1064 Participants Needed

Guselkumab for Ulcerative Colitis

(QUASAR Trial)

Recruiting at 498 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Janssen Research & Development, LLC
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing guselkumab, a medication that targets inflammation, in patients with moderate to severe ulcerative colitis. Guselkumab works by attaching to a protein to reduce inflammation in the colon. This medication has shown promise in treating conditions like ulcerative colitis.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications, but it mentions that some medications might be prohibited. It's best to discuss your specific medications with the trial team.

Is Guselkumab safe for humans?

The QUASAR Phase 2b study looked at the safety of Guselkumab in people with ulcerative colitis and found it to be generally safe for use in humans.12345

How is the drug guselkumab different from other treatments for ulcerative colitis?

Guselkumab is unique because it targets the interleukin-23p19 subunit, which is a different mechanism compared to other treatments for ulcerative colitis. It is also administered as a subcutaneous injection, which may be more convenient for some patients compared to intravenous treatments.16789

What data supports the effectiveness of the drug Guselkumab for treating ulcerative colitis?

The QUASAR Phase 2b Induction Study showed that Guselkumab, which targets a specific part of the immune system, was effective in patients with moderate to severe ulcerative colitis who did not respond well to other treatments.17101112

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe ulcerative colitis who haven't responded well to other treatments. Participants must have a confirmed diagnosis of UC and meet specific lab test requirements. Those with only rectal UC, less than 20 cm of colon affected, fistulas, or certain other bowel diseases can't join.

Inclusion Criteria

Screening laboratory test results within the parameters specified in the protocol
My ulcerative colitis is moderate to severe, based on a specific score.
I have been diagnosed with ulcerative colitis.
See 1 more

Exclusion Criteria

I have been diagnosed with a specific type of colitis or Crohn's disease.
I am not taking any medications or treatments that are not allowed.
My ulcerative colitis affects only my rectum or less than 20 cm of my colon.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Study 1

Participants receive guselkumab or placebo intravenously, with clinical response assessed at Week 12

12 weeks

Induction Study 2

Participants receive guselkumab or placebo intravenously, with clinical remission assessed at Week 12

12 weeks

Maintenance Study

Participants receive guselkumab or placebo subcutaneously every 4 or 8 weeks, with clinical remission assessed at Week 44

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Guselkumab
Trial Overview The study is testing the effectiveness and safety of guselkumab compared to a placebo in treating ulcerative colitis. Guselkumab is given to see if it can help reduce symptoms and improve the condition of those with active UC.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Maintenance Study: Maintenance Dose Regimen 2Experimental Treatment1 Intervention
Group II: Maintenance Study: Maintenance Dose Regimen 1Experimental Treatment1 Intervention
Group III: Induction Study 2: Guselkumab IVExperimental Treatment1 Intervention
Group IV: Induction Study 1: Guselkumab Dose 2Experimental Treatment1 Intervention
Group V: Induction Study 1: Guselkumab Dose 1Experimental Treatment1 Intervention
Group VI: Induction Study 2: Placebo IVPlacebo Group1 Intervention
Group VII: Induction Study 1: Placebo IVPlacebo Group1 Intervention
Group VIII: Maintenance Study: Placebo SCPlacebo Group1 Intervention

Guselkumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tremfya for:
🇪🇺
Approved in European Union as Tremfya for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

In a study involving 214 adults with moderately-to-severely active ulcerative colitis, combination therapy with guselkumab and golimumab resulted in a higher clinical response rate at week 12 (83%) compared to golimumab monotherapy (61%) and guselkumab monotherapy (75%).
The safety profile was generally acceptable, with no deaths or serious complications reported during the treatment period, although some adverse events like infections and anemia were noted, indicating the need for monitoring in future studies.
Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial.Feagan, BG., Sands, BE., Sandborn, WJ., et al.[2023]
In the QUASAR Phase 2b Induction Study, guselkumab, an interleukin-23p19 antagonist, demonstrated significant efficacy in treating moderately to severely active ulcerative colitis, with 61.4% and 60.7% of patients achieving clinical response at week 12 for the 200 mg and 400 mg doses, respectively, compared to only 27.6% for placebo.
The safety profile of guselkumab was comparable to that of the placebo, indicating that it is a safe treatment option for patients who have not responded adequately to other therapies.
Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study.Peyrin-Biroulet, L., Allegretti, JR., Rubin, DT., et al.[2023]
Tofacitinib, an oral medication that inhibits Janus kinases, has shown effectiveness in inducing and maintaining remission in adults with moderate to severe ulcerative colitis, providing a new treatment option for patients who do not respond to conventional therapies or biologics.
The review focuses on the efficacy and safety of tofacitinib based on randomized controlled trials, highlighting its potential role in the treatment strategy for ulcerative colitis, pending regulatory approval.
Positioning Tofacitinib in the Treatment Algorithm of Moderate to Severe Ulcerative Colitis.Danese, S., D'Amico, F., Bonovas, S., et al.[2019]

Citations

Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial. [2023]
Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study. [2023]
Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. [2022]
Treatment efficacy and safety of low-dose azathioprine in chronic active ulcerative colitis patients: A meta-analysis and systemic review. [2023]
[A retrospective analysis of azathioprine in the treatment of 24 patients with refractory ulcerative colitis]. [2014]
Positioning Tofacitinib in the Treatment Algorithm of Moderate to Severe Ulcerative Colitis. [2019]
REMIT-UC: Real-World Effectiveness and Safety of Tofacitinib for Moderate-to-Severely Active Ulcerative Colitis: A Canadian IBD Research Consortium Multicenter National Cohort Study. [2023]
Is tofacitinib a game-changing drug for ulcerative colitis? [2021]
Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study. [2023]
Guselkumab: First Global Approval. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study. [2023]
Infliximab-induced psoriasis in an ulcerative colitis patient successfully treated with guselkumab. [2023]
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