Safety and Efficacy of CBP-0276 to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects

NCT07204639 | Recruiting Phase 2

• 1 other identifier: CBP-0276-202507-PoC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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, 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).

Conditions

Psoriasis

Keywords

CBP-0276, Randomized trial phase 2, Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index-75

  Change on 75% at least for Psoriasis Area and Severity Index (PASI)75

  Week 18

Secondary Outcomes (6)

• Psoriasis Area and Severity Index-90 (PASI-90)

  Week 6,12,18,24, 30 and 36

• Scalp-specific Physician's Global Assessment

  Week 6,12,18,24, 30 and 36

• Psoriasis Symptoms and Signs Diary

  Week 6,12,18,24, 30 and 36

• Dermatology Life Quality Index

  Week 6,12,18,24, 30 and 36

• Frequency of adverse events

  Week 6,12,18,24, 30 and 36

Study Arms (2)

CBP-0276 200mg BID

EXPERIMENTAL

CBP-0276 oral 200mg twice a day for 36 weeks

Drug: CBP-0276 200mg BID

Placebo for CBP-0276

EXPERIMENTAL

Placebo for CBP-0276 orally twice a day for 36 weeks

Drug: Placebo for CBP-0276

Interventions

CBP-0276 200mg BID DRUG

CBP-0276 200mg twice a day, orally for 30 weeks

CBP-0276 200mg BID

Placebo for CBP-0276 DRUG

Placebo for CBP-0276 twice a day, orally for 30 weeks

Placebo for CBP-0276

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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. 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 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.

You may not qualify if:

• Use of phototherapy 4 weeks or less prior randomization
• 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 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

Sponsors & Collaborators

• Clarent Biopharma, Inc.: lead

Study Sites (1)

Innovacion y Desarrollo de Estrategias en Salud

Mexico City, 14320, Mexico

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Veronica Narvaez Rosales, MD

  Innovacion y Desarrollo de Estrategias en Salud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana M Andrade Plata, MD

CONTACT

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

Araceli G Medina Nolasco, MD

CONTACT

+525545755504; araceli.medina@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: The participant, study operating staff, members of the Safety Monitoring Committee, 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. Investigational products will have the same pharmaceutical form and will be dispensed in containers/dosers previously identified with the ID number that corresponds to each subject prior to administration. The containers will be made of plastic and identical for both products under investigation and labeled with the following information: protocol number, ID number, date and time of administration. The analysts' blindness will remain with respect to the randomization scheme.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion: July 31, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)