Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis

Innovaderm Research Inc.

Overview

This is an open-label study to evaluate the effects of bimekizumab in patients with psoriasis vulgaris and who also have active psoriatic arthritis (PsA).

This study is being conducted to evaluate the effects of bimekizumab administered subcutaneously (SC) to patients with psoriasis vulgaris and who also have active PsA who have an inadequate skin response to anti-interleukin (IL)23 therapy. Approximately 20 adult subjects with psoriasis vulgaris and active PsA who have an inadequate skin response to anti-IL23 will receive bimekizumab 320 mg solution administered SC every 4 weeks for 16 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Psoriasis Vulgaris Active Psoriatic Arthritis

Interventions

BimekizumabDRUG

Self-administration of two (2-160 mg/mL \[1 mL\]) pre-filled syringes or autoinjectors at baseline (Day1) and at Weeks 4, 8,12, and 16

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patient 18 years of age or older at the time of consent. 2. Patient with a history of psoriasis vulgaris and PsA (as determined by the investigator) for ≥ 6 months prior to the screening visit. 3. Patient with moderate-to-severe psoriasis vulgaris before initiating treatment with an anti-IL23 agent. 4. Patient with an inadequate skin response to at least 12 weeks treatment with an anti-IL23 agent for the treatment of psoriasis vulgaris as defined by a PGA ≥ 2 and plaque psoriasis covering ≥ 1% of total BSA (excluding palms and soles) at the screening and Day 1 visits. 5. Patient with active PsA as defined by ≥ 1 joint that is tender (TJC68) and/or swollen (SJC66) at Day 1. Exclusion Criteria: 1. Female who is breastfeeding, pregnant, or who is planning to become pregnant during the study or within 4 months after the last study product administration. 2. Patient with evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis. 3. Patient with any known clinically significant medical condition or presence of a skin or rheumatologic disease that would, in the opinion of the investigator, put the patient at undue risk or interfere with the interpretation of study results. 4. Patient who plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives (of the study product), whichever is longer, after the last study product administration. 5. Patient with an active infection (except common cold) that would place them at increased risk, a recent serious infection, or a history of opportunistic, recurrent, or chronic infections. 6. Patient with a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis). 7. Patient with known or suspected hypersensitivity to bimekizumab or any component of the investigational product, including any nonmedicinal ingredient, or component of the container. 8. Patient who has received any marketed or investigational biological agent, except anti-IL23 agents, within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1. 9. Patient who has received treatment with bimekizumab prior to Day 1.

Outcomes

Primary Outcomes

Physician Global Assessment (PGA) x Body Surface Area (BSA)

The product of physician's global assessment and body surface area (PGA×BSA) is a measure of psoriasis severity (0-400), with higher scores indicating more severe disease.

Time frame: Week 24

Proportion of patients achieving MDA

A patient will be considered to have achieved MDA when meeting 5/7 of the following criteria: tender joints count ≤ 1; swollen joints count ≤ 1; Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%; patient pain visual analog scale (VAS) ≤ 15 mm; patient's global assessment of arthritis visual analog scale (PtGA VAS) ≤ 20 mm; Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5; tender entheseal points ≤ 1.

Time frame: Week 24

Secondary Outcomes

Physician Global Assessment (PGA)

The PGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity, with higher scores indicating more severe disease.

Time frame: Weeks 12 and 24

Body Surface Area (BSA)

The overall BSA affected by psoriasis vulgaris will be evaluated (from 0% to 100%).

Time frame: Weeks 12 and 24

Psoriasis Area and Severity Index (PASI)

The PASI is a composite score that considers the degree of erythema, induration/infiltration, and desquamation (each scored from 0 to 4 separately) for each of 4 body regions.

Time frame: Weeks 12 and 24

American College of Rheumatology (ACR)

The ACR is a composite including the number of tender and number of swollen joints, patient's global assessment of arthritis visual analog scale (PtGA VAS), physician global assessment visual analog scale (MDGA VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient pain visual analog scale (VAS), and C-reactive protein (CRP) levels. The proportion of patients achieving ACR20, ACR50, and ACR70 will be calculated.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.