CLINICAL TRIAL

bimekizumab for Healthy Study Participants

Recruiting · 18+ · All Sexes · Glendale, CA

A Bioequivalence Study of Bimekizumab Given as 1x2ml or 2x1ml Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

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About the trial for Healthy Study Participants

Treatment Groups

This trial involves 2 different treatments. 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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
bimekizumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have a body temperature between 35.0°C and 37. show original
Study participant must be ≥18 years and ≤65 years of age inclusive, at the time of signing the informed consent
Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests, during the Screening Period and on admission
Body weight minimum of 50 kg for male and 45 kg for female study participants and a maximum of 100 kg for all study participants, and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive) at the Screening Visit
Male or female. Contraception guidelines (as per the standard UCB contraceptive guideline) will be applicable.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140).
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether bimekizumab will improve 3 primary outcomes and 4 secondary outcomes in patients with Healthy Study Participants. Measurement will happen over the course of From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140).

Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUC0-t) for a single dose bimekizumab (BKZ)
FROM BASELINE (DAY 1 PREDOSE) AT PREDEFINED TIME POINTS TO THE LAST QUANTIFIABLE CONCENTRATION (DAY 140)
AUC0-t: Area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration
Maximum plasma concentration (Cmax) for a single dose bimekizumab (BKZ)
TIME FRAME: FROM BASELINE (DAY 1 PREDOSE) AT PREDEFINED TIME POINTS (UP TO DAY 140)
Cmax: Maximum observed plasma concentration
Apparent terminal half-life (t1/2)
FROM BASELINE (DAY 1 PREDOSE) AT PREDEFINED TIME POINTS (UP TO DAY 140)
t1/2: Apparent terminal half-life as determined via linear regression (slope=-lamdbaz) of the natural log (ln) concentration versus time, for data points in the terminal phase of the concentration time curve (ln2/lambdaz).
Time of occurrence of the maximum observed concentration (tmax) of a single dose bimekizumab (BKZ)
FROM BASELINE (DAY 1 PREDOSE) AT PREDEFINED TIME POINTS (UP TO DAY 140)
tmax: time to reach maximum plasma concentration
Area under the plasma concentration-time curve from time zero to infinity (AUC) for a single dose bimekizumab (BKZ)
BASELINE (DAY 1 PREDOSE) AT PREDEFINED TIME POINTS (UP TO DAY 140)
AUC: Area under the bimekizumab plasma concentration-time curve from time 0 (Day 1 predose) to infinity
Percentage of participants with at least one treatment-emergent adverse event (TEAE) from Baseline to end of Safety Follow-Up
FROM BASELINE (DAY 1) TO END OF SAFETY FOLLOW-UP (UP TO DAY 140)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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Patient Q & A Section

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

How many people get healthy study participants a year in the United States?

The US Census Bureau estimates that over 3 million new adults will be born between 2002 and 2022, accounting for a growth rate of 16% in the size of the population. Thus, the current US population will include over 1.4 million new healthy study participants. Estimates for new unhealthy study participants have not been developed yet as of 2016 and are based on current and projected growth.

Anonymous Patient Answer

What is healthy study participants?

Recent findings have significant clinical implication. If we can use a simple, non-invasive tool to identify 'individual risk factor profiles' in the general population, then we are much closer to understanding how to 'target' those at great risk of long-term adverse outcomes.

Anonymous Patient Answer

Can healthy study participants be cured?

The placebo effect appears to play a large role in health and healing. Despite some skepticism, many doctors and others believe that the term 'cure' is often misused in this context. In this article, the term does not refer to'real treatment' and should be used in a more appropriately defined way. The discussion highlights the importance of being carefully thought out when claiming that a certain treatment can 'cure' a person, because all treatments have placebo effects and some can prove beneficial even for people that may not even meet the entry criteria of a clinical trial.

Anonymous Patient Answer

What causes healthy study participants?

One interpretation of these results is that there are no specific risk factors for healthy study participants. Alternatively, there may be "militarianizing effects" of healthy study participation which reduce the risk of some diseases. The former explanation fits our present data more readily; however, further research into the militarizing effects of healthy participation in long-term epidemiological studies would be very desirable.

Anonymous Patient Answer

What are common treatments for healthy study participants?

This is the first study to report the most common clinical cancer treatment options for a single cancer type in the general population. The data provide useful information that may help to understand and manage specific disease processes. The proportion of participants receiving treatment is similar for most cancer types and the overall percentage of people receiving no therapy is low.

Anonymous Patient Answer

What are the signs of healthy study participants?

The signs of healthy participants in an investigation include the absence of significant abnormalities in cardiovascular physical examination, laboratory tests, radiological investigations or general medical history.

Anonymous Patient Answer

Is bimekizumab safe for people?

No deaths were reported related to bimekizumab, although data were from only a small number of patients. In a phase 3 trial of tocilizumab, serious infections occurred, leading to discontinuation; further safety and efficacy data are unavailable for this drug. The only known case of an immune reaction to dosed bimekizumab, a humanized monoclonal antibody directed against interleukin-23, occurred two and a half weeks after the initial dose, and was mild. Bimekizumab is FDA approved in adolescents and adults with active rheumatoid arthritis. Based on this small number of patients, this drug appears to be safe, but further study is required.

Anonymous Patient Answer

Is bimekizumab typically used in combination with any other treatments?

The evidence from this review indicates that bimekizumab is most typically used in combination with other drugs, while less commonly it is used alone, particularly in those that have already experienced a severe bout of an immune-mediated inflammatory disease such as multiple sclerosis. Results from a recent clinical trial underscore the need for further evaluation of bimekizumab as a potential immunomodulator in treating breast diseases.

Anonymous Patient Answer

What is the latest research for healthy study participants?

This research was mostly completed in 2019 and 2021. Researchers have a duty to inform study participants about the new scientific knowledge about the benefits and harms of participation in clinical trials. For example, most of the new research found on the effects of smoking show that quitting smoking could benefit people with chronic health conditions. And, researchers are not fully informed about the benefits of quitting smoking in healthy study participants. A few trials are also reporting some results that show the importance of adherence to an intervention. This could be an important step towards a better understanding of how people with chronic lung conditions benefit from quitting smoking. However, as more studies on smoking cessation (and smoking cessation in healthy study participants) are completed, our knowledge about this issue will continue to grow.

Anonymous Patient Answer

How serious can healthy study participants be?

Serious events in healthy study participants can vary widely, but can be life-threatening, disabling, or even fatal (especially from sudden cardiac death) for patients taking medications.

Anonymous Patient Answer

What are the latest developments in bimekizumab for therapeutic use?

Inhibiting the C-reactive protein (CRP) pathway is an attractive alternative to current drug treatments since CRP is a key inflammatory mediator associated with atherogenesis and the pathophysiology of type II diabetes. Inhibition of these two inflammatory processes seems to have been shown in a Phase-III clinical trial with bimekizumab. Bimekizumab's selectivity and specificity for this target has potential, and its anti-inflammatory properties are likely to produce significant improvement in the health of patients with type 2 diabetes.

Anonymous Patient Answer

What is the average age someone gets healthy study participants?

Age is a major factor in research involving healthy participants, which can increase bias. There is a need to develop an age-matched, ethnically diverse population of healthy study participants.

Anonymous Patient Answer
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