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

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• CBP-0276 200mg BID — DRUG
  CBP-0276 200mg twice a day, orally for 30 weeks
• Placebo for CBP-0276 — DRUG
  Placebo for CBP-0276 twice a day, orally for 30 weeks

Study Details

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).

Key Dates

First listed

Oct 2, 2025

Start date

Oct 1, 2025

Status verified

Jun 2026

Primary completion

Jul 31, 2026

Completion

Aug 30, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CBP-0276 200mg BID
  CBP-0276 oral 200mg twice a day for 36 weeks
• Experimental: Placebo for CBP-0276
  Placebo for CBP-0276 orally twice a day for 36 weeks

Primary Outcome Measure

Psoriasis Area and Severity Index-75 [ Time Frame: Week 18 ]

Central Contacts

• Diana M Andrade Plata, MD
  +525535209755
  [email protected]
• Araceli G Medina Nolasco, MD
  +525545755504
  [email protected]

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