5mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks

Placebo for KPL-404 SC qwk for 12 weeks

KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at weeks 4 and 8.

Placebo for KPL-404 SC q4wk for 12 weeks

Outcomes

Primary Outcome Measures

Cohorts 1 and 2: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Cohorts 1 and 2: Maximum Serum Concentration (Cmax)
Cohorts 1 and 2: Area Under the Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
Cohort 3 and 4: Change from Baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) at Week 12

Secondary Outcome Measures

Cohorts 1 and 2: Change from Baseline in DAS28-CRP at Week 12
Cohort 3 and 4: Incidence of TEAEs
Cohort 3 and 4: Cmax
Cohort 3 and 4: AUC0-t

Full Information

First Posted
January 3, 2022
Last Updated
September 20, 2023
Sponsor
Kiniksa Pharmaceuticals, Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05198310
Brief Title
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
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kiniksa Pharmaceuticals, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis.
Detailed Description
This is a 28-week (up to 4-week screening period, 12-week treatment period, and 12-week safety follow-up period), multicenter, randomized, double-blind, placebo-controlled, multiple dose, proof-of-concept study with PK lead-in designed to assess the safety, PK, efficacy and PD of KPL-404 in subjects with moderate to severe, active Rheumatoid Arthritis (RA) who have an inadequate response to or are intolerant to a Janus kinase inhibitor (JAKi) AND/OR at least one biologic disease-modifying anti-rheumatic drug (bDMARD). The objectives of the study are to evaluate safety, efficacy, and PD of KPL-404 compared with placebo across the estimated therapeutic range and to characterize PK across varying dose levels of KPL-404.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
inadequate responders, moderate to severe, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 KPL-404
Arm Type
Experimental
Arm Description
KPL-404 2mg/kg Subcutaneous (SC) q2wk for 12 weeks
Arm Title
Cohort 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for KPL-404 SC q2wk for 12 weeks
Arm Title
Cohort 2 KPL-404
Arm Type
Experimental
Arm Description
KPL-404 5mg/kg SC q2wk for 12 weeks
Arm Title
Cohort 2 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for KPL-404 SC q2wk for 12 weeks
Arm Title
Cohort 3 KPL-404
Arm Type
Experimental
Arm Description
KPL-404 5mg/kg SC qwk for 12 weeks
Arm Title
Cohort 3 KPL-404 and Placebo
Arm Type
Experimental
Arm Description
KPL-404 5mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks
Arm Title
Cohort 3 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for KPL-404 SC qwk for 12 weeks
Arm Title
Cohort 4 KPL-404
Arm Type
Experimental
Arm Description
KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at weeks 4 and 8.
Arm Title
Cohort 4 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for KPL-404 SC q4wk for 12 weeks
Intervention Type
Drug
Intervention Name(s)
KPL-404
Intervention Description
Humanized monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Cohorts 1 and 2: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to 24 weeks
Title
Cohorts 1 and 2: Maximum Serum Concentration (Cmax)
Time Frame
Predose on Days 1-169
Title
Cohorts 1 and 2: Area Under the Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
Time Frame
Predose on Days 1-169
Title
Cohort 3 and 4: Change from Baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) at Week 12
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Cohorts 1 and 2: Change from Baseline in DAS28-CRP at Week 12
Time Frame
Baseline, Week 12
Title
Cohort 3 and 4: Incidence of TEAEs
Time Frame
Up to 24 weeks
Title
Cohort 3 and 4: Cmax
Time Frame
Predose on Days 1-169
Title
Cohort 3 and 4: AUC0-t
Time Frame
Predose on Days 1-169

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body weight ≥ 40 to ≤ 140 kg for all cohorts. Diagnosis of RA for ≥ 3 months fulfilling the 2010 American College of Rheumatology (ACR)/European Union League Against Rheumatism (EULAR) classification criteria for RA and that is categorized as ACR RA functional Class 1-3. Treated with a biological disease-modifying anti-rheumatic drug (bDMARDs) AND/OR Janus kinase inhibitor (JAKi) therapy for RA for ≥ 3 months and had inadequate response or had to discontinue bDMARD AND/OR JAKi therapy due to intolerance or toxicity, regardless of treatment duration. Currently receiving conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks before the first dose of investigational product. The following csDMARDs are allowed: oral or parenteral methotrexate ([MTX]; 7.5 to 25 mg/week), sulfasalazine (≤ 3000 mg/day), hydroxychloroquine (≤ 400 mg/day), chloroquine (≤ 250 mg/day), and leflunomide (≤ 20 mg/day). A combination of up to 2 background csDMARDs is allowed, except the combination of MTX and leflunomide. Meets all of the following disease activity criteria: Six or more swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at screening and baseline visits; Level of high-sensitivity C-reactive protein ≥ 3 mg/L (by central laboratory); Documented seropositivity for serum Rheumatoid Factor (RF) and/or Anti-citrullinated protein antibody (ACPA) (>ULN) at screening or by prior laboratory evaluation. Has completed a locally approved authorized COVID-19 vaccine regimen according to local guidance at least 3 weeks before the first dose of the Investigational Product. Must have discontinued all bDMARDs or JAKi prior to the first dose of investigational product. The washout period for bDMARDs or JAKi prior to the first dose of investigational product is specified below. For bDMARDs or JAKi not listed below washout should be at least 5 times the mean elimination half-life of a drug: ≥ 4 weeks for etanercept; ≥ 8 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; ≥ 1 year for rituximab; ≥ 2 weeks for JAKi (either investigational or commercially available treatment). Voluntarily sign and date an informed consent form approved by independent ethics committee/Institutional Review Board (IRB) Exclusion Criteria: Prior exposure to any other anti-CD40/CD40L agent. Inadequate response to 5 or more classes of advanced targeted therapies (bDMARD or tsDMARD; e.g., TNF inhibitors, IL-6 receptor inhibitors, T-cell costimulatory inhibitors, anti-CD-20 antibodies, JAK inhibitors). This does not include prior discontinuation due to drug intolerance. Injectable corticosteroids (including intra-articular) or treatment with > 10 mg/day dose oral prednisone or equivalent within 8 weeks prior to randomization. History of any arthritis with onset prior to age 16 years or current diagnosis of inflammatory joint disease other than RA (Current diagnosis of secondary Sjogren's syndrome is permitted). History of thromboembolic event or a significant risk of future thromboembolic events Clinically significant active infection including signs/symptoms suggestive of infection, any significant recurrent or chronic infection, or subjects at a high risk of infection History of cancer within the last 5 years from screening, except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. History of any of the following cardiovascular conditions: Moderate to severe congestive heart failure (New York Heart Association class III or IV); Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting; Uncontrolled hypertension as defined by a confirmed systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg. Clinically relevant or significant electrocardiogram (ECG) abnormalities, including ECG with QT interval corrected for heart rate (QTc) > 500 msec.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Project Manager
Phone
7814319100
Email
clinicaltrials@kiniksa.com
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Carewell Arthritis Center
City
Apple Valley
State/Province
California
ZIP/Postal Code
92307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Attune Health Research Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Wallace Rheumatic Studies Center, LLC
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Withdrawn
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
TriWest Research Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Medvin Clinical Research
City
Tujunga
State/Province
California
ZIP/Postal Code
91042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Inland Rheumatology Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Medvin Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
International Medical Research
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principle Investigator
Facility Name
Sweet Hope Research Specialty, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
San Marcus Research Clinic, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
West Broward Rheumatology Associates, Inc.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Withdrawn
Facility Name
Graves Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Bluegrass Community Research, Inc
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Withdrawn
Facility Name
Accurate Clinical Research, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Johns Hopkins University - Johns Hopkins Arthritis Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Withdrawn
Facility Name
Northwell Health, Division of Rheumatology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Saint Francis Hospital- Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Arthritis and Rheumatology Research Institute
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Trinity Universal Research Assoc
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Arthritis & Osteoporosis Center of Coastal Bend
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Corpus Christi Rheumatology
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Dallas Fort Worth Clinical Research Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Individual Site Status
Withdrawn
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Rheumatology Clinic of Houston
City
Tomball
State/Province
Texas
ZIP/Postal Code
77377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Rheumatology and Pulmonary Clinic
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
UMHAT "Dr. Georgi Stranski"
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Medical center "Artmed" LTD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
UMHAT Sveti Ivan Rilski
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Vesalion s.r.o.
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prinicipal Investigator
Facility Name
CCR Czech a.s.,
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Revmatologicky Utsav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Medical Plus S.R.O.
City
Uherské Hradiště
ZIP/Postal Code
686 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Aleksandre Aladashvili Clinic LLC
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
LTD Israel-Georgian Medical Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
JSC Evex Hospitals
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
LTD Georgian-Dutch Hospital
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University Hospital Cologne AöR
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50934
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Qualiclinic Ltd (Qualiclinic Inc)
City
Budapest
ZIP/Postal Code
1036-H
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Porcika Klinika
City
Hódmezővásárhely
ZIP/Postal Code
6800
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Vita Verum Medical Egeszsegugy
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centrum Kliniczno-Badawcze
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Silmedic sp. z o.o.
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
NZOZ Lecznica MAK-MED s.c.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
RCMed Oddzial Sochaczew
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centrum Medyczne Reuma Park
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Clinresco Centres (Pty) Ltd
City
Kempton Park
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Jacaranda Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Umhlanga Hospital Medical Center
City
Umhlanga
State/Province
Kwazulu-Natal
ZIP/Postal Code
4319
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Panorama Medical Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Winelands Medical Research Cen
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs