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).
Signed written informed consent
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
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
Parallel
CBP-0276 200mg BID
DrugCBP-0276 200mg twice a day, orally for 30 weeks
Placebo for CBP-0276
DrugPlacebo for CBP-0276 twice a day, orally for 30 weeks
Psoriasis Area and Severity Index-75
Change on 75% at least for Psoriasis Area and Severity Index (PASI)75
Psoriasis Area and Severity Index-90 (PASI-90)
Change on PASI90 after treatment
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
Psoriasis Symptoms and Signs Diary
Changes on PSSD symptom score of 0 among patients with baseline score ≥1
Dermatology Life Quality Index
Dermatology Life Quality Index (DLQI) 0/1 at Week 4 and 8 among patients with baseline DLQI ≥2
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