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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 weeks
Treatment ~ Varies
Follow Up ~weeks 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12 and 24 for reporting.

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 more

Side effects data

From 2021 Phase 2 trial • 214 Patients • NCT03662542
6%
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.

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

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05528510 — Phase 3
Ulcerative Colitis Research Study Groups: Group 2: Guselkumab, Group 3: Placebo, Group 1: Guselkumab
Ulcerative Colitis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT05528510 — Phase 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05528510 — Phase 3
Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT05528510 — Phase 3
~139 spots leftby Oct 2025