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Monoclonal Antibodies

Dupilumab for Ulcerative Colitis

Verified Trial
Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be ≥18 years of age at the time of signing the informed consent
Evidence of biomarker enrichment at time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8, week 24 and week 52
Awards & highlights

Study Summary

This trial will evaluate the effect of dupilumab on UC symptoms, safety and effectiveness in patients with moderate-severe UC and eosinophilic phenotype.

Who is the study for?
Adults aged 18+ with moderately to severely active Ulcerative Colitis and an eosinophilic phenotype can join. They must have certain symptoms scored by the Mayo score, not responded well to standard treatments like biologics or corticosteroids, and cannot be planning surgery for UC complications.Check my eligibility
What is being tested?
The trial is testing Dupilumab against a placebo in a double-blind setup where neither participants nor researchers know who's getting what. It aims to see if Dupilumab is effective and safe over a year of treatment followed by a 12-week observation.See study design
What are the potential side effects?
While specific side effects are not listed here, Dupilumab could potentially cause reactions at the injection site, allergic reactions, eye problems or inflammation in various organs similar to other drugs that modulate the immune system.

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 screening shows specific markers that the trial targets.
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My ulcerative colitis is moderate to severe, based on a specific score.
Select...
My UC hasn't improved with standard treatments or I can't tolerate them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8, week 24 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who are in clinical remission at Week 24
Secondary outcome measures
Change from baseline (Screening visit) in the normalized enrichment scores (NES) in type 2 inflammation transcriptome signature at Week 24 and Week 52.
Change from baseline in abdominal pain assessed by Abdominal Pain Numerical Rating Scale (NRS) at Week 8, Week 24, and Week 52
Change from baseline in the partial Mayo score at Week 8, Week 24, and Week 52
+11 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Dupilumab
DB Period: Placebo
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
Initial loading dose followed by regular administration for the duration of the treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Initial loading dose followed by regular administration for the duration of the treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,160 Previous Clinical Trials
3,514,362 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
523 Patients Enrolled for Ulcerative Colitis
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
379,645 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,855 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
34 Patients Enrolled for Ulcerative Colitis

Media Library

Ulcerative Colitis Research Study Groups: Dupilumab, Placebo

Frequently Asked Questions

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

Has Dupilumab received regulatory approval from the Federal Drug Administration?

"There is evidence that dupilumab has a moderate safety profile, thus it received an evaluation of 2."

Answered by AI

What is the highest participant capacity for this trial?

"Affirmative. The official records on clinicaltrials.gov have indicated that this research endeavor is actively enrolling individuals. It was initially listed on December 1st 2023 and most recently updated February 15th 2023, with the aim of recruiting 100 subjects between two medical centres."

Answered by AI

Does this research endeavor still have availability for participants?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting participants; it was initially posted on December 1st 2023 and the most recent update occured on February 15th 2023. The study requires 100 volunteers from 2 locations."

Answered by AI

Who else is applying?

What site did they apply to?
Care Access Research, Lumberton-Site Number:8400018
Other
Javara Research-Site Number:8400008
Smart Medical Research, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Smart Medical Research, Inc: < 24 hours
~12 spots leftby Jun 2024