Induction Optimization With Stelara for Crohn's Disease

NCT04629196 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 19-01401
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 16

Secondary Outcomes (4)

• Number of Patients With a Clinical Response

  Week 16

• Number of Patients With a Composite Clinical and Biomarker Remission

  Week 16

• Change in Crohn's Disease Activity Index (CDAI) Score

  Week 0, Week 16

• Number of Patients With Improvement in Health-related Quality of Life

  Week 16

Study Arms (2)

IV Weight-Based Induction Dose

EXPERIMENTAL

Drug: Ustekinumab

Standard Subcutaenous Dose

ACTIVE COMPARATOR

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

A second IV weight-based induction dose of Stelara at week 8

Also known as: Stelara

IV Weight-Based Induction Dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• a. 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
• b. 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

NYU Langone Health

New York, New York, 10013, United States

Location

Related Publications (1)

• 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.

  PMID: 40357993 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: David Hudesman, MD
• Organization: NYU Langone Health

David.Hudesman@nyulangone.org

646-501-9327

Study Officials

• David Hudesman, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: February 16, 2022
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
• Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to IBD\ Research@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)