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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBP-0276 200mg QD | Experimental | 80 subjects with active PsA will receive oral capsules for 24 weeks |
|
| CBP-0276 800mg QD | Experimental | 80 subjects with active PsA will receive oral capsules for 24 weeks |
|
| Placebo | Placebo Comparator | 80 subjects with active PsA will recibe placebo for 24 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBP-0276 capsules 100mg | Drug | capsule with CBP-0276 powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 24 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | week 16 after randomization |
| Magnitude of change on ACR 50/70% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro Gutierrez Castrellon, MD, PhD | Contact | 5554198746 | pedro.gutierrez@elemental.org.mx | |
| Diana M Andrade Platas, MD | Contact | +525535209755 | diana.andrade@elemental.org.mx |
| Name | Affiliation | Role |
|---|---|---|
| Diana Gómez Marin, MD | Innovación y Desarrollo en Ciencias de la Salud SRL de CV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa) | Mexico City | Mexico City | 14090 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29928910 | Background | Alinaghi F, Calov M, Kristensen LE, Gladman DD, Coates LC, Jullien D, Gottlieb AB, Gisondi P, Wu JJ, Thyssen JP, Egeberg A. Prevalence of psoriatic arthritis in patients with psoriasis: A systematic review and meta-analysis of observational and clinical studies. J Am Acad Dermatol. 2019 Jan;80(1):251-265.e19. doi: 10.1016/j.jaad.2018.06.027. Epub 2018 Jun 19. | |
| 26555117 |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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Randomized, double-blind, multicenter, placebo-controlled phase 2 clinical study, comprised for a 2-week total screening period, a 24-week blinded core treatment period, and 4-week follow-up observational period. Subject will be allocated to receive 200mg QD (branch A), 800mg QD (branch B) or placebo for 24 weeks
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Quadruple (participant, care provider, investigator, outcomes assessor). The participant, study operating staff and sponsor will remain blind to the assigned treatment. To ensure such masking, a non-blind pharmacist delegated by the Principal Investigator will be responsible for dispensing the investigational product. The Sponsor and the research center will have two blind/non-blind teams. The study interventions (CLT-0276 and placebo) will have the same pharmaceutical form (capsule) and will be dispensed in containers/dosers previously identified with the ID number that corresponds to each subject. The containers will be made of plastic and identical for both products and labelled with the following information: protocol number and ID number. The analysts' blindness will remain with respect to the randomization scheme
| Placebo | Drug | Capsule with placebo for CBP-0276 |
|
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% |
| 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | week 4, 8, 12, 16, 20 and 24 after randomization |
| Eder L, Haddad A, Rosen CF, Lee KA, Chandran V, Cook R, Gladman DD. The Incidence and Risk Factors for Psoriatic Arthritis in Patients With Psoriasis: A Prospective Cohort Study. Arthritis Rheumatol. 2016 Apr;68(4):915-23. doi: 10.1002/art.39494. |
| 34385474 | Background | FitzGerald O, Ogdie A, Chandran V, Coates LC, Kavanaugh A, Tillett W, Leung YY, deWit M, Scher JU, Mease PJ. Psoriatic arthritis. Nat Rev Dis Primers. 2021 Aug 12;7(1):59. doi: 10.1038/s41572-021-00293-y. |
| 30499246 | Background | Singh JA, Guyatt G, Ogdie A, Gladman DD, Deal C, Deodhar A, Dubreuil M, Dunham J, Husni ME, Kenny S, Kwan-Morley J, Lin J, Marchetta P, Mease PJ, Merola JF, Miner J, Ritchlin CT, Siaton B, Smith BJ, Van Voorhees AS, Jonsson AH, Shah AA, Sullivan N, Turgunbaev M, Coates LC, Gottlieb A, Magrey M, Nowell WB, Orbai AM, Reddy SM, Scher JU, Siegel E, Siegel M, Walsh JA, Turner AS, Reston J. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019 Jan;71(1):5-32. doi: 10.1002/art.40726. Epub 2018 Nov 30. |
| 32035535 | Background | Nash P. Inhibition of interleukins 17A and 17F in psoriatic arthritis. Lancet. 2020 Feb 8;395(10222):395-396. doi: 10.1016/S0140-6736(20)30220-8. No abstract available. |
| 37511421 | Background | Lee BW, Moon SJ. Inflammatory Cytokines in Psoriatic Arthritis: Understanding Pathogenesis and Implications for Treatment. Int J Mol Sci. 2023 Jul 19;24(14):11662. doi: 10.3390/ijms241411662. |
| 26135703 | Background | McInnes IB, Mease PJ, Kirkham B, Kavanaugh A, Ritchlin CT, Rahman P, van der Heijde D, Landewe R, Conaghan PG, Gottlieb AB, Richards H, Pricop L, Ligozio G, Patekar M, Mpofu S; FUTURE 2 Study Group. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 Sep 19;386(9999):1137-46. doi: 10.1016/S0140-6736(15)61134-5. Epub 2015 Jun 28. |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |