Is living with psoriasis impacting your child’s life?
Short Study Summary
Medical condition:
Pediatric Psoriasis
Participation duration:
- Screening: up to 5 weeks
- Initial Treatment Period: 16 weeks ~ 4 months
- Maintenance Period: 32 weeks ~ 8 months
- Open Label Extension: Approximately 2 years
- Safety Follow Up Period: ~ 4 months
- Total duration of study: A little more than 3 years
Phase: 3
What is Psoriasis
Psoriasis is a common, chronic inflammatory disease characterized by inflammation of the skin. Plaque psoriasis is the most common form of the disease, and usually results in areas of red, inflamed skin, often covered with silver-colored scales on areas of the skin. The plaques can be painful as the skin cracks and bleeds. In severe cases, plaques grow and merge into one another, covering large areas. Psoriasis can affect people of any age and is essentially similar in adults and children.
What is the BE TOGETHER study?
The aim of the BE TOGETHER study is to learn more about the investigational drug and evaluate the effectiveness and safety when taken by children and adolescents living with psoriasis. Investigational means that the drug is not currently approved by the Food and Drug Administration (FDA) for this patient population except for in research studies like the BE TOGETHER study.
- Investigational drug
- Comparator drug
Who can participate in the BE TOGETHER study?
What happens if my child participates?
If you and your child choose to participate, there are a few different periods of the study:
Screening Period
Initial Treatment Period
Maintenance Period
Open Label Extension Period
Safety Follow Up Period
How does my child participate?
Complete the online questions to see if your child pre-qualifies
Submit your contact information
Answer our call to respond to questions and learn more about the study
Confirm your and your child’s interest
Speak with the study site about the next steps for your child to participate
Frequently Asked Questions
Where can I find more information about this study?
You can learn more about this study by visiting https://www.clinicaltrials.gov/study/NCT06425549.
What is a clinical research study?
Why is clinical research important?
Clinical studies rely on the participation of volunteers. It can take several years for a potential medication to reach the public. Often, this timeline is due to how long it takes to complete the clinical study.
All approved prescription drugs have gone through clinical studies to make sure that they are effective and to understand what side effects may be involved.
Who runs clinical research studies?
Every clinical study site is led by a principal investigator, who is a medical doctor. Clinical studies also have a research team that may include doctors, nurses, and other health care professionals.
What are the phases of clinical research studies?
Phase 1: Researchers test an investigational drug or medicine in a small group of people for the first time to assess its safety.
Phase 2: The study investigational drug is given to a larger group e.g., 50-200 of people (compared to Phase 1) to see if it is effective and to further evaluate its safety.
Phase 3: The study investigational drug is given to large groups e.g., 100s-1000s of people to confirm its efficacy, monitor side effects, compare it to commonly used medications or placebo (an inactive substance), and collect information that will allow the study investigational drug to be used safely.