QUASAR: Guselkumab in Moderately to Severely Active Ulcerative Colitis
Research type
Research Study
Full title
A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentre Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis.
IRAS ID
269914
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen Cilag-International NV
Eudract number
2018-004002-25
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
4 years, 11 months, 18 days
Research summary
Ulcerative colitis is a chronic inflammatory bowel disorder of unknown cause, which can involve all areas of the large intestine/Colon. Ulcerative colitis is most commonly diagnosed in late adolescence and early adulthood, but a diagnosis may occur at any age. Clinically, patients with UC suffer from diarrhea, rectal bleeding, weight loss, abdominal pain, fever, and may also display problems outside of the colon, most commonly arthritis. There is a high unmet need for new treatment options in UC that are safe and effective, especially new therapies that can provide improved long-term efficacy (ie, sustained remission) over currently available therapies within the UK NHS hospitals.
This study is looking to collect data from 1000 participants worldwide to see if a drug known as Guselkumab (TREMFYA®) is safe and effective in treating Ulcerative Colitis (UC). Guselkumab has been approved in many regions of the world including US and Europe, for the treatment of adults with moderate to severe plaque psoriasis. As well as this study, Guselkumab is also being studied for the treatment of psoriatic arthritis, Crohn’s Disease, and pediatric psoriasis.
The study consists of 5 distinct phases;
- Screening period, for 8 weeks,
- Induction studies 1 (or 2), for either 12 or 24 weeks, dependent on response to treatment,
- Maintenance study for 52 weeks,
- Long-Term Extension (LTE) for upto 104 weeks.
- Followed by a safety visit 12 weeks post last dose.During these visits a variety of tests will be carried out. These tests include, but are not limited to, endoscopy, blood pressure, ECG, physical exam, questionnaires and blood samples. Patients will be randomly assigned (like flipping a coin) to receive either guselkumab or placebo.
REC name
West of Scotland REC 1
REC reference
19/WS/0137
Date of REC Opinion
9 Oct 2019
REC opinion
Further Information Favourable Opinion