Arthritis, RheumatoidPhase 2NCT05198310
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
A Phase 2 study testing KPL-404 in people with Arthritis, Rheumatoid, run by Kiniksa Pharmaceuticals, Ltd. at 42 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- KPL-404
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 42 sitesin 7 countries
- Study dates
- 14 Dec 2021to 6 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
42 sites in 7 countries.
42 sites in 7 countries
United States19 sites
Arthritis and Rheumatology Research Institute
Allen, Texas, 75013
Carewell Arthritis Center
Apple Valley, California, 92307
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801
Trinity Universal Research Assoc
Carrollton, Texas, 75007
Arthritis & Osteoporosis Center of Coastal Bend
Corpus Christi, Texas, 78404
Medvin Clinical Research
Covina, California, 91722
International Medical Research
Daytona Beach, Florida, 32117
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Sweet Hope Research Specialty, Inc.
Hialeah, Florida, 33016
Saint Francis Hospital- Memphis
Memphis, Tennessee, 38119
Southwest Rheumatology Research LLC
Mesquite, Texas, 75150
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130
Millennium Research
Ormond Beach, Florida, 32174
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321
DM Clinical Research
Tomball, Texas, 77375
Rheumatology Clinic of Houston
Tomball, Texas, 77377
Inland Rheumatology Clinical Trials
Upland, California, 91786
Medvin Clinical Research
Whittier, California, 90602
Hungary6 sites
Qualiclinic Ltd (Qualiclinic Inc)
Budapest, 1036-H
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062
Porcika Klinika
Hódmezővásárhely, 6800
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, 6725
Vita Verum Medical Egeszsegugy
Székesfehérvár, 8000
Poland5 sites
Centrum Kliniczno-Badawcze
Elblag, 82-300
Silmedic sp. z o.o.
Katowice, 40-282
Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj
Poznan, 61-397
RCMed Oddzial Sochaczew
Sochaczew, 96-500
Centrum Medyczne Reuma Park
Warsaw
Georgia4 sites
Aleksandre Aladashvili Clinic LLC
Tbilisi, 0102
LTD Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112
JSC Evex Hospitals
Tbilisi, 0159
LTD Georgian-Dutch Hospital
Tbilisi, 0172
South Africa4 sites
Panorama Medical Centre
Cape Town, Western Cape, 7500
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, 1619
Jacaranda Hospital
Pretoria, Gauteng, 0002
Umhlanga Hospital Medical Center
Umhlanga, KwaZulu-Natal, 4319
Czechia3 sites
Vesalion s.r.o.
Ostrava, 702 00
Revmatologicky Utsav
Prague, 128 50
Medical Plus S.R.O.
Uherské Hradiště, 686 01
About this study
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
Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis.
Read the 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- KPL-404, Placebo
- Keywords
- inadequate responders, moderate to severe, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPL-404Drug
Also called abiprubart
Humanized monoclonal antibody
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 KPL-404 2 mg/kg Every 2 Weeks (q2wk) | Experimental | KPL-404 2 mg/kg subcutaneous (SC) q2wk for 12 weeks Receives: Drug: KPL-404 |
| Cohort 1 Placebo | Placebo comparator | Placebo SC q2wk for 12 weeks Receives: Drug: Placebo |
| Cohort 2 KPL-404 5 mg/kg q2wk | Experimental | KPL-404 5 mg/kg SC q2wk for 12 weeks Receives: Drug: KPL-404 |
| Cohort 2 Placebo | Placebo comparator | Placebo SC q2wk for 12 weeks Receives: Drug: Placebo |
| Cohort 3 KPL-404 5 mg/kg qwk | Experimental | KPL-404 5mg/kg SC once weekly (qwk) for 12 weeks Receives: Drug: KPL-404 |
| Cohort 3 KPL-404 5 mg/kg q2wk | Experimental | KPL-404 5mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks Receives: Drug: KPL-404; Drug: Placebo |
| Cohort 3 Placebo | Placebo comparator | Placebo SC qwk for 12 weeks Receives: Drug: Placebo |
| Cohort 4 KPL-404 400 mg q4wk | Experimental | KPL-404 SC every 4 weeks (q4wk) for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8. Receives: Drug: KPL-404 |
| Cohort 4 Placebo | Placebo comparator | Placebo SC q4wk for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse event (AE): any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. Serious AE (SAE): AE that: results in death; is immediately life-threatening; requires in-patient hospitalization/prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital abnormality/birth defect; is an important medical event. TEAEs: AEs not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug during treatment period. AE severity: mild (Grade [Gr] 1); moderate (Gr 2); severe (Gr 3); potentially life threatening (Gr 4); death (Gr 5). AEs of special interest: thrombosis, serious infection, serious and non-serious bacterial infections, eye disorders, and anaphylaxis/hypersensitivity reactions.
Measured: From first dose of study drug to 24 weeks
Cohorts 1 and 2: Maximum Serum Concentration (Cmax)
Measured: Days 1 (Dose 1) and 57 (Dose 4)
Cohorts 1 and 2: Area Under the Serum Concentration-time Curve From Time of Administration to the End of the Dosing Interval, (AUCtau)
Measured: Days 1 (Dose 1) and 57 (Dose 4)
Cohort 3 and 4: Change From Baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) at Week 12
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score < 2.6, low disease activity = score < 3.2). A negative value in change from BL indicates an improvement.
Measured: Baseline, Week 12
Secondary outcomes (7)
Cohorts 1 and 2: Change From Baseline in DAS28-CRP at Week 12
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score < 2.6, low disease activity = score < 3.2). A negative value in change from BL indicates an improvement.
Measured: Baseline, Week 12
Cohorts 3 and 4: Number of Participants With TEAEs
Adverse event (AE): any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. Serious AE (SAE): AE that: results in death; is immediately life-threatening; requires in-patient hospitalization/prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital abnormality/birth defect; is an important medical event. TEAEs: AEs not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug during treatment period. AE severity: mild (Grade [Gr] 1); moderate (Gr 2); severe (Gr 3); potentially life threatening (Gr 4); death (Gr 5). AEs of special interest: thrombosis, serious infection, serious and non-serious bacterial infections, eye disorders, and anaphylaxis/hypersensitivity reactions.
Measured: From first dose of study drug to 24 weeks
Cohort 3 and 4: Cmax
Measured: Days 1 (Dose 1) and 57 (Dose 4 or 8)
Cohort 3 and 4: AUCtau
Measured: Days 1 (Dose 1) and 57 (Dose 4 or 8)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
An ACR20 response is defined as at least a 20% improvement in both tender joint count (TJC) and swollen joint count (SJC), and at least a 20% improvement in three of the following five criteria: patient global assessment (PGA), physician global assessment (PhGA), functional ability measure [Health Assessment Questionnaire (HAQ)], patient's assessment of pain (visual analog scale; VAS) and C-reactive protein (CRP).
Measured: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
An ACR50 response is defined as at least a 50% improvement in both tender joint count (TJC) and swollen joint count (SJC), and at least a 50% improvement in three of the following five criteria: patient global assessment (PGA), physician global assessment (PhGA), functional ability measure [Health Assessment Questionnaire (HAQ)], patient's assessment of pain (visual analog scale; VAS) and C-reactive protein (CRP).
Measured: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
An ACR70 response is defined as at least a 70% improvement in both tender joint count (TJC) and swollen joint count (SJC), and at least a 70% improvement in three of the following five criteria: patient global assessment (PGA), physician global assessment (PhGA), functional ability measure [Health Assessment Questionnaire (HAQ)], patient's assessment of pain (visual analog scale; VAS) and C-reactive protein (CRP).
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start14 Dec 2021
- Primary completion8 Feb 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiniksa Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198310
- Sponsor's protocol ID
- KPL-404-C211
- Other IDs
- 2022-000169-42
- Status last verified
- Jul 2025
- First submitted
- 3 Jan 2022
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05198310
- Acronym / sponsor ID
- KPL-404-C211
- Conditions
- Arthritis, Rheumatoid
- Keywords
- inadequate responders, moderate to severe, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Kiniksa Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 22 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 KPL-404 2 mg/kg Every 2 Weeks (q2wk) | Experimental | Drug: KPL-404KPL-404 2 mg/kg subcutaneous (SC) q2wk for 12 weeks |
| Cohort 1 Placebo | Placebo comparator | Drug: PlaceboPlacebo SC q2wk for 12 weeks |
| Cohort 2 KPL-404 5 mg/kg q2wk | Experimental | Drug: KPL-404KPL-404 5 mg/kg SC q2wk for 12 weeks |
| Cohort 2 Placebo | Placebo comparator | Drug: PlaceboPlacebo SC q2wk for 12 weeks |
| Cohort 3 KPL-404 5 mg/kg qwk | Experimental | Drug: KPL-404KPL-404 5mg/kg SC once weekly (qwk) for 12 weeks |
| Cohort 3 KPL-404 5 mg/kg q2wk | Experimental | Drug: KPL-404, Drug: PlaceboKPL-404 5mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks |
| Cohort 3 Placebo | Placebo comparator | Drug: PlaceboPlacebo SC qwk for 12 weeks |
| Cohort 4 KPL-404 400 mg q4wk | Experimental | Drug: KPL-404KPL-404 SC every 4 weeks (q4wk) for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at Weeks 4 and 8. |
| Cohort 4 Placebo | Placebo comparator | Drug: PlaceboPlacebo SC q4wk for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Meets all of the following disease activity criteria:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KPL-404Also: abiprubartHumanized monoclonal antibody | Drug | Cohort 1 KPL-404 2 mg/kg Every 2 Weeks (q2wk), Cohort 2 KPL-404 5 mg/kg q2wk, Cohort 3 KPL-404 5 mg/kg q2wk, Cohort 3 KPL-404 5 mg/kg qwk, Cohort 4 KPL-404 400 mg q4wk |
| PlaceboMatching placebo | Drug | Cohort 1 Placebo, Cohort 2 Placebo, Cohort 3 KPL-404 5 mg/kg q2wk, Cohort 3 Placebo, Cohort 4 Placebo |
Primary outcome
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug to 24 weeks
Adverse event (AE): any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. Serious AE (SAE): AE that: results in death; is immediately life-threatening; requires in-patient hospitalization/prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital abnormality/birth defect; is an important medical event. TEAEs: AEs not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug during treatment period. AE severity: mild (Grade [Gr] 1); moderate (Gr 2); severe (Gr 3); potentially life threatening (Gr 4); death (Gr 5). AEs of special interest: thrombosis, serious infection, serious and non-serious bacterial infections, eye disorders, and anaphylaxis/hypersensitivity reactions.
Cohorts 1 and 2: Maximum Serum Concentration (Cmax)
Time frame: Days 1 (Dose 1) and 57 (Dose 4)
Cohorts 1 and 2: Area Under the Serum Concentration-time Curve From Time of Administration to the End of the Dosing Interval, (AUCtau)
Time frame: Days 1 (Dose 1) and 57 (Dose 4)
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
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score < 2.6, low disease activity = score < 3.2). A negative value in change from BL indicates an improvement.
7 secondary outcomes
Cohorts 1 and 2: Change From Baseline in DAS28-CRP at Week 12
Time frame: Baseline, Week 12
Cohorts 3 and 4: Number of Participants With TEAEs
Time frame: From first dose of study drug to 24 weeks
Cohort 3 and 4: Cmax
Time frame: Days 1 (Dose 1) and 57 (Dose 4 or 8)
Cohort 3 and 4: AUCtau
Time frame: Days 1 (Dose 1) and 57 (Dose 4 or 8)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KPL-404 in people with Arthritis, Rheumatoid, run by Kiniksa Pharmaceuticals, Ltd. at 42 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Hungary, Poland, Georgia, South Africa and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.