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Arthritic PsoriasisPhase 2NCT07706530

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

A Phase 2 study testing CBP-0276 capsules 100mg in people with Arthritic Psoriasis, run by Clarent Biopharma, Inc. at 1 site in Mexico.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritic Psoriasis
What is being tested?
CBP-0276 capsules 100mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
1 siteMexico
Study dates
Jul 2026to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • Had a serious infection (systemic infection, use of intravenous anti-infective therapy, or hospitalization due to infection) within 4 weeks prior to screening, or had an active or chronic infection at screening that the investigator considers unsuitable for inclusion in this trial;
  • History of severe opportunistic infections (including but not limited to Pneumocystis carinii pneumonia, coccidioidomycosis, etc.) or immunodeficiency disease;
Show all 22Show fewer
  • 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;
  • Use of any of the following medications or participation in a clinical study (defined as signed informed consent): A) Use of any biologic drugs in the last 6 months, such as a TNF inhibitor within a specified time period prior to randomization (e.g., use of recombinant human tumor necrosis factor receptor-antibody fusion protein within 4 weeks prior to randomization; subjects who had received infliximab within 8 weeks before randomization; received adalimumab, golimumab, or certolizumab within 10 weeks before randomization); B) Had used at least 2 bDMARDs (including at least 2 different classes of TNF inhibitors) before randomization; C) Subjects who had used traditional synthetic disease-modifying antirheumatic drugs (csDMARDs) or systemic immunosuppressive agents (such as cyclophosphamide, cyclosporine, azathioprine, and mycophenolate mofetil) other than MTX, LEF, PDE-4 inhibitor, or SSZ within 4 weeks before randomization; D) Subjects who had received psoriatic arthritis or psoriasis herbal preparations patent medicines (such as Tripterygium wilfordii, total glucosides of peony, sinomenine, and kunxian) within 4 weeks before randomization; E) Had received any intra-articular injection therapy (such as glucocorticoids and hyaluronic acid) within 4 weeks before randomization; F) Phototherapy/photochemotherapy (including psoralen and ultraviolet A (PUVA) phototherapy, ultraviolet B (UVB) within 4 weeks prior to randomization; G) Received topical psoriasis treatments/other systemic treatments within 4 weeks prior to randomization, such as topical corticosteroids, vitamin D3 derivatives, or retinoids; however, the following topical treatments were allowed: non-medical scalp lotions (i.e., without glucocorticoids or vitamin D3 derivatives, calcineurin inhibitors, etc.), mild emollients (without alpha or beta hydroxy acids, urea, salicylic acid); H) Oral, intravenous, or intramuscular glucocorticoids within 4 weeks prior to randomization; I) Prior exposure to anti-interleukin 17 (IL-17), anti-IL-17 receptor, anti-IL-12/IL-23, and IL-23p19 agents; J) Used of other biologic agents for the treatment of psoriasis/psoriatic arthritis within 6 months or 5 half-lives (whichever is longer) prior to randomization (including but not limited to, for example, anti-IL-6, anti-CD20 monoclonal antibody, CTLA4 antibody) or JAK inhibitor; K) Subjects who had used other clinical trial drugs, vaccines or medical devices or were expected to have residual effects of the trial treatment within 2 weeks or 5 half-lives (whichever is longer) before randomization (except for those who are clearly given placebo throughout the trial); L) Subjects who are allergic to the ingredients or excipients of the investigational product, or to other biological agents; M) Had received a live attenuated vaccine within 12 weeks prior to randomization, or planned to receive a live attenuated vaccine during the study, or within 20 weeks after the end of study treatment; or N) Had used strong opioid analgesics (such as methadone, morphine, hydromorphone, etc.) within 6 weeks prior to randomization.
  • Abnormal and clinically significant screening laboratory value that, in the opinion of the investigator, would pose an unacceptable risk to the subject if he or she participated in the study, or any of the following abnormalities as specified: A) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) ≥ 3x upper limit of normal (ULN); or total bilirubin or gamma-glutamyl transpeptidase (GT) ≥ 1.5 times the ULN; B) Serum creatinine ≥ 1.5 times ULN; C) Hemoglobin < 85.0 g/L for male subjects and < 80.0 g/L for female subjects; D) Total leukocyte count (WBC) < 3.0 * 109/L; E) Neutropenia (neutrophils < 1.5 * 109/L); or F) Thrombocytopenia (platelets < 100 * 109/L);
  • Pregnant or lactating (pregnancy is defined as the state after conception and until the termination of gestation);
  • Subjects of childbearing potential who are pregnant or planning to donate sperm/ova or are unwilling to take highly effective contraceptive measures from the signing of the informed consent form to 20 weeks (5 half-lives) after the use of the investigational product;
  • History of alcohol or illicit drug abuse within one year prior to screening;
  • Any other condition that, in the opinion of the investigator, would prevent the subject from following and completing the study protocol or interfere with the study analysis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pedro Gutierrez Castrellon, MD, PhD contact

5554198746

pedro.gutierrez@elemental.org.mx

Diana M Andrade Platas, MD contact

+525535209755

diana.andrade@elemental.org.mx

Mexico1 site

  • Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)

    Mexico City, Mexico City, 14090

    Diana M Andrade Platas, MD, +525554564480, diana.andrade@elemental.org.mx

    Tom Jilmer Castillo, MD, +523324120245, tom.castillo@idecsa.com.mx

Other trials in Mexico

About this study

Official title: A Phase 2 Randomized, Double Blind, Clinical Trial (RCT) to Assess the Efficacy, Safety, and Tolerability of Oral CBP-0276 200mg QD, 800mg QD or Placebo for CBP-0276, Administered to Adults With Active Psoriatic Arthritis (PsA).

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

Read the detailed description

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

Being tested
CBP-0276 capsules 100mg, Placebo
Keywords
arthritic psoriasis adults
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBP-0276 capsules 100mgDrug

    capsule with CBP-0276 powder

  • PlaceboDrug

    Capsule with placebo for CBP-0276

Study groups in NCT07706530
Study groupRoleWhat they receive
CBP-0276 200mg QDExperimental80 subjects with active PsA will receive oral capsules for 24 weeks
Receives: Drug: CBP-0276 capsules 100mg
CBP-0276 800mg QDExperimental80 subjects with active PsA will receive oral capsules for 24 weeks
Receives: Drug: CBP-0276 capsules 100mg
PlaceboPlacebo comparator80 subjects with active PsA will recibe placebo for 24 week
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: week 24 after randomization

Secondary outcomes (10)

  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%

    Measured: 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%

    Measured: 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

    Measured: 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

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

  5. 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

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

  6. 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

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

  7. 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)

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

  8. 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

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

  9. 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

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

  10. Frequency and severity of adverse events

    The frequency of AESIs evaluated by Full version of MEDRA Ver. 28.0

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07706530
Sponsor's protocol ID
CBP-0276-PsA01
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29928910

  • 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.

    PubMed 26555117

  • 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.

    PubMed 34385474

  • 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.

    PubMed 30499246

  • 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.

    PubMed 32035535

  • 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.

    PubMed 37511421

  • 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.

    PubMed 26135703

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBP-0276 capsules 100mg in people with Arthritic Psoriasis, run by Clarent Biopharma, Inc. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pedro Gutierrez Castrellon, MD, PhD (5554198746, pedro.gutierrez@elemental.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on severity of symptoms at lest 20% at week 24 (time frame: week 24 after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07706530, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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