Bimekizumab for Psoriatic Arthritis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pa0012 40027, Herne, Germany
Psoriatic Arthritis+2 More
Bimekizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called bimekizumab is safe and effective for people with psoriatic arthritis.

See full description

Eligible Conditions

  • Psoriatic Arthritis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Psoriatic Arthritis

Study Objectives

This trial is evaluating whether Bimekizumab will improve 2 primary outcomes and 28 secondary outcomes in patients with Psoriatic Arthritis. Measurement will happen over the course of From PA0012 Entry Visit until Safety Follow-Up (up to Week 212).

Week 140
American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011
Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
Week 24
American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011
Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
Week 52
American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011
Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
Week 212
Incidence of treatment-emergent adverse events (TEAEs) during the study
Incidence of treatment-emergent serious adverse events (SAEs) during the study
TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Psoriatic Arthritis

Side Effects for

Ustekinumab Initial Period (SS)
Nasopharyngitis
9%
Headache
4%
Hypertension
3%
Upper respiratory tract infection
3%
Back pain
2%
Intervertebral disc protrusion
1%
Urinary tract infection
1%
Cardiac arrest
1%
Macular hole
1%
Wound infection
1%
Heart injury
1%
Brain injury
1%
Psoriasis
1%
Hydrocephalus
0%
Vocal cord paresis
0%
False positive tuberculosis test
0%
Spinal column stenosis
0%
Myocardial infarction
0%
Mastoiditis
0%
Otitis externa
0%
Infective tenosynovitis
0%
Colitis ulcerative
0%
Acute myocardial infarction
0%
Death
0%
Toxicity to various agents
0%
Haemorrhoids
0%
Gastroenteritis
0%
Necrotising fasciitis
0%
Tibia fracture
0%
Otitis media acute
0%
Upper limb fracture
0%
Liver function test increased
0%
Oesophageal candidiasis
0%
Subglottic laryngitis
0%
Intracranial aneurysm
0%
Humerus fracture
0%
Pneumonia
0%
Tendon injury
0%
Diabetes mellitus
0%
Facet joint syndrome
0%
Thyroid adenoma
0%
Arthritis
0%
Oesophageal adenocarcinoma
0%
Epistaxis
0%
Osteochondrosis
0%
Gastric cancer
0%
Cerebral infarction
0%
Haemorrhage in pregnancy
0%
Alcoholism
0%
Suicide attempt
0%
Metabolic surgery
0%
Oral candidiasis
0%
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03370133) in the Ustekinumab Initial Period (SS) ARM group. Side effects include: Nasopharyngitis with 9%, Headache with 4%, Hypertension with 3%, Upper respiratory tract infection with 3%, Back pain with 2%.

Trial Design

1 Treatment Group

Bimekzumab dosage regimen
1 of 1
Experimental Treatment

This trial requires 1131 total participants across 1 different treatment group

This trial involves a single treatment. Bimekizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Bimekzumab dosage regimen
Drug
Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimekizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline of pa0010 or pa0011, week 140 in pa0012
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline of pa0010 or pa0011, week 140 in pa0012 for reporting.

Closest Location

Pa0012 50041 - Quebec City, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Patient Q&A Section

What are the signs of arthritis, psoriatic?

"The signs of arthritis are joint inflammation, joint swelling, and stiffness. These may be present without joint trauma, or when there is joint trauma. On palpation, arthritic joints may appear red, warm and tender. Involvement of the metacarpophalangeal and metatarsophalangeal joints is commonly found. Other symptoms may include swelling in the wrists and legs, joint stiffness, pain when moving the joints, warmth, and redness. Pain is also a common symptom of inflammatory arthritis." - Anonymous Online Contributor

Unverified Answer

What causes arthritis, psoriatic?

"In people with arthritis and no psoriasis, the risk of developing psoriasis is about the same as for the general population. Psoriasis starts before the arthritis. The arthritis-psoriasis link is probably due to the presence of a shared susceptibility gene." - Anonymous Online Contributor

Unverified Answer

What are common treatments for arthritis, psoriatic?

"The most common treatment for arthritis is nonpharmaceutical. Drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs) may be used in the short-term. There is no strong evidence supporting that one treatment (anti-TNF or other) is better than the other. There are no conclusive reviews that have been done to compare their effectiveness. However, there is concern that there are adverse effects related to medications and that people on these medications should be encouraged to report any side effects to their doctors as often as they need to. Painkillers such as opioids are rarely used. There is no clear evidence on which anti-oxidants, such as vitamin C or vitamin E, may be useful in treating joint pain." - Anonymous Online Contributor

Unverified Answer

Can arthritis, psoriatic be cured?

"Despite the evidence showing in favour of remission for PsA with biological therapy (i.e. TNF-blocker (i.e. infliximab (infusion, Humira)) and the first anti-TNF in combination with methotrexate (MTX)) versus placebo, no remission has been found for PsA. Moreover, a high remission rate for PsA with methotrexate and IFN-alpha therapy has been demonstrated." - Anonymous Online Contributor

Unverified Answer

What is arthritis, psoriatic?

"Psoriatic arthritis, although rare, is an independent cause of chronic, debilitating pain in the wrists, ankles, or knees. Infiltration of the synovium by T lymphocytes and abnormal bone erosions (osteolysis) are important features. It can occur with or without arthritis or psoriasis." - Anonymous Online Contributor

Unverified Answer

How many people get arthritis, psoriatic a year in the United States?

"Although more than 50 million Americans suffer from at least one arthritis, over 45 million of them have arthritis that keeps them out of work for one month or longer." - Anonymous Online Contributor

Unverified Answer

What does bimekizumab usually treat?

"Onset of improvement in joint symptoms occurred within the first 8 weeks of commencement of treatment with bimekizumab. The majority of patients (81%) on treatment at any time point had a decrease in pain and inflammation of at least 1 point on the DAS28-ESR. Overall, 24% of patients were on treatment by week 8." - Anonymous Online Contributor

Unverified Answer

Is bimekizumab typically used in combination with any other treatments?

"There are numerous reports of bimekizumab's efficacy both as monotherapy and in combination with many immunomodulatory agents including etanercept, adalimumab, or infliximab. Further studies are warranted to see whether it achieves similar results in the context of psoriasis treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets arthritis, psoriatic?

"In a representative sample of persons with arthritis, psoriatic, and rheumatoid arthritis, the average ages of onset of disease are at least 6 to 12 years older than for similar conditions in the general population." - Anonymous Online Contributor

Unverified Answer

What is bimekizumab?

"Both trials showed benefit when bimekizumab was used as a monotherapy. Both trials did not show benefit in patients receiving bimekizumab when paired with methotrexate. Further studies with more patients are needed to assess its utility in the long term as compared to other treatments." - Anonymous Online Contributor

Unverified Answer

Does bimekizumab improve quality of life for those with arthritis, psoriatic?

"Treatment with BTZ does not reduce pain at 2-week or 3-month assessments. However, patients in the BTZ group reported significantly fewer joint flares compared with placebo, at 3-week and 3-month assessments." - Anonymous Online Contributor

Unverified Answer

Is bimekizumab safe for people?

"There were no detectable differences in serious events or in patients who could be treated safely with bimekizumab in this retrospective analysis. As there was a tendency towards a more frequent use of steroids, especially in the first year, randomized controlled studies must be performed to investigate the long-term effects of bimekizumab in psoriasis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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