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

ConditionArthritic Psoriasis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorClarent Biopharma, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CBP-0276 capsules 100mg

    Drug

    capsule with CBP-0276 powder

  • Placebo

    Drug

    Capsule with placebo for CBP-0276

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: CBP-0276 200mg QDExperimental treatment 1 intervention
Group B: CBP-0276 800mg QDExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
week 24 after randomization

Secondary outcomes

1

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
2

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
3

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
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clarent Biopharma, Inc.

Lead sponsor

Source ClinicalTrials.gov

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