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

NCT07204639 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-10-02

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

RAP103 400mg single dose

RAP103 400mg single dose, orally 8 weeks

DRUG

RAP103 200mg BID

RAP103 200mg BID, orally 8 weeks

DRUG

Placebo for RAP400

Placebo for RAP400mg single dose for 8 weeks

DRUG

Placebo for RAP200mg

Placebo for RAP400mg single dose for 8 weeks

Sponsors & Collaborators

  • Elemental Traslational Research SAPI

    collaborator UNKNOWN

  • Innovacion y Desarrollo de Estrategias en Salud

    collaborator OTHER

  • Elemental CRO

    collaborator UNKNOWN

  • Clarent Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Veronica Narvaez Rosales, MD · Innovacion y Desarrollo de Estrategias en Salud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-12-22
Completion
2025-12-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07204639 on ClinicalTrials.gov