NCT05499416WithdrawnPhase 4
Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis
Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy
Source: ClinicalTrials.gov · Last updated 15 Mar 2023
Reason given: Sponsor decision.
Brief summary (registry, in English)
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).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 3 Aug 2022
- Start date
- Jan 2023
- Primary completion date
- Sept 2023
- Lead sponsor
- Innovaderm Research Inc.
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT05499416
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis.
- 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.
- Patient with known or suspected hypersensitivity to bimekizumab or any component of the investigational product, including any nonmedicinal ingredient, or component of the container.
- 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.
- Patient who has received treatment with bimekizumab prior to Day 1.
Other illness
- 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.
- 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.
- Patient with a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Other
- 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.
Who the study is looking for
- Male or female patient 18 years of age or older at the time of consent.
- Patient with a history of psoriasis vulgaris and PsA (as determined by the investigator) for ≥ 6 months prior to the screening visit.
- Patient with moderate-to-severe psoriasis vulgaris before initiating treatment with an anti-IL23 agent.
- 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.
- Patient with active PsA as defined by ≥ 1 joint that is tender (TJC68) and/or swollen (SJC66) at Day 1.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.