Trial Outcomes & Findings for Induction Optimization With Stelara for Crohn's Disease (NCT NCT04629196)

Last Updated: 2024-11-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Week 16

Results posted on

2024-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	IV Weight-Based Induction Dose Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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
Overall Study STARTED	6	6
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	IV Weight-Based Induction Dose Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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
Overall Study Subject discontinued study drug	1	0
Overall Study Subject study drug dosing increased	1	1
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Induction Optimization With Stelara for Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Weight-Based Induction Dose n=3 Participants Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose n=3 Participants Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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	Total n=6 Participants Total of all reporting groups
Age, Continuous	24.67 years STANDARD_DEVIATION 2.05 • n=5 Participants	37.67 years STANDARD_DEVIATION 7.13 • n=7 Participants	31.17 years STANDARD_DEVIATION 8.35 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	IV Weight-Based Induction Dose n=3 Participants Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose n=3 Participants Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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
Crohn's Disease Activity Index (CDAI) Score	84.67 score on a scale Standard Deviation 64.82	33.3 score on a scale Standard Deviation 47.14

SECONDARY outcome

Timeframe: Week 16

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.

Outcome measures

Outcome measures
Measure	IV Weight-Based Induction Dose n=3 Participants Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose n=3 Participants Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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
Number of Patients With a Clinical Response	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 16

Defined as a CDAI \< 150 and a C-reactive protein (CRP) \<5mg/l or a fecal calprotectin \<150 ug/g

Outcome measures

Outcome measures
Measure	IV Weight-Based Induction Dose n=3 Participants Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose n=3 Participants Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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
Number of Patients With a Composite Clinical and Biomarker Remission	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 0, Week 16

Outcome measures

Outcome measures
Measure	IV Weight-Based Induction Dose n=3 Participants Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose n=3 Participants Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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
Change in Crohn's Disease Activity Index (CDAI) Score	158 score on a scale Standard Deviation 52.14	251 score on a scale Standard Deviation 39.13

SECONDARY outcome

Timeframe: Week 16

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).

Outcome measures

Outcome measures
Measure	IV Weight-Based Induction Dose n=3 Participants Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose n=3 Participants Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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
Number of Patients With Improvement in Health-related Quality of Life	3 Participants	2 Participants

Adverse Events

IV Weight-Based Induction Dose

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Standard Subcutaenous Dose

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

David Hudesman, MD

NYU Langone Health

Phone: 646-501-9327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	IV Weight-Based Induction Dose n=6 participants at risk Ustekinumab: A second IV weight-based induction dose of Stelara at week 8 Ustekinumab: 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	Standard Subcutaenous Dose n=6 participants at risk Ustekinumab: A standard 90mg subcutaneous dose of Stelara at week 8 Ustekinumab: 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
Gastrointestinal disorders Increased stool frequency	33.3% 2/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
General disorders Increased fatigue	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Gastrointestinal disorders Abdominal Pain	33.3% 2/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Gastrointestinal disorders Exodontia	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Infections and infestations Paronychia of right finger	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Infections and infestations Covid-19	50.0% 3/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Skin and subcutaneous tissue disorders Acne	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Gastrointestinal disorders Loose stool and food sensitivity	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Infections and infestations Cold	33.3% 2/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	33.3% 2/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Reproductive system and breast disorders Right Testicle swelling and pain	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Injury, poisoning and procedural complications Splinter in left index finger	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Infections and infestations Viral symptoms	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Respiratory, thoracic and mediastinal disorders sore throat	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Gastrointestinal disorders incontinence	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Vascular disorders Vein procedure	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Infections and infestations Stomach Virus	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Immune system disorders Poison Ivy	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit
Injury, poisoning and procedural complications Possible infusion reaction	16.7% 1/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit	0.00% 0/6 • Adverse events assessed up to 16 weeks. Serious adverse events, including all-cause mortality, assessed up to 30 after the last dose of study drug (up to 20 weeks). PI monitors AEs at every follow-up visit