Clinical Studies | UCB
Welcome to our Clinical Studies section
Clinical studies involving healthy volunteers and patients play a vital role in the development of new drugs. These studies are conducted to ensure that all investigational drugs are safe and effective. Over recent years, along with drug discovery, drug development and clinical studies have benefitted from scientific and technological advancements as well as a greater understanding of the needs clinical study participants have.
At UCB we’ve moved away from seeing patients as just patients. By really listening and engaging with them as partners we are striving for greater understanding of their needs or ways to improve our clinical studies. To improve and accelerate development, we will keep patients’ needs front and center, leverage new technologies, and adaptive clinical study design to improve the patient experience.
We strive for our solutions to provide the best individual experience for patients, and we aim for the participants of our studies to be reflective of the populations that will ultimately benefit from our new medicines. This means encompassing a broader spectrum of the population in clinical trials, ultimately advancing health for all patients and helping us better understand our investigational drugs and make better medicines.
We are committed to working toward a clinical trials infrastructure that promotes clinical trial diversity to better reflect the intended treatment population. We continue our work to identify best practices around key drivers such as scientific rigor, informing innovation, and improving the health of all our patients and communities worldwide.
Learn more about clinical studies and how clinical study sites are selected?
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A selection of studies
Previous
Ocular myasthenia gravis - MyVision Study - MG0038](/content/innovation/clinical-studies/current-studies?studyId=MG0038/index.html)
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Moderate to severe chronic obstructive pulmonary disease with chronic bronchitis - SCALA Study – COPD01](/content/innovation/clinical-studies/current-studies?studyId=COPD01/index.html)
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Non-cystic fibrosis bronchiectasis - ATMOS Study – NCFB01](/content/innovation/clinical-studies/current-studies?studyId=NCFB01/index.html)
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SLC6A1 neurodevelopmental disorder (NDD) - SPIRIT Study - GTEP01](/content/innovation/clinical-studies/current-studies?studyId=GTEP01/index.html)
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Palmoplantar Pustulosis – BE SEEN Study – PPP001](/content/innovation/clinical-studies/current-studies?studyId=PPP001/index.html)
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Breastfeeding women with autoimmune conditions – BE CARING Study – UP0122](/content/innovation/clinical-studies/current-studies?studyId=UP0122/index.html)
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Systemic lupus erythematosus - PHOENYCS FLY Study - SL0044](/content/innovation/clinical-studies/current-studies?studyId=SL0044/index.html)
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Moderate to severe plaque psoriasis - BE UNIQUE Study - PS0039](/content/innovation/clinical-studies/current-studies?studyId=PS0039/index.html)
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Moderate to Severe Plaque Psoriasis - BE TOGETHER Study - PS0021](/content/clinical-studies/Clinical-Trials?studyId=PS0021/index.html)
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Stereotypical prolonged seizures - STARS Study - EP0162](/content/clinical-studies/Clinical-Trials?studyId=EP0162/index.html)
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Four phases of clinical research
For pharmaceutical companies to make new medicines available to the general public, the safety, quality and efficacy of all potential new drugs must be proven. This is done through a series of rigorous clinical studies, also referred to as clinical trials, research studies or medical research. Clinical research consists of four phases. The first three are conducted before approval is granted and the last phase takes place after approval.
Phase 150-100 healthy volunteers
- Details: They help researchers to understand how a new drug works in humans and to learn more about what dose should be used in the next phase of studies. Phase I trials are short and volunteers are closely monitored at the research center where the trial is being conducted.
- Goals: Assess drug safety, Determine the side effects, Evaluate how the drug should be taken.
Phase 2100-300 patients
- Details: With the condition for which the medicine, device, product or treatment has been developed. Phase II studies test how safe and effective the study medication is in a group of approximately 100 to 300 patients with the condition for which the medicine has been developed. Several Phase II trials are generally performed to test the drug in different patient groups and at different doses. Patients are closely monitored in Phase II trials but do not need to stay at the research centers.
- Goals: Assess short-term safety and effectiveness, Find the dose at which the drug works best with the least side effects, Small-scale placebo comparison.
Phase 3**+100 - +1000** patients
- Details: Phase III studies are much larger, involving between approximately several hundred and several thousands of patients. They help to determine if the new drug can be considered both safe and effective in the medium to long term. As in phase II studies patients are closely monitored but do not need to stay at the research centers.
- Goals: Confirm safety and effectiveness, Compare the new drug to other compounds (e.g. a placebo or other therapies).
Phase 41000+ Many thousands of patients
- Details: Phase IV research is conducted after the new drug has been approved. In these studies, the new drug is prescribed in an everyday healthcare environment. As safety is a major focus of Phase IV trials, which often involve several thousands of patients, this allows rarer side effects, if any, to be detected. In phase IV studies patients are also closely monitored but do not need to stay at the research centers.
- Goals: Conducted after the drug is approved, Study the effectiveness of the drug in a wide variety of patients, Monitor safety in a large group to enable the development of new uses for the compound.
Frequently Asked Questions (FAQ)
Do you want to know more about our clinical studies?
Have a look at our FAQ!