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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
18 years of age or older
Moderately to severely active UC as per the modified Mayo score
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12 and 24
Awards & highlights

ASTRO Trial Summary

This trial will test if the drug guselkumab is effective in treating ulcerative colitis.

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.Check my eligibility
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).See study design
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.

ASTRO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My ulcerative colitis is moderate to severe according to the Mayo score.

ASTRO Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Clinical Remission
Clinical Response
Endoscopic Improvement
+3 more

Side effects data

From 2021 Phase 2 trial • 214 Patients • NCT03662542
8%
Colitis Ulcerative
8%
Upper Respiratory Tract Infection
4%
Headache
3%
Neutropenia
1%
Tuberculosis of Intrathoracic Lymph Nodes
1%
Poisoning
1%
Pulmonary Embolism
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy Phase: Combination Therapy
Combination Phase: Combination Therapy
Safety Follow-up: Golimumab Monotherapy
Safety Follow-up: Guselkumab Monotherapy
Combination Phase: Golimumab Monotherapy
Monotherapy Phase: Golimumab Monotherapy
Combination Phase: Guselkumab Monotherapy
Monotherapy Phase: Guselkumab Monotherapy
Safety Follow-up: Combination Therapy

ASTRO 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 2
2018
Completed Phase 2
~280
Guselkumab Dose 1
2018
Completed Phase 2
~280
Guselkumab Dose 3
2018
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,304 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
9 Previous Clinical Trials
1,881 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 1: Guselkumab, Group 3: Placebo
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different hospitals or care centers are participating in this research?

"Currently, this research is being conducted at 25 different locations. These include sites in Lake Success, Westlake and Chesterfield as well as other cities. If you choose to participate in this study, it would be best to select the location nearest you to minimize travel demands."

Answered by AI

Are there any spots available for volunteers in this research?

"Yes, this trial is currently open for enrollment. According to the information on clinicaltrials.gov, the study was posted on September 13th, 2020 and updated November 2nd, 2020."

Answered by AI

What are the risks associated with Guselkumab Dose 1?

"There is some evidence that Guselkumab Dose 1 is effective, and it has been through multiple safety trials, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Emory University
Northwell Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

What is the method of treatment? Pill? IV? Sub-Q injection?
PatientReceived no prior treatments

Why did patients apply to this trial?

I am currently on Xeljanz 10 mg., one pill per day in the morning. For me, this is a solid 'maintenance' medication, with little to no side effects. I still have occasional flares, and from having annual and sometimes more frequent colonoscopies while on Xeljanz and prior to other clinical trials, this course of treatment does not further mucosal healing.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Emory University: < 24 hours
Average response time
  • < 1 Day
~40 spots leftby Jun 2024