Your session is about to expire
← Back to Search
Monoclonal Antibodies
Guselkumab for Ulcerative Colitis (ASTRO Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12 and 24
Awards & highlights
Pivotal Trial
Summary
This trial tests an injectable medication called guselkumab on people with severe ulcerative colitis. It aims to see if blocking a protein that causes inflammation can help these patients achieve remission.
Who is the study for?
This trial is for adults with moderately to severely active ulcerative colitis who haven't responded well to or can't tolerate standard treatments. They must have been diagnosed at least 12 weeks before the study starts and cannot be on certain medications, have recent or upcoming surgery that could affect results, just rectal UC, other types of colitis, Crohn's disease, or an active COVID-19 infection.
What is being tested?
The trial is testing three different doses of a medication called Guselkumab against a placebo in people with ulcerative colitis. The main goal is to see if Guselkumab helps patients achieve clinical remission better than no treatment (placebo).
What are the potential side effects?
Guselkumab may cause side effects such as infections due to immune system suppression, allergic reactions at the injection site, headaches, and possibly increased risk of developing cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 12 and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12 and 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Clinical Remission
Clinical Response
Endoscopic Improvement
+3 moreSide effects data
From 2021 Phase 2 trial • 214 Patients • NCT036625426%
Colitis Ulcerative
6%
Headache
6%
Anaemia
3%
Neutropenia
1%
Influenza
1%
Upper Respiratory Tract Infection
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Phase: Combination Therapy
Combination Phase: Golimumab Monotherapy
Monotherapy Phase: Golimumab Monotherapy
Safety Follow-up: Golimumab Monotherapy
Monotherapy Phase: Combination Therapy
Safety Follow-up: Guselkumab Monotherapy
Monotherapy Phase: Guselkumab Monotherapy
Combination Phase: Guselkumab Monotherapy
Safety Follow-up: Combination Therapy
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: GuselkumabExperimental Treatment2 Interventions
Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
Group II: Group 1: GuselkumabExperimental Treatment2 Interventions
Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
Group III: Group 3: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo SC injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab Dose 1
2018
Completed Phase 2
~240
Guselkumab Dose 2
2018
Completed Phase 2
~240
Guselkumab Dose 3
2018
Completed Phase 1
~30
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Ulcerative Colitis (UC) include biologic therapies, 5-aminosalicylates, and glucocorticoids. Biologic therapies, such as Guselkumab, work by inhibiting specific cytokines like interleukin-23 (IL-23), which play a crucial role in the inflammatory process of UC.
By targeting IL-23, these therapies help reduce inflammation and promote mucosal healing. 5-aminosalicylates, like mesalamine, act locally in the colon to reduce inflammation and are often used for mild to moderate UC. Glucocorticoids, such as prednisone, are potent anti-inflammatory agents used for short-term flare control but are not suitable for long-term maintenance due to their side effect profile.
Understanding these mechanisms is essential for UC patients as it helps tailor treatment plans to effectively manage symptoms and maintain remission.
Emerging Therapies for Inflammatory Bowel Diseases.Novel topical therapies for distal colitis.
Emerging Therapies for Inflammatory Bowel Diseases.Novel topical therapies for distal colitis.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
988 Previous Clinical Trials
6,385,539 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis
Janssen Research & Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC
10 Previous Clinical Trials
1,906 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have a severe case of COVID-19.My ulcerative colitis affects only my rectum.I haven't had surgery in the last 8 weeks and don't plan to during the study.I am 18 years old or older.My ulcerative colitis is moderate to severe according to the Mayo score.I was diagnosed with ulcerative colitis more than 12 weeks ago.I have been diagnosed with a specific type of colitis or Crohn's disease.My condition did not improve with standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Guselkumab
- Group 2: Group 3: Placebo
- Group 3: Group 1: Guselkumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT05528510 — Phase 3
Share this study with friends
Copy Link
Messenger