Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2023
• Main ID: NCT03464136
• Date of registration: 07/03/2018
• Prospective Registration: Yes
• Primary sponsor: Janssen Scientific Affairs, LLC
• Public title: Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year SEAVUE
• Scientific title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease
• Date of first enrolment: March 29, 2018
• Target sample size: 386
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03464136
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Serbia, Spain, United Kingdom, United States

Contacts

• Name: Janssen Scientific Affairs, LLC Clinical Trial
• Affiliation: Janssen Scientific Affairs, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has Crohn's Disease (CD) or fistulizing CD of at least 3 months' duration, with
colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography,
histology, and/or endoscopy

- Has moderately-to-severely active CD with a baseline Crohn's disease activity index
(CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450

- Has one or more ulceration on screening ileocolonoscopy (which by definition, would
result in an Simple Endoscopic Score for Crohn's Disease [SES-CD] of at least 3)

- Has failed or was intolerant to conventional therapy (corticosteroids, azathioprine
[AZA], 6-mercaptopurine [6-MP] and/or methotrexate [MTX]) at adequate doses or is
corticosteroid dependent

- Has not previously received an approved biologic for Crohn's Disease (i.e.,
infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or
approved biosimilars of these agents)

- Participants on oral corticosteroids (e.g., prednisone, budesonide) at a
prednisone-equivalent dose of <=40 or milligram/day (mg/day) or <=9 mg/day of
budesonide are budesonide <=9 mg/day are permitted if doses are stable for 3 weeks
prior to baseline

- Participants on AZA, 6-MP, or MTX at screening (or recently prior), must discontinue
these medications at least 3 weeks prior to baseline

Exclusion Criteria:

- Has complications of CD that are likely to require surgery or would confound the
ability to assess the effect of ustekinumab or adalimumab treatment using the CDAI,
such as: active stoma; short-gut syndrome and severe or symptomatic strictures or
stenosis

- Currently has, or is suspected to have, an abscess. Recent cutaneous and perianal
abscesses are not exclusionary if drained and adequately treated at least 3 weeks
prior to baseline, or 8 weeks prior for intra-abdominal abscesses, if there is no
anticipated need for any further surgery. Participants with active fistulas may be
included if there is no anticipation of a need for surgery and there are currently no
abscesses present

- Has had any kind of bowel resection within 6 months prior to baseline or other
intra-abdominal surgery or a hospital admission for bowel obstruction within 3 months
prior to baseline

- 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-Guerin (BCG) vaccination within 12 months or any
other live bacterial or live viral vaccination within 2 weeks of baseline

- Has a history of, or ongoing, chronic or recurrent infectious disease, including but
not limited to, chronic renal infection, chronic chest infection, recurrent urinary
tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or
infected skin wounds or ulcers



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Biological: Ustekinumab (90 mg)

Biological: Placebo for Ustekinumab

Biological: Ustekinumab (6 mg/kg)

Biological: Placebo for Adalimumab

Biological: Adalimumab (40 mg)

Primary Outcome(s)

Percentage of Participants With Clinical Remission at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

Percentage of Participants With Serious Infections [Time Frame: Up to Week 52 and up to Week 76]

Percentage of Participants With Anti-drug Antibodies [Time Frame: Up to Week 52]

Percentage of Participants With Clinical Remission at Week 16 [Time Frame: Week 16]

Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52 [Time Frame: Week 52]

Percentage of Participants With Clinical Remission Through Week 52 [Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52]

Percentage of Participants With Infections [Time Frame: Up to Week 52 and up to Week 76]

Percentage of Participants With Serious Adverse Events (SAEs) [Time Frame: Up to Week 52 and up to Week 76]

Percentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52 [Time Frame: At Weeks 8, 16 and 52]

Percentage of Participants With Abdominal Pain (AP) Improvement Through Week 52 [Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52]

Percentage of Participants With Adverse Events (AEs) [Time Frame: Up to Week 52 and up to Week 76]

Percentage of Participants With Corticosteroid-free Remission at Week 52 [Time Frame: Week 52]

Percentage of Participants With Reduction in Frequency of Diarrhea Through Week 52 [Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52]

Percentage of Participants With Durable Clinical Response at Week 52 [Time Frame: Week 52]

Percentage of Participants With Clinical Response at Week 52 [Time Frame: Week 52]

Percentage of Participants With Endoscopic Remission at Week 52 [Time Frame: Week 52]

Percentage of Participants With Durable Clinical Remission at Week 52 [Time Frame: Week 52]

Percentage of Participants With Clinical Response Through Week 52 [Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52]

Secondary ID(s)

2017-004209-41

CR108449

CNTO1275CRD3007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/01/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03464136