Oral CBP-0276 or Placebo in Adults With Active Psoriatic Arthritis (PsA)

NCT07706530 | Not Yet Recruiting Phase 2

• 1 other identifier: CBP-0276-PsA01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthritic Psoriasis

Keywords

arthritic psoriasis adults

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change of severity of symptoms at week 16

  week 16 after randomization

• Magnitude of change on ACR 50/70%

  week 4, 8, 12, 16, 20 and 24 after randomization

• Changes on disease activity

  week 4, 8, 12, 16, 20 and 24 after randomization

• Changes on disability index

  week 4, 8, 12, 16, 20 and 24 after randomization

• Changes on dactilitis severity

  week 4, 8, 12, 16, 20 and 24 after randomization

Study Arms (3)

CBP-0276 200mg QD

EXPERIMENTAL

80 subjects with active PsA will receive oral capsules for 24 weeks

Drug: CBP-0276 capsules 100mg

CBP-0276 800mg QD

EXPERIMENTAL

80 subjects with active PsA will receive oral capsules for 24 weeks

Drug: CBP-0276 capsules 100mg

Placebo

PLACEBO COMPARATOR

80 subjects with active PsA will recibe placebo for 24 week

Drug: Placebo

Interventions

CBP-0276 capsules 100mg DRUG

capsule with CBP-0276 powder

CBP-0276 200mg QD; CBP-0276 800mg QD

Placebo DRUG

Capsule with placebo for CBP-0276

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must voluntarily sign the informed consent form before any study-related procedures, understand and communicate with the investigator smoothly during the trial, and understand and voluntarily strictly abide by the provisions of this clinical study protocol;
• Age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form, male or female;
• Body Mass Index (BMI) ≥ 18 and ≤ 39 kg/m2 at screening;
• Fulfilled the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) and had symptoms of psoriatic arthritis for more than 6 months but less than 12 months of evolution at screening
• Had active PsA before randomization (defined as ≥ 3/68 tender joint count and ≥ 3/66 swollen joint count);
• Active plaque psoriasis (at least one plaque lesion) at screening, or a history of plaque psoriasis;
• Failure to respond or stabilize on NSAIDs and/or csDMARDs (Inadequate Responders)
• Female subjects of childbearing potential must have a negative pregnancy test during the screening period and prior to randomization.

You may not qualify if:

• History of Drug-induced psoriasis (including, but not limited to, psoriasis induced by beta-blockers, calcium channel inhibitors, or lithium);
• Had other active inflammatory diseases or autoimmune diseases other than psoriatic arthritis, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, inflammatory bowel disease arthritis, etc.;
• History of organ transplantation (except for corneal transplantation within 3 months prior to screening;
• History of lymphoproliferative disorders, including symptoms and signs of lymphoma or underlying lymphoproliferative disorders;
• History of severe opportunistic infections (including but not limited to Pneumocystis carinii pneumonia, coccidioidomycosis, etc.) or immunodeficiency disease;
• History of invasive fungal infection;
• Any active malignancy or history of malignancy within 5 years prior to screening, with the exception of cured squamous or basal cell carcinoma of the skin or in situ cervical cancer;
• Joint surgery (including but not limited to meniscectomy, joint transplant, joint replacement, arthrodesis, etc.) within 8 weeks prior to screening; or the joint had not recovered after surgery (including but not limited to incision infection, unhealed wound, open drainage, etc.) at the time of screening;
• Major surgery within 8 weeks prior to screening, or planned surgery during the study;
• Had donated or lost ≥ 400 mL of blood within 8 weeks prior to randomization and/or planned to donate blood during the study;
• History of moderate to severe congestive heart failure (New York Heart Association \[NYHA\] functional class ≥ III), cardiovascular events, or severe bleeding events within 3 months prior to screening;
• Subjects with serious, progressive, uncontrolled cardiovascular and cerebrovascular diseases, liver, kidney, lung, gastrointestinal tract, hematopoietic system, endocrine system, nervous system diseases, or other conditions that the investigator considered unsuitable for this trial;
• Subjects with a history of depression and/or active suicidal ideation as assessed by Sheehan-Suicidality Tracking Scale (S-STS) or any suicide attempt, suicidal behavior, or clinical judgment of the investigator to be at risk of suicide during the screening period were excluded;
• Subjects with a history, symptoms and examination findings suggestive of active TB or latent TB at screening.
• Positive test for hepatitis B, C, syphilis, or human immunodeficiency virus (HIV) antibody at screening;

Sponsors & Collaborators

• Clarent Biopharma, Inc.: lead

Study Sites (1)

Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)

Mexico City, Mexico City, 14090, Mexico

Location

Related Publications (7)

• 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.

  PMID: 29928910 BACKGROUND

• 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.

  PMID: 26555117 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.

  PMID: 34385474 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.

  PMID: 30499246 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.

  PMID: 32035535 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.

  PMID: 37511421 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.

  PMID: 26135703 BACKGROUND

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Diana Gómez Marin, MD

  Innovación y Desarrollo en Ciencias de la Salud SRL de CV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Gutierrez Castrellon, MD, PhD

CONTACT

5554198746; pedro.gutierrez@elemental.org.mx

Diana M Andrade Platas, MD

CONTACT

+525535209755; diana.andrade@elemental.org.mx

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)