Safety and Efficacy of RAP-103 to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects

Randomized, controlled trial, Proof of Concept, Phase 2 aimed to evaluate the effect of RAP-103 in dose of 400mg/day/one dose a day, 200mg/day twice dose a day, or placebo administrated for 8 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 4 and 8 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).

Safety and Efficacy of RAP-103 in dose of 400mg/day/one dose a day, 200mg/day twice dose a day, or placebo administrated for 8 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 8 weeks of oral RAP-103 (Dose 400mg/day/one dose a day, 200mg/day twice dose a day), or placebo on Psoriasis Area and Severity Index (PASI)75 or static Physician's Global Assessment (sPGA) score of 0 or 1; Secondary Aims: To assess the effect over 8 weeks of oral RAP-103 (Dose 400mg/day/one dose a day, 200mg/day twice dose a day), or placebo on secondary clinical improvement on 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 4 and 8 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). 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 3 different groups: A) Group 1 to receive 400mg/day/oral/one dose a day of RAP-103 for 8weeks, B) Group 2 to receive 200mg/day/oral/twice dose a day of RAP-103 for 8weeks and C) Group 3 to receive Placebo for group for 400mg/day/oral/one dose a day 8weeks o Group 3 to receive Placebo for group for 200mg/day/oral/twice dose a day for 8weeks. Throughout the trial, patients, investigators, and sponsors providing oversight remained blinded to treatment assignments. After completion of the 6-week period, eligible patients will be invited to enter to our full RCT phase 2, when they have at least 6 weeks without using RAP103 (washout period). 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).