PsoriasisPhase 2CBP-0276-PsoNCT07204639
Safety and Efficacy of CBP-0276 to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects
A Phase 2 study testing CBP-0276 200mg BID in people with Psoriasis, run by Clarent Biopharma, Inc. at 1 site in Mexico.
Trial summary
Randomized, controlled trial, Proof of Concept, Phase 2 aimed to evaluate the effect of CBP-0276 in dose of 200mg twice dose a day, or placebo administrated for 36 weeks to improve Psoriasis Area and Severity Index (PASI)75 or static Physician's Global Assessment (sPGA) score of 0 or 1; PASI50, PASI90, PASI100… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- CBP-0276 200mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2025to 30 Aug 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Patients must be willing to participate in the study and sign the informed consent form
- Type of patient and target disease characteristics
- Men and women, diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity, in the opinion of the investigator
- Deemed by the investigator to be a candidate for systemic therapy
- ≥10% of body surface area (BSA) involvement at screening visit and Day 1
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- Psoriasis Area and Severity Index (PASI) score ≥12, and static Physician's Global Assessment (sPGA) ≥3 at screening visit and Day 1
- Age and reproductive status
- Men and women aged 18 years to 70 years at the time of screening visit
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening visit, and a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin within 24 hours prior to the start of study drug
- Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period
- Women of childbearing potential must agree to correctly use a highly effective method(s) of contraception for the duration of treatment plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion (total of 33 days after last dose of study drug). WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but must still undergo pregnancy testing as described in this protocol
- Male patients who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment(s) plus 5 half-lives of the study treatment (3 days) for a total of 3 days post-treatment completion.
- Additionally, male patients must be willing to refrain from sperm donation during this time
- Investigators shall counsel WOCBP, and male patients who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of <1% when used consistently and correctly.
Who cannot join
- Use of phototherapy 4 weeks or less prior randomization
- Infectious/immune-related exclusions
- History or evidence of outpatient active infection and/or febrile illness within 7 days prior to Day 1
- History of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous antimicrobial treatment within 60 days prior to Day 1
- Any untreated bacterial infection within 60 days prior to Day 1
- Any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis)
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- Any history of proven infection of a joint prosthesis in which the prosthesis was not removed or replaced, or received antibiotics for suspected infection of a joint prosthesis in which the prosthesis was not removed or replaced
- Received live vaccines within 60 days prior to Day 1, or plans to receive a live vaccine during the study, or within 60 days after completing study treatment
- Presence of herpes zoster lesions at screening or Day 1
- History of serious herpes zoster or serious herpes simplex infection, which includes, but is not limited to, any episode of disseminated herpes simplex, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (recurrent is defined as 2 episodes within 2 years)
- Evidence of, or positive test for, hepatitis B virus at screening. Positive hepatitis B lab testing is defined as 1) positive hepatitis B surface antigen (HBsAg+) OR 2) presence of hepatitis B virus DNA OR 3) positive anti-hepatitis B core antibody without concurrent positive hepatitis B surface antibody (HBcAb+ and HBsAb-)
- Evidence of, or positive test for, hepatitis C virus (HCV) at screening. A positive test for HCV is defined as: positive for hepatitis C antibody (anti-HCV Ab) AND 2) positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction)
- Positive for human immunodeficiency virus by antibody testing (HIV-1 and -2 Ab) at screening
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status (eg, history of opportunistic infections [eg, Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidioidomycosis], history of splenectomy, primary immunodeficiency)
- Any of the following tuberculosis (TB) criteria:
- History of active TB prior to screening visit, regardless of completion of adequate treatment
- Signs or symptoms of active TB (eg, fever, cough, night sweats, and weight loss) during screening, as judged by the investigator
- Any imaging of the chest (eg, chest x-ray, chest computed tomography scan) obtained during the screening period, or any time within 6 months prior to screening with documentation, showing evidence of current active or history of active pulmonary TB
- Latent TB infection (LTBI) defined as positive interferon gamma release assay (IGRA), by QuantiFERON-TB Gold testing at screening, in the absence of clinical manifestations
- Note: Patient is eligible if (i) there are no current signs or symptoms of active TB AND (ii) patient has received adequate documented treatment for LTBI within 5 years of screening OR has initiated prophylactic treatment for LTBI per local guidelines and is rescreened after 1 month of treatment. To continue in the study, patient must agree to complete a locally recommended course of treatment for LTBI. Use of rifampin, however, is not recommended as it can reduce efficacy of apremilast used as a comparator in this trial
- Note: An IGRA test that is indeterminate must be retested for confirmation. If the second test is again indeterminate, the patient will be excluded from the study. If the retest is positive, the patient should be treated as having LTBI. If the retest is negative, the patient may be eligible provided no other exclusion criteria for TB are met.
- Medical history and concurrent diseases
- Any major surgery within 8 weeks prior to Day 1, or any planned surgery for the first 52 weeks of the study
- Has donated blood >500 mL within 4 weeks prior to Day 1, or plans to donate blood during the course of the study
- Drug or alcohol abuse, as determined by the investigator, within 6 months prior to Day 1
- Medical marijuana or prescription marijuana taken for medicinal reasons
- Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the medical monitor, will substantially increase the risk to the patient if he or she participates in the study
- Unstable cardiovascular disease, defined as a recent clinical cardiovascular event (eg, unstable angina, myocardial infarction, stroke, rapid atrial fibrillation) in the last 3 months prior to screening, or a cardiac hospitalization (eg, revascularization procedure, pacemaker implantation) within 3 months prior to screening
- Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) >160 mm Hg or diastolic BP >100 mm Hg
- Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the patient has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted.
- Class III or IV congestive heart failure by New York Heart Association Criteria
- Has cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence)
- Any uncontrolled psychiatric illness (such as untreated depression, or bipolar disorder) judged as clinically significant by the investigator during screening or at Day 1 OR any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by medical history or by electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) documentation, or by answering "yes" to Question 4 or 5 for suicidal ideation on the eC-SSRS at screening or at Day 1, or is clinically deemed to have a suicide risk by the investigator
- Prior exposure to investigational product on the last 6 months (ie, deucravacitinib or apremilast)
- If the patient has received biologics previously, the following exclusion criteria for washout will apply: Antibodies to IL-12, IL-17, or IL-23 within 6 months of Day 1 prior randomization; Tumor necrosis factor inhibitor(s) within 2 months of Day 1; Agents that modulate integrin pathways to impact lymphocyte trafficking (eg, natalizumab), or agents that modulate B cells or T cells within 3 months of Day 1; or Rituximab within 6 months of Day 1
- Has received systemic nonbiologic psoriasis medications and/or any systemic immunosuppressant therapy, including, but not limited to methotrexate, azathioprine, cyclosporine, Janus kinase inhibitors, mercaptopurine, mycophenolate mofetil, tacrolimus, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues within 4 weeks prior to Day 1
- Has used leflunomide within 6 months prior to Day 1
- Has used opioid analgesics within 4 weeks prior to Day 1
- Has received lithium, antimalarials, or intramuscular gold within 4 weeks of the first administration of any study medication
- Has used any strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin) within 4 weeks prior to Day 1
- Has used topical medications/treatments that could affect psoriasis evaluation (including, but not limited to, high potency corticosteroids (World Health Organization [WHO] Classes I-V), >3% salicylic acid, urea, alpha- or beta-hydroxyl acids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, pimecrolimus, and tacrolimus) within 2 weeks prior to Day 1
- Note: Low-potency topical steroids (WHO Class VI and VII) are permitted on the palms, soles, face, and intertriginous areas but should not be used within 24 hours prior to any study visit. Bland emollients (defined as emollients without urea or alpha or beta hydroxy acids or other ingredients that are pharmaceutically active) are allowed on all body regions but should not be used within 24 hours prior to any study visit.
- Use of shampoos containing corticosteroids, coal tar, >3% salicylic acid, or vitamin D3 analogues within 2 weeks prior to Day 1
- Has received an experimental antibody or experimental biologic therapy within the previous 6 months OR received any other experimental therapy or new investigational agent within 30 days or 5 half-lives (whichever is longer) prior to Day 1 OR is currently enrolled in an investigational study
- Laboratory evaluations
- Absolute white blood cell count <3000/mm3
- Absolute lymphocyte count <500/mm3
- Absolute neutrophil count <1000/mm3
- Platelet count <100,000/mm3
- Hemoglobin <9 g/dL
- Alanine aminotransferase and/or aspartate aminotransferase >3 × upper limit of normal (ULN)
- Total, unconjugated, and/or conjugated bilirubin >2 × ULN
- Thyroid-stimulating hormone outside the normal reference range AND free T4 (thyroxine) or T3 (triiodothyronine) outside the normal reference range
- Electrocardiogram abnormalities that are considered clinically significant and would pose an unacceptable risk to the patient if participating in the study
- Renal impairment based on an estimated glomerular filtration rate <45 mL/min
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Innovacion y Desarrollo de Estrategias en Salud
Mexico City, 14320
Cesar D Nieto Rufino, MD, MSc, +525554564480, cesar.nieto@ideas-salud.mx
Paola Juarez Valdez, MD, +525528950479, paola.juarez@ideas-salud.mx
About this study
Official title: Safety and Efficacy of CBP-0276 200mg/Day Twice Dose a Day, or Placebo Administrated for 36 Weeks, to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects 18y to 70y: Randomized Controlled Trial
Randomized, controlled trial, Proof of Concept, Phase 2 aimed to evaluate the effect of CBP-0276 in dose of 200mg twice dose a day, or placebo administrated for 36 weeks to improve Psoriasis Area and Severity Index (PASI)75 or static Physician's Global Assessment (sPGA) score of 0 or 1; PASI50, PASI90, PASI100, Scalp-specific Physician's Global Assessment (Ss-PGA) 0/1 with at least a 2-point improvement among patients with a baseline ss-PGA ≥3, sPGA 0, PSSD symptom score of 0 among patients with baseline score ≥1, Dermatology Life Quality Index (DLQI) 0/1 at Week 6,12,18,24, 30 and 36 among patients with baseline DLQI ≥2, adjusted by transcriptomics profile (post-hoc analysis), Percentage of subjects which achieve The Minimum Clinically Important Difference (MCID) on DLQI (a ≥4-point reduction from baseline) at Week 4 and 8, Frequency of solicited and unsolicited adverse events (SAEs and USAEs) (Medra), and Changes on inflammatory and anti-inflammatory cytokine levels during treatment (IL-17, IL-23, IL-6, TNF-alpha, IL1-b, IL-10).
Read the detailed description
Safety and Efficacy of CBP-0276 in dose of 200mg/ twice dose a day, or placebo administrated for 36 weeks, to improve severity and quality of life on moderate to severe psoriasis in subjects 18y to 70y: Randomized, double blind, phase 2, Proof of Concept, placebo controlled clinical trial. Primary Aim: To assess the effect over 18 weeks of oral CBP-0276(Dose 200mg/day twice dose a day), or placebo on Psoriasis Area and Severity Index (PASI)75; Secondary Aims: To assess the effect over 6,12,18,24, 30 and 36 weeks of oral CBP-0276 (Dose 200mg/day twice dose a day), or placebo on static Physician's Global Assessment (sPGA) score of 0 or 1, PASI50, PASI90, PASI100, Scalp-specific Physician's Global Assessment (Ss-PGA) 0/1 with at least a 2-point improvement among patients with a baseline ss-PGA ≥3, sPGA 0, PSSD symptom score of 0 among patients with baseline score ≥1, Dermatology Life Quality Index (DLQI) 0/1 among patients with baseline DLQI ≥2, Percentage of subjects which achieve The Minimum Clinically Important Difference (MCID) on DLQI (a ≥4-point reduction from baseline), Frequency of solicited and unsolicited adverse events (SAEs and USAEs) (Medra), and Changes on inflammatory and anti-inflammatory cytokine levels during treatment (IL-17, IL-23, IL-6, TNF-alpha, IL1-b, IL-10). Adults 18 years to 70y of age with moderate to severe plaque psoriasis who fulfill the inclusion criteria will be included in the study. Patients with a history of prior therapy, including biologic therapy, could be included after specified washout periods before randomization. Subjects will be included in 2 different groups: Group 1 to receive 200mg oral twice dose a day of CBP-0276 for 36weeks and Group 2 to receive Placebo for CBP-0276 for 36weeks. Throughout the trial, patients, investigators, and sponsors providing oversight remained blinded to treatment assignments. The collection of nonserious AEs will start at initiation of study treatment until the final study visit. All SAEs will be collected from the date of the patient's written consent until 30 days after the final dose of the study drug or patient's participation in the study if the last scheduled visit occurred at a later time. The AEs of interest will include malignancies, infections (serious, opportunistic, fungal, tuberculosis, and herpes zoster), thromboembolic (arterial and venous) events, major adverse cardiovascular events (MACE; cardiovascular death, nonfatal myocardial infarction, and stroke), and skin events (acne and folliculitis). Solicited AEs will include select infection AEs, certain cardiovascular events, and suicidal ideation and behavior. All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA, version 28.0).
- Conditions
- Psoriasis
- Being tested
- CBP-0276 200mg BID, Placebo for CBP-0276
- Keywords
- CBP-0276, Randomized trial phase 2, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-0276 200mg BIDDrug
CBP-0276 200mg twice a day, orally for 30 weeks
Placebo for CBP-0276Drug
Placebo for CBP-0276 twice a day, orally for 30 weeks
| Study group | Role | What they receive |
|---|---|---|
| CBP-0276 200mg BID | Experimental | CBP-0276 oral 200mg twice a day for 36 weeks Receives: Drug: CBP-0276 200mg BID |
| Placebo for CBP-0276 | Experimental | Placebo for CBP-0276 orally twice a day for 36 weeks Receives: Drug: Placebo for CBP-0276 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index-75
Change on 75% at least for Psoriasis Area and Severity Index (PASI)75
Measured: Week 18
Secondary outcomes (6)
Psoriasis Area and Severity Index-90 (PASI-90)
Change on PASI90 after treatment
Measured: Week 6,12,18,24, 30 and 36
Scalp-specific Physician's Global Assessment
Change on Scalp-specific Physician's Global Assessment (Ss-PGA) 0/1 with at least a 2-point improvement among patients with a baseline ss-PGA ≥3
Measured: Week 6,12,18,24, 30 and 36
Psoriasis Symptoms and Signs Diary
Changes on PSSD symptom score of 0 among patients with baseline score ≥1
Measured: Week 6,12,18,24, 30 and 36
Dermatology Life Quality Index
Dermatology Life Quality Index (DLQI) 0/1 at Week 4 and 8 among patients with baseline DLQI ≥2
Measured: Week 6,12,18,24, 30 and 36
Frequency of adverse events
Frequency of solicited and unsolicited adverse events (SAEs and USAEs)
Measured: Week 6,12,18,24, 30 and 36
Changes on inflammatory cytokines
Changes on inflammatory and anti-inflammatory cytokine levels during treatment (IL-17, IL-23, IL-6, TNF-alpha, IL1-b, IL-10)
Measured: Week 6,12,18,24, 30 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Subjects will be included in 2 different parallel groups: * Group 1 to receive 200mg twice dose a day of CBP-0276 for 36weeks * Group 2 to receive Placebo for CBP-0276 for 36weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarent Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Narvaez Rosales, MD, Principal investigator, Innovacion y Desarrollo de Estrategias en Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204639
- Sponsor's protocol ID
- CBP-0276-202507-PoC
- Acronym
- CBP-0276-Pso
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CBP-0276 200mg/Day Twice Dose a Day, or Placebo Administrated for 36 Weeks, to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects 18y to 70y: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07204639
- Acronym / sponsor ID
- CBP-0276-Pso / CBP-0276-202507-PoC
- Conditions
- Psoriasis
- Keywords
- CBP-0276, Randomized trial phase 2, Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clarent Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, controlled trial, Proof of Concept, Phase 2 aimed to evaluate the effect of CBP-0276 in dose of 200mg twice dose a day, or placebo administrated for 36 weeks to improve Psoriasis Area and Severity Index (PASI)75 or static Physician's Global Assessment (sPGA) score of 0 or 1; PASI50, PASI90, PASI100, Scalp-specific Physician's Global Assessment (Ss-PGA) 0/1 with at least a 2-point improvement among patients with a baseline ss-PGA ≥3, sPGA 0, PSSD symptom score of 0 among patients with baseline score ≥1, Dermatology Life Quality Index (DLQI) 0/1 at Week 6,12,18,24, 30 and 36 among patients with baseline DLQI ≥2, adjusted by transcriptomics profile (post-hoc analysis), Percentage of subjects which achieve The Minimum Clinically Important Difference (MCID) on DLQI (a ≥4-point reduction from baseline) at Week 4 and 8, Frequency of solicited and unsolicited adverse events (SAEs and USAEs) (Medra), and Changes on inflammatory and anti-inflammatory cytokine levels during treatment (IL-17, IL-23, IL-6, TNF-alpha, IL1-b, IL-10).
Detailed description
Safety and Efficacy of CBP-0276 in dose of 200mg/ twice dose a day, or placebo administrated for 36 weeks, to improve severity and quality of life on moderate to severe psoriasis in subjects 18y to 70y: Randomized, double blind, phase 2, Proof of Concept, placebo controlled clinical trial. Primary Aim: To assess the effect over 18 weeks of oral CBP-0276(Dose 200mg/day twice dose a day), or placebo on Psoriasis Area and Severity Index (PASI)75; Secondary Aims: To assess the effect over 6,12,18,24, 30 and 36 weeks of oral CBP-0276 (Dose 200mg/day twice dose a day), or placebo on static Physician's Global Assessment (sPGA) score of 0 or 1, PASI50, PASI90, PASI100, Scalp-specific Physician's Global Assessment (Ss-PGA) 0/1 with at least a 2-point improvement among patients with a baseline ss-PGA ≥3, sPGA 0, PSSD symptom score of 0 among patients with baseline score ≥1, Dermatology Life Quality Index (DLQI) 0/1 among patients with baseline DLQI ≥2, Percentage of subjects which achieve The Minimum Clinically Important Difference (MCID) on DLQI (a ≥4-point reduction from baseline), Frequency of solicited and unsolicited adverse events (SAEs and USAEs) (Medra), and Changes on inflammatory and anti-inflammatory cytokine levels during treatment (IL-17, IL-23, IL-6, TNF-alpha, IL1-b, IL-10). Adults 18 years to 70y of age with moderate to severe plaque psoriasis who fulfill the inclusion criteria will be included in the study. Patients with a history of prior therapy, including biologic therapy, could be included after specified washout periods before randomization. Subjects will be included in 2 different groups: Group 1 to receive 200mg oral twice dose a day of CBP-0276 for 36weeks and Group 2 to receive Placebo for CBP-0276 for 36weeks. Throughout the trial, patients, investigators, and sponsors providing oversight remained blinded to treatment assignments. The collection of nonserious AEs will start at initiation of study treatment until the final study visit. All SAEs will be collected from the date of the patient's written consent until 30 days after the final dose of the study drug or patient's participation in the study if the last scheduled visit occurred at a later time. The AEs of interest will include malignancies, infections (serious, opportunistic, fungal, tuberculosis, and herpes zoster), thromboembolic (arterial and venous) events, major adverse cardiovascular events (MACE; cardiovascular death, nonfatal myocardial infarction, and stroke), and skin events (acne and folliculitis). Solicited AEs will include select infection AEs, certain cardiovascular events, and suicidal ideation and behavior. All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA, version 28.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be included in 2 different parallel groups: * Group 1 to receive 200mg twice dose a day of CBP-0276 for 36weeks * Group 2 to receive Placebo for CBP-0276 for 36weeks
| Arm | Type | Receives |
|---|---|---|
| CBP-0276 200mg BID | Experimental | Drug: CBP-0276 200mg BIDCBP-0276 oral 200mg twice a day for 36 weeks |
| Placebo for CBP-0276 | Experimental | Drug: Placebo for CBP-0276Placebo for CBP-0276 orally twice a day for 36 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed written informed consent
- Type of patient and target disease characteristics
- Age and reproductive status
- Additionally, male patients must be willing to refrain from sperm donation during this time
Key exclusion criteria (55 listed)
- Use of phototherapy 4 weeks or less prior randomization
- Infectious/immune-related exclusions
- Any of the following tuberculosis (TB) criteria:
- Note: Patient is eligible if (i) there are no current signs or symptoms of active TB AND (ii) patient has received adequate documented treatment for LTBI within 5 years of screening OR has initiated prophylactic treatment for LTBI per local guidelines and is rescreened after 1 month of treatment. To continue in the study, patient must agree to complete a locally recommended course of treatment for LTBI. Use of rifampin, however, is not recommended as it can reduce efficacy of apremilast used as a comparator in this trial
- Note: An IGRA test that is indeterminate must be retested for confirmation. If the second test is again indeterminate, the patient will be excluded from the study. If the retest is positive, the patient should be treated as having LTBI. If the retest is negative, the patient may be eligible provided no other exclusion criteria for TB are met.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBP-0276 200mg BIDCBP-0276 200mg twice a day, orally for 30 weeks | Drug | CBP-0276 200mg BID |
| Placebo for CBP-0276Placebo for CBP-0276 twice a day, orally for 30 weeks | Drug | Placebo for CBP-0276 |
Primary outcome
Psoriasis Area and Severity Index-75
Time frame: Week 18
Change on 75% at least for Psoriasis Area and Severity Index (PASI)75
6 secondary outcomes
Psoriasis Area and Severity Index-90 (PASI-90)
Time frame: Week 6,12,18,24, 30 and 36
Scalp-specific Physician's Global Assessment
Time frame: Week 6,12,18,24, 30 and 36
Psoriasis Symptoms and Signs Diary
Time frame: Week 6,12,18,24, 30 and 36
Dermatology Life Quality Index
Time frame: Week 6,12,18,24, 30 and 36
Frequency of adverse events
Time frame: Week 6,12,18,24, 30 and 36
Changes on inflammatory cytokines
Time frame: Week 6,12,18,24, 30 and 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veronica Narvaez Rosales, MD principal investigator
Innovacion y Desarrollo de Estrategias en Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBP-0276 200mg BID in people with 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 15 inclusion and 55 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: looking for participants now, as of the sponsor's last update on 30 Jun 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. 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 Diana M Andrade Plata, MD (+525535209755, diana.andrade@elemental.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index-75 (time frame: Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.