Randomized trial aimed to assess in adults with PsA the effect of oral CBP-0276 administrated at a dose of 200mg QD, or 800mg QD vs. Placebo for CBP-0276 for 24 weeks. Primary outcome is the change at least 20% on severity of symptoms eat week 24, using the American College Rheumatologic Score (ACR) and key secondary outcomes are the change on ACR20% at week 16 and ACR50/70% at week 24. Eligible patients will be randomly assigned (1:1:1) to receive oral CBP-0276 200mg QD, 800mg QD or placebo for CBP-0276 for 24 weeks
Randomized trial aimed to assess in adults with PsA the effect of oral CBP-0276 administrated at a dose of 200mg QD, or 800mg QD vs. Placebo for CBP-0276 for 24 weeks. Primary outcome is the change at least 20% on severity of symptoms eat week 24, using the American College Rheumatologic Score (ACR) and key secondary outcomes are the change on ACR20% at week 16 and ACR50/70% at at week 24. Additional secondary outcome include a) ACR50/70% at week 4, 8, 12, 16 and 20; b) changes on Disease Activity at week 4, 8, 12, 16, 20 and 24; c) Changes on disability index at week 4, 8, 12, 16, 20 and 24; d) Changes on dactilitis and enthesitis severity; d) Changes on Quality of Life and e) Changes on plaque psoriatic activity. Exploratory outcomes include changes at week 4,8,12,16 and 24 on a) tender joint count; b) global patient evaluation and c) patient level of fatigue and imapct on daily life. Elegible patients are 18-75 years, BMI between 18 and 39 kg/m2, fulfill the classification criteria for PsA, had symptoms for at least 6 months and less than 12 months before screening, had active disease at baseline (3 of 68 or more tender joints and 3 of 66 or more swollen joints), had at least one active plaque psoriatic lesion or documented history of plaque psoriasis and failed to respond or stabilize on NSAIDs and/or csDMARDs will be included. Enrolled patients will be randomly assigned (1:1:1) to receive oral CBP-0276 200mg QD, 800mg QD or placebo for CBP-0276 for 24 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
capsule with CBP-0276 powder
Capsule with placebo for CBP-0276
Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)
Mexico City, Mexico City, Mexico
Change on severity of symptoms at lest 20% at week 24
Proportion of randomized subjects achieving American College Rheumatologic Score (ACR) at least 20% (ACR20) response at Week 24. ACR is a validated score that measure improvement after begining of therapy in arthritis. Minimum valure 20% represents te minimum improvement and ACR 75% to 100% represents the highest improvement.
Time frame: week 24 after randomization
Change of severity of symptoms at week 16
Proportion of randomized subjects achieving American College Rheumatologic Score at least 20% (ACR20) response at Week 16. Minimum value is 0% and maximum is 100%
Time frame: week 16 after randomization
Magnitude of change on ACR 50/70%
Proportion of subjects achieving American College Rheumatologic Score (ACR) at least 50/70% from baseline to week 4, 8, 12, 16, 20 and 24. Minimum value is 0% and maximum is 100%
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization
Changes on disease activity
Change from baseline in the DAS 28-joint count using Hs-CRP (DAS28-HsCRP) at week 4, 8, 12, 16, 20 and 24. The DAS28-CRP (Disease Activity Score in 28 joints using C-Reactive Protein) is a composite index used by rheumatologists to measure the disease activity of Rheumatoid Arthritis (RA). It evaluates inflammation through swollen/tender joint counts, a patient's overall health assessment, and a standard or high-sensitivity CRP (hs-CRP) blood test. Minimum value is 0.96 no activity and maximum is 9.4 which means maximal activity
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization
Changes on disability index
Change from baseline in the HAQ-DI at week 4, 8, 12, 16, 20 and 24. The Health Assessment Questionnaire Disability Index (HAQ-DI) is a widely used patient-reported tool that measures a patient's physical functional ability and daily living limitations (often used for conditions like arthritis). It evaluates 20 daily activities across eight categories (dressing, arising, eating, walking, hygiene, reach, grip, and common activities). Minimum is 0 which means no disability and maximum is 3 which means maximum disability
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Enrollment
240
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization
Changes on dactilitis severity
Change from baseline in Leeds Dactilitis Index-Basics at week 4, 8, 12, 16, 20 and 24. The Leeds Dactylitis Index-Basic (LDI-B) is a validated, objective clinical tool used to measure the severity and activity of dactylitis (inflammation/swelling of entire fingers or toes) in conditions like psoriatic arthritis. Minim value is cero (no activity) and maximum could reach around 3,000 which means maximum dactilitis activity
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization
Changes on quality of life
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 4, 8, 12, 16, 20 and 24. The HAQ-DI (Health Assessment Questionnaire - Disability Index) is a widely used, standardized patient-reported questionnaire designed to measure a person's functional status and ability to perform daily living activities. It is frequently used to monitor conditions like rheumatoid arthritis, osteoarthritis, and other rheumatic disease. Minimum value is 0 and maximum value is 3
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization
Changes on psoriasis activity
Change from baseline in the Psoriasis Area and Severity Index (PASI 75 and PASI 90; in patients with body surface area affected by psoriasis ≥3% at baseline) 4, 8, 12, 16, 20 and 24. The PASI (Psoriasis Area and Severity Index) is the standard clinical tool used by dermatologists to measure the overall severity and body coverage of psoriasis. It is commonly calculated in clinical trials and doctor's offices to track disease progression and treatment effectiveness. Minimum valaue is 0 (no activity) and maximum is 72 (Maximum activity)
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization
Changes on tender joint count
Changes on TJC68 Score from baseline to week 4, 8, 12, 16, 20 and 24 after randomization. The TJC68 score (Tender Joint Count 68) is a standardized clinical measurement used in rheumatology to evaluate joint pain across 68 specific joints in the body. It is primarily used to assess the severity and peripheral arthritis activity of diseases like Psoriatic Arthritis (PsA) and Rheumatoid Arthritis (RA). Minimum value is 0 and maximum is 68
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization
Changes on patient's level of fatigue and its impact on daily life
Changes on FACIT-Fatigue Score from baseline to week 4, 8, 12, 16, 20 and 24 after randomization. The FACIT-Fatigue Scale is a 13-item questionnaire used to measure the severity of fatigue and its impact on daily activities. It asks patients to rate their fatigue-related experiences over the past 7 days on a 5-point Likert scale, ranging from 0 (Not at all) to 4 (Very much). Minimum is 0 and maximum is 52
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization
Frequency and severity of adverse events
The frequency of AESIs evaluated by Full version of MEDRA Ver. 28.0
Time frame: week 4, 8, 12, 16, 20 and 24 after randomization