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Monoclonal Antibodies
Ustekinumab (Stelara) Induction Optimization for Crohn's Disease
Phase 4
Waitlist Available
Led By David Hudesman, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 45 years of age with amenorrhea for at least 6 months and a serum FSH level > 40 IU/mL
Stable dose of prednisone of 20mg or less or budesonide 9mg daily for at least 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
Study Summary
This trial is testing a new weight-based induction dose of a medication given at week 8 to see if it results in clinical remission at week 16, compared to the standard dose given at week 8.
Who is the study for?
Adults aged 18-70 with moderate to severe Crohn's disease, confirmed by tests, can join this trial. They must have stable medication doses and agree to use effective birth control if of childbearing potential. Excluded are those with a history of certain cancers, significant infections including HIV or hepatitis B/C, recent hospitalization or surgery, substance abuse issues, known allergies to the drug being tested (Ustekinumab), or any serious health conditions.Check my eligibility
What is being tested?
The trial is testing whether giving a second IV dose of Ustekinumab at week 8 is more effective than the standard subcutaneous dose for inducing remission in Crohn's disease by week 16. Participants will be randomly assigned to one of these two treatment approaches.See study design
What are the potential side effects?
Ustekinumab may cause side effects such as infections due to lowered immunity, allergic reactions at the injection site, headache, tiredness and possibly rare but serious effects like heart failure or liver damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 45, have not had a period for 6 months, and my FSH level is above 40.
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I have been on a stable dose of prednisone (20mg or less) or budesonide (9mg) daily for at least 2 weeks.
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My inflammation markers are high, as shown by recent tests.
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I cannot become pregnant due to surgery or other reasons.
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I am postmenopausal.
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I have been on a stable dose of my medication for at least 4 weeks.
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I am 45 or older and have not had a period for at least 18 months.
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My Crohn's disease is moderate to severe.
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I am between 18 and 70 years old.
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I have been diagnosed with Crohn's disease for at least 3 months, confirmed by tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with clinical remission
Secondary outcome measures
Change in Crohn's Disease Activity Index (CDAI) Score
Number of patients with a clinical response
Number of patients with a composite clinical and biomarker remission
+2 moreSide effects data
From 2018 Phase 4 trial • 43 Patients • NCT0218717250%
Upper respiratory infection
27%
Common cold
9%
Urinary tract infection
9%
Anxiety
9%
Back pain
9%
Dizziness
9%
Fracture
9%
Skin and subcutaneous tissue disorders
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
5%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IV Weight-Based Induction DoseExperimental Treatment1 Intervention
Group II: Standard Subcutaenous DoseActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
FDA approved
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,373 Previous Clinical Trials
841,099 Total Patients Enrolled
David Hudesman, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
47 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a consistent dose of oral mesalamine for 2 weeks.I had a positive test for a gut infection but am now clear or have no ongoing symptoms.My condition is diagnosed as indeterminate colitis.My current medications have not changed recently.I am over 45, have not had a period for 6 months, and my FSH level is above 40.I haven't taken any biologic or small molecule therapy in the last 4 weeks.I have been on a stable dose of prednisone (20mg or less) or budesonide (9mg) daily for at least 2 weeks.I do not have severe ongoing issues with my kidneys, liver, blood, hormones, lungs, heart, nerves, lupus, or mental health.I have or might have a disease related to abnormal growth of lymph cells.I have a positive Quantiferon Gold test and am not under treatment for it.I have not had a BCG vaccine in the last year or any live vaccine in the last 2 weeks.I am not pregnant and agree not to donate eggs or try for a baby during the study and for 16 weeks after.I have no cancer history except for certain skin or cervical cancers that were successfully treated.I tested positive for the hepatitis B surface antigen but negative for HBV DNA.My Crohn's disease is moderate to severe.I am a man who can father children and will use contraception during the study and for 16 weeks after.I am 45 or older and have not had a period for at least 18 months.I am using effective birth control or my partner is sterilized.As a female, I meet the specific requirements set before joining the study.I have had part of my colon removed.You have had a serious problem with drugs or alcohol in the past year.My inflammation markers are high, as shown by recent tests.I cannot become pregnant due to surgery or other reasons.I am postmenopausal.I have been on a stable dose of my medication for at least 4 weeks.I am HIV positive.I have had an organ transplant, but not a corneal transplant over 3 months ago.My main issue is an active perianal fistula.I have a permanent ileostomy.My condition mainly causes blockages due to scar tissue.I currently have an infection.I haven't changed my prednisone or budesonide dose in the last 2 weeks.I have hepatitis C but haven't cleared the virus or completed successful treatment.I have been diagnosed with Crohn's disease for at least 3 months, confirmed by tests.I haven't changed my dose of 6-MP, methotrexate, or azathioprine in the last month.I haven't changed my mesalamine dose in the last 2 weeks.I am between 18 and 70 years old.I have an immune deficiency syndrome.I had surgery on my intestines within the last month.I have previously used Stelara or anti-IL 23 medication.I have or had heart failure or a disease that damages the protective covering of nerves.I have undergone allergy shots to prevent severe allergic reactions.
Research Study Groups:
This trial has the following groups:- Group 1: IV Weight-Based Induction Dose
- Group 2: Standard Subcutaenous Dose
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
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