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

NCT07204639 | Not Yet Recruiting Phase 2

• 1 other identifier: RAP103-202507-PoC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Psoriasis

Keywords

RAP103, Randomized trail phase 2, RAP103

Outcome Measures

Primary Outcomes (2)

• Psoriasis Area and Severity Index-75

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

  Day 0, Day 30 and Day 60

• static Physician's Global Assessment

  Change on static Physician's Global Assessment (sPGA) score of 0 or 1

  Day 0, Day 30 and Day 60

Secondary Outcomes (6)

• PASI50-100

  Day 0, Day 30 and Day 60

• Scalp-specific Physician's Global Assessment

  Day 0, 30 and 60

• Psoriasis Symptoms and Signs Diary

  Day 0, 30 and 60

• Dermatology Life Quality Index

  Day 0, 30 and 60

• Frequency of adverse events

  Day 30 and 60 after begin of treatment

Study Arms (4)

RAP103 Active 400mg single dose

EXPERIMENTAL

Drug: RAP103 400mg single dose

RAP103 Active 200mg BID

EXPERIMENTAL

Drug: RAP103 200mg BID

Placebo for RAP 400mg

PLACEBO COMPARATOR

Drug: Placebo for RAP400

Placebo for 200mg

PLACEBO COMPARATOR

Drug: Placebo for RAP200mg

Interventions

RAP103 400mg single dose DRUG

RAP103 400mg single dose, orally 8 weeks

RAP103 Active 400mg single dose

RAP103 200mg BID DRUG

RAP103 200mg BID, orally 8 weeks

RAP103 Active 200mg BID

Placebo for RAP400 DRUG

Placebo for RAP400mg single dose for 8 weeks

Placebo for RAP 400mg

Placebo for RAP200mg DRUG

Placebo for RAP400mg single dose for 8 weeks

Placebo for 200mg

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
• Elemental Traslational Research SAPI: collaborator
• Innovacion y Desarrollo de Estrategias en Salud: collaborator
• Elemental CRO: collaborator

Study Sites (1)

Innovacion y Desarrollo de Estrategias en Salud

Mexico City, Mexico City, 14320, Mexico

Location

MeSH Terms

Conditions

Psoriasis

Interventions

RAP-103; 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be included in 4 different parallel groups: * Group 1 to receive 400mg/day/oral/one dose a day of RAP-103 for 8weeks * Group 2 to receive 200mg/day/oral/twice dose a day of RAP-103 for 8weeks * Group 3 to receive Placebo for group for 400mg/day/oral/one dose a day 8weeks * Group 3 to receive Placebo for group for 200mg/day/oral/twice dose a day for 8weeks

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 30, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

ME (1)