Psoriasis study: CBP-0276
Official title Safety and Efficacy of CBP-0276 to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects
ClinicalTrials.gov ID: NCT07204639
What this study is testing
What is CBP-0276?
an investigational oral medicine being studied as a potential treatment for moderate to severe psoriasis
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether CBP-0276 is safe and works better than placebo in reducing psoriasis severity and improving patients' quality of life.
- Who it's for
- Adults who have moderate to severe psoriasis.
- What's involved
- Participants will take a pill (200 mg) twice a day or a placebo for 36 weeks and will have regular clinic visits for skin assessments, questionnaires, and blood tests.
- Time commitment
- The trial lasts about 9 months, with visits roughly every 6 weeks (weeks 6, 12, 18, 24, 30, and 36).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 18 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Signed written informed consent a. 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.
- Deemed by the investigator to be a candidate for systemic therapy
- ≥10% of body surface area (BSA) involvement at screening visit and Day 1
You likely can't join if
- 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...
- 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)
See the full eligibility criteria
Who can join
- Signed written informed consent a. 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
- 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...
- 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...
- 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)...
- 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.
What rules you out
- 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)
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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
- Has received systemic nonbiologic psoriasis medications and/or any systemic immunosuppressant therapy, including, but not limited to methotrexate, azathioprine, cyclosporine, Janus kinase inhibitors, mercaptopurine...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 18 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mexico City, Mexico. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.