Arthritis, Psoriatic
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Interventions
DRUGIcotrokinra
Icotrokinra will be administered.
DRUGPlacebo
Placebo will be administered.
DRUGActive reference comparator
Active reference drug will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening * Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory * Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis * Have active plaque psoriasis with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with psoriasis * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
Exclusion criteria
* Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis * Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances * Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients * Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease * Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16 | Week 16 | The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Achieve Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and an IGA Score of >=2 at Baseline | Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. |
| Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline | Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. |
| Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline | Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score. |
| Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline | Week 16 | Proportion of participants with an IGA psoriasis score of 0 or 1 and \>=2 grade improvement from baseline at week 16 among participants with \>=3% BSA and an IGA score of \>=2 at baseline will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema, and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| Proportion of Participants who Achieve an ACR 50 Response at Week 16 | Week 16 | The ACR 50 responders are participants with an improvement of \>= 50 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein). |
| Proportion of Participants who Achieve an ACR 70 Response at Week 16 | Week 16 | The ACR 70 responders are participants with an improvement of \>= 70 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein). |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16 | From Baseline to Week 16 | The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Changes From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 | From Baseline to Week 16 | SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains are averaged to calculate PCS. Total score range for PCS is 0-100 (100=highest level of physical functioning). |
| Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline | Week 16 | Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to lateral elbow epicondyle, left and right, medial femoral condyle, left and right, and achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Resolution is defined as participants have enteritis (LEI score \>0) at baseline and no enthesis (LEO score =0) at the visit (week 16). |
| Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline | From Baseline to Week 16 | Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI total scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). |
| Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline | Week 16 | Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. Resolution is defined as participants have dactylitis (score \>0) at baseline and no dactylitis (score =0) at the visit (week 16). |
| Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline | From Baseline to Week 16 | Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. |
| Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16 | Week 16 | MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures: tender joint count less than or equal to (\<=) 1; swollen joint count \<= 1; psoriasis activity and severity index \<= 1 or body surface area \<= 3; patient pain VAS score of \<= 15; patient global disease activity VAS (arthritis and psoriasis) score of \<= 20; health assessment questionnaire (HAQ) score \<= 0.5; and tender entheseal points \<= 1. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 | From Baseline to Week 16 | The FACIT-fatigue is a self-administered, 13-item questionnaire measuring items on tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses to all items are rated on a 5-point likert response scale ranging from 0 "not at all" to 4 "very much." The total score ranges from 0 to 52, with higher values indicating less fatigue. |
Countries
Argentina, Australia, Bulgaria, China, Czechia, Denmark, Germany, Hong Kong, Hungary, India, Japan, Poland, Spain, Taiwan, Thailand, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed