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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05499416
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Innovaderm Research Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robert Bissonnette, MD
Principal Investigator Affiliation Innovaderm Research Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris, Active Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Bimekizumab 320 mg SC injections

Bimekizumab 320 mg solution administered via SC injections every 4 weeks for 16 weeks.

Interventions

Drug: - Bimekizumab

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Tiphanie Weber

[email protected]

1-866-575-3111

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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