Back to all Current clinical trials
Back to all Current clinical trials
QUASAR Jr
The purpose of this study is to evaluate the effectiveness of guselkumab in pediatric participants with moderately to severely active ulcerative colitis through open label induction and through maintenance therapy among participants who were induction responders.
- Category
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Trial status
Not yet recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
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ERM Project ID
109056
Trial contact details
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Contact person
Sharyn Grossman
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Phone
0400 757 347
What you need to know
Who can take part?
Must be:
- Aged 14 -17 at enrolment
- Weigh more than 10 kg
- Biopsy confirmed UC
- Moderate to severely active UC confirmed by biopsy at time of screening
- Medically stable
- Inadequate response/loss of response to biologic and/or conventional therapies or be corticosteroid dependent
Must Not:
- Have UC limited to the rectum only or to less than (s Disease (CD)
What is involved for me?
- Regular clinic visits
- Blood tests
- Stool tests
- Diary completion
- Colonoscopy
- Questionnaires
- Medicine by infusion
- Medicine by injection
- Pregnancy tests
