Crohn DiseasePhase 4NCT04629196
Induction Optimization With Stelara for Crohn's Disease
A Phase 4 study testing Ustekinumab in people with Crohn Disease, run by NYU Langone Health at 2 sites in United States.
Trial summary
This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2022to 17 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between the ages of 18 and 70
- History of Crohn's disease for at least 3 months confirmed by colonoscopy and/or cross sectional imaging reviewed by the PI
- Moderate to Severe Crohn's disease defined as a CDAI between 220 and 450
- Either a CRP >8mg/L or a fecal calprotectin > 250ug/g within 4 weeks of starting ustekinumab
- Stable Concomitant medications (prior to first dose of ustekinumab)
- Stable dose of 6-MP, azathioprine, or methotrexate for at least 4 weeks
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- Stable dose of oral mesalamine for at least 2 weeks
- Stable dose of prednisone of 20mg or less or budesonide 9mg daily for at least 2 weeks
- If subject is a female, before randomization she must be:
- Postmenopausal, defined as
- ≥ 45 years of age with amenorrhea for at least 18 months, OR
- ≥ 45 years of age with amenorrhea for at least 6 months and a serum FSH level > 40 IU/mL
- OR
- Of childbearing potential, in which case she must satisfy at least one of the below:
- Surgically sterile (has had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
- If heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, film, gel or suppository), or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for a period of 16 weeks after the last administration of study agent, OR
- Not heterosexually active. Note: If a woman participant's childbearing potential changes after start of the study (e.g., a pre-menarchal woman experiences menarche) or if women of childbearing potential who are not heterosexually active at screening become heterosexually active, they must agree to utilize a highly effective method of birth control, as described above.
- Female participants of childbearing potential (menstrual and not surgically sterile), must have a negative serum beta-human chorionic gonadotropin (ᵦ-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 (prior to randomization) and agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 16 weeks after the last administration of study agent.
- Male participants who are not surgically sterilized and are heterosexually active with a woman of childbearing potential, must agree to use a barrier method of contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) and to not donate sperm during the study and for 16 weeks after last receiving study agent. Note that barrier methods must also be used in all male subjects sexually active with pregnant partners for at least 16 weeks after last study agent administration.
Who cannot join
- Past Stelara or anti-IL 23 use.
- Active infection.
- Has any known malignancy or has a history of malignancy (except for basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening).
- Indeterminate colitis.
- Active perianal fistula as the primary symptom.
- Fibrostenotic disease with primarily obstructive symptoms.
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- Hospitalization within the past 2 weeks.
- Bowel resection within the past 4 weeks.
- Subtotal colectomy.
- Permanent Ileostomy.
- Is infected with human immunodeficiency virus (HIV; positive serology for HIV antibody).
- Has a concomitant diagnosis or any history of congestive heart failure or demyelinating disease.
- Has current signs or symptoms, or a history of severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, systemic lupus erythematosus, or psychiatric diseases.
- Has a transplanted organ (except for corneal transplant performed > 3 months prior to screening).
- Has a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, supraclavicular, epitrochlear, or paraaortic areas), or splenomegaly.
- Has previously undergone allergy immunotherapy for prevention of anaphylactic reactions.
- Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
- Has known allergies, hypersensitivity, or intolerance to ustekinumab or excipients (refer to the ustekinumab prescribing information).
- Has a clinically significant substance abuse problem (eg, drugs or alcohol) at screening or during the previous 12 months prior to baseline.
- Any biologic or small molecule therapy within 4 weeks of start of ustekinumab.
- Positive quantiferon gold that is not being treated and followed by Infectious Disease
- Tests positive for HBV surface antigen (HBsAg), regardless of the results of other hepatitis B tests. Subjects who test positive only for core antibody (anti-HBc) must undergo further testing for hepatitis B DNA acid (HBV DNA test). If the HBV DNA test is positive, the subject is not eligible for this study. If the HBV DNA test is negative, the subject is eligible for this study. In the event the HBV DNA test cannot be performed, the subject is not eligible for this study.
- Change in dose of 6-MP, methotrexate, or azathioprine within one month of the start of ustekinumab.
- Change in prednisone or budesonide dose within 2 weeks of start of ustekinumab
- Change in mesalamine dosage within 2 weeks of start of ustekinumab
- Has a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
- Has received a Bacillus Calmette-Guérin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 2 weeks of baseline.
- Have immune deficiency syndrome (e.g., severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, and chronic granulomatous disease).
- Is seropositive for antibodies to hepatitis C (HCV) without a history of clearance or successful treatment, defined as being negative for HCV RNA in the past year and, if treated, at least 24 weeks after completing antiviral treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
Baltimore, Maryland, 21201
NYU Langone Health
New York, New York, 10013
About this study
This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.
- Conditions
- Crohn Disease
- Being tested
- Ustekinumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called Stelara
A second IV weight-based induction dose of Stelara at week 8
UstekinumabDrug
Also called Stelara
A standard 90mg subcutaneous dose of Stelara at week 8
UstekinumabDrug
Also called Stelara
All patients will receive IV ustekinumab weight-based dose at 260mg (55kg or less), 390mg (more than 55kg to 85kg), or 520mg (more than 85kg) at time point 0
| Study group | Role | What they receive |
|---|---|---|
| IV Weight-Based Induction Dose | Experimental | Not described Receives: Drug: Ustekinumab |
| Standard Subcutaenous Dose | Active comparator | Not described Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Disease Activity Index (CDAI) Score
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit.
A CDAI score of less than 150 is considered to be clinical remission.
Measured: Week 16
Secondary outcomes (4)
Number of Patients With a Clinical Response
A clinical response is defined as a drop in CDAI score by at least 100 points between week 0 and week 16, or a CDAI < 150.
Measured: Week 16
Number of Patients With a Composite Clinical and Biomarker Remission
Defined as a CDAI < 150 and a C-reactive protein (CRP) <5mg/l or a fecal calprotectin <150 ug/g
Measured: Week 16
Change in Crohn's Disease Activity Index (CDAI) Score
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit.
A CDAI score of less than 150 is considered to be clinical remission, a score greater than 220 is considered to define moderate to severe disease, and a score greater than 300 is considered to be severe disease.
Measured: Week 0, Week 16
Number of Patients With Improvement in Health-related Quality of Life
Defined as increase in SIBDQ by at least 9 points between week 0 and week 16.
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a 10-item health-related quality of life (HRQoL) questionnaire validated for use in CD patients. It assesses 4 domains: physical, social, emotional, and systemic and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). The absolute score ranges from 10 (poor HRQOL) to 70 (optimum HRQOL).
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start16 Feb 2022
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Why it stopped: Other effective drugs have been introduced to market since the beginning of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hudesman, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629196
- Sponsor's protocol ID
- 19-01401
- Status last verified
- Oct 2024
- First submitted
- 10 Nov 2020
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Publications
Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
PubMed 40357993
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Optimization With Stelara for Crohn's Disease
- ClinicalTrials.gov ID
- NCT04629196
- Acronym / sponsor ID
- 19-01401
- Conditions
- Crohn Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Other effective drugs have been introduced to market since the beginning of the study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Weight-Based Induction Dose | Experimental | Drug: Ustekinumab |
| Standard Subcutaenous Dose | Active comparator | Drug: Ustekinumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males or females between the ages of 18 and 70
- History of Crohn's disease for at least 3 months confirmed by colonoscopy and/or cross sectional imaging reviewed by the PI
- Moderate to Severe Crohn's disease defined as a CDAI between 220 and 450
- Either a CRP >8mg/L or a fecal calprotectin > 250ug/g within 4 weeks of starting ustekinumab
- Stable Concomitant medications (prior to first dose of ustekinumab)
Key exclusion criteria (29 listed)
- Past Stelara or anti-IL 23 use.
- Active infection.
- Has any known malignancy or has a history of malignancy (except for basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening).
- Indeterminate colitis.
- Active perianal fistula as the primary symptom.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: StelaraA second IV weight-based induction dose of Stelara at week 8 | Drug | IV Weight-Based Induction Dose |
| UstekinumabAlso: StelaraA standard 90mg subcutaneous dose of Stelara at week 8 | Drug | Standard Subcutaenous Dose |
| UstekinumabAlso: StelaraAll patients will receive IV ustekinumab weight-based dose at 260mg (55kg or less), 390mg (more than 55kg to 85kg), or 520mg (more than 85kg) at time point 0 | Drug | IV Weight-Based Induction Dose, Standard Subcutaenous Dose |
Primary outcome
Crohn's Disease Activity Index (CDAI) Score
Time frame: Week 16
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. A CDAI score of less than 150 is considered to be clinical remission.
4 secondary outcomes
Number of Patients With a Clinical Response
Time frame: Week 16
Number of Patients With a Composite Clinical and Biomarker Remission
Time frame: Week 16
Change in Crohn's Disease Activity Index (CDAI) Score
Time frame: Week 0, Week 16
Number of Patients With Improvement in Health-related Quality of Life
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40357993Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Related trials for Crohn Disease
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Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Crohn Disease
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INSIGHT-IBD Pragmatic Study
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RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
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RecruitingPhase 2
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hudesman, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ustekinumab in people with Crohn Disease, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's Disease Activity Index (CDAI) Score (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.